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BIOTRONIK BK Series Sealing Caps are single-component silicone devices, designed to be safe and effective through design functionality, simplicity and material biocompatibility. BK Sealing Caps are designed to be chronically implantable.
Here's an analysis of the provided text in the context of your request:
It's important to note that the provided text is a "Safety and Effectiveness Summary" from an FDA 510(k) submission for a medical device (BIOTRONIK BK Series Sealing Caps). It's a regulatory document, not a scientific study report in the traditional sense. Therefore, many of the details you're asking for, such as sample sizes for training/test sets, number of experts, and MRMC studies, are not directly applicable or present in this type of document.
The document focuses on demonstrating substantial equivalence to predicate devices and adherence to established standards, rather than proving the device meets performance metrics in the way an AI algorithm's performance would be evaluated.
Here's an attempt to answer your questions based on the provided text, while also highlighting what information is not available given the nature of the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Derived from text) | Reported Device Performance |
|---|---|
| Material Biocompatibility: Material "extensively used" and "cleared" by FDA in prior submissions. "Thoroughly tested for biocompatibility", "commonly used in many market-released Class III products", "acute and chronic biocompatibility tests performed", "long-term implantation studies". | Material: Silopren LSR-4070. All production and biocompatibility test results were "within specifications". No risks in excess of comparable competitor caps or older BIOTRONIK caps. |
| Ease of Use: | Tested for ease of use. (Pass, implied by "within specifications") |
| Withstand Ligature Application: | Tested for ability to withstand ligature application. (Pass, implied by "within specifications") |
| Potential Fluid Leakage: | Tested for potential fluid leakage. (Pass, implied by "within specifications") |
| Adherence to IS-1 Standards: | Tested for adherence to IS-1 standards. (Pass, implied by "within specifications") |
| Packaging and Transportation Durability: | Performed to ensure quality. (Pass, implied by "within specifications") |
| Sterilization Validation: | Performed to ensure sterility. (Pass, implied by "within specifications") |
| Safety Data: No known adverse safety and effectiveness data on these accessories. No articles related to safety in literature search. | "BIOTRONIK is not aware of any other adverse safety and effectiveness data on these accessories." Literature search "yielded no articles related to the safety of pacemaker lead sealing caps." |
| Effectiveness (Implied): Designed to be "safe and effective through design functionality, simplicity". "Chronically implantable". | (Effectiveness is demonstrated through meeting the above criteria and through substantial equivalence to predicate devices with established effectiveness). |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the individual tests (ease of use, ligature, leakage, IS-1 adherence, etc.).
- Data Provenance: Not specified. Given it's a 510(k) for a US market, it's presumed the tests were conducted under controlled laboratory or engineering conditions by the manufacturer (BIOTRONIK). The material was previously cleared in other FDA submissions, implying acceptance within US regulatory framework.
- Retrospective/Prospective: Not applicable in the context of these engineering and safety tests. Biocompatibility tests would have been prospective studies (animal or in-vitro) at the time of their original clearance. Long-term implantation studies mentioned would have been prospective at the time they were conducted for the material's initial clearance.
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. The ground truth for these types of engineering/material tests is established by objective measurements against predefined specifications (e.g., a specific leakage rate limit, a defined force a ligature must withstand, specific biochemical reactions in biocompatibility tests). There is no "expert ground truth" in the diagnostic sense here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study requiring adjudication of human-interpreted results. Test results would be objective measurements against established criteria.
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 medical accessory (sealing cap for pacemaker leads), not a diagnostic AI algorithm or an imaging device interpreted by human readers.
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 (expert consensus, pathology, outcomes data, etc)
- Ground Truth: For the various tests (ease of use, ligature, leakage, IS-1, durability, sterilization, biocompatibility), the ground truth is based on pre-defined engineering specifications, international standards (IS-1), and validated protocols for material and device testing. For biocompatibility, it would be established by scientific consensus on what constitutes a safe biological response (e.g., lack of cytotoxicity, sensitization, irritation, etc.).
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device. The concept of a "training set" does not apply.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this type of device.
Summary of what the document implies about "studies":
The document refers to various tests and validations rather than "studies" in the clinical trial sense. These include:
- Biocompatibility tests: Acute and chronic, conducted for the material (Silopren LSR-4070) previously.
- Long-term implantation studies: Also conducted for the material.
- Product-specific tests: For ease of use, ligature application, fluid leakage, and IS-1 standards adherence.
- Quality assurance: Packaging and transportation durability, sterilization validation.
The "study that proves the device meets the acceptance criteria" is, in essence, the culmination of these engineering, material, and validation tests, all of which "were within specifications." The primary "proof" for regulatory purposes in a 510(k) is often the demonstration of substantial equivalence to predicate devices, leveraging their established safety and effectiveness, combined with direct testing of the current device against relevant standards and specifications.
§ 870.3620 Pacemaker lead adaptor.
(a)
Identification. A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions.”