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The KLS-Martin Sternal Talon is intended for use in stabilization and fixation of anterior chest wall fractures including Sternal Fixation subsequent to Sternotomy and Sternal reconstructive procedures.

The KLS-Martin Sternal Talon is a two-piece clamping device with various foot depths and lengths that utilizes a ratcheted locking system. Each piece of the device is placed on opposing sides of the sternum and is designed to interlock providing a stabilized fixation thus allowing for various sternal widths. The device has a three position screw which allows the ratchet to open, close and lock. In an emergency situation, the device can be reopened by turning the screw to the open position. A second emergency re-entry is provided by cut points adjacent to the screw. The KLS Martin Sternal Talon is manufactured from TI-6AL-4V Titanium Alloy

Here's an analysis of the provided text regarding the KLS Martin Sternal Talon, focusing on the acceptance criteria and supporting study information.

It's important to note that the provided documents (a 510(k) summary and FDA clearance letter) are for a medical device (implant), not a software algorithm or AI model. Therefore, many of the typical questions for AI performance studies (like sample sizes for test/training sets, ground truth establishment by experts, MRMC studies, or standalone algorithm performance) are not applicable here. The "acceptance criteria" for a medical device involve demonstrating substantial equivalence to a predicate device through engineering tests and material properties, rather than diagnostic accuracy metrics.

1. Table of Acceptance Criteria and Reported Device Performance

• Utilizes a ratcheted locking system.
• Three-position screw (open, close, lock).
• Emergency re-entry (turning screw to open, cut points).
• Interlocking design for stabilized fixation. | Device description confirms these features. (Implied successful functioning based on substantial equivalence) |
  | Biocompatibility | (Not explicitly stated as a test in the summary, but implied by material choice and predicate comparison) | Usage of Ti-6Al-4V Titanium Alloy, a commonly accepted biocompatible material for implants. |
  | Mechanical Strength/Fixation | (Not explicitly detailed as a specific test in the summary, but implied necessity for sternal fixation) | Designed to "interlock providing a stabilized fixation" and "apply pressure medially to ensure fixation." Substantial equivalence to predicate suggests comparable mechanical performance. |

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

This is not applicable as the submission is for a medical device (implant), not a diagnostic algorithm. There is no "test set" in the context of an AI performance study. The evaluation is based on material properties, design, and comparison to legally marketed predicate devices.

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

Not applicable. Ground truth for a medical device like this is established through engineering principles, material science, and regulatory standards, not by expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" requiring adjudication in this type of submission.

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 not an AI or diagnostic algorithm, so no MRMC study was performed.

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" for this medical device submission is centered around:

• Substantial Equivalence: The primary ground truth is the demonstration that the KLS Martin Sternal Talon is "substantially equivalent" in intended use, indications for use, technological characteristics, and safety/effectiveness to existing, legally marketed predicate devices (e.g., Ethi-Pack Surgical Stainless Steel Suture, Pioneer Silicoat Sternal Cable, PectoFix DSF System, Synthes Sternal Fixation System, Sternal Band, Lorenz Sternal Closure System, KLS Martin Sternal Plating System).
• Material Science and Engineering Principles: The use of Ti-6Al-4V Titanium Alloy is a fundamental "ground truth" for biocompatibility and mechanical strength in implantable devices.
• Regulatory Standards: Compliance with relevant FDA regulations for Class II devices (21 CFR 888.3030) implies adherence to established safety and performance benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is not an AI or algorithm that requires a training set.

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

Not applicable. There is no training set for this type of medical device submission.

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