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The HALLU® -PLATES are intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Examples include:
-Hallux rigidus
-Severe hallux valgus (IM angle > 20° and HV angle > 40°)
-Deformity from rheumatoid arthritis
-Failed previous surgical procedure
-Traumatic arthritis
-Neuromuscular instability.

The HALLU® -PLATES are available in two different designs :

• the HALLU®-C PLATE -
• the HALLU®-S PLATE -
  The HALLU®-C PLATE and the HALLU® -S PLATE are low profile Titanium plates dedicated to first metatarso-phalangeal arthrodesis. Those implants are pre-bent for optimal anatomical adaptation (10° valgus and 10°dorsiflexion). Their fixation is provided by Titanium SNAP-OFF® screws available in a two diameters: 3.0 and 2.7 mm. They exist in different colors for size identification. The bone contact surface is sand blasted in order to maximize plate stability. The range of HALLU -C PLATE and HALLUS S PLATE include 6 sizes ( 31eft/3right) for optimal anatomic fit. Moreover, the HALLU®-S PLATE has an anatomical design providing optimal bone coverage.

The provided text describes a medical device, the HALLU®-PLATES, and its regulatory clearance based on substantial equivalence to predicate devices, rather than a study proving performance against specific acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding AI/software device studies (e.g., sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, ground truth for training) is not applicable.

However, I can extract the information related to the device's testing and the standards it met.

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Breakdown of Applicable Information:

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

• Sample Size: Not explicitly stated as this was a physical device test, not a data-driven software evaluation. The document mentions "Test 1" and "Test 2," implying multiple samples of the plate were tested for bending and fatigue.
• Data Provenance: The tests were conducted to comply with French Standard ISO 9585 and ASTM Standard F-382-99. This implies the tests were performed in a controlled laboratory setting, likely in the country of origin of the sponsor (France) or a qualified testing facility. The study type is experimental/bench testing, not retrospective or prospective human data.

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

• This question is not applicable as the "ground truth" for a physical device test like this is defined by established engineering standards (ISO 9585 and ASTM F-382-99) and the physical properties of the materials and design, not by expert human interpretation.

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

• This question is not applicable for a physical device test. The compliance is determined by measurements against predefined standard thresholds.

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, a MRMC comparative effectiveness study was not done. This is a physical bone plate, not an AI or imaging device that would involve human readers.

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

• Yes, a standalone test was done. The device's performance (bending strength, stiffness, fatigue strength) was evaluated independently against established physical standards. This is analogous to a "standalone" test for a physical product.

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

• The ground truth was based on established engineering standards for bone plates: French Standard ISO 9585 and ASTM Standard F-382-99.

8. The sample size for the training set:

• Not applicable. This device underwent physical bench testing, not a machine learning training process.

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

• Not applicable. As above, there was no training set for a machine learning model.

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The washers are intended to be used to provide additional surface area contact between the screw head and bone surface, when used in combination with bone screws between the occord froution of the mandible, hand, foot and the midfacial skeleton where there exists a condition of a thin cortex or osteoporotic bone.

The Howmedica® and Howmedica® Leibinger Bone Screw Washers consist of sizes ranging from .8 mm internal diameter to 3.5 mm internal diameter. The washers are used in conjunction with screws, of like or similar material, currently available in Luhr® and Leibinger®-Luhr® plating systems, which were cleared under various 510(k) notifications (K761228, K854886, K862482, K862534, K882454, K901941, K913355, K923861, K935448, K950595, K951415, K961485, K961497, K963739, K963740, K970912,) and any future styles of Howmedica® and Howmedica Leibinger® screws found substantially equivalent.

This document is a 510(k) summary for medical devices, specifically bone screw washers. It details the device's intended use, materials, and establishes substantial equivalence to previously cleared devices. However, it does not contain the kind of performance study data, acceptance criteria, ground truth establishment, or sample size details that would typically be found in a clinical study report or a more detailed technical submission for a diagnostic AI/ML device.

Therefore, many of the requested points cannot be answered from the provided text.

Here is what can be inferred or explicitly stated from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance for this type of device (bone screw washers) is based on substantial equivalence to predicate devices in terms of intended use, materials, design, and operational principles.
• Reported Device Performance: Not applicable in the context of diagnostic performance metrics. The document asserts that the device is substantially equivalent to predicate devices.

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

• Sample Size (Test Set): Not applicable. There was no "test set" in the sense of a dataset of patient cases used to evaluate diagnostic performance. The substantial equivalence argument relies on a comparison of device characteristics rather than a performance study on a test set.
• Data Provenance: Not applicable for a performance study. The "data" here refers to the specifications and characteristics of the bone screw washers and their predicate devices.

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

• Not applicable. There was no test set requiring ground truth establishment by experts for diagnostic performance.

4. Adjudication method for the test set:

• Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is not an AI/ML diagnostic device, and no MRMC study was conducted.

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:

• The "ground truth" in this context is the safety and effectiveness of the predicate devices. The device is deemed safe and effective because it is substantially equivalent to devices already cleared for market. This isn't "ground truth" in the diagnostic sense, but rather regulatory precedent.

8. The sample size for the training set:

• Not applicable, as this is not an AI/ML device requiring a training set.

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

• Not applicable.

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