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The Patient Assistant model PA97000 initiates the recording of cardiac event data in the device memory of a Medtronic insertable cardiac monitor. The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic.

The PA97000 Patient Assistant (hereinafter referred to as PA97000) is a hand-held, battery operated, Bluetooth Low Energy (BLE) device used by patients to mark symptoms in the memory of their implantable device, as illustrated in Figure 1: Image of PA97000. It is intended for unsupervised use away from a hospital or clinic.

The provided text is a summary of the 510(k) submission for the Medtronic Patient Assistant Model PA97000. It describes the device, its intended use, and the testing performed to support its substantial equivalence to a predicate device. However, it does not contain a table of acceptance criteria and reported device performance in the typical sense of a clinical or analytical performance study with specific metrics like sensitivity, specificity, or accuracy.

The information primarily focuses on design verification and validation, rather than a study with a test set, ground truth, or expert adjudication for determining performance against clinical acceptance criteria.

Therefore, I cannot fulfill all parts of your request as the specific information is not present in the provided text.

Here's what can be extracted based on the document:

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

This information is not explicitly provided in the document in the format requested (specific performance metrics against acceptance criteria). The text states that "Device verification testing was performed to demonstrate the PA97000 meets established performance criteria" but does not detail what those criteria are or the quantitative results against them. The listed tests are primarily engineering design verification and validation.

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

This information is not provided. The text mentions "extensive testing" and "design verification testing" but does not specify sample sizes for any test sets that would typically be used for evaluating clinical or analytical performance.

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 information is not provided. As there's no mention of a clinical or analytical performance study with a test set requiring ground truth, there's no information about experts or their qualifications.

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

This information is not provided for the same reasons as above.

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 device. The Patient Assistant Model PA97000 is a hardware device (a hand-held, battery-operated device) that initiates recording of cardiac event data. It is not an AI-based diagnostic tool, nor does it involve "human readers" in the context of an MRMC study.

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

This is not applicable to this device. It is a physical device, not an algorithm, and its function involves user interaction (a patient pressing a button) to mark symptoms. While it operates "unsupervised" in terms of clinical oversight, it's not an "algorithm-only" performance in the sense of AI.

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

This information is not provided. No clinical or analytical ground truth is mentioned in the context of performance evaluation, as the focus is on engineering verification.

8. The sample size for the training set:

This information is not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

This information is not provided for the same reason as above.

Summary of Device and Testing (from the text):

The device under review is the Medtronic Patient Assistant Model PA97000.

Device Purpose: The PA97000 is a hand-held, battery-operated device that allows patients to mark symptoms in the memory of their implanted cardiac device (an Insertable Cardiac Monitor). It provides feedback to the user about searching for the implanted device and successful symptom marking.

Study Type and Goal (as described): The submission aimed to demonstrate substantial equivalence to the predicate device, Patient Assistant Model PA96000. This was supported by "design verification testing" and "hazard analysis." The primary change from the predicate was an update in the communication protocol from Telemetry B to Bluetooth Low Energy (BTLE).

Tests Performed (Design Verification and Validation):

• Safety Design Verification
• EMC Design Verification
• Environmental Design Verification
• Mechanical Design Verification
• Firmware Design Verification
• Packaging Design Verification
• Security Design Validation
• System Design Validation
• Human Factors Testing
• Biocompatibility

Conclusion of the Submission: The intended use, design, materials, and performance of the PA97000 are substantially equivalent to the predicate PA96000, supported by thorough hazard analysis and extensive testing.

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