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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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The GraMedica opti-Toe Device is indicated for reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. The GraMedica opti-Toe components are to be cemented in place and assembled for reconstruction of the toe. Patients should protect their weight-bearing only until soft tissue healing has occurred.

The GraMedica opti-Toe is comprised of two mated components (proximal and middle phalangeal) which join together to form a single intramedullary fixation unit. The implants are offered in two sizes, small and large, and the middle phalangeal component is offered with and without a 10 degree angulation.

The document provided is a 510(k) premarket notification from the FDA for a medical device called "opti-Toe". This type of document focuses on establishing substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study. Therefore, the information typically requested in your prompt regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance for AI/ML devices is not present in this regulatory filing.

However, I can extract the non-clinical performance testing information that was conducted to support the substantial equivalence claim for the opti-Toe device.

Here's a summary of the non-clinical performance testing performed:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in a numerical or categorical format for the non-clinical tests. Instead, the testing was performed to demonstrate the device's functional integrity and similarity to predicate devices. The "reported device performance" is the successful completion of these tests.

2. Sample Sizes Used for the Test Set and Data Provenance:

• Cadaveric Simulated Use Study: The document does not specify the number of cadavers used.
• Assembly/Disassembly Force, Static/Dynamic Bending: The document does not specify the number of devices or iterations tested for these mechanical evaluations.
• Data Provenance: The testing was non-clinical (laboratory and cadaveric) and conducted for regulatory submission purposes. No information on country of origin of data or retrospective/prospective nature is applicable as it's not a clinical trial with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. For non-clinical tests like mechanical and cadaveric studies, "ground truth" as it relates to expert consensus on clinical findings is not established. The "ground truth" for these tests would be the measured physical properties and observations of functionality.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods are typically for clinical trials or expert label review, not for non-clinical mechanical or cadaveric testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC study is a type of clinical study generally used for diagnostic devices involving human readers evaluating medical images. This document describes a K-wire equivalent fixation device and its non-clinical testing, so an MRMC study was not conducted or applicable.

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

Not applicable. This device is a physical medical implant (a toe fixation device), not an algorithm or AI system.

7. The Type of Ground Truth Used:

For the non-clinical tests:

• Cadaveric Simulated Use Study: "Ground truth" was the observed functionality and ease of use in a cadaveric model.
• Mechanical Testing (Assembly/Disassembly Force, Static/Dynamic Bending): "Ground truth" was the objective measurements of force and bending properties according to established engineering standards or internal protocols, likely compared against predicate device performance or relevant industry standards for similar devices.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device; therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. As there is no training set for an AI/ML device, this question is not relevant.

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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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The OsteoWedge™ Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction 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 OsteoWedge™ 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 plates are available in six (6) wedge sizes. The fully threaded screws are available in 2 diameters, with numerous lengths.

The OsteoWedge™ Opening Wedge Bone Locking System is a medical device used for stabilizing and/or correcting angular deviations in the bones of the foot. Its acceptance was based on demonstrating substantial equivalence to predicate devices, namely the Arthrex, Inc. Low Profile Plate and Screw System and the Darco International, Inc. DACRO Locking Bone Plate System.

Here's an analysis of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the OsteoWedge™ system were primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices. This involves showing that the new device has the same intended use and technological characteristics as the predicate devices, or if it has different technological characteristics, that it does not raise different questions regarding its safety and effectiveness.

The reported device performance is implicitly that it meets the safety and effectiveness profile equivalent to the predicate devices.

• Bend Testing (Static Four Point Bending & Dynamic Four Point Bending)
• Bending Strength
• Torsion Testing
• Self-Tapping Performance
• Axial Pullout Testing
• Insertion and Removal Testing
• Cleaning and Sterilization Testing
  Conclusion: The submission states that "the differences between the OsteoWedge™ Opening Wedge Bone Locking Plate System and the predicate devices do not raise any questions regarding its safety and effectiveness." |

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not describe a "test set" in the context of clinical data or patient samples. The submission relies on non-clinical (bench) testing to support substantial equivalence.

• Sample Size for Test Set: Not applicable in the context of clinical data. The sample sizes would refer to the number of devices or components tested during the non-clinical mechanical and sterilization tests, but these specific numbers are not provided in the summary.
• Data Provenance: Not applicable for clinical data. The non-clinical testing was conducted to evaluate the device's physical properties and performance against engineering standards. The location or specific context of these non-clinical tests is not detailed beyond being "performed to support substantial equivalence."

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 the submission did not rely on clinical data, expert consensus, or ground truth established by medical experts for a "test set" to prove device performance in a diagnostic or clinical efficacy manner. The assessment was based on engineering and performance characteristics relative to predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable as there was no clinical "test set" requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "Clinical trial or testing was not required for the OsteoWedge™ Opening Wedge Bone Locking System." Since no clinical trials were done, an MRMC study was certainly not performed, and therefore, an effect size of human readers with AI assistance is not relevant.

6. If a Standalone Performance (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a physical bone plate system, not an AI algorithm or diagnostic tool. The concept of "standalone performance" for an algorithm or human-in-the-loop performance is not applicable to this type of medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical testing, the "ground truth" refers to established engineering standards, material properties, and mechanical performance metrics (e.g., bending strength, torsion resistance, pullout strength). These are objective, measurable physical properties, not clinical outcomes or expert interpretations.

8. The Sample Size for the Training Set

Not applicable. This device is hardware and does not involve AI or machine learning, 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 for an AI algorithm, this question is irrelevant to the device submission.

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The HyProCure Subtalar Implant is indicated for use in the treatment of the hyperpronated foot by stabilization of the subtalar joint. The implant is designed to block anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, ground truth establishment methods, expert qualifications, or adjudication methods for a medical device.

The document is a 510(k) clearance letter from the FDA for a device called "HyProCure Subtalar Implant System." It states that the device is "substantially equivalent" to legally marketed predicate devices. It lists the indications for use, but does not include any performance data, study details, or acceptance criteria.

Without this information, I cannot fulfill your request.

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