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The Polarus Cap Screw is intended to be used in conjunction with the Polarus Humeral Rod. It engages the 5.0 mm proximal screw in the rod to prohibit / minimize the screw from backing out and to prohibit the in growth of bone into the 1/4-20 hole.

The Polarus Cap Screw is intended to be used in conjunction with the Polarus Rod family cleared under K920666 and K951740. Its purpose is to engage the proximal-most 5.0 interlocking screw in the rod 10 prohibit/minize backing out of that screw and to prohibit ingrowth of bone into the 1/4-20 hole. The Polarus Cap Screw is manufactured from two different materials. The cap is manufactured from a titanium alloy per ASTM F 136 and the tip portion is manufactured from medical grade polyethylene per ASTM F 648. The Polarus Cap Screw is provided sterile and is packaged in inner and outer PETG blisters with Tyvek lids. Sterility is achieved by a minimum of 2.5 megarads gamma radiation. Verification of sterility is performed using the AAMI - Method 1. Sterility assurance level is 104. We make no claims as to the pyrogenicity of this product. Instrumentation is provided nonsterile in a tray. On file at Acumed is data which shows that the instrumentation can be successfully steam sterilized under specific process parameters which will obtain a resulting SAL of 104.

This appears to be a 510(k) premarket notification summary for a medical device called the "Polarus Cap Screw." It explicitly states that the safety and effectiveness of the device are expected to be similar based on substantial equivalence to predicate devices, rather than on an independent study demonstrating specific acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving those criteria are met, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth methodologies.

Here's a breakdown of why the requested information cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance: This document does not establish specific acceptance criteria for the Polarus Cap Screw in terms of performance metrics. Instead, it relies on substantial equivalence.

2. Sample sized used for the test set and the data provenance: No test set or data provenance is mentioned because no independent performance study is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no independent study with a test set and ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 device is a physical medical implant, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate devices to which the Polarus Cap Screw is deemed substantially equivalent.

8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does state regarding demonstrating safety and effectiveness:

• Methodology: Substantial equivalence to legally marketed predicate devices.
• Predicate Devices:
  • Set screw for the Howmedica Vitallium IM Device
  • Ace Medical AIM Titanium Humeral Nail System's end cap
  • Alta IM Rod's cap screw
  • Synthes Titanium Solid Humeral Nail System's end cap
• Basis for Equivalence: Similarities in indication, intended use, material (titanium), design, and size.
• Sterilization: The device is provided sterile via a minimum of 2.5 megarads gamma radiation, with sterility verification using AAMI - Method 1 to achieve a Sterility Assurance Level (SAL) of 10^-4.
• Instrumentation Sterilization: Instrumentation is provided non-sterile but can be successfully steam sterilized under specific process parameters to achieve an SAL of 10^-4.

In conclusion, this 510(k) summary (K013616) demonstrates the device meets regulatory requirements through substantial equivalence to existing devices, not through a new performance study with defined acceptance criteria, test sets, or ground truth as typically found for diagnostic or AI-driven devices.

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