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510(k) Data Aggregation
(142 days)
Small Cannulated Screws (2.5mm - 4.0mm diameter) are intended for fixation of fractures and non-unions of small bones and small bone arthrodeses. Examples include, but are not limited to scaphoid and other carpal and phalangeal fusions, osteotomies, and bunionectomies.
Large Cannulated Screws (4.5mm – 7.5 mm diameter) are intended for fracture fixation of large bones and large bone fragments. Diameters 6.5 mm and larger are intended for large bone fragments such as slipped capital femoral epiphyses; pediatric femoral neck fractures; tibial plateau fractures; SI joint disruptions; intercondylar femur fractures; subtalar arthrodesis and fixation of pelvis and iliosacral joint.
The OrthoPediatrics Cannulated Screw System is a cancellous screw system intended for the use in the fixation of bone fragments. The subject Cannulated Screw System is composed of cannulated screws offered in a variety of sizes and options to accommodate patient anatomy, as well as washers and associated instrumentation to facilitate or aid in placement of the subject screws. The cannulated design of these screws allows them to be used in combination with a guide wire, also included in this system, for precise placement into bone. The included Bone Screw Washers provide optional increased stabilization between the screw head and cortical bone. All subject screws and washers are manufactured from medical grade stainless steel per ASTM F138. All instruments are manufactured from stainless steel per ASTM F899, with the exception of the guide wires, which are manufactured from cobalt chrome per ASTM F562.
This document does not describe an AI/ML powered device, therefore, the requested information elements related to AI/ML device performance and testing are not applicable.
The document describes the OrthoPediatrics Cannulated Screw System, a medical device for bone fixation. The provided text outlines the regulatory submission, intended use, device description, and a summary of technological characteristics compared to predicate devices to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text, indicating where information is not available due to the nature of the device (not an AI/ML product) or the submission type (510(k)):
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-Clinical Tests (Mechanical Properties) | The subject device was tested for mechanical properties relevant to bone screws. The specific acceptance criteria (e.g., minimum torque values, maximum pullout forces) are not explicitly stated in the summary. However, the reported performance indicates that: "Testing demonstrated the subject device to be substantially equivalent to predicate Synthes Cannulated Screws (K963172 and K012945) devices." This implies that the device met the performance levels expected to be equivalent to the predicate devices. Testing included: - Torque to Failure per ASTM F543 - Driving Torque per ASTM F543 - Axial Pullout per ASTM F543 |
| MR Environment Compatibility | "The OrthoPediatrics Cannulated Screw System was evaluated for use in an MR Environment and were determined to be MR Conditional." (This indicates it met the criteria for MR Conditional labeling, though the specific criteria are not detailed in this summary.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the sample size for the non-clinical mechanical tests. It only mentions the types of tests performed.
- Data Provenance: The mechanical testing data would typically be generated in a lab setting, likely in the country of manufacture or a designated testing facility. The specific country or whether the data is retrospective/prospective is not mentioned. Given it's pre-market testing for a physical device, it would be considered prospective testing for the device's design.
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 physical bone screw system, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth for its performance evaluation in the context of this 510(k) submission. Mechanical testing relies on standardized test methods (e.g., ASTM standards) rather than expert consensus on data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical device undergoing mechanical performance testing. Adjudication methods are relevant for studies involving human interpretation of data, such as in imaging or clinical trials.
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 physical medical device (cannulated screw system), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical performance data, the "ground truth" is established by adherence to standardized testing methods (e.g., ASTM F543) and quantifiable physical properties. There is no expert consensus, pathology, or outcomes data used as "ground truth" for the performance evaluation of the device itself in this submission. The "ground truth" for substantial equivalence lies in demonstrating that the mechanical properties are comparable to legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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(133 days)
The OsteoMed ExtremiFix Mid & Large Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, and fracture fixation of foot, ankle, and long bones (upper and lower extremity). The screws are intended for single use only. The system drills and guide wires are single use instruments.
The OsteoMed ExtremiFix Mid & Large Screw System is a rigid fixation system consisting of screws in both cannulated and solid versions, all of which are available in various overall and distal thread lengths to accommodate specific patient anatomies. The headed and headless compression screws are made of biocompatible Ti 6-Al 4-V Titanium Alloy. Longer sizes of the single-use only implants are provided individually sterile packed, while the majority of screws and all instruments are provided in modules to allow for customization specific to the surgical indication. The system includes washers for use with 4.5mm, 5.5mm, 6.5mm and 7.0mm headed screws. The washers are made of biocompatible Titanium Alloy. The OsteoMed ExtremiFix Mid & Large Screw System is sterilized in a sterilization tray which is available from OsteoMed.
The provided text describes the OsteoMed ExtremiFix Mid & Large Screw System, a bone fixation device. It details the performance data presented to the FDA for substantial equivalence, which primarily relies on bench testing and biocompatibility evaluation. It explicitly states that no clinical studies or animal studies were performed to demonstrate safety and efficacy. Therefore, the concept of "acceptance criteria" and "device performance" in the context of clinical outcomes, expert adjudication, or human reader improvement with AI assistance, as outlined in the request, is not applicable to this submission.
The acceptance criteria and performance are related to the mechanical properties and biocompatibility of the screws, compared to predicate devices.
Here's the information parsed from the document, tailored to the available data:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (based on comparison to predicate) | Reported Device Performance | Comments |
|---|---|---|
| Required mechanical strength criteria for intended use | Met required mechanical strength criteria | Demonstrated through verification testing against predicate devices. |
| Performed equal or better than predicate devices | Performed equal or better than predicate devices | Demonstrated through verification testing. |
| Biocompatibility standards (ISO 10993-1) | Conforms to ISO 10993-1 requirements | Evaluated for cytotoxicity, sensitization, irritation, systemic toxicity, sub-chronic toxicity, genotoxicity, implantation, and pyrogen testing. |
| ASTM F-136 for chemical composition | Conforms to ASTM F-136 | Applies to the Titanium alloy implant material. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated for each bench test. However, the testing was conducted on samples of the OsteoMed ExtremiFix Mid & Large Screw System.
- Data Provenance: The document implies in-house laboratory testing ("Verification testing was conducted") as part of the submission to the FDA. No geographical origin or retrospective/prospective nature of the performance testing is specified beyond it being non-clinical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. The ground truth for this device's performance was established through standardized engineering bench tests and material characterization, not human expert interpretation or adjudication.
4. Adjudication method for the test set
- Not Applicable. As the performance evaluation was based on objective physical and material tests, there was no adjudication method involving human experts.
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. This is a medical implant (bone fixation screw system), not an AI-powered diagnostic device. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a medical implant, not an algorithm or software. The device itself (the screws) is the "standalone" component in the context of its physical function.
7. The type of ground truth used
- Bench Test Results and Material Standards: The ground truth was based on the objective measurements from bench testing (e.g., force, strength, torque, pullout) and compliance with established material standards (e.g., ASTM F-136 for Titanium alloy) and biocompatibility guidance (ISO 10993-1).
8. The sample size for the training set
- Not Applicable. This device does not involve a training set as it is not an AI/machine learning product. Performance was assessed through direct testing and comparison to predicate devices, not through a learning algorithm.
9. How the ground truth for the training set was established
- Not Applicable. (See #8).
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(168 days)
InFix Cannulated Screw System is generally intended for fracture fixation of various bones and bone fragments, such as femoral neck, intercondylar femoral, malleolus, pilon tibial, calcaneus, talus, tibial plateau, tarsal, wrist, metacarpal, carpal, scaphoid and radius fracture. InFix Cannulated Screw System is also intended for fixation arthrodesis, iliosacral dislocations, and hallux valgus corrections.
Accessories implants:
The round washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone.
The InFix Cannulated Screw System includes eight cannulated screw specifications and associated washers, which are manufactured from stainless steel and titanium alloy. The cannulated screw is a self-tapping and self-drilling screw with a cancellous thread that can be guided into a position via a guided wire. They are used to aid in the alignment and stabilization of fractures to the skeletal system.
Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:
This document is a 510(k) premarket notification for the InFix Cannulated Screw System, which is a Class II medical device. The primary purpose of this submission is to demonstrate substantial equivalence to existing predicate devices, rather than to prove de novo safety and effectiveness through extensive clinical trials.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biomechanical Testing (ASTM F543) | Self-tapping performance | Results indicate substantial equivalence to legally marketed devices. |
| Torsional strength | Results indicate substantial equivalence to legally marketed devices. | |
| Axial pullout strength | Results indicate substantial equivalence to legally marketed devices. | |
| Driving torque | Results indicate substantial equivalence to legally marketed devices. | |
| Cleaning Validation | AAMI TIR30:2011 guidance requirements | Test result shows that the acceptance criteria is met. |
| Sterilization Validation | ANSI/AAMI/ISO 17665-1 requirements | Test result shows that the acceptance criteria is met. |
Details Regarding the Study and Acceptance Criteria:
This submission relies heavily on non-clinical tests to demonstrate substantial equivalence. Clinical effectiveness studies as one might find for a novel AI device are not presented here because this is a hardware medical device for which the FDA determination is about substantial equivalence to already approved devices. Therefore, the "acceptance criteria" here are largely benchmarks against the performance of predicate devices and adherence to recognized standards.
2. Sample size used for the test set and the data provenance:
- Biomechanical Test: The document states "The biomechanical tests ASTM F543 were performed". It does not specify the exact number of screws or test samples used for each performance metric (self-tapping, torsional, axial pullout, driving torque).
- Cleaning Validation & Sterilization Validation: Similarly, the document does not specify the number of samples used for these validation tests.
- Data Provenance: Not explicitly stated, but typically these tests would be conducted in a laboratory setting by the manufacturer or a contracted lab. The tests are non-clinical, so "country of origin of the data" in terms of patient demographics is not applicable. These are prospective tests performed to meet regulatory requirements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this context. For a hardware device demonstrating substantial equivalence through non-clinical testing, ground truth is established by objective engineering measurements against specified physical properties and performance standards (e.g., ASTM F543). There isn't a need for expert consensus on an interpretation of an output, as would be the case for an AI diagnostic device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 are used for expert review of images or data to establish a ground truth or resolve discrepancies in diagnostic labeling. This is not relevant for biomechanical or validation 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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices or software that assists human interpretation. The InFix Cannulated Screw System is a physical bone fixation device, not a diagnostic tool or AI-assisted product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant. The concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the biomechanical tests (ASTM F543), the "ground truth" is established by engineering standards and direct physical measurements. The performance of the InFix Cannulated Screw System is compared against the known performance characteristics of the predicate devices and the requirements of the ASTM standard.
- For cleaning and sterilization validations, the "ground truth" is adherence to the specified industry standards (AAMI TIR30:2011 and ANSI/AAMI/ISO 17665-1).
8. The sample size for the training set:
- Not applicable. This device is hardware and does not involve machine learning or AI, and therefore has no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for this hardware device, there is no ground truth to be established for it.
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(54 days)
Cortical Screws are intended for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula.
Large Cannulated Screws (4.5mm diameter and larger) are intended for fracture fixation of large bones and large bone fragments. Diameters 6.5mm and larger are intended for large bones and large bone fragments such as femoral neck fractures; slipped capital femoral epiphyses; tibial plateau fractures; ankle arthrodeses; pediatric femoral neck fractures; intercondylar femur fractures; and subtalar arthrodeses.
Small Cannulated Screws (4.0mm diameter and smaller) are intended for fixation of fractures and non-unions of small bones and small bone arthrodeses. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.
Cannulated screws are machined, metallic screws with a cannulation that are self drilling and self tapping, which can be guided into position by a guide wire.
Cortical and cancellous screws are machined, metallic screws and are self tapping.
All screws utilize a hex shaped recess that accepts a standard hex drive. Each type is offered in a variety of diameters and lengths, as well as short, medium, and fully threaded options.
Materials: The devices are manufactured from 316L Stainless Steel which meets ASTM F138 standards.
Function: Bone screws functions are to provide immediate stability and temporary fixation during the natural healing process.
The provided text is a 510(k) premarket notification for OrthoPediatrics Bone Screws. It primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than presenting a study against specific acceptance criteria for the new device's performance.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria.
Key reasons for this include:
- 510(k) Premarket Notification Focus: A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device) and does not require premarket approval (PMA). This is typically achieved by demonstrating "substantial equivalence," not by conducting new clinical studies or setting and meeting new performance acceptance criteria for the device itself.
- Lack of Performance Data: The document describes the device, its materials, function, and indications for use. It lists predicate devices. However, there is no mention of specific performance metrics (e.g., strength, durability, fatigue life, accuracy) for the OrthoPediatrics Bone Screws, nor any study data (sample sizes, ground truth, expert opinions) that would demonstrate the device meets such criteria.
- No Mention of AI/Algorithm: The context of "AI," "test set," "training set," "experts," "adjudication," "MRMC," and "standalone algorithm performance" strongly suggests a request related to an AI/Machine Learning device. The OrthoPediatrics Bone Screws are described as machined, metallic screws, which are physical hardware devices, not software or AI-driven systems.
In summary, this document is for a medical device (bone screws) seeking market clearance through substantial equivalence, and as such, it does not include performance studies with acceptance criteria in the manner described for software or AI-based diagnostic/assistive devices.
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(62 days)
Synthes Large Fragment DCL is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of osteopenic bone and fixation of non-unions or malunions.
The Large Fragment DCL system consists of limited-contact profile plates in broad and narrow sizes, which include combination dynamic compression/locking screw holes. The plates accept 4.5 mm cortex, 6.5 mm cancellous, 4.5 mm cannulated, 7.0 mm cannulated, and 5.0 mm locking screws. This device is manufactured in either stainless steel or titanium.
Synthes DCL System is a plate and screw system intended to treat fractures of various long bones. The primary feature of this system is limited-contact profile and the combination dynamic compression/locking screw holes. The standard screws facilitate reduction and create compression between the plate and bone, while the locking screws form a locked, fixed angle construct with the plate.
The DCL System includes both broad and narrow straight plates. The broad plates are 5.2 mm thick, 17.5 mm wide and are available in lengths ranging from 121 mm - 409 mm (6 - 22 screw holes). The narrow plates are 4.2 mm thick, 13.5 mm wide and are available in lengths ranging from 49 mm - 409 mm (2 - 22 screw holes). The screw holes are combined to allow placement of standard 4.5 mm cortex, 6.5 mm cancellous and 4.5 mm and 7.0 mm cannulated screws on one side of each hole, or 5.0 mm threaded conical, locking screws on the opposite side. The holes are uniformly spaced along the length of the plate. The holes are oriented so that the compression component of the holes is always directed towards the middle of the plate.
The DCL System utilizes a locking feature that screw to the plate, enabling unicortical or bicortical screw purchase. This feature consists of conical shaped, threaded locking screw holes in the plates that correspond with the conical- shaped, threaded head of the screw.
The 5.0 mm locking screws feature self-tapping tips, flat head profiles with rounded edges, and are available in lengths from 14mm to 90mm. The threads just below the head of each locking screw engages with the threaded side of the holes in the DCL plate. The engagement of these screws to the plate creates a locked, fixed angle construct.
The provided document is a 510(k) premarket notification for a medical device, the Synthes Large Fragment Dynamic Compression Locking (DCL) System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and detailed study results as one might find for novel devices or drugs.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
Here's why and what information is provided:
-
Acceptance Criteria and Reported Performance: The document does not specify quantitative acceptance criteria or a study designed to measure the device's performance against such criteria (e.g., a specific threshold for bone healing rates, reduction in non-union incidence, or mechanical stability in a clinical setting). Instead, it focuses on demonstrating that the device is
- Identical or similar in intended use: "fixation of various long bones..."
- Identical or similar in technological characteristics: "limited-contact profile plates... combination dynamic compression/locking screw holes... manufactured in either stainless steel or titanium... utilizes a locking feature that screw to the plate..."
- Raises no new questions of safety or effectiveness: This is implied by the comparison to predicate devices and adherence to material standards.
-
Study That Proves the Device Meets Acceptance Criteria: There is no description of such a study. The 510(k) process relies heavily on:
- Comparison to Predicate Devices: The document explicitly lists "Synthes Broad and Narrow Dynamic Compression Plates" and "Synthes Anatomical Locking Plate System" as predicate devices (Page 0, Section Predicate Device). On Page 3, Section 12.0, it states: "A comparison of Synthes' DCL System to Synthes Broad and Narrow Dynamic Compression Plates and Synthes Anatomical Locking Plate System follows." This comparison is the primary "proof" of substantial equivalence.
- Material Standards: The device is manufactured from 316L stainless steel, commercially pure titanium, and Titanium - 6% Aluminum - 7% Niobium (Ti-6Al-7Nb), all of which adhere to specific American Society for Testing and Materials (ASTM) standards (F 139, F67, F 1295, respectively) (Page 1, Section 7.0). Adherence to these standards is intended to ensure biocompatibility and mechanical properties similar to already approved devices.
- Sterilization Validation: Moist heat sterilization parameters have been validated using AAMI guidelines to provide a sterility assurance level (SAL) of 10^-6 (Page 1, Section 8.0). This addresses a critical safety aspect.
In summary, the provided text describes a regulatory submission (510(k)) that does not include the detailed clinical study information you are asking for. It focuses on demonstrating substantial equivalence to existing devices rather than presenting novel performance data against pre-defined acceptance criteria.
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