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The Forma Medical Optimal Plating System is intended for fixation of fractures, osteotomies, arthrodeses, and bone reconstructions in adult patients with normal or osteopenic bone. Indications include flat (scapula), long (clavicle, upper and lower extremities including metacarpals, and phalanges), irregular (pelvis, hand, foot) bones and joints (wrist, ankle). The Forma Medical Optimal Plating System is not indicated for ribs, sternum, spine, or the skull.

The Forma Medical Optimal Plating System is designed to hold bones in relative stability for fracture fixation and arthrodesis. The plates and screws are available in multiple sizes based on patient anatomy and clinical application. The screws are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F67, F136, F1537, and F138. The plates are manufactured from titanium, titanium alloy, or stainless steel, as specified in ASTM F67, F136, and F138. The system includes plates, screws and instruments. The system instrumentation is manufactured from stainless steel, aluminum, and other surgical grade materials.

The provided text describes mechanical testing performed to demonstrate substantial equivalence for the Forma Medical Optimal Plating System. It does not contain information about an AI/ML-enabled device or a study involving human readers. Therefore, many of the requested fields are not applicable.

Here's the relevant information:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size (number of screws or plates) used for each mechanical test. Data provenance (country of origin, retrospective/prospective) is not applicable for mechanical testing of a physical device.

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. Ground truth for mechanical testing is established by engineering standards and measurement, not expert consensus.

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

Not applicable. Adjudication methods are relevant for subjective assessments, not for objective mechanical testing.

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 device is a physical bone fixation system, not an AI-enabled diagnostic tool.

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

Not applicable. This device is a physical bone fixation system, not an AI-enabled diagnostic tool.

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

The ground truth for the mechanical testing is based on established engineering standards (ASTM F543-23, ASTM F382-17) and an analytical formula (Chapman analytical formula for pullout strength).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable. This is a physical device, not an AI model.

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Forma Medical Headless Compression Screws are indicated for fixation of intra-articular and extra articular fractures, avulsions, non-unions, and osteotomies of small bone fragments; as well as arthrodesis of small joints.

Forma Medical Headless Compression Screws are designed to hold bones in relative stability for fracture fixation and arthrodesis. The screws are available in multiple diameters and lengths based on patient anatomy and clinical application. The screws are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1537, and F138. The system includes screws and instruments. The system instrumentation is manufactured from stainless steel, aluminum, and other surgical grade materials.

The provided text is a 510(k) summary for the Forma Medical Headless Compression Screw. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

It does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance, specifically regarding AI/ML device performance or human reader improvement.

The document solely focuses on demonstrating substantial equivalence based on technological characteristics and mechanical performance compared to predicate devices. It mentions mechanical testing per ASTM F543 for torsional strength, insertion/removal torque, and pullout strength. However, it does not provide specific acceptance criteria values or detailed results of these tests.

Therefore, it is not possible to answer the user's request based on the provided text. The request asks for details about acceptance criteria and a study proving "the device meets the acceptance criteria," implying a performance study, likely clinical, which is entirely absent from this 510(k) summary for a mechanical orthopedic implant.

To reiterate, the document details:

• Device name and indications for use.
• Comparison of technological characteristics (classification, regulation, product code, indications for use, description, material, lengths, cannulation) between the Forma Medical screw and several predicate devices.
• Mention of mechanical testing (torsional strength, insertion/removal torque, pullout strength per ASTM F543) to support substantial equivalence.

It does not contain information regarding:

• A table of acceptance criteria with reported device performance values.
• Sample sizes for a test set or data provenance.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes for human reader improvement with AI.
• Standalone algorithm performance.
• Types of ground truth (expert consensus, pathology, outcomes data).
• Training set sample size.
• How ground truth for the training set was established.

These specific points are relevant to AI/ML software as a medical device (SaMD) clearances, not directly to a mechanical orthopedic implant like a compression screw where the focus is on mechanical and material equivalence.

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