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510(k) Data Aggregation
(34 days)
The Intended Use of the Cannulated Screw and Kirschner (Kwire) System is for the treatment and fixation of bone fractures and osteotomies of various bones including the clavicle, acetabulum, pelvis, scapula, humerus, radius, ulna, femur, tibia, phalanges, carpals, metacarpals, tarsals, metatarsals and fibula.
Cannulated Screws and Kwires are a self-tapping, self-drilling screw with a cortico/cancellous or cancellous thread that can be guided into position by Kwire placement. Partial or fully threaded screws are available in various different lengths and diameters to provide fixation in various size bones. The screws are made of Titanium Alloy or Stainless Steel. The Kirschner Wires (Kwires) are threaded, spaded or blunt ranging from 0.8 to 1.4mm in diameter and ranging from 100 to 200mm in length and made of 316L Stainless Steel.
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(90 days)
The Cannulated PsiFGuard is an accessory to systems intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroilitis. It is indicated for use during sacroiliac joint guidewire placement to provide feedback to the surgeon via visual and audible alerts that indicate a change in conductivity at the tip of the probe and may indicate contact of the tip with bone and possible cortex perforation.
The Cannulated PsiFGuard is a device that assists surgeons to place a guidewire in the sacroiliac joint during posterior sacroiliac fusion surgery. The Cannulated PsiFGuard device serves to alert the surgeons prior to a possible cortex perforation during quidewire placement, by analyzing the electrical conductivity of the surrounding tissues. The Cannulated PsiFGuard consists of a stainless steel needle component and electronic handle (DSG Handle or the DSG Connect Handle).
The Cannulated PsiFGuard has exactly the same principles of operation as the previously cleared systems, i.e. the tip of the instrument simultaneously penetrates the tissue for guidewire placement and senses possible cortex perforation or contact with bone. The devices then provide a visual and audible feedback to the surgeon to indicate changes in conductivity associated with possible bone perforation. If the DSG Connect handle is used, the device also allows for the signal generated by the device to be transferred to a tablet, to visually reproduce the audio signal over time.
The provided document does not contain detailed information about the acceptance criteria and a specific study that proves the device meets those criteria for the Cannulated PsiFGuard. The "Performance Data" section mentions a cadaver study and mechanical performance evaluation, but it lacks the specific metrics, sample sizes, and detailed outcomes that would constitute clear acceptance criteria and proof of meeting them.
However, based on the limited information available and inferences from typical FDA submissions, here's a structured response addressing the requested points:
Acceptance Criteria and Device Performance for Cannulated PsiFGuard
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Inferred) | Reported Device Performance (From document) |
|---|---|
| Guidewire placement accuracy (in sacroiliac joint fusion procedures with the device vs. standard technique) | Demonstrated in a cadaver study. (Specific metrics of accuracy, e.g., % accurate placement, error margin, were not provided). |
| Ability to measure tissue impedance and provide alerts | Demonstrated in a cadaver study. (Specific sensitivity/specificity or other performance metrics were not provided). |
| Mechanical robustness under cantilever bending loads | Withstood mechanical action induced by sacroiliac joint guidewire placement. (Specific thresholds or pass/fail criteria were not provided). |
| Functionality as intended | "In all instances, the Cannulated PsiFGuard functioned as intended and the performance observed was as expected." |
2. Sample size used for the test set and the data provenance
- Sample Size: The document mentions a "cadaver study" but does not specify the number of cadavers or individual guidewire placements analyzed.
- Data Provenance: Prospective (cadaveric study setting). The country of origin is not specified, but the applicant (SpineGuard S.A.) is based in Vincennes, France.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document.
4. Adjudication method for the test set
This information is not provided in the document.
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
A multi-reader multi-case (MRMC) comparative effectiveness study involving human readers/surgeons and AI assistance is not described in the document. The device provides "visual and audible alerts" to a surgeon, but the study described is a cadaver study for device performance, not a study evaluating human performance with and without the device's assistance. The device is not an AI/Software as a Medical Device (SaMD) in the typical sense that would necessitate such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is explicitly designed to provide real-time feedback (visual and audible alerts) to a surgeon during guidewire placement. Therefore, it's an "in-the-loop" device, and a standalone algorithm-only performance assessment would not be applicable or relevant to its intended use. The cadaver study investigated the device's ability to measure impedance and provide alerts, which is its core standalone function within the human-assisted workflow.
7. The type of ground truth used
For the cadaver study:
- For guidewire placement accuracy: Likely determined by imaging (e.g., fluoroscopy, CT scans) after placement, or direct anatomical visualization, to verify correct guidewire position relative to the sacroiliac joint.
- For cortex perforation/bone contact detection: Likely determined by direct visual inspection during disarticulation/dissection of the cadaveric specimens, or confirmation via imaging, combined with the device's alert.
8. The sample size for the training set
The document does not mention a training set in the context of device performance studies. The Cannulated PsiFGuard's principle of operation is based on established electrical conductivity sensing technology, as described by its reference device (K201454 Cannulated PediGuard with DSG Connect technology, SpineGuard S.A.). This suggests the core technology was already developed and potentially "trained" (in an engineering sense) or validated in prior devices, rather than requiring a new "training set" for a machine learning algorithm.
9. How the ground truth for the training set was established
As no training set is mentioned in the context of this submission, this information is not applicable/not provided.
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(257 days)
The aap Cannulated Headless Bone Screws are indicated for use in non-spinal fragment fixation, osteotomy and arthrodesis of human bones appropriate for the size of the screw. The devices are intended for single use only. The aap Cannulated Headless Bone Screws are indicated for adults, and children (2 years to less than 12 years) and adolescents (aged 12 through 21, up to but not including the 22nd birthday) in which growth plates have fused or in which growth plates will not be crossed by fixation.
K-Wires are indicated for use as guide wire for osteosynthesis implants and for application as implant according to the AO/ASIF principles of fracture management.
The K-Wires are indicated for adults, and children (2 years to less than 12 years) and adolescents (aged 12 through 21, up to but not including the 22nd birthday) in which growth plates have fused or in which growth plates will not be crossed by fixation.
The subject device Cannulated Headless Bone Screws are cannulated at both the leading end (tip) and at the trailing end. The leading/trailing diameters are: 2.5/3.4 mm. 3.5/4.5 mm. 4.0/4.8 mm. 4.5/5.3 mm, 5.5/6.2 mm, 6.5/7.2 mm, and 7.5/7.9 mm., The leading thread have different pitches which facilitates closure of any fracture gap and generates compression across the bone fragments. The subject screws are provided in overall lengths ranging from 12 mm, and with threaded lengths (at the leading end or tip) ranging from 4 mm to 40 mm. The subject screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and ISO 5832-3.
The subject K-Wire is provided in one size with a diameter of 2.4 mm and a length of 250 mm. The subject K-Wire has a trocar point, is threaded, and is manufactured from stainless steel conforming to ASTM F138 and ISO 5832-1.
This document describes the aap Cannulated Headless Bone Screws, a medical device for bone fixation. Since this is a 510(k) summary, the core of the submission is to demonstrate substantial equivalence to existing legally marketed devices, rather than establishing brand-new performance criteria for a novel device. Therefore, the "acceptance criteria" here are largely defined by demonstrating that the new device performs at least as well as and shares similar characteristics with the predicate devices.
Here's an analysis of the provided information based on your questions:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of explicit acceptance criteria with numerical targets as one might see for a novel device, the "acceptance criteria" here are met by demonstrating similarity and comparable performance to the predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (as demonstrated in the submission) |
|---|---|
| Intended Use: The device must have the same or similar intended use as the predicate devices. | The aap Cannulated Headless Bone Screws have the same intended use as the primary predicate K111316 and reference devices K130590 and K131459, and similar technological characteristics for bone fracture fixation (bone screws and K-Wire). |
| Technological Characteristics: The device must have similar technological characteristics (e.g., design, materials, operating principles) as the predicate devices. | The subject device bone screws have similar ranges of thread diameters, threaded lengths, and screw designs to the primary predicate K111316 and reference device K130590. The K-Wire dimensions are within the range of K-Wires cleared in K131459. |
| Material Composition: The device materials must be identical or equivalent to those of the predicate devices. | The screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and ISO 5832-3, using materials and processes identical to predicate devices. The K-Wire is manufactured from stainless steel conforming to ASTM F138 and ISO 5832-1, also using processes identical to predicate devices. |
| Biocompatibility: The device must be biocompatible, demonstrated by using identical/equivalent materials and manufacturing processes as predicate devices. | Biocompatibility for the subject device materials was referenced from K111316, K130590, and K131459, indicating identical materials and processes as previously cleared devices. |
| Sterilization: The device must be able to be sterilized to a sterility assurance level (SAL). | The devices are provided non-sterile and are to be sterilized to a SAL of 10-6 by the end user using the same sterilization method (moist heat) and parameters as previously cleared devices. Analysis showed the subject devices do not create a new worst case for moist heat sterilization. |
| Mechanical Performance: The device must meet recognized industry standards for mechanical performance. | Mechanical testing of the subject device screws was performed according to ASTM F543. While specific quantitative results aren't provided in this summary, the implication is that they meet the standard to support substantial equivalence. |
| Packaging and Shelf Life: The device packaging and shelf-life characteristics must be consistent with predicate devices. | Packaging and shelf life information for the subject devices was referenced from K111316, K130590, and K131459. |
| Manufacturing Process: The device must be manufactured using identical or similar processes as predicate devices. | All subject device final finished components are manufactured in the same facilities using identical manufacturing processes as used for previously cleared aap device components. |
| Pediatric Population Use Support: The device's use in pediatric populations must be supported by comparison to predicate devices. | Reference device K161616 is used to support the use of the subject screws in the pediatric population. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices or clinical cases for this submission's testing. The non-clinical performance data mentions "mechanical testing of the subject device screws according to ASTM F543." ASTM F543 outlines test methods, but the specific number of screws tested is not provided in this summary.
- Data Provenance: The data is primarily non-clinical performance data which includes mechanical testing, sterilization validation, and references to previous submissions (K111316, K130590, K131459, K161616) for biocompatibility, packaging, and shelf-life. There is no clinical data included in this submission. The origin of the reference data for predicate devices is not specified, but previous 510(k) submissions would have their own established provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission relies on non-clinical performance testing and substantial equivalence to predicate devices, not on establishing ground truth via expert review of clinical cases.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. There's no test set requiring human adjudication for diagnostic or interpretive tasks. The evaluation is based on engineering specifications, material standards, and mechanical test results.
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 medical device (bone screws and K-wires), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed.
6. 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 or software.
7. The Type of Ground Truth Used
The "ground truth" for this submission is established through:
- Engineering Specifications and Material Standards: Compliance with recognized standards like ASTM F136, ISO 5832-3, ASTM F138, ISO 5832-1, ASTM F543, ISO 17665-1, ISO 10993-1. These standards define the acceptable properties and performance for such devices.
- Bench Testing: Mechanical testing data according to ASTM F543.
- Referencing Predicate Devices: The established regulatory clearances and performance data of the cited predicate devices (K111316, K130590, K131459, K161616) serve as a de-facto "ground truth" for comparison under the substantial equivalence pathway.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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(79 days)
The 4.0 mm Cannulated Screws and associated washers are indicated for arthrodesis and osteotomies of small bones and small joints, and ankle fracture.
The 5.5 mm. 6.5 mm. 7.0 mm. and 8.0 mm Cannulated Screws. Cannulated Hip Pins and associated washers are indicated for fracture fixation, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device.
The Smith & Nephew 2.5 mm, 3.0 mm Headless Compression Screws are indicated for fixation of fractures, bunionectomies and osteotomies of small bones, and arthrodesis of small joints.
The Smith & Nephew 2.0 mm QFX Screw is indicated for osteotomies of the lesser metatarsals, and osteotomies and fractures of the phalanges.
The subject Cannulated Screw System includes the 2.0 QFX Screw, 2.5mm and 3.0mm Headless Compression Screws, 4.0mm, 5.5mm, 6.5mm, 7.0mm, and 8.0mm Cannulated Screws and associated Washers (K090675, K111994, K213126).
The Smith & Nephew Cannulated Screw System consists of stainless steel (316L conforming to ASTM F139 and ISO 5832-1 or titanium (Ti-6Al-4V conforming to ASTM F1472/SO 5832-3) implantable devices of many styles for use in fracture fixation. The Smith & Nephew Cannulated Screws product family includes Large Cannulated Screws, Cannulated Hip Pins, Hip Screws, QFX Screws, and associated Washers. The components are available in various diameters, thread options, and lengths. All screws are designed with a self-drilling, self-tapping tip to facilitate easy implantion with a reverse cutting flute design to assist with implant removal. Select screws are designed with low-profile screw heads for reduced soft tissue irritation, and 3.0mm and 7.0mm screws are available headless.
The implants within this system are single-use and are Gamma sterilized.
The provided text is a 510(k) summary for a "Cannulated Screw System" and details that the submission is for labeling updates, specifically updated indications for use. The critical information here is that there are no changes to the device's design, technological characteristics, function, sterilization, or packaging.
Therefore, the submission explicitly states: "no performance testing (bench, animal, clinical) was required." This means there is no study described in this document that proves the device meets specific acceptance criteria based on performance. The clearance is based on the substantial equivalence of the device itself (which was previously cleared) and the fact that the labeling changes do not impact safety or effectiveness.
Because no performance study was conducted for this specific submission, I cannot fill in the requested table and information points.
Here's a breakdown of why based on the input:
- 1. A table of acceptance criteria and the reported device performance: Not applicable. No performance study was conducted.
- 2. Sample size used for the test set and the data provenance: Not applicable. No performance study was conducted.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No performance study was conducted.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No performance study was conducted.
- 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 device is a screw system, not an AI-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a screw system, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No performance study was conducted.
- 8. The sample size for the training set: Not applicable. No machine learning training was performed.
- 9. How the ground truth for the training set was established: Not applicable. No machine learning training was performed.
The core of this 510(k) submission is to update the indications for use based on existing, cleared devices, implying that the safety and effectiveness have already been established through prior submissions for functionally identical devices. The changes are specifically for "user clarification" of the indications.
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(261 days)
Cannulated Screw and Double Compression Cannulated Screw are intended for the treatment of fractures, and arthrodesis of bones with the appropriate screw size.
The Cannulated Compression Taper Screw (2.5-3.0 mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist.
The Cannulated Compression Taper Screw (3.5 mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, ostectomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, femur, and fibula.
Cannulated Screws are implantable medical devices developed for application in osteosynthesis, with the purpose of reducing, compressing, aligning, stabilizing, and fixing different types of fractures, in small, medium, and large bones, of lower and upper limbs, and can be used in isolated form or associated with washers. This submission also includes the corresponding washers for Cannulated Screws.
The screws have a hexagonal connection for a wrench and can be found in three different models: Cannulated Screw, Double Compression Cannulated Screw and Cannulated Compression Taper Screw. These devices are found in a variety of diameters to meet the range of anatomies of the patients, are presented in Titanium Alloy according to the standard ASTM F136, being provided in non-sterile condition.
The provided text is a 510(k) Premarket Notification from the FDA regarding "Cannulated Screws." It details the device's indications for use, technological characteristics, and performance data. However, this document does not contain information about an AI/ML-driven medical device, a study involving human readers or expert ground truth, or an AI algorithm's performance.
The "Performance Data" section discusses mechanical properties testing of the physical screws (torsional properties, driving torque, axial pullout strength, chemical and mechanical properties) against ASTM standards. It concludes that the device presents safety and efficacy in terms of its mechanical properties, but this pertains to the physical product, not a diagnostic or AI-assisted system.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-driven device, as the provided document does not pertain to such a device.
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(447 days)
The Cannulated Compression Device System is indicated for fracture fixation of small and long bones. The system is not intended for spinal use.
The Cannulated Compression Device System is used to aid in the alignment and stabilization of bone fractures. The system consists of the following parts:
- A cannulated compression device body with distal threads for bone engagement and distal portals that allow passage of deployable integral anchors to achieve stabilization distally within the bone. The anchors may be retracted for removal of the device if and when it is necessary. The device will be provided in a pre-assembled condition with the deployable anchors and a distal end cap already installed. The device will be available in a variety of lengths.
- A compression nut will be provided separately in various configurations, including both threaded and non-threaded versions. The compression nut has a proximal head and internal threads. The proximal head engages the bone fragment. The internal threads allow engagement to the cannulated compression device body. As the compression nut is tightened onto the device body compression is achieved across the bone fragments. The rate of compression varies based on the proximal head configuration selected.
ODi-NA will manufacture the implants from implant grade titanium allov (Ti-6AL-4V-ELI) per ASTM F136. The implants will be offered in both sterile (steam) and non-sterile packaging configurations and are intended for single-use.
The provided text is a 510(k) summary for the Cannulated Compression Device System. It describes the device, its indications for use, and a comparison to predicate devices, along with performance data. However, it does not contain the information required to fill in the table and answer all the questions about acceptance criteria and a study proving a device meets them, particularly in the context of an AI/ML algorithm.
This document describes a physical medical device (cannulated compression device for bone fracture fixation), not an AI/ML algorithm or software. Therefore, many of the requested fields are not applicable to the content provided (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance).
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from F543-17 & F1264-16) | Reported Device Performance |
|---|---|
| Torsional strength (per ASTM F543-17, Annex A1) | Evaluated |
| Driving torque (per ASTM F543-17, Annex A2) | Evaluated |
| Pullout strength (per ASTM F543-17, Annex A3) | Evaluated |
| Static bend strength (per ASTM F1264-16, Annex A1) | Evaluated |
| Dynamic bend strength (per ASTM F1264-16, Annex A4) | Evaluated |
| Endotoxin limit (20.0 USP Endotoxin Units per device, per ANSI/AAMI ST72) | Meet specified endotoxin limit |
| Compression features performance (comparative to predicate) | Comparatively tested |
Note: The document states that the device was "evaluated" and "tested" against these standards and criteria, and that it "meets the specified endotoxin limit." Specific numerical results of these evaluations and tests are not provided in this summary. The "acceptance criteria" here refers to the standards used for mechanical and biological testing of the physical hardware, not the performance of an AI/ML system.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The study described is for a physical medical device, involving mechanical and biological testing according to ASTM standards. There is no "test set" in the context of software/AI data, nor "data provenance." The tests would involve physical samples of the device and biological samples for pyrogen testing.
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 / Not provided. This information is relevant for AI/ML studies where human experts establish ground truth for image interpretation or diagnosis. For a physical device, ground truth is established by measured physical properties or biochemical assays against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are used in AI/ML studies to resolve disagreements among human experts when establishing ground truth. This is not relevant for the mechanical and biological testing of a physical 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 / Not provided. MRMC studies are specific to evaluating AI/ML systems, particularly in medical imaging, to compare human performance with and without AI assistance. This document describes a physical bone fixation device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not provided. This pertains to the performance of an AI/ML algorithm without human intervention. The device in question is a physical surgical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the mechanical tests (torsional strength, driving torque, pullout strength, bend strength), the "ground truth" would be the measured physical properties of the device, compared against the specifications defined by the ASTM standards (F543-17 and F1264-16).
- For the pyrogen testing, the "ground truth" is the measured endotoxin level compared against the specified limit of 20.0 USP Endotoxin Units per device, as per ANSI/AAMI ST72 using the Limulus amebocyte lysate (LAL) test.
8. The sample size for the training set
- Not applicable / Not provided. This is relevant for AI/ML algorithms.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This is relevant for AI/ML algorithms.
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(97 days)
The OsteoCentric 2.4mm and 3.0mm Cannulated Screw are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.
The OsteoCentric 3.5mm Cannulated Screws are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodesis of the carpals and phalanges, steochnondritis dissecans, and ligament fixation.
The OsteoCentric 4.5mm Cannulated Screws are intended for fracture fixation of long bones and long bone fragments.
The OsteoCentric 6.5mm to 8.0mm Cannulated Screws are intended for fracture fixation of long bones and long bone fragments, long bone osteotomies, femoral neck fractures, slipped capital femoral epiphyses as an adjunct to treatment with a dynamic hip screw (DHS) in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, SI joint disruptions, fixation of pelvis and iliosacral joints, and subtalar arthrodesis.
The OsteoCentric 7.0mm and 8.0mm Cannulated Nut is indicated for fracture fixation where fracture compression is desired, and where insertion of the nut-and-bolt system does not increase the risk of morbidity due to the need for surgical access to both sides of the compressed area. The device may also be used when compression between separate bones is desired (e.g. syndesmosis) as long as there is not increased morbidity associated with the insertion of a nutand-bolt system, as discussed above.
The OsteoCentric Technologies Cannulated Fasteners and Nuts consists of cannulated screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws and nuts are provided non-sterile. The screws and nuts are manufactured from Stainless Steel per ASTM F138 or from Titanium per ASTM F136 or F1295. The purpose of this submission is to modify the indications for use.
Here's an analysis of the provided text regarding the acceptance criteria and study for the device:
Regarding Acceptance Criteria and Supporting Study:
The document does not contain any explicit acceptance criteria or a study that proves the device meets those criteria.
Instead, the document is a 510(k) Premarket Notification for OsteoCentric Technologies' Cannulated Fasteners and Nuts. The core of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than proving performance against specific acceptance criteria through new testing.
The key statement that clarifies this is:
"No performance testing was required, as no physical changes were made to the devices, the ranges of sizes are comparable to predicate devices with the same indications, and no additional testing is required for the indications modifications proposed."
Therefore, most of the requested information regarding acceptance criteria, performance data, sample sizes, and expert reviews is not applicable or not present in this specific regulatory submission. The substantial equivalence argument relies on the existing clearance of predicate devices and the lack of significant changes to the subject device that would warrant new performance testing.
However, based on the information provided, we can infer some details related to the regulatory pathway and the basis for clearance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Material Composition: | |
| Stainless Steel per ASTM F138 | Device is manufactured from Stainless Steel per ASTM F138 |
| Titanium per ASTM F136 or F1295 | Device is manufactured from Titanium per ASTM F136 or F1295 |
| Technological Characteristics: | |
| Indications for Use identical to predicates | Asserted to be identical to predicates with minor modifications not raising new safety/effectiveness issues. |
| Materials of manufacture identical to predicates | Asserted to be identical to predicates. |
| Principles of operation identical to predicates | Asserted to be identical to predicates. |
| Sizes comparable to predicates | Asserted to be comparable to predicate devices with the same indications. |
| Safety and Effectiveness: | |
| Not raise new issues of safety and effectiveness compared to predicates | Concluded that minor differences do not raise new issues of safety and effectiveness. |
| No physical changes made to the devices | No physical changes were made to the devices. |
| No additional testing required for proposed indications modifications | No additional testing was required for the proposed indications modifications. |
Important Note: The "acceptance criteria" here are inferred from the substantial equivalence argument. The document explicitly states "No performance testing was required," meaning there are no new, specific quantitative performance metrics or studies reported in this submission to meet new acceptance criteria. The criteria for clearance are met by demonstrating equivalence to devices that already met prior acceptance criteria.
2. Sample size used for the test set and the data provenance
- Not Applicable. The document explicitly states: "No performance testing was required." Therefore, there was no 'test set' in the context of new performance data for this submission. The substantial equivalence is based on the characteristics of the device being analogous to already cleared predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As no new performance testing was conducted, there was no test set requiring ground truth established by experts within the scope of this submission. The ground truth for the predicate devices' original clearances would have been established, but that information is not part of this document.
4. Adjudication method for the test set
- Not Applicable. No new test set or performance study was conducted.
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 device is a medical implant (cannulated fasteners and nuts), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a medical implant, not an algorithm or software. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. No new ground truth was established for this submission, as no new performance testing was conducted. The clearance is based on substantial equivalence to predicate devices, which would have had their performance and safety established through various means (including historical usage, engineering principles, and potentially prior testing) during their initial clearance processes.
8. The sample size for the training set
- Not Applicable. This device is a physical medical implant, not an AI or machine learning model that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As explained above, there is no training set for this device.
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(238 days)
Cannula for Organ Perfusion is a single-use device indicated for hypothermic flushing and replacement of residual blood in donor organs with a legally marketed organ preservation solution at the time of organ removal from the donor during the preparation of these organs for transplantation. This device is indicated for use with gravity flow; no testing has been provided for use with pump systems, such as mechanical perfusion devices.
The Cannula for Organ Perfusion is a device designed and intended as a component to an organ perfusion and transport system / organ preservation solution, used in an organ transplantation procedure. The device is a cannula (available in several different sizes) intended for flushing and replacement of residual blood in donor organs with organ preservation solution during the preparation processes of these organs for transplantation. The cannulas are single use, sterile, non-toxic and nonpyrogenic devices. As a component to an organ perfusion and transport system / organ preservation solution, the Cannula for Organ Perfusion is also a Class II medical device, subject to Product Code KDN and MSB, 21 CFR 876.5880: "This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set." (21 CFR 876.5880(a)).
The Cannulas come in multiple sizes, according to the French catheter scale, including 8F, 10F, 12F, 16F (adjustable to 18F with a slidable ring), 20F (adjustable to 28F with a slidable ring), 25F (adjustable to 34F with a slidable ring). In addition, there is a configuration of the cannula that is intended for "back table" procedures, which is available in a 16F size.
This FDA 510(k) submission describes the "Cannula for Organ Perfusion" device. The document primarily focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide a table of acceptance criteria with corresponding performance metrics for the device in the manner typically seen for algorithmic or diagnostic devices. Instead, it relies on bench testing results and biocompatibility testing to demonstrate safety and effectiveness.
Here's a re-interpretation of "acceptance criteria" based on the performed tests:
| Acceptance Criteria (Inferred from tests) | Reported Device Performance |
|---|---|
| Tensile strength (ISO 10555-1) | Pass |
| Leakage and tightness (ISO 10555-1) | Pass |
| Flow rate (ISO 10555-1) | Adequate flow of liquid |
| Sterility (SAL 1 x 10^-6) | Achieved via ETO sterilization |
| Shelf life | Established via real-time aging testing |
| Biocompatibility: Cytotoxicity | Complies with EN ISO 10993-1 |
| Biocompatibility: Sensitizing effect | Complies with EN ISO 10993-1 |
| Biocompatibility: Intracutaneous reactivity | Complies with EN ISO 10993-1 |
| Biocompatibility: Systemic (acute) toxicity | Complies with EN ISO 10993-1 |
| Biocompatibility: Blood compatibility | Complies with EN ISO 10993-1 |
| Biocompatibility: Rabbit pyrogenicity | Complies with EN ISO 10993-1 |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The tests performed are bench tests (tensile strength, leakage, flow rate) and biocompatibility tests, which typically do not involve a "test set" in the context of patient data. The "samples" would be individual units of the cannula. There is no mention of country of origin for any data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/not provided. The device is a physical medical device (cannula) and the tests performed are physical and biological evaluations, not diagnostic or image-based assessments requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable/not provided as there is no "test set" requiring adjudication in the context of this submission. The tests are laboratory-based and measure physical properties or biological responses.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance
This information is not applicable. The device is a physical cannula for organ perfusion, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical cannula, not an algorithm.
7. The Type of Ground Truth Used
This information is not applicable in the traditional sense of a diagnostic device. For the bench tests, the "ground truth" would be the established engineering and ISO standards against which the device performance is measured (e.g., specific tensile strength values for a "Pass"). For biocompatibility, the "ground truth" is compliance with documented biological safety standards like EN ISO 10993-1, which dictate acceptable levels of biological response.
8. The Sample Size for the Training Set
This information is not applicable/not provided. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set.
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(30 days)
The OsteoCentric 2.4mm Cannulated Screw is intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.
The OsteoCentric Trauma 7.0mm and 8.0mm Cannulated Screws are intended for fracture fixation of large bones and large bone fragments, femoral neck fractures, slipped capital femoral epiphyses, as an adjunct to DHS in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, and subtalar arthrodesis.
The OsteoCentric 7.0mm and 8.0mm Cannulated Nut is indicated for fracture fixation where fracture compression is desired, and where insertion of the nut-and-bolt system does not increase the risk of morbidity due to the need for surgical access to both sides of the compressed area. The device may also be used when compression between separate bones is desired (i.e.- the syndesmosis) as long as there is not increased morbidity associated with the insertion of a nut-and-bolt system, as discussed above.
The OsteoCentric Technologies Cannulated Fasteners and Nuts within the product line of the SMV Scientific Cannulated Screws consists of cannulated screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws and nuts are provided non-sterile. The screws and nuts are manufactured from Stainless Steel per ASTM F138 or from Titanium per ASTM F136 or F1295.
The provided text describes a 510(k) premarket notification for "Cannulated Fasteners and Nuts" and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria for a novel AI/ML-based medical device. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not present in this document.
However, I can extract the information related to the performance testing that was conducted to support the substantial equivalence claim.
Here's a summary based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format with corresponding reported device performance values. Instead, it states that "OsteoCentric Technologies has conducted mechanical testing with engineering analyses and geometric comparisons to demonstrate that the modifications to the SMV Scientific Cannulated Screws provide adequate and substantially equivalent mechanical performance (torsional strength, driving torque, and pullout strength) for their intended use." This implies the acceptance criteria were based on demonstrating mechanical performance comparable to the predicate devices.
The reported performance is qualitative, stating that the device provides "adequate and substantially equivalent mechanical performance" for the tested parameters.
Performance Testing Summary
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance (Qualitative) |
|---|---|---|
| Mechanical Strength | Performance comparable to legally marketed predicate devices for their intended use, demonstrating substantial equivalence. (Specific thresholds are not provided in the document). | "adequate and substantially equivalent mechanical performance (torsional strength, driving torque, and pullout strength) for their intended use." |
| Torsional Strength | (Implied: Engineering analysis supports substantial equivalence to predicates.) | Engineering analysis conducted. (Specific values or comparison results are not provided). |
| Pullout Resistance | (Implied: Engineering analysis supports substantial equivalence to predicates.) | Engineering analysis conducted. (Specific values or comparison results are not provided). |
| Driving Torque | Per ASTM F543 (Implied: Results meet or are comparable to predicate performance and standard requirements). | Testing completed per ASTM F543. (Specific values or comparison results are not provided). |
| Cleaning Validation | Per AAMI TIR12:2010 and ANSI/AAMI TIR30:2011 (Implied: Validation demonstrates effective cleaning). | Validation completed. (Specific results or acceptance criteria for cleaning are not detailed). |
| Sterilization Validation | Per AAMI TIR12:2010 (Implied: Validation demonstrates effective sterilization). | Validation completed. (Specific results or acceptance criteria for sterilization are not detailed). |
| Geometric Comparison | Device characteristics (e.g., sizes) are nearly identical to predicates. | "The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates: - Indications for Use - Materials of manufacture - Principles of operation - Sizes" |
Other Requested Information (Not Applicable or Not Provided in this Document)
The document is a 510(k) summary for a standard orthopedic implant (cannulated fasteners and nuts), not an AI/ML-based device. Therefore, the following information is not present or not relevant in this context:
- Sample size used for the test set and the data provenance: Not applicable. The testing described is mechanical, not based on a "test set" of patient data in the AI/ML sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert radiologists assessing images.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical testing, the "ground truth" would be the results obtained from standardized mechanical tests (e.g., peak torque, ultimate tensile strength) and comparison to established engineering specifications or predicate device performance.
- The sample size for the training set: Not applicable (no AI/ML training set).
- How the ground truth for the training set was established: Not applicable.
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(55 days)
The MESA and DENALI Spinal Systems (including ARI Staples) and the EVEREST Spinal System are cleared for the following indications:
Posterior non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion.
Except for the ARI staples, the MESA, DENALI and EVEREST Spinal Systems are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior non-cervical fixation in pediatric patients. The MESA, DENALI and EVEREST Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
This traditional 510(k) premarket notification is to introduce the Cannulated Power Driver Attachment instrument for use with Stryker Power Systems.
The Cannulated Power Driver Attachment is an accessory to the Everest and Range (Mesa and Denali) pedicle screw systems intended to facilitate the insertion of pedicle screws using powered instrumentation. The Cannulated Power Driver Attachment, also referred to as the power adaptor or subject device, serves as a mechanical interface between the power driver and screwdriver instrument. When the adaptor is attached, the driver (corded and cordless) provides appropriate power to rotate screw drivers for the insertion of pedicle screws. No changes have been made to the indications for use of the associated thoracolumbar spinal implant systems Everest and Range (Mesa and Denali) Spinal Systems. The indications for use of each spinal system remain consistent with their most recent 510(k) clearance.
The provided text is a 510(k) summary for the "Cannulated Power Driver Attachment". This document is for a medical device that assists in the surgical insertion of pedicle screws, not an AI/ML-driven device for diagnosis or prediction. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable.
However, I can extract information related to the acceptance criteria and how the device met them.
1. A table of acceptance criteria and the reported device performance
The document states that the "Cannulated Power Driver Attachment Instrument has demonstrated substantial equivalence to the predicate device." It further states: "The performance of the Cannulated Power Driver Attachment has met all acceptance criteria."
While specific numerical acceptance criteria (e.g., torque values, cycles to failure) are not provided in this summary, the general acceptance criteria can be inferred from the context of "substantial equivalence" and "verification and validation activities."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Demonstrated substantial equivalence to the predicate device (K200666 and others). |
| Compatibility with Stryker Power Drivers | Connection to various Stryker Power Drivers does not represent a new worst case for powered pedicle screw insertion. |
| Functionality for Pedicle Screw Insertion | Aids in the rotation of the bone screw to facilitate insertion (when used with Stryker Power Drivers). |
| Mechanical Integrity/Performance | Met all acceptance criteria through Verification and Validation activities. (Specific criteria, e.g., torque, fatigue, not detailed in summary). |
| Material and Design Equivalence | Has equivalent materials, fundamental scientific technologies, and design compared with the predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This device is a mechanical instrument. Testing would involve engineering evaluations (e.g., mechanical stress tests, fatigue tests) rather than data from human subjects or medical images. Therefore, the concepts of "test set sample size" and "data provenance" as typically applied to AI/ML systems are not relevant here. The "test set" would be the manufactured Cannulated Power Driver Attachment instruments subjected to various non-clinical performance evaluations. The number of units tested is not specified.
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)
This is not applicable as the device is a mechanical instrument. Ground truth in this context would be defined by engineering standards and specifications, not expert medical opinion on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a mechanical 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 as this is a mechanical medical instrument, not an AI/ML diagnostic or predictive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable as this is a mechanical medical instrument, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a mechanical device would be established by engineering specifications, validated test methods, and performance benchmarks against predicate devices. The summary indicates that "Verification and validation activities" were conducted to demonstrate that the device "met all acceptance criteria" and "does not represent a new worst case for powered pedicle screw insertion," implying a comparison to established performance characteristics of the predicate device.
8. The sample size for the training set
Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable as this is not an AI/ML device.
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