(127 days)
The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates the data management features in the Reveal Family of Insertable Cardiac Monitors (ICM) to initiate recording of cardiac event data in the implanted device memory.
The Patient Assistant is a handheld, battery-operated, radio-frequency device used to communicate with the Reveal Insertable Cardiac Monitors. It utilizes Medtronic's Telemetry B protocol for communication. The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates one or more of the data management features in the Reveal Insertable Cardiac Monitor. The Patient Assistant's function is to mark symptomatic episodes in the implanted device memory.
The provided text describes a 510(k) premarket notification for the Medtronic Patient Assistant Model PA96000. It focuses on demonstrating substantial equivalence to a predicate device (Patient Assistant Model 9538 - K103764).
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list acceptance criteria in a quantitative table with corresponding reported device performance metrics. Instead, it describes various verification and validation tests and states that the device "meets established performance criteria" or "performs as intended."
However, we can infer some criteria and reported performance from the "Summary of Testing and Performance data" section:
| Acceptance Criteria (Implied) | Reported Device Performance | Study Type/Location in Document |
|---|---|---|
| Hardware functions according to specification. | All tests passed. "The results provide verification evidence that requirements in PA96000 Hardware Requirements Specification met the acceptance criteria as set per those requirements." | Hardware Verification Testing (Page 5) |
| Firmware operates per specification and meets Level of Concern (Major). | All firmware testing successfully completed. "The analysis and testing performed demonstrates the firmware as identified operates per specification." | Firmware Verification Testing (Page 5) |
| Mechanical design meets input requirements. | All testing passed. "Mechanical Design Verification has been completed showing the product design output meets its design input requirements... All testing was completed and passed." | Mechanical Design Verification Testing (Page 5) |
| Meets environmental requirements. | All testing passed. "The testing performed demonstrates the PA96000 meets its environmental requirements." | Environmental Verification Testing (Page 5) |
| Enables users to mark symptomatic events without hazardous use errors. | 100% of participants completed tasks without hazardous use errors. "90% of representative users with appropriate training were able to mark a symptomatic event." "Deemed safe and effective for use." | Human Factors Testing (Page 5) |
| Biologically safe for patient contact. | Biological safety demonstrated. "This biological evaluation report demonstrates the biological safety of the PA96000 Patient Assistant." | Biocompatibility Testing (Page 6) |
| Packaging integrity meets standards. | All packaging tests passed. "The PA96000 Patient Assistant product packaging... passed all aspects of the package testing and is acceptable for use as intended." | Packaging Verification Testing (Page 6) |
| Overall system operates per design input requirements. | All system validation testing successfully completed. "The analysis and testing performed demonstrates the PA96000 operates per the Design Input Requirement Specification." | System Validation (Page 6) |
2. Sample Sizes Used for the Test Set and Data Provenance
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Human Factors Testing:
- Sample Size for Test Set: 20 participants (Page 5).
- Data Provenance: Not explicitly stated, but the study was conducted by Medtronic, Inc. It's likely from a US population, and the nature of the testing suggests it was prospective as participants were recruited for the study.
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No other specific sample sizes for test sets (e.g., for hardware, firmware, mechanical, environmental, biocompatibility, packaging, or system validation) are provided in terms of "cases" or "data provenance" as one might expect for a clinical study. These are typically engineering verification tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies described are primarily engineering verification and human factors testing, not clinical studies requiring independent expert ground truth establishment for a diagnostic output. For the human factors study, the "ground truth" would be the successful completion of tasks and lack of use errors, which is assessed by the study design and observers.
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies for establishing ground truth for diagnostic devices by reconciling differences in expert opinions. This document describes a device primarily focused on communication and data activation, not diagnostic interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable/provided. The device described is a "Patient Assistant" for an Insertable Cardiac Monitor (ICM), intended to "activate the data management features... to initiate recording of cardiac event data." It is not an AI-powered diagnostic tool that assists human readers (e.g., radiologists, cardiologists) in interpreting medical images or signals. Therefore, an MRMC study or AI-assistance improvement metric would not be relevant in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable/provided in the context of an "algorithm only" performance as it pertains to AI/diagnostic devices. The Patient Assistant is a physical device that interacts with an ICM; its "performance" is about its functionality (e.g., communication, battery life, mechanical integrity, usability) rather than an isolated algorithm's diagnostic accuracy. The firmware testing could be considered "standalone" in that it verifies the software's performance against specifications, but it's not in the sense of a standalone diagnostic algorithm.
7. The Type of Ground Truth Used
For the various verification and validation tests:
- Hardware, Firmware, Mechanical, Environmental, System Validation: The "ground truth" is adherence to design input requirements and established performance specifications (e.g., "operates per specification," "meets environmental requirements," "meets established performance criteria").
- Human Factors Testing: The "ground truth" is successful task completion and the absence of hazardous use errors as determined by observers and predefined criteria of the study design.
- Biocompatibility: Adherence to ISO 10993-1 standards for biological safety.
- Packaging: Adherence to ASTM D-4169 standards for package integrity.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. The device described is a hardware patient assistant with firmware, not a machine learning or AI algorithm that requires a "training set" of data for development. The studies mentioned are verification and validation of engineering design and human factors, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for the same reasons as point 8.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.