(270 days)
The Anscore™ system is intended for use in heart rate variability (HRV) measurements in response to paced respiration and controlled exercises.
The Anscore™ is a cart-based system with a computer-based user interface and data acquisition system for testing, data collection and data transmission for remote processing. The device features a 3 lead ECG and a breathing apparatus, in order to conduct heart rate variability testing. Heart rate variability testing is one of various measurement tools used by physicians in their assessment of autonomic function and dysfunction.
Here's a breakdown of the acceptance criteria and study information for the Boston Medical Technologies, Inc. (BMT) Anscore™ Health Management System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria in a dedicated table format nor does it present specific performance metrics from a new study being reported in this submission for the Anscore™ Health Management System (K993875).
Instead, the submission states:
- "The Anscore™ system is the same as the previously 510(k)-cleared Anscore™ Health Management System and, thus, the results of the performance testing for that cleared system apply to this device."
- "Final testing for the system included various performance tests to confirm compliance with functional requirements and performance specifications."
- "Physiological input was simulated using calibrated instrumentation representative of a range of test subjects and physiological states."
Therefore, based on the provided text, a table can only reflect what is implicitly stated:
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Compliance with functional requirements and performance specifications | Final testing confirmed compliance. Results of prior 510(k) (K991831) are applicable. Physiological input was simulated using calibrated instrumentation. |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Physiological input was simulated using calibrated instrumentation representative of a range of test subjects and physiological states."
- Sample Size for Test Set: Not specified in terms of human subjects. The testing involved "simulated physiological input," implying that a physical test set of human subjects or real patient data was not used for this specific submission's performance claim. Instead, the performance relies on the previous K991831 clearance.
- Data Provenance: Not explicitly stated for this particular submission's performance data, as it refers back to a previous clearance (K991831). The simulation used "calibrated instrumentation."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable, as the testing involved "simulated physiological input" and referenced prior clearance. No human expert consensus for ground truth is described in this document for the performance testing cited.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as no human expert review or adjudication process is described for establishing ground truth in the reported performance testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study is not mentioned in the provided text. The device is for objective physiological measurement (HRV, ECG), not for interpretation by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, the described "performance tests to confirm compliance with functional requirements and performance specifications" using "simulated physiological input" indicate a standalone evaluation of the device's measurement capabilities. The Anscore™ system is an "ECG monitor and Respiration Pacer," suggesting it provides objective data, and the testing focuses on its accuracy and functionality in producing these measurements.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the performance testing, as described, was established through "calibrated instrumentation". This means the "ground truth" was the known, reference values provided by the calibrated instruments simulating physiological inputs.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The Anscore™ system, as described, appears to be a direct measurement device (ECG monitor, respiration pacer for HRV) rather than an AI/ML algorithm that requires a training set. The technical characteristics state it uses "the same monitoring technology" as predicates. Therefore, no training set for an AI component is mentioned or implied.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as no training set for an AI component is mentioned.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).