(90 days)
The XYZ System is intended for biofeedback for relaxation and re-education of muscles.
The XYZ System contains 5 major parts. The Analog to Digital Housing with Isolation Ampitifiers and Isolated Power, the Analog to Digital Housing with Issac De Amplifiers an Housing with Isolathon Ampilliers and Toulater Converter, the IBM-PC compatible computer and XYZ Software.
Here's an analysis of the provided text regarding the XYZ System's acceptance criteria and studies:
Analysis of the Provided Text (K983550 Summary):
The provided document is a 510(k) summary for the "XYZ System." A 510(k) submission is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on proving that a new device meets specific, pre-defined quantitative performance acceptance criteria through extensive clinical trials.
Based on the provided text, the application does not detail specific acceptance criteria in terms of quantitative metrics (e.g., sensitivity, specificity, accuracy) for device performance in biofeedback or relaxation. Instead, it focuses on demonstrating equivalence to the predicate device, emphasizing safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, the document does not present quantitative acceptance criteria in the typical sense (e.g., statistical thresholds for clinical performance). The "acceptance criteria" here are implicitly tied to demonstrating equivalence to the predicate device and meeting safety/performance standards.
| Acceptance Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (as stated in the K983550) |
|---|---|
| Intended Use Equivalence: Biofeedback for relaxation and re-education of muscles. | Meets: "The XYZ System is substantially equivalent in intended use... as the J&J Physicdata 1-330 System, K#945826. Both devices have the same intended use..." |
| Indication Statements Equivalence: Biofeedback, Relaxation Training, and Physiological Monitoring. | Meets: Identical to predicate. |
| Effectiveness Equivalence: Device is effective for its intended use. | Meets: States "Effective" (derived from predicate's effectiveness). |
| Personal Safety Equivalence: Device is safe. | Meets: States "Safe" (derived from predicate's safety). |
| Hardware Instrumentation: Use of J&J 1-330 Amplifier Modules (or equivalent performance). | Meets: "Uses same J&J 1-330 amplifier modules, as well as, CapScan EEG/EMG amplifier." |
| Software Program/Features: Similar auditory/visual representations of signals, data recording. | Meets: "Similar" software program and "None" for difference in software features. |
| Performance Standards Met: Electrical isolation (UL-544), software validation. | Meets: "Performance standards met include UL-544 (electrical isolation), software validation requirements and testing procedures for the multi-channel isolation board." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The document explicitly states "Not Applicable" for "Discussion of Clinical Tests Performed." The non-clinical tests performed relate to hardware and software validation, not a test set for clinical performance evaluation.
- Data Provenance: Not applicable for clinical test data. Non-clinical testing would have been conducted by the manufacturer (Ele-Monitoring International Corporation).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No clinical tests or expert ground truth establishment for a clinical test set were reported.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set or adjudication was reported.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, a "multi reader multi case (MRMC) comparative effectiveness study" was not done or reported in this 510(k) submission. The document clearly states "Not Applicable" for clinical tests.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm performance study was not explicitly reported in terms of specific performance metrics. The software validation mentioned is for functional correctness and safety, not for standalone clinical performance evaluation against a specific ground truth. The device is a biofeedback system, implying human-in-the-loop interaction rather than a standalone diagnostic or interpretative algorithm.
7. The Type of Ground Truth Used
- For the non-clinical tests (electrical isolation, software validation), the "ground truth" would be the applicable engineering standards (e.g., UL-544 requirements) and the pre-defined software specifications. This is not clinical ground truth (e.g., pathology, expert consensus).
8. The Sample Size for the Training Set
- Not applicable. This device is a biofeedback system, not an AI/ML algorithm that typically requires a 'training set' for model development in the sense of image analysis or diagnostic prediction. The "software" in this context refers to the operating system and processing of biofeedback signals, not a learned model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no mention of a training set for an AI/ML model for this device.
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.