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Found 48 results
510(k) Data Aggregation
(29 days)
Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System Regulation Number: 21 CFR 882.5250
LOOP XL Cranial Bone Fixation System Common Name: Cover, Burr Hole
Regulatory Class: II
Regulation: 882.5250
The Cranial LOOP Cranial Bone Fixation Systems: Cranial LOOP (L) and Cranial Loop (XL), are longterm implantable devices indicated for post-craniotomy bone flap fixation.
In cranial bone fixation procedures, the Cranial LOOP (FC050000) and Cranial LOOP (L) (FC050100) are for use within the osteotomy line (calvarial gap) while the Cranial LOOP (XL) (FC050200) is to be used for covering a standard 14 mm cranial burr hole only.
The Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System is a biocompatible, postoperative cranial bone fixation system that fixes the bone flap to the skull, without any specific surgical instrument for its handling or implantation. It is provided sterile, for single use. Cranial LOOP and Cranial LOOP L are applied in the craniotomy gap. They can fix cranial thicknesses ranging from 1.5 mm to 24 mm and gaps ranging between 1.7 mm and those made using a craniotome standard cranial router. Cranial LOOP XL is applied in a burr hole made using a standard drill 14 mm. They can fix cranial thicknesses ranging from 4mm to 24 mm.
The request cannot be fulfilled as no information regarding acceptance criteria, study details, sample sizes, expert involvement, or specific ground truth methods is provided for an AI/CADe device. The provided text is a 510(k) clearance letter for a cranial bone fixation system, which is a physical implant, not a software or AI device. The document explicitly states "No clinical testing was performed to support this submission." and focuses on "Biomechanical and functional testing" for a physical device.
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(537 days)
Re: K221606
Trade/Device Name: Absorbable Cranial Flap Fixation System Regulation Number: 21 CFR 882.5250
System |
| Regulation Number | 21 CFR § 882.5250
|
| Regulation Number | 21 CFR § 882.5250
The Absorbable Cranial Flap Fixation System is intended to be used for fixation of cranial bone flaps following craniotomy.
The Absorbable Cranial Flap Fixation System is comprised of a lower disc, an upper disc, a connecting rod and a rotating lock. The lower disc consists of a circular disk through which the connecting rod is centrally extruded outward. The upper disc consists of a circular disk with a threaded hole to accept the connecting rod. The upper disc is driven to move axially along the connecting rod by rotating the rotating lock so that the discs tightly grip the bone flap and provide rigid attachment and coplanar alignment to the surrounding bone.
The Absorbable Cranial Flap Fixation System is made from poly-L-lactic acid. The device is supplied sterile and is intended for single use.
The Heat/Contouring Pen is an accessory used to cut off the excess connecting rod of the Absorbable Cranial Flap Fixation System. The Heat/Contouring Pen is a disposable, lithium battery powered handheld device that includes a cutting heating head and a smoothing head. The Heat/Contouring Pen is supplied sterile and is intended for single use.
The provided text describes the regulatory clearance of a medical device, the "Absorbable Cranial Flap Fixation System," by the FDA. It includes a summary of non-clinical testing performed to demonstrate its substantial equivalence to a predicate device. However, this document does not contain information about an AI-based device or a study involving AI with human readers.
Therefore, I cannot provide details on:
- Acceptance criteria specific to AI device performance.
- Sample sizes for test sets or training sets related to AI.
- Data provenance for AI studies.
- Number and qualifications of experts for AI ground truth.
- Adjudication methods for AI test sets.
- Multi-reader multi-case (MRMC) comparative effectiveness studies with AI.
- Standalone algorithm performance for AI.
- Type and establishment of ground truth for AI training sets.
The document entirely focuses on the mechanical and biological performance of a physical medical implant.
Here's the information that is available in the document regarding the non-AI device's acceptance criteria and related studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implied by "Pass" and "No statistical difference") | Reported Device Performance |
|---|---|---|
| Tripping Force | The device's locking function is comparable to the predicate device, meaning there is no statistical difference in the tension force required to release the upper disc. | Pass. No statistical difference between the predicate and subject device. |
| Compression Force | The maximum force required for the device to deform or crack meets pre-defined acceptance criteria and shows no statistical difference compared to the predicate device. | Pass. The acceptance criteria were met, and the results showed no statistical difference between the subject and predicate device. |
| Torque Force | The maximum force required for the connecting rod to break shows no statistical difference compared to the predicate device. | Pass. No statistical difference between the subject and predicate device. |
| Biocompatibility: | ||
| In Vitro Cytotoxicity (ISO 10993-5) | Percent cell viability ≥ 70%. | The percent cell viability of the subject device was 94.7% (>70%). Conclusion: Non-Cytotoxic |
| Skin Sensitization (ISO 10993-10) | No visible change observed in the test article groups when compared to controls, indicating no sensitization. | Under the conditions of the study, no visible change was observed in the test article groups. Conclusion: Non-Sensitizer |
| Intracutaneous Reactivity (ISO 10993-10) | Overall mean score difference between the test article and vehicle |
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(353 days)
Product Code & Regulation Number:
GWO, GXR, HBW (21CFR§882.5320, 21CFR§882.5250, 21CFR§882.5360)
Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.
The Neuro Plating System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and in 3 colors (silver, blue and gold) by anodizing. The range of screw diameter is from 0.8mm to 1.95mm in lengths of 3.0 to 6.0mm. It is made of Ti-6Al-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, green and gold) by anodizing.
Neuro Plating System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in reconstructive processes. The plate is placed on the fractured bone and the screw is inserted into the bone through a plate hole to fix. If necessary, the plate may be bent or cut to meet the anatomical needs of patient.
The Neuro Plating System has two types of sterilization method; Neuro Plating System is non-sterile state packed in PE bag which must be sterilized before use and Neuro Plating System - Sterile Kit is provide sterile state with gamma sterilization packed in Tyvek and PET. Both are single use only.
The provided text is a 510(k) Pre-Market Notification for the Neuro Plating System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study.
Therefore, much of the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth is not directly available or applicable in the context of this 510(k) summary. This document primarily relies on non-clinical (mechanical and sterilization) testing to show equivalence.
However, I can extract information related to non-clinical testing and the comparison to predicate devices, which serves as the "proof" for substantial equivalence in this regulatory context.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, there isn't a table of specific clinical "acceptance criteria" with numerical targets and reported clinical device performance. Instead, the "acceptance criteria" are implied by the performance of the predicate device, and the "reported device performance" refers to the non-clinical tests conducted on the subject device to show it is equivalent.
| Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Subject Device) |
|---|---|
| Mechanical Performance: |
- Comparable bending strength
- Comparable torsion strength
- Comparable axial pullout strength | Non-clinical tests performed:
- 4 Point Bending Test
- Torsion Test & Axial Pullout Strength Test
Rationale for equivalence: "The subject device's titanium grade is the same as the predicate device's, but the subject device is thicker than the predicate device. Therefore, the performance testing of the subject device is expected to be substantially equivalent to the predicate device." (This implies the subject device met or exceeded the predicate's performance in these tests, although specific numerical results are not provided in this summary.) |
| Sterilization Efficacy: - Achieves sterility for pre-sterilized kits
- Compatibility with steam sterilization for non-sterile components | Non-clinical tests performed:
- Packaging Process Validation Test (only Neuro Plating System - Sterile Kit)
- Gamma Sterilization Validation (only Neuro Plating System - Sterile Kit)
Rationale for equivalence: "Validation of sterilization parameters... of the subject device are supported by sterilization validation... as provided in the primary predicate K190811." |
| Biocompatibility: - Biocompatible materials and design, similar to predicate | Rationale for equivalence: "...biocompatibility of the subject device are supported by... biocompatibility testing as provided in the primary predicate K190811." |
| Shelf Life: - Maintained functionality and sterility over intended shelf life (for pre-sterilized kits) | Non-clinical tests performed:
- Shelf life (only Neuro Plating System - Sterile Kit) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided summary. For mechanical tests, this would typically involve a specific number of samples for each test (e.g., n=5 or n=10 per test), but the exact numbers are not present.
- Data Provenance: Not specified, but implied to be from laboratory testing conducted on device samples. Country of origin for testing is not stated. The data is "non-clinical" (bench testing), not patient data, so "retrospective or prospective" is not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the submission relies on non-clinical, laboratory bench testing (mechanical and sterilization) rather than clinical data requiring expert review or ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable as the submission relies on non-clinical, laboratory bench testing. Adjudication methods are typically relevant for clinical studies where subjective assessments or multiple interpretations of patient data might occur.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic imaging aids or AI assistance where human readers interpret cases. The Neuro Plating System is a surgical implant, not a diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- No, a standalone (algorithm only) performance study was not done. This concept applies to AI/software as a medical device. The Neuro Plating System is a physical implant.
7. The Type of Ground Truth Used
- Not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). For the non-clinical tests, the "ground truth" would be the engineering specifications and established acceptable performance limits (often derived from the predicate device or relevant ASTM standards). For example, a "ground truth" for the 4-point bending test would be a minimum bending force or deformation standard that the device must meet, typically aligned with or surpassing the predicate's performance.
8. The Sample Size for the Training Set
- Not applicable. The Neuro Plating System is a physical medical device, not an AI/machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, there is no "training set" for this device.
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(357 days)
Neuro System - MR Conditional
Classification Name(s): Cover, Burr Hole
Regulatory Class: Class II, §882.5250
Neuro:
- Neurosurgery
- Nasoethmoidal fractures
- Infraorbital area fractures
- Frontal sinus wall Fractures
- Infant craniofacial surgery
Dental: - Maxillofacial surgery
The DePuy Synthes Mandibular Modular Fixation System is a plate and screw system, manufactured from commercially pure titanium, and is intended for use in:
- Oral, maxillofacial surgery: trauma; surgical correction of dentofacial deformities; reconstructive surgery; and maxillofacial surgery
- Neurosurgery: osteosynthesis of the cranial bones.
Dental: The DePuy Synthes Single Vector Distractor with Detachable Feet is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or posttraumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating fonns of clefts of the lip and palate, and congenital mandbular hypoplasia, such as Hemifacial Microsomia, Treacher Collins Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome.
The DePuy Synthes Single Vector Distractor with Detachable Feet is also ideal for treating hypoplasias of an acquired origin such as from post-traumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone.
Neuro: The DePuy Synthes Single Vector Distractor with Detachable Feet can be used for stabilization and advancement of the mid-face, in which a deficiency of mid-facial bone requires gradual bone distraction. Such deficiencies include, but are not limited to Plagiocephaly, Trigonocephaly, Scaphocephaly, and Brachycephaly.
The DePuy Synthes Cranial Tube Clamp is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
Dental: The DePuy Synthes Low Profile Neuro System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes Low Profile Neuro System is intended for cranial closure and/or bone fixation, craniotomies, cranial trauma repair and reconstruction.
Dental: The DePuy Synthes Low Profile Neuro System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes Low Profile Neuro System is intended for cranial closure and/or bone fixation, craniotomies, cranial trauma repair and reconstruction.
Dental: The DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates are intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates are intended for use in selective trauma of the craniofacial skeleton and craniofacial surgery.
Dental: The DePuy Synthes External Midface Distractor is intended for use in maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically, it is intended for distraction of the maxilla utilizing a LeFort I osteotomy, the midface utilizing a LeFort II or III osteotomy in adult and pediations where gradual bone distraction is required.
Neuro: The DePuy Synthes External Midface Distractor is intended for use in craniofacial surgery and reconstructive procedures. Specifically, it is intended for distraction of the cranium utilizing a monobloc osteotomy in adult and pediativ populations where gradual bone distration is required.
The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are intended for use as follows: Neuro:
• Nasoethmoidal fractures
- Infraorbital area fractures
- Frontal sinus wall fractures ●
- Infant craniofacial surgery
Dental: - Maxillofacial surgery
Dental: DePuy Synthes Neuro Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: DePuy Synthes Neuro Plate and Screw System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.
Dental: The DePuy Synthes Low Profile Neuro System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes Low Profile Neuro System is intended for cranial closure and/or bone fixation, craniotomies, cranial trauma repair and reconstruction.
Dental: The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the craniofacial skeleton and craniofacial surgery.
The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device.
The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the cranium, where gradual bone distraction is required in adults and pediatric patients.
Dental: The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the craniofacial skeleton and craniofacial surgery.
The DePuy Synthes MatrixNEURO Cranial Plating System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.
The DePuy Synthes MatrixNEURO Preformed Mesh is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.
The DePuy Synthes Maxillofacial Titanium Micro set consists of titanium bone plates (shapes include L,Y,H,T, Double-Y, Mesh and Straight) and self-tapping screws.
The DePuy Synthes Mandibular Modular Fixation System is a plate and screw system manufactured from titanium. The plates are available in a variety of shapes and sizes, and attach to bone via 2.0 mm, 2.4 mm or 2.7 mm screws.
The DePuy Synthes Single Vector Distractor with Detachable Feet is a subcutaneous bone distractor activated by a drive component. It features two telescoping components activated by a jack screw, fixed to the bone with bone screws. Bone lengthening and distraction are achieved by gradually activating the device. Upon removal, the telescoping components and jack screw are disengaged and removed, leaving the subcutaneous foot plates in the patient.
The DePuy Synthes Cranial Flap Tube Clamp consists of two clamp discs with a clamp shaft in between the discs. The clamp shaft consists of a 1.6 mm tube which is secured to the bottom disc. The top disc has a thickness of 0.4 mm and the plate diameters range from 8.0 to 20. mm.
The DePuy Synthes Low Profile Neuro System consists of titaniurn plates, and screws in a variety of shapes and sizes designed for various cranio-facial procedures.
Synthes ø1.6 mm Low Profile Neuro System self-drilling, self·tapping, and ø1.9 mm emergency self-tapping screws in 3 mm lengths are to be added to the system.
The DePuy Synthes 1.3 & 1.5 mm Contourable Ti. Mesh Plates come in a variety of shapes and sizes to meet the anatomical need of the patient. The plates are sterile and for single use only.
The DePuy Synthes External Midface Distractor is an external distraction osteogenesis device that attaches to the cranium and midface and is used to gradually lengthen the midface at the LeFort I, II, and III levels (including monobloc). The device consists of an external headframe, a central adjustment mechanism, a veridical central rod, horizontal crosspieces containing distraction screws, and separate footplates assemblies that attach to the zygoma and maxilla.
The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are either self-drilling or self tapping, have a flat head profile with rounded edges with a cruciform recess, and are available in various lengths.
DePuy Synthes Neuro Plate and Screw System consists of plates, burr hole covers, and meshes that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with 1.8 mm screws and 2.1 mm emergency screws. The screws will be used with Synthes 1.8 mm hexagonal screwdriver blades. System components are manufactured in either titanium alloy and are intended for single use only.
The DePuy Synthes 1.6 mm burr hole covers come in various sizes to accommodate various fracture and osteotomy sites, have a low plate/screw head profile and use existing (previously cleared) 1.6 mm or 1.9 mm emergency self-tapping and self-drilling screws. The DePuy Synthes 1.6 mm Burr Hole Covers have 5 lobes to accommodate a shunt/drain and are available in 12, 15, 17, and 24 mm diameters with a plate thickness of 0.5 mm.
The DePuy Synthes Craniofacial Plate and Screw System consist of plates and meshes that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with 1.8 mm screws and 2.1 mm emergency screws. The screws will be used with Synthes 1.8 mm hexagonal screwdriver blades. System components are manufactured in either titanium or titanium alloy and are intended for single use only.
DePuy Synthes Craniomaxillofacial (CMF) Distraction System is a modular distractor system intended for correction and reconstruction of the cranium in adults, adolescents, children, infants, and neonates. The distractor construct consists of the distractor body, footplates, extension arms, and bone screws, all of which are available in multiple configurations to meet patient and surgeon needs. The distractor body is first assembled with the desired footplates, and then the footplates are secured to bone using the bone screws. After implantation the distractor is activated through the rotation of an advancement/lead screw with an activation instrument percutaneously.
The DePuy Synthes Orbital Plates, components of the Synthes Craniofacial Plate and Screw System, consist of anatomically shaped orbital plates that come in various sizes and configurations to fit the patient anatomy. These devices are designed for use with DePuy Synthes craniofacial bone screws commercially available in the U.S. System components are manufactured in titanium and are intended for single use only.
The DePuy Synthes MatrixNEURO Cranial Plating System consists of bone fixation implants offered in a variety of shapes and sizes to meet the anatomical needs of the patient.
The reconstruction meshes are manufactured from titanium, are designed for use with DePuy Synthes MatrixNEURO Cranial Plating System screws, are offered sterile, and are intended for single use only.
The screws are manufactured from titanium alloy, are designed for use with DePuy Synthes MatrixNEURO plates, burr hole covers, and meshes, maybe be offered sterile or non-sterile, and are intended for single use only.
The DePuy Synthes MatrixNEURO Cranial Plating System consists of bone fixation implants offered in a variety of shapes and sizes to meet the anatomical needs of the patient.
The DePuy Synthes MatrixNEURO Preformed Meshes are precontoured to cover common cranial defects manufactured from grade 2 titanium that are designed for use with MatrixNEURO Cranial Plating System screws. The Preformed Meshes are offered sterile packed and are intended for single use only.
The provided text is a 510(k) Premarket Notification from the U.S. Food & Drug Administration (FDA) regarding several DePuy Synthes Craniomaxillofacial Neuro Devices. It describes changes to the labeling of these devices to indicate "MR Conditional" use.
The document consistently states that the purpose of the submission is to add MR Conditional information to the device labeling. It explicitly mentions that the intended use and technological characteristics of the devices remain unchanged. This implies that the devices are already cleared for their stated indications and the current submission is concerned with demonstrating their safety in an MR environment.
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted to support the MR Conditional safety of the devices. This is not a study proving clinical effectiveness or diagnostic accuracy of an AI/algorithm-based device, but rather a set of engineering tests to confirm a physical device's compatibility with an MR environment.
Based on the provided text, here's how to address your request:
1. A table of acceptance criteria and the reported device performance:
The document repeatedly cites the ASTM standards as the basis for performance testing, which inherently contain acceptance criteria within them. The document does not provide specific quantitative performance results for each device against these criteria, but rather states that "Non-clinical testing is provided to support the conditional safety." This implies that the devices met the acceptance criteria defined by these ASTM standards.
| Acceptance Criteria (ASTM Standards) | Reported Device Performance |
|---|---|
| Magnetically Induced Displacement Force: ASTM F2052-14 | Non-clinical testing provided to support conditional safety. (Implied: Met standard) |
| Magnetically Induced Torque: ASTM F2213-06 | Non-clinical testing provided to support conditional safety. (Implied: Met standard) |
| Radio Frequency (RF) Heating: ASTM F2182-11a | Non-clinical testing provided to support conditional safety. The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating. (Implied: Met standard) |
| Image Artifacts: ASTM F2119-07 | Non-clinical testing provided to support conditional safety. (Implied: Met standard) |
2. Sample sized used for the test set and the data provenance:
- Sample Size: The document does not specify the number of individual devices or prototypes tested for each type of assessment (displacement, torque, heating, artifacts). These are engineering tests typically performed on representative samples.
- Data Provenance: The data provenance is "non-clinical testing" conducted by the manufacturer, DePuy Synthes. The "DUKE model" for RF heating is mentioned, which is a widely accepted phantom model for electromagnetic simulations in medical device testing. There's no information about the country of origin of the data beyond it being part of a US FDA submission. It is a prospective test in the sense that the testing was conducted to support the MR Conditional labeling.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable in the context of this submission. The "ground truth" for MR Conditional safety is established by engineering tests against recognized consensus standards (ASTM), not by human expert review of clinical cases. The tests directly measure physical properties like temperature increase or magnetic force, and these measurements are compared to the limits specified in the standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a human reader study requiring adjudication. The assessment is based on objective physical measurements and adherence to ASTM standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This submission is for physical medical devices (implants), not an AI/algorithm-based diagnostic or assistive software. No MRMC study was performed because the device is not an AI reading tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm, so standalone performance is irrelevant. The tests are for the physical properties of the implants.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" for these tests is defined by the physical laws and empirically derived thresholds outlined in the ASTM standards for MR compatibility. For example, a certain temperature rise in a standard phantom model is deemed acceptable if it remains below a specified limit.
8. The sample size for the training set:
Not applicable. There is no "training set" as this is not a machine learning or AI model.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set.
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(282 days)
Name: CirFIX Cranial Bone Fixation System: Flap Fixator and Burr Hole Cover Regulation Number: 21 CFR 882.5250
|
| Classification Name and
Reference | 882.5250
CirFIX® Cranial Bone Fixation System: Flap Fixator is intended for use to post-craniotomy bone flap fixation and the Burr Hole Cover is to be used for covering a single burr hole.
The CirFIX® Cranial bone fixation system: Flap Fixator is a biocompatible, postoperative cranial bone fixation system that fixes the bone flap to the skull after craniotomy and Burr Hole Cover which is for covering a single burr hole resulting from cranial surgery.
The CirFIX® Cranial bone fixation system is provided in sterile, for a single use. With available sizes for cranial thickness ranging from 3 mm to 14 mm and burr holes with an epicranial diameter from 10 to 15 mm, made by standard perforators or with spherical drills, can be covered.
The provided document is a 510(k) summary for the CirFIX Cranial Bone Fixation System. It details the device's technical characteristics, its intended use, and a comparison to predicate devices, along with summaries of non-clinical, mechanical, and performance testing. However, the document does not contain information about studies involving human readers, AI assistance, ground truth established by experts for a test set, or specific acceptance criteria with quantitative reported performance metrics for an AI/algorithm-based device.
The questions posed are typical for the evaluation of AI/Machine Learning-enabled medical devices, particularly those involving image analysis or diagnostic support, where performance is often measured by metrics like sensitivity, specificity, or reader agreement. The CirFIX system described is a physical medical device (bone fixation system), not an AI/ML software device. Therefore, the questions related to AI/ML device performance validation are not applicable to the content provided.
However, I can extract the information relevant to the device's performance testing and acceptance criteria for a physical device as described in the document.
Acceptance Criteria and Study for CirFIX Cranial Bone Fixation System:
The document describes pre-market testing to demonstrate substantial equivalence to predicate devices, focusing on functional, biomechanical, and cadaver testing. The "acceptance criteria" are implicitly met if the device performs as intended and is equivalent or better than predicate devices in specified mechanical tests, and demonstrates safe and effective implantation in simulated clinical use.
Since this is a physical device, the concept of "ground truth" and "expert consensus" for diagnostic accuracy (as would be for an AI model) does not directly apply in the same way. Instead, performance is assessed against physical and mechanical benchmarks and practical surgical considerations.
Here's a breakdown of the provided information, noting where the requested AI-specific information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of quantitative acceptance criteria with specific numerical targets and matching reported performance values. Instead, it describes tests and states that the criteria were met, or that results were adequate or equivalent to predicate devices.
| Test Category | Test Method Summary | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| A. Functional Testing | |||
| A.1. Functionality of implantable parts (Burr hole diameter & Bone thickness) | Goal: Verification the available sizes for cranial: (A) Burr hole diameter (B) Bone thickness. Method: Fully assembled devices were tested. Simulated surgery to each size of burr hole diameter and bone thickness. | Device must fit and function correctly across the specified ranges of burr hole diameters (10-15 mm epicranial diameter, various sizes like 11/7, 11/8, 13/9, 14/11, 15/12 mm) and cranial bone thicknesses (3 mm to 14 mm). | "All tested samples meet the functionality acceptance criteria and relevancy the test result has demonstrated that the technological characteristics of CirFIX® Cranial bone fixation system is substantially equivalent to the predicate devices do not raise any new safety or effectiveness issues." |
| A.2. Functionality of implantable parts and the driver (Maximum torque force) | Goal: Determine the maximum torque force (breaking force) of the threads mechanism of the driver and upper platforms (Screw). Method: Fully assembled devices were tested. A calibrated dynamometer was used to apply a torque force on the driver until platforms or bolt broke. | The threads mechanism and driver should withstand a sufficient torque force without breaking, ensuring proper and safe implantation. (No specific numerical target provided, but breakage should occur above expected use forces). | (Result column is blank in the original document for this specific test, but the general conclusion for mechanical testing states performance as intended.) The overall conclusion notes that mechanical and performance testing confirms the device performs as intended and is substantially equivalent. |
| B. Biomechanical Testing | |||
| B.1. Strength to bone flap compression (Push-in) | Goal: Simulate strength to bone flap compression (Push-in) and determine the force required to sink the bone flap up to a maximum of 2 mm. Method: A push load was applied to model which simulates the cranium and bone flap with three Flap Fixators representing clinical use. | The device should withstand push-in forces up to a certain threshold (implicitly, without exceeding 2 mm sinking at expected forces), demonstrating adequate strength and stability for bone flap fixation. (No specific numerical force target provided). | "All tested samples meet the specifications. The devices have an adequate biomechanical behavior at push-in and pull-out. The relevancy of the test results in determining the substantial equivalence of the proposed device." |
| B.2. Push-in | Goal: Simulate patient's pressure on the device and determine the force required to sink the devices up to a maximum of 2 mm. Method: Fully assembled devices were tested in holes equivalent to those in which they will be implanted. The implanted devices were placed under a calibrated dynamometer and a cylindrical tool used to apply force on the upper platform. | The device should resist sinking beyond 2 mm under simulated patient pressure, ensuring stability in vivo. (No specific numerical force target provided). | (Result column is blank in the original document, but the general conclusion for biomechanical testing covers this as "adequate biomechanical behavior.") |
| B.3. Pull-out | Goal: Simulate pulling forces caused by increased ICP, to determine the maximum force that the device can withstand before sliding out from the burr hole. Method: Fully assembled devices were tested in holes equivalent to those in which they will be implanted. A calibrated dynamometer was used to apply a traction force on the button of lower platform until the lower platform slid out from the hole. | The device must withstand a sufficient pulling force simulating increased intracranial pressure (ICP) without sliding out, ensuring secure fixation. (No specific numerical force target provided). | (Result column is blank in the original document, but the general conclusion for biomechanical testing covers this as "adequate biomechanical behavior.") |
| C. Cadaver Testing | Goal: Evaluation of the devices when simulating their implantation on the skull of patients in a clinical environment, following the procedures described in the products' Instructions for Use. Method: The test was performed on two cadaveric specimens with fully assembled devices, testing four different craniotomies. Various aspects were analyzed (see "Test Method Summary" column for list). | Device must demonstrate: 1. Sufficient space for placement; 2. No danger to surgeon; 3. Correct positioning; 4. Rapid/simple application; 5. Absence of dura mater damage; 6. Easy removal; 7. Lateral and axial stability; 8. Low profiles; 9. Adaptation to curvatures; 10. Adaptation to thicknesses; 11. No artifacts on neuroimaging; 12. Fast application with no special tools. This implies safe, effective, and user-friendly performance in a simulated surgical environment. | "Correct implantation is verified in a simulated real-life situation. The devices show adequate performance and safety. The results demonstrate that the CirFIX® Cranial bone fixation system is equivalent, in terms of performance and safety and to the relevant extent, to the predicate devices." |
2. Sample size used for the test set and the data provenance
- Manufacturing/Mechanical Testing: The document mentions "All tested samples" for functionality and biomechanical tests, but does not specify the exact numerical sample size for these tests.
- Cadaver Testing: "The test was performed on two cadaveric specimens with fully assembled devices."
- Data Provenance: The tests are reported as "Non-Clinical Testing" and "Mechanical and performance testing." Given they are laboratory and cadaver tests, the data provenance is prospective (generated for this submission). The origin is not explicitly stated as a country for the labs, but Ossaware Biotech Co., Ltd. is based in Taiwan.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. As this is a physical medical device (bone fixation system), "ground truth" and "expert qualifications" in the context of diagnostic accuracy/AI model performance are not applicable. The cadaver testing described would involve the expertise of the individuals performing the simulated surgical procedures and evaluating the outcomes, but these are not referred to as "experts establishing ground truth" for a diagnostic test.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
N/A. Adjudication methods like 2+1 or 3+1 are typically used for establishing consensus "ground truth" in image interpretation or diagnostic studies, which is not relevant for this physical device's mechanical and functional testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A. This is a physical medical device, not an AI/ML-enabled diagnostic device. No MRMC study was conducted or is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. This is a physical medical device, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
N/A. For this physical device, "ground truth" refers to established engineering principles, material properties, and surgical requirements for bone fixation. Performance is assessed against these physical and functional benchmarks rather than diagnostic accuracy.
8. The sample size for the training set
N/A. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
N/A. This is a physical device, not an AI/ML model that requires a training set.
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(217 days)
NuCrani Plates, KTC Burr Hole Cover, DC Plate Regulation Number: 21 CFR 882.5250 Regulation Name: Burr
| | |
| Classification
Regulation | 21 CFR 882.5250
| 21 CFR 882.5250
The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery.
The NeuroVention Cranial Fixation System is a series of burr hole covers and plates with various configurations to facilitate surgeon selection of the implant he/she determines to be most appropriate for the patient and the surgical circumstances. Each is provided non-sterile single use and is made of titanium as per ASTM F67, titanium alloy (Ti-6AI4V ELI) implantable components that comply with ASTM F136 or PEEK per ASTM F2026. Class I exempt instrumentation is available for delivery and removal: Screwdriver Adapter (handle), Torx Drivers, Forceps. Additionally, a Class II Drill bit is included to create pilot holes for the screws.
This document, K192162, describes a 510(k) premarket notification for the "NeuroVention Cranial Fixation System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information provided primarily relates to mechanical performance and material biocompatibility.
Here's an analysis of the provided text in relation to your request about acceptance criteria and study proving device meets them:
Key Takeaway: This document does not describe a clinical study or an AI/algorithm-driven device. It is for a physical medical device (cranial fixation system) and relies on mechanical testing and material equivalence to demonstrate substantial equivalence to a predicate device.
Therefore, many of your requested points regarding AI/algorithm performance, human readers, ground truth establishment for training/test sets, and expert consensus are not applicable to this specific submission.
However, I can extract the relevant information from the document that addresses mechanical performance, which serves as the "study" for this type of device.
Acceptance Criteria and Reported Device Performance (Mechanical Testing)
The document primarily relies on mechanical testing to demonstrate substantial equivalence. The acceptance criteria for these tests are implicitly that the "Subject device [is] equivalent or better than the predicate devices" and that "All testing met or exceeded the requirements as established by the test protocols and applicable standards."
Here's a table summarizing the "acceptance criteria" (implied through performance comparison to predicates and standards) and the reported performance for the mechanical tests:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Withstand expected loads without failure (General) | "A review of the mechanical data indicates that the components of the Subject device are capable of withstanding expected loads without failure." |
| Meeting established test protocols and applicable standards | "All testing met or exceeded the requirements as established by the test protocols and applicable standards." |
| Equivalent or better mechanical strength compared to predicates | "Mechanical testing shows the mechanical strength of the Subject device to be equivalent or better than the predicate devices." |
| "All results passed acceptance criteria and were equivalent or better when compared to the predicates." | |
| Static Compression | Passed acceptance criteria, equivalent or better than predicates. |
| Skull Conformity | Passed acceptance criteria, equivalent or better than predicates. |
| Screw Axial Pushout | Passed acceptance criteria, equivalent or better than predicates. |
| Screw Torque to Failure per ASTM F543-13 | Passed acceptance criteria, equivalent or better than predicates. |
| Usability testing of Drill Bit | Passed acceptance criteria, equivalent or better than predicates. |
Addressing Other Requested Information (and why some are not applicable):
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in terms of number of physical test articles for each mechanical test. This is common for 510(k) mechanical testing summaries, where the focus is on meeting standards rather than statistical clinical significance as in a clinical trial.
- Data Provenance: Not applicable as this is mechanical/biocompatibility testing, not clinical data from patients. The testing would have been conducted by the manufacturer or a contracted testing lab.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. The "ground truth" for this device is established by engineering principles, mechanical test standards (e.g., ASTM F543-13), and material specifications (e.g., ASTM F67, F136, F2026). No clinical experts (like radiologists) are involved in establishing ground truth for mechanical performance.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for subjective assessments, primarily in clinical data interpretation (e.g., reading medical images). Mechanical testing results are objective measurements against defined standards.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a physical cranial fixation system, not an AI or imaging system. No human reader studies (MRMC) would be relevant here.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Ground Truth: For mechanical testing, the "ground truth" is defined by widely accepted engineering test standards (e.g., ASTM standards) and the specifications of the predicate device. For biocompatibility, it's defined by the material's conformity to established standards (e.g., ASTM F67-13, ASTM F136, ASTM F2026) and its history of safe use as an implantable material.
-
The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
-
How the ground truth for the training set was established:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
In summary, the provided document is a 510(k) clearance for a traditional physical medical device. The "study" proving it meets "acceptance criteria" consists of mechanical performance testing (as outlined in the table above) and biocompatibility assessments, which demonstrated substantial equivalence to a legally marketed predicate device (Stryker Universal Neuro 3 System). The concept of AI performance metrics, expert reviews, and large human data sets is outside the scope of this type of device and submission.
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(243 days)
- 21 C.F.R. 882.5320 = GWO =
- 21 C.F.R 882.5250 ■ GRX
- 21 C.F.R. 882.5360 ■ HBW
6.
The Optimus Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures.
The Neuro Plating System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and comes in 3 anodized colors (silver, blue and gold). The screws range in diameter from 0.8mm to 1.95mm and in lengths of 3.0mm to 6.0mm. They are made of Ti- 6Al-4V ELI titanium alloy (ASTM F136) and come in 3 anodized colors (silver, green and gold).
The Neuro Plating System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in the reconstructive process. The plate is placed on the fractured bone and the screw is inserted into the bone through a plate hole to achieve fixation. If necessary, the plate may be bent or cut to meet the anatomical needs of the patient.
The Neuro Plating System has two types of sterilization methods: 1.) the Neuro Plating System is non-sterile state packed in a PE bag which must be sterilized before use; and 2.) the Neuro Plating System - Sterile Kit is provided sterile using gamma sterilization packed in Tyvek and PET. Both are single use only.
The provided text describes the regulatory clearance of a medical device, the Optimus Neuro Plating System, and details its substantial equivalence to predicate devices. It does not present a study proving the device meets specific acceptance criteria in terms of AI or algorithm performance.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to regulatory acceptance for market clearance based on substantial equivalence to existing devices, rather than performance metrics for an AI-powered system or diagnostic accuracy study.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to this type of submission.
Here's how the provided information relates to your request:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present "acceptance criteria" in the sense of performance metrics for an AI system. Instead, it presents a comparison table demonstrating the "substantial equivalence" of the modified device to its predicate devices across various attributes. The "performance" here refers to the device proving it is as safe and effective as the predicate, not a quantifiable clinical outcome or AI accuracy.
Table: Comparison of Modified Device to Predicate Devices for Substantial Equivalence
| Feature/Criterion | Modified Device (Optimus Neuro Plating System) Performance/Description | Unmodified (Predicate) Device (K141911) Performance/Description | Unmodified (Predicate) Device (K183352) Performance/Description | Equivalence Outcome / "Acceptance" |
|---|---|---|---|---|
| Manufacturer | OSTEONIC Co., Ltd. | OSTEONIC Co., Ltd. | OSTEONIC Co., Ltd. | - |
| Device Name | NEURO PLATING SYSTEM | NEURO PLATING SYSTEM | NEURO PLATING SYSTEM | - |
| 510(K) # | K190811 | K141911 | K183352 | - |
| Class | 2 | 2 | 2 | Equivalent |
| Product Code | GWO, GRX, HBW | GWO, GRX, HBW | GWO, GRX, HBW | Equivalent |
| Intended Use | Intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures. | Intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures. | Intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures. | Equivalent |
| Material (Chemical Composition) | Plate: Pure Titanium ASTM F67; Screw: Titanium Alloy ASTM F136 | Plate: Pure Titanium ASTM F67; Screw: Titanium Alloy ASTM F136 | Plate: Pure Titanium ASTM F67; Screw: Titanium Alloy ASTM F136 | Equivalent |
| Surface Treatment | Plate: Anodized; Screw: Anodized | Plate: Anodized; Screw: Anodized | Plate: Anodized; Screw: Anodized | Equivalent |
| Shape and Dimension | Straight, burr hole with various lengths and thickness. Plate sizes: 0.3mm to 0.6mm thick. Screw diameter: 0.8mm to 1.95mm; lengths: 3.0mm to 6.0mm. | Straight, angle, Y-shape, X-shape, burr hole, square, matrix and mesh with various lengths and thickness. Plate: various length and thickness (0.1 to 0.6mm). Screw diameter: 0.8 to 1.8mm; lengths: 3.0 to 6.0mm. | D-Y Shape, Y-Shape, Burr hole Plate and mesh with various lengths and thickness (0.3 to 0.6mm). | Plates and screws were found to be substantially equivalent through 4 point bending testing, torsional testing, and axial pullout strength testing. The modified devices passed all testing. |
| Single Use | YES | YES | YES | Equivalent |
| Sterile | Neuro Plating System: Non sterile, steam sterilization before use. Neuro Plating System Sterile Kit: sterile, gamma irradiation. | Non sterile, steam sterilization before use. | Non sterile, steam sterilization before use. | Neuro Plating System - Sterile Kit (gamma irradiation) added. Plates and screws were evaluated through packaging process validation test, gamma sterilization validation and shelf life. The modified devices passed all testing. |
| Non-clinical tests performed on modified device | 4 Point Bending Test, Torsion Test & Axial Pullout Strength Test, Packaging Process Validation Test (Sterile Kit only), Gamma Sterilization Validation (Sterile Kit only), Shelf life (Sterile Kit only), MR safety test. Test results demonstrated that the subject devices are substantially equivalent to the predicate devices. | Testing on predicate devices, by which the modified device was compared for substantial equivalence. | Testing on predicate devices, by which the modified device was compared for substantial equivalence. | "Test results demonstrated that the subject devices are substantially equivalent to the predicate devices." "overall higher than the predicate devices" (for some mechanical tests) |
2. Sample size used for the test set and the data provenance:
- Test Set Description: The "test set" in this context refers to the samples of the physical device that underwent non-clinical laboratory testing (e.g., mechanical strength, sterilization validation).
- Sample Size: The document does not specify the exact number of units used for each test (e.g., how many plates/screws for the 4-point bending test). It only states that "The following tests were performed on the modified devices."
- Data Provenance: The tests were performed by Osteonic Co., Ltd. (the manufacturer) in South Korea. The data would be internally generated "non-clinical tests." The provenance typically refers to the source of the clinical data (e.g., patient records), which is not relevant here as this is a device clearance based on engineering and material testing. The tests are prospective as they were conducted for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. This submission is for a physical medical implant, not an AI or diagnostic imaging device that requires interpretation by medical experts to establish ground truth for performance evaluation. The "ground truth" for the device's characteristics (e.g., material strength, sterility) is established by standardized engineering tests and established quality control methods, not expert consensus on medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This refers to a method used to resolve discrepancies in expert interpretations (e.g., for image annotations or diagnoses), which is not relevant to the non-clinical engineering and material tests performed for this device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a type of study performed for diagnostic AI tools to evaluate their impact on human interpretation. This submission is for a physical neuro plating system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This describes the performance evaluation of an AI algorithm in isolation. The Optimus Neuro Plating System is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical device, the "ground truth" for demonstrating substantial equivalence is based on:
- Engineering specifications and standards: ASTM F67, ASTM F136, ISO 10993.
- Validated test methods: 4 Point Bending Test, Torsion Test, Axial Pullout Strength Test, Packaging Process Validation Test, Gamma Sterilization Validation, Shelf life, MR safety tests.
- Comparison to predicate device performance data in these established physical and biological safety metrics.
8. The sample size for the training set:
- Not applicable. This is relevant for AI/ML models. This document describes a physical medical device.
9. How the ground truth for the training set was established:
- Not applicable. Relevant for AI/ML models.
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(30 days)
Product Code & Regulation Number:
- " Primary GWO, GXR, HBW (21CFR§882.5320, 21CFR§882.5250. 21CFR8882.5360
Optimus Neuro System is intended for use in selective trauma of the cranial surgery and reconstructive procedure.
The Optimus NEURO System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and in 3colors (silver, blue and gold) by anodizing. The range of screw diameter is from 0.8mm to 1.8mm in lengths of 3.0 to 6.0mm. It is made of Ti-6AI-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, green and gold) by anodizing.
The device is packed separately in a PE bag. The plate and screw are single use only, non-sterile products. The devices must be sterilized before use.
Optimus NEURO System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in reconstructive processes. The placed on the fractured bone and the screw is inserted into the bone through a plate hole to fix. If necessary, the plate may be bent or cut to meet the anatomical needs of patient
This document describes the Optimus Neuro System, a device intended for use in cranial surgery and reconstructive procedures. It's important to note that this submission focuses on the device itself (plates and screws), not an AI algorithm. Therefore, many of the requested AI-specific details are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion (Type of Test) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| 4 Point Bending Test | Subject device performance should be comparable or superior to the predicate device. | "The test results of the subject device were overall higher than the predicate devices..." |
| Packaging Process Validation Test | Packaging must ensure device integrity and sterility until use. | Test performed, implied successful. |
| Sterilization Parameters Validation | Device must be able to be effectively sterilized. | Supported by primary predicate K141911. |
| Biocompatibility | Device materials must be biocompatible. | Supported by primary predicate K141911. |
| Functional Equivalence | Differences in shape and dimensions should not raise new issues in safety and performance. | "performance test data provided in this submission proves that this differences do not raise new issues in safety and performance." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the "4 Point Bending Test" or "Packaging Process Validation Test." It refers to "the subject device and the predicate devices," suggesting that a sufficient number of units were tested to draw conclusions.
- Data Provenance: The manufacturing company, Osteonic Co., Ltd., is based in Seoul, Korea. The tests were likely conducted in a controlled lab environment. The study is retrospective in the sense that it's comparing a modified device to an existing predicate, and the testing isn't on human subjects for clinical outcomes, but rather on the physical properties of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as this is a submission for a medical device (plates and screws), not an AI algorithm requiring expert ground truth for image or data interpretation. The "ground truth" here is based on engineering standards and physical test results.
4. Adjudication Method for the Test Set
This is not applicable as it pertains to expert disagreement in AI-driven diagnostic tasks, which is not relevant to this device's testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as this is a medical device (plates and screws), not an AI algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as this is a medical device (plates and screws), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Engineering Standards: Adherence to material specifications (ASTM F67, ASTM F136) and performance standards (e.g., implied stress/strain limits for the 4-point bending test).
- Physical Test Results: Direct measurements of mechanical properties (bending strength) and packaging integrity.
- Previous Validation Data: Relying on sterilization and biocompatibility data from the primary predicate device (K141911).
8. The Sample Size for the Training Set
This is not applicable as this is a medical device (plates and screws) and does not involve AI or machine learning models that require a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons as above.
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(123 days)
Madison, Wisconsin 53703
Re: K181539
Trade/Device Name: OSSDSIGN Cranioplug Regulation Number: 21 CFR 882.5250
Regulation Description: Burr Hole Cover
- Classification Name: Cover, Burr Hole (21 CFR 882.5250, Product
OSSDSIGN Cranioplug is an implant intended to cover and plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. These osseous defects are surgically created and are not intrinsic to the stability of the bony structure. The ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is indicated for use in adults and adolescents age 12 and older.
OSSDSIGN Craniopluq003 is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate which together provide the mechanical performance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators.
Here's an analysis of the provided text regarding the acceptance criteria and study for the OSSDSIGN Cranioplug.
Upon reviewing the provided FDA 510(k) summary, it's important to note that this document describes a medical device (a burr hole cover) and its non-clinical testing, not a diagnostic AI/ML device. Therefore, many of the requested categories, such as data provenance, expert adjudication, MRMC studies, standalone performance with ground truth for AI, etc., are not applicable as this is not an AI/ML product.
The document focuses on demonstrating the substantial equivalence of the "OSSDSIGN Cranioplug" (subject device) to a legally marketed predicate device ("OSSDSIGN Cranioplug") through bench and biological performance testing.
Acceptance Criteria and Device Performance for OSSDSIGN Cranioplug
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied/Direct) | Reported Device Performance (OSSDSIGN Cranioplug003) |
|---|---|---|
| Energy absorption, flap reattachment | Sustained deformation energy comparable to predicate device. | Sustained deformation energy of 0.06 J (same as predicate). |
| Flap Fixation Dynamic Load | No flap deformation after simulating 50 years of sleep with hourly repositioning, comparable to predicate device. | No flap deformation. All Cranioplug models tested. |
| Cytotoxicity | No evidence of causing cell lysis or toxicity (ISO 10993-5 compliant). | No evidence of causing cell lysis or toxicity. |
| In vivo implantation (Biocompatibility) | Biocompatibility, adequate resorption rate, and osteoconduction (ISO 10993-6 compliant). | In vivo studies show biocompatibility, adequate resorption rate and osteoconduction. |
| Mechanical Performance | Meet mechanical performance for safety and efficacy (implicitly comparable to predicate). | The device provides mechanical performance for safety and efficacy. |
| Biologic Performance | Meet biologic performance for safety and efficacy (implicitly comparable to predicate). | The device provides biologic performance for safety and efficacy. |
Note: The acceptance criteria are largely implied based on establishing substantial equivalence to the predicate device. The goal is to demonstrate that the new device performs as safely and effectively as the predicate.
Regarding AI/ML Specific Questions (Not Applicable to this Device):
The following questions are not applicable to the OSSDSIGN Cranioplug as it is a physical medical implant (burr hole cover), not an AI/ML diagnostic or assistive device.
2. Sample size used for the test set and the data provenance: Not applicable. This involves physical device testing, not data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI device involves expert annotations; for this physical device, "ground truth" is established by physical measurements and biological assays.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, "ground truth" is derived from standardized physical testing methods (e.g., universal testing machine, dynamic load simulation) and biological assays (cytotoxicity, in vivo implantation results/histology).
8. The sample size for the training set: Not applicable. This device does not have a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established: Not applicable.
Summary of the Study (Non-Clinical for a Physical Device):
The study described is a non-clinical evaluation to demonstrate the substantial equivalence of the OSSDSIGN Cranioplug (subject device) to its predicate device (an earlier version of the Cranioplug, K140309).
Key aspects of the study:
- Objective: To show that the subject device is as safe and effective as the predicate device, despite minor differences in materials (Titanium grade) and dimensions (titanium thickness, additional size).
- Methodology: Bench testing and biological performance testing.
- Bench Testing:
- Energy absorption, flap reattachment: Devices installed in an anatomical model and tested in a Universal Testing Machine to a 2mm displacement to determine deformation energy.
- Flap Fixation Dynamic Load: Three Cranioplugs fixating a flap in an anatomical model, tested with an 8.5 kg head weight simulating 50 years of sleep with hourly repositioning.
- Biological Performance:
- Cytotoxicity: ISO elution method (ISO 10993-5) using extracts in IX MEM at 37°C for 24 hours.
- In vivo implantation: A 52-week sheep implantation study, compliant with ISO 10993-6.
- Bench Testing:
- Results: The subject device met the performance standards demonstrated by the predicate device in all tests.
- Energy absorption was identical to the predicate (0.06 J).
- No flap deformation observed under dynamic loading.
- No evidence of cytotoxicity.
- Biocompatibility, adequate resorption rate, and osteoconduction were observed in vivo.
- Conclusion: Nonclinical tests demonstrate that OSSDSIGN Cranioplug003 is as safe and effective as its legally marketed predicate device.
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(56 days)
Texas 75024
Re: K181382
Trade/Device Name: Guardian™ Burr Hole Cover System Regulation Number: 21 CFR 882.5250
|
| Classification Name: | 882.5250
The GuardianTM burr hole cover system is intended for use following cranial surgery as an implantable 14-mm (0.55-in) burr hole cover for the skull. It can also be used to secure a lead with a 1.29-mm (0.051-in) or 1.39-mm (0.055-in) diameter
The GuardianTM burr hole cover system is used to close a cranial burr hole and secure an implanted, compatible lead, when applicable. The burr hole cover system is nonpyrogenic and has three main features: base, clip, and cover. The base is intended for burr holes with a 14-mm (0.55-in) diameter. It contains two grooved slots to hold a lead in place. The clip fits into the base to hold the lead. The locking mechanism temporarily holds a lead in place before the burr hole cover is secured. The cover snaps onto the base, closing the burr hole and locking a lead in place.
The document describes a 510(k) premarket notification for a modification to the Guardian™ Burr Hole Cover System to include an "MR Conditional" statement in the labeling. The acceptance criteria and the study that proves the device meets them are related to this MR Conditional status.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Related to MR Conditional Status) | Reported Device Performance (Guardian™ Burr Hole Cover System) |
|---|---|
| Device establishes "MR Conditional" status (as per FDA Guidance, "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment") | Demonstrated to be "MR Conditional" |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state a "test set" in the context of medical imaging or diagnostic device performance evaluation. Instead, the testing was for the "MR Conditional" status. This typically involves physical testing of the device itself according to specific MR safety standards. Therefore, the "sample size" would refer to the number of physical devices tested to assess their behavior in an MR environment. The document does not specify the exact number of units tested.
- Data Provenance: The testing was conducted "following the FDA Guidance, 'Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment'." This implies a laboratory or testing facility setting, rather than clinical patient data. The country of origin of the data is not specified, but the submission is to the US FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not directly applicable to this type of submission. Establishing "MR Conditional" status for a passive implant primarily involves engineering and physics expertise for conducting MR safety tests and interpreting their results according to established international standards (e.g., ASTM F2052, F2119, F2182). It does not typically involve a panel of medical experts establishing "ground truth" on patient images or outcomes. The "ground truth" in this context is the objective measurement of MR-related effects (e.g., heating, artifact, force).
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. MR safety testing data is typically objective and quantitative, and does not require adjudication by medical experts in the way clinical diagnostic study results might.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No, an MRMC comparative effectiveness study was not done. This submission is for a burr hole cover system (a passive implant), not a diagnostic imaging AI algorithm.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This is a medical device, not an algorithm. The "standalone" performance refers to the device's inherent physical properties and behavior in an MR environment.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for determining MR Conditional status is based on objective, quantifiable measurements from MR safety testing protocols defined in recognized standards (e.g., SAR measurements, temperature rise, displacement force, torque, image artifact assessment). This is not derived from expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic study.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/machine learning device. The testing involved physical devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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