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Kirschner wires (K-Wires) and Steinmann pins are used for fixation of bone reconstruction, as guide pins for insertion of other implants, or to be implanted through the skin so that traction may be applied to the skeletal system. The pins and wires may be used in the threaded form depending upon the desired application.

Zimmer Kirschner Wires and Steinmann Pins are used for fracture stabilization during the healing process. These wires are available in multiple diameters and lengths and threaded/unthreaded (smooth) versions.

The provided document describes the Zimmer Kirschner Wires and Steinmann Pins and their substantial equivalence to predicate devices, not an AI/ML powered medical device. Therefore, much of the requested information regarding AI/ML study specifics (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this submission.

However, I can extract the relevant information regarding acceptance criteria and performance as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document refers to "the Pins and Wires materials" and "All items in the scope" for testing.
• Data Provenance: Not explicitly stated, however, the testing was conducted per international and national standards (ISO 10993-1, ASTM F366-10, ISO 5838-1) and US Good Laboratory Practices (21 CFR § 58). This implies the testing was performed in a controlled laboratory environment. Retrospective or prospective nature is not applicable as this concerns physical device testing.

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

• Not applicable. This submission pertains to physical medical devices (wires and pins), not an AI/ML algorithm requiring expert ground truth for interpretation. The ground truth is objective measurement against specified standards.

4. Adjudication method for the test set

• Not applicable. See point 3. Testing involves objective measurements and adherence to engineering standards.

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 device.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used

• The ground truth for the performance testing was established by objective technical standards and material specifications. Specifically:
  • Biocompatibility: Conformance to ISO 10993-1 and 21 CFR § 58.
  • Material and Dimensional Properties: Conformance to ASTM F366-10 and ISO 5838-1.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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The Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws are available in several diameters and lengths, in both threaded and non-threaded designs with a variety of point geometries.

The provided text does not contain information about acceptance criteria, device performance, or a study demonstrating that a device meets acceptance criteria. The document is a 510(k) summary for Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws, outlining its indications for use, device description, and substantial equivalence to predicate devices. It also includes an FDA response confirming substantial equivalence.

Therefore, I cannot provide the requested table or answer the specific questions about a study based on the given information.

To answer your request, a document detailing device performance data, acceptance criteria, and specific study methodologies would be required.

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The Treu Bone Fixation Screws and Pins are intended to be used as implants for the fixation of bone fractures, fusion of joints or bone reconstructions or as guide pins for insertion of other implants.

Treu Bone Screws are available in thread diameters ranging from ø1.5 mm to ø7 mm, lengths ranging from 6 mm to 130 mm, are either cannulated or non-cannulated and made of stainless steel or titanium alloy.

Treu Schanz Screws are available in wire diameters ranging from ø3.0 mm to ø6.0 mm, lengths ranging from 60 mm to 350 mm, thread lengths ranging from 20 mm and are made of stainless steel.

Treu Kirschner Wires are available in wire diameters ranging from ø0.8 mm to ø3.0 mm, lengths ranging from 70 mm to 500 mm, are partially or completely smooth or threaded and are made of stainless steel.

Treu Steinmann Pins are available in wire diameters ranging from ø3.0 mm to ø6.0 mm, lengths ranging from 80 mm to 500 mm, are partially or completely smooth or threaded and are made of stainless steel.

Treu Larsen Pins are available in one diameter (ø1.6 mm) and four lengths (60, 80, 100, 120 mm). The head of the pin is 2.5 mm thick and the anchoring hole is ø1.2 mm to facilitate a ø1 mm cerclage wire. The proximal part of the Larsen Pin is prepared for cutting and fits in conventional as well as mini drivers.

The provided document is a 510(k) summary for Treu Bone Fixation Screws and Pins. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through a clinical study with detailed results as often seen with AI/software as a medical device (SaMD) or novel device submissions.

Therefore, the document does not contain the following information typically associated with a study proving acceptance criteria for AI medical devices:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test and training sets.
• Data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study or related effect sizes.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).

Instead, the submission demonstrates substantial equivalence based on:

1. Device Description: Detailed specifications of the Treu Bone Fixation Screws and Pins (materials, dimensions, cannulated/non-cannulated, smooth/threaded).
2. Intended Use: Clearly states the intended use as implants for fixation of bone fractures, fusion of joints, bone reconstructions, or as guide pins for insertion of other implants.
3. Substantial Equivalence to Predicate Devices: Lists several existing legally marketed devices (K983006, K021932, K062103, etc.) from manufacturers like Stryker, Synthes, Darco, DePuy, OsteoMed, and Störk Instrumente. The conclusion states that the Treu devices are substantially equivalent to these predicate devices based on the available information.

In summary, this 510(k) submission for Treu Bone Fixation Screws and Pins relies on demonstrating that the device is as safe and effective as other devices already on the market through substantial equivalence, rather than providing the detailed clinical study information requested for acceptance criteria proof, which is more common for novel technologies or AI/SaMD.

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