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• AV conduction disorders or intraventricular paroxysmal/permanent conduction disorders with permanent atrial tachycardia: atrial fibrillation or flutter (lead implanted in the ventricle),
• Sinus bradycardia, sinoatrial block, brady-tachy syndrome without atrioventricular conduction disorder (lead implanted in the atrium).

Opus S, Model 4121 and 4124 are single-chamber programmable pacemakers. The electronic circuit and battery are encapsulated in a hermetic titanium case. Pacing leads are connected through a medical grade silicone elastomer connector. The different functions are assured by a hybrid circuit with passive components and integrated circuits (microprocessor and custom circuit). The programmer system consists of a programming head, programmer software, and an IBM-compatible PC.

The provided text describes the safety and effectiveness information for the ELA Medical Opus S Model 4121 and 4124 pacemakers, which are single-chamber SSI pacemakers. The document details the device description, comparison to predicate devices, potential adverse effects, and a summary of studies conducted to ensure its performance.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them:

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

The document does not explicitly present a table of "acceptance criteria" alongside specific numerical "reported device performance" in the way one might expect for a quantitative clinical study. Instead, it describes various "Tests" conducted under different "Test groups." The general statement, "All test results demonstrated that the established pass / fail criterion was met in all cases," indicates that the devices successfully passed the acceptance criteria for each test.

Below is a table summarizing the test groups and the types of tests performed. The "Acceptance Criteria" for these are implied to be success in passing the specific validation or performance standards relevant to each test type (e.g., proper mechanical function, electrical isolation, sterility). The "Reported Device Performance" is the overarching statement that all criteria were met.

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

The document comprehensively lists various in-vitro functional testing performed on the Opus S Model 4121 and 4124 pacemakers. However, it does not specify the sample sizes used for these in-vitro tests (e.g., how many units were subjected to thermal shock, how many connectors were tested). It also does not mention the country of origin of the data or whether the tests were prospective or retrospective. Given that these are in-vitro functional tests, they would inherently be prospective.

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)

This type of information (number and qualifications of experts for ground truth) is typically relevant for studies involving human interpretation or clinical endpoints (e.g., image analysis, disease diagnosis). The studies described here are primarily in-vitro functional and environmental tests for a medical device (pacemaker). Such tests rely on engineering specifications, standardized protocols, and instrument measurements rather than expert human interpretation for "ground truth." Therefore, this information is not applicable to the described verification and validation activities.

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

Similar to point 3, adjudication methods (like 2+1 or 3+1 consensus) are typically used in studies where there's subjectivity in determining ground truth (e.g., reviewing medical images). For the in-vitro functional and environmental tests described, the 'truth' is determined by whether the device's performance meets pre-defined engineering specifications and standards. There is no mention of an adjudication method as it would not be relevant for these types of objective functional 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

The document describes the verification and validation of a pacemaker, which is an implantable electronic device, not an AI-powered diagnostic tool requiring human reader assistance. Therefore, no MRMC comparative effectiveness study was performed or is applicable to this device. This information is irrelevant in the context of pacemaker approval.

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

This question is also generally related to AI algorithms. While the pacemaker itself functions in a "standalone" manner within the patient, and its software (implant and programmer) underwent validation, the concept of "standalone performance" in the context of an "algorithm only without human-in-the-loop performance" typical for AI diagnostics does not directly apply here. The device's performance is its intrinsic function, which was verified through extensive testing as detailed. There isn't an "algorithm" in the sense of a predictive model being assessed for its diagnostic accuracy.

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

For the in-vitro functional and environmental tests conducted on the pacemaker, the "ground truth" is established by engineering specifications, international standards (e.g., for EMI, ESD, vibration), and predefined pass/fail criteria derived from the device's design requirements. For example, for "Electrical Isolation," the ground truth is a measurement confirming that certain leakage currents or resistance levels are not exceeded. For "Sterilization Process Validation," the ground truth is evidence of sterility (e.g., via biological indicators) after the process. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for these specific tests. Biocompatibility was handled by relying on predicate device history, which implicitly references previous outcomes data and regulatory acceptance.

8. The sample size for the training set

The document describes the verification and validation of manufactured devices, not the development of an AI model that requires a "training set." Therefore, this information is not applicable. The "training" for such a device effectively happens during its design and manufacturing process, using engineering principles and established requirements.

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

As there is no training set in the context of AI/machine learning for this device, the question of how its ground truth was established is not applicable.

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