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The Model 2872 Lead Adaptor Kit is designed to connect two pacing leads with bipolar connectors (IS-1 Bl)* to a pulse generator featuring a bipolar connector block which meets the IS-1 Bl* standard.

*IS-1 refers to an International Connector Standard (ISO 5841-3; 1992) whereby pulse generators and leads so designated are assured of a basic mechanical fit.

The Model 2872 lead adaptor consists of stainless steel connectors, MP35N conductor coils, and silicone rubber insulation. Also packaged in the kit are wrench / setscrew assemblies, and a tube of medical grade adhesive.

Here's an analysis of the provided K982220 510(k) summary, detailing the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The K982220 submission is for a medical device (Bipolar Lead Adaptor Kit) and the "acceptance criteria" are essentially the performance requirements and specifications that the new device (Model 2872) had to meet to demonstrate substantial equivalence to its predicate device (Medtronic Model 5866-38M Lead Adaptor Kit). The "reported device performance" refers to the results of the tests conducted on the Model 2872.

It's important to note that for this type of device, the "acceptance criteria" are primarily engineering specifications and not diagnostic performance metrics like sensitivity/specificity.

Note on Resistance Criteria: The summary explicitly lists the maximum allowed resistance for the new device as 200Ω for both tip/tip connector block and ring/ring connector block. When comparing to the predicate device, it states the predicate had a maximum of 15Ω for both. This difference is listed as a feature difference, but the submission indicates the new device met its specified requirements, implying the 200Ω was the target for the new device and it achieved it. This suggests a different electrical performance target or design for the new device compared to the predicate, but it was deemed acceptable by Medtronic for substantial equivalence.

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

The 510(k) summary does not explicitly state the sample sizes for the device integrity testing (visual, dimensional, electrical, pull strength, flex life verification). It simply states that "Medtronic, Inc. performed device integrity testing" and "All test results for the device met specified requirements."

Given the nature of bench testing for a lead adaptor, samples would typically consist of a statistically significant number of manufactured units or prototypes to ensure reliability and consistency. However, the exact number is not provided in this summary.

Data Provenance: The studies were performed by Medtronic, Inc., which implies an internal, prospective bench testing approach during the device development and validation process. The country of origin of the data would be the United States, where Medtronic, Inc. is based and where the testing was presumably conducted.

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

This type of information is not applicable to this 510(k) submission. For a device like a pacemaker lead adaptor, "ground truth" doesn't involve expert medical interpretation or diagnosis. Instead, the "ground truth" is established by:

• Engineering specifications and standards: The device must meet predefined electrical, mechanical, and material properties.
• International standards: The device must adhere to standards like ISO 5841-3; 1992 (IS-1).
• Comparison to a legally marketed predicate device: The new device must demonstrate "substantial equivalence" to a device already on the market through performance testing.

Therefore, there are no "experts" in the sense of medical professionals establishing a ground truth for a test set. The validation relies on technical specifications and engineering testing.

4. Adjudication Method for the Test Set

This is not applicable to this 510(k) submission. Adjudication methods like "2+1" or "3+1" are used in clinical studies where multiple experts evaluate patient data (e.g., medical images) and their discrepancies need to be resolved. For bench testing of a device's physical and electrical properties, there's typically no need for such an adjudication process. Test results are either within specification or not.

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

This is not applicable to this 510(k) submission. This device is a passive, implantable medical component (a lead adaptor), not an AI-powered diagnostic tool or a system that involves human readers interpreting data. Therefore, an MRMC study and AI-related performance metrics are irrelevant for this type of device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This is not applicable to this 510(k) submission. There is no algorithm involved in the function of a pacemaker lead adaptor. It is a physical connector.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Engineering specifications and performance standards: The device must meet predefined thresholds for resistance, pull strength, flex life, and dimensional accuracy.
• Compliance with international standards: Specifically, the IS-1 standard (ISO 5841-3; 1992) for basic mechanical fit of pacemaker components.
• Demonstration of substantial equivalence to a predicate device: The predicate (Medtronic Model 5866-38M) serves as the benchmark for acceptable performance and safety.

8. The Sample Size for the Training Set

This is not applicable to this 510(k) submission. The device is not based on a machine learning algorithm; therefore, there is no "training set."

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

This is not applicable for the same reason as above (no training set for a non-AI device).

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