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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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This device is intended for use in internal fixation of small bones including the craniomaxillofacial skeleton and hand secondary to trauma or for reconstruction.

This submission describes self drilling bone screws intended for use in internal fixation of small bones including the craniomaxillofacial skeleton and hand, secondary to trauma or for reconstruction. The Self Drilling Screw is available in 1.2 and 1.7 mm diameters with lengths ranging from 4-7 mm and in a 2.0 mm diameter with lengths ranging from 5-8 mm.

The provided document is a 510(k) summary for the Leibinger® Self-Drilling Screw and the FDA's response letter indicating substantial equivalence. This type of submission is for medical devices and focuses on demonstrating equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria through a standalone study.

Therefore, the information typically requested for AI/device performance studies (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, etc.) is not present in this document. The document highlights the device's intended use, materials, design, and operational principle to establish similarity with predicate devices.

Here's why the requested information isn't available and what the document does provide:

• Acceptance Criteria & Reported Performance: This document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present a study comparing the device's performance against such criteria. The "performance" being evaluated here is primarily whether the new device is substantially equivalent to existing legally marketed devices based on its characteristics.
• Study Details (Sample Size, Data Provenance, Ground Truth, Adjudication, MRMC, Standalone): These are all elements of a clinical or technical performance study, which is not described. The 510(k) pathway often relies on bench testing, material characterization, and comparison to predicate devices rather than de novo clinical performance trials, especially for low-to-moderate risk devices like bone screws, if substantial equivalence can be shown.
• Training Set Information: This product is a physical medical device (a screw), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

Based on the provided text, here is what can be extracted, acknowledging that most of the requested fields are not applicable to this type of regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as numerical performance metrics. The underlying "acceptance criteria" for a 510(k) submission are met if the FDA determines the device is substantially equivalent to a predicate device. This is based on similarities in intended use, materials, design, and operational principles, and that it doesn't raise different questions of safety and effectiveness.
• Reported Device Performance: The document states that "Equivalence for this device is based on similarities in intended use, material, design and operational principle" to the KLS Martin Centre-Drive Drill-Free™ Screw [K944565] and the Leibinger® Luhr Small Bone Screws [K963739, K963740 and K963741]. This is the "performance" shown: it is sufficiently similar to devices already on the market.

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

• Not Applicable. This document does not describe a "test set" in the context of performance evaluation for an AI or diagnostic device. The evaluation is based on device specifications and comparison to predicates.

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

• Not Applicable. No ground truth establishment by experts is described for a performance study.

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

• Not Applicable. No adjudication method is 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:

• Not Applicable. This is a physical bone screw, not an AI-assisted diagnostic device.

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

• Not Applicable. This is a physical bone screw, not an algorithm.

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

• Not Applicable. There is no "ground truth" established for performance evaluation in a clinical study detailed in this document. The "truth" in this context is the FDA's regulatory determination of substantial equivalence based on the provided technical information and comparison to predicate devices.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not an AI algorithm.

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

• Not Applicable. This is a physical medical device, not an AI algorithm.

Summary of what the document does provide:

• Device Name: Leibinger® Self-Drilling Screw
• Intended Use: Internal fixation of small bones including the craniomaxillofacial skeleton and hand secondary to trauma or for reconstruction.
• Device Description: Available in 1.2, 1.7, and 2.0 mm diameters with various lengths. Manufactured from titanium alloy. Self-drilling, one-step insertion.
• Predicate Devices: KLS Martin Centre-Drive Drill-Free™ Screw [K944565] and Leibinger® Luhr Small Bone Screws [K963739, K963740, K963741].
• Basis for Equivalence: Similarities in intended use, material, design, and operational principle.
• Regulatory Outcome: FDA found the device "substantially equivalent" to predicate devices, allowing it to be marketed.

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