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The osteo-WEDGE II ® Open Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.

The osteo-WEDGE II® Open Wedge Bone Locking Plate System consists of plates and screws and incorporates a screw-to-plate locking mechanism. The plate is attached to a prepared surface of the involved bone(s) of the foot using six (6) screws for fixation. The fully threaded screws are available in 2 diameters, with numerous lengths and previously cleared under K111326.

The provided text describes the 510(k) premarket notification for the "OsteoWedge II Open Wedge Bone Locking Plate System." This document primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance testing. It does not describe an AI/ML-based medical device. Therefore, many of the requested categories related to AI/ML device evaluation (like sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this submission.

Here's a summary of the information that is available in the provided text, structured to address the relevant points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable. This submission details non-clinical, mechanical testing of a medical implant, not an AI/ML device that uses patient data as a test set. The testing involved mechanical components (plates and screws).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. Ground truth, in the context of expert review, is not relevant for the mechanical performance testing described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication is not relevant for the mechanical performance testing described.

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 not an AI/ML device; therefore, no MRMC study was conducted.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done

• No. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. The "ground truth" for this device's performance would be the physical properties and mechanical behavior of the materials and design, evaluated against engineering standards (like ASTM F382-99(2008)), rather than clinical outcomes or expert labels.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device; there is no "training set."

9. How the ground truth for the training set was established

• Not Applicable. This is not an AI/ML device; there is no "training set."

Study that proves the device meets the acceptance criteria:

The study that proves the device meets the acceptance criteria is termed "Non-Clinical Performance Testing" in the document.

• Description: "Non-clinical testing was performed to demonstrate the change of the plate geometry is substantially equivalent to other predicate devices."
• Specific Tests Performed: "Static and dynamic four-point bending testing per ASTM F382-99(2008)."
• Conclusion: Based on this testing, the "OsteoWedge II Open Wedge Bone Locking Plate System is shown to be substantially equivalent to legally marketed predicate devices."

The provided text is a 510(k) clearance letter and an associated summary for a Class II metallic bone fixation appliance. It explicitly details that the submission is based on demonstrating "substantial equivalence" through non-clinical, mechanical performance testing to legally marketed predicate devices, not through clinical trials or AI/ML algorithm evaluation.

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HyProCure II (HYP II and HYP IIs) is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion.

The HyProCure II is an implant which stabilizes the talus on the tarsal mechanism. The system consists of an implant designed to be inserted into the sinus tarsi and corresponding instrumentation to facilitate insertion.

This document is a 510(k) summary for the HyProCure II device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment is not present in the provided text.

Here is an attempt to address the points based only on the provided text, with clear indications where the information is missing:

1. A table of acceptance criteria and the reported device performance

Based on the document, direct acceptance criteria and reported device performance in the context of a formal study with quantitative metrics are not provided. The document states:

2. Sample sized 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: Not applicable/Not provided. The document explicitly states: "Non-clinical data was not necessary to show substantial equivalence." This implies a performance study (with a test set) comparing the device to performance criteria was not conducted for this 510(k) submission.
• Data Provenance: Not applicable/Not provided.

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, as no traditional test set requiring expert ground truth was mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided, as no traditional test set requiring expert adjudication was mentioned.

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 MRMC study was mentioned. The device, HyProCure II, is a physical implant (sinus tarsi implant), not an AI-powered diagnostic tool, so such a study would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not provided, as no traditional test set requiring ground truth was mentioned. The basis for safety and effectiveness is substantial equivalence to a legally marketed predicate device.

8. The sample size for the training set

• Not applicable/Not provided. The device is a physical implant and does not involve machine learning algorithms that require a training set.

9. How the ground truth for the training set was established

• Not applicable/Not provided, as there is no training set for this type of device.

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