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BK-N Sealing Caps are intended for use as components of cardiac pacing systems. BK-N Sealing Caps provide a permanent barrier of silicone insulation between the electrical conductive elements of the implantable therapeutic device lead(s) or adapter(s) and the physiological environment. BK-N Sealing Caps are designed to accommodate lead diameters of 4F, 5F and 7F.

BIOTRONIK BK-N Sealing Caps are single-component silicone devices, designed to be safe and effective through design functionality, simplicity and material biocompatibility. BK-N Sealing Caps are designed to be chronically implantable. The material of construction is Silopren LSR-4070.

I am sorry, but the provided text does not contain the specific information required to complete the table and answer all the questions regarding acceptance criteria and a study proving device performance.

The document is a 510(k) submission for the BIOTRONIK BK-N Sealing Cap, focusing on its substantial equivalence to previously marketed devices and changes in material. While it discusses the device's design, materials, and some testing, it does not present a detailed study with acceptance criteria and reported device performance in the format requested.

It mentions that "All production and biocompatibility test results were within specifications," but it does not elaborate on what those specifications (acceptance criteria) were or provide specific quantitative results of the tests.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:

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

Missing Information for the Table: No specific quantitative acceptance criteria or corresponding quantitative performance results are provided in the document for any of these tests. The document only broadly states that results were "within specifications."

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The document mentions tests were performed by BIOTRONIK, suggesting internal testing, but details like location or whether it was retrospective/prospective are not present.

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 to the type of testing described (material and functional engineering tests). This information is typically relevant for studies involving subjective human assessment (e.g., image interpretation).

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

• Not applicable for the type of testing described (material and functional engineering tests).

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

• No, a TRMC comparative effectiveness study was not done. This type of study is not relevant for this device. The document describes engineering and biocompatibility testing for a physical implantable component, not a diagnostic AI system or a system requiring human interpretation.

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

• A standalone performance assessment was done in the sense that the device itself was subjected to various tests (biocompatibility, electrical insulation, extraction force, etc.) without human interaction as part of its functional performance evaluation. However, this is not a "standalone algorithm performance" in the context of AI.

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

• The "ground truth" for the tests mentioned (biocompatibility, electrical insulation, etc.) would be established by engineering specifications, industry standards, and regulatory requirements for such medical devices, along with validated laboratory test methods and equipment. For example, a successful biocompatibility test would mean the material elicited no unacceptable biological response according to established standards.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. This is not an AI/machine learning device.

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