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This submission (K950550) asserts substantial equivalence to existing devices rather than defining specific performance-based acceptance criteria for the XH-1 itself. The "study" presented is a comparison to a predicate device (Myopulse) and other 510(k)-cleared devices to demonstrate similar technical features.

1. Table of Acceptance Criteria and Reported Device Performance

No.	Item	Acceptance Criteria (Predicate/Comparable Device Feature)	Reported Device Performance (XH-1)
1	Frequency	0.9 Hz (Myopulse); Adjustable to 1 Hz (K850013, K893878, K893879)	0.9 Hz
2	Biphasic Wave without Direct Current	Biphasic wave without direct current (Myopulse)	Equivalent
3	Wave Form	Similar (Myopulse)	Similar
4	Pulse Peak Output Voltage & Current (10,000 ohms load)	+90V, -115V; +9mAmp, -11.5mAmp (Myopulse)	+110V, -110V; +11mAmp, -11mAmp
5	Output Frequency Fixed	Fixed (Myopulse)	Equivalent
6	Output Pulse-Width Fixed under Constant Resistant Load	Fixed (Myopulse)	Equivalent
7	Interpulse Rest Time	Approximately 1.1 second (Myopulse); Adjustable to 1-second off time (K893878, K893879, K926510)	Approximately 1.1 second
8	Continuous Output at 0.9 Hz	Continuous output at 0.9 Hz (Myopulse); Adjustable to continuous output (K840346, K926510)	Continuous output
9	Average Output Current (10,000 ohms load)	0.013 mAmp (Myopulse)	0.18 mAmp
10	Electrical Consumption / Battery Life	One 9V battery, 350 hours operation (Myopulse)	Two AA batteries, 3V, 700 hours operation
11	Electrode Coupling Medium	Sponge moistened with water (Myopulse)	Paper towel moistened with water
12	Function: to relax muscle spasm	To relax muscle spasm (Myopulse)	Equivalent
13	History of Clinical Usage	Since 1968 to present (Myopulse)	Since 1987 to present
14	Adverse Effects	Equivalent (Myopulse)	Equivalent
15	Proprietary Name (e.g., Neuromuscular Stimulator)	Equivalent proprietary names (K840346, K926510)	Equivalent

Note: For items marked "Equivalent" or "Similar" in the original table, the "Acceptance Criteria" column reflects the predicate device's characteristic that the XH-1 claims equivalence to. For quantifiable metrics, the predicate's value is listed as the implicit "acceptance criterion." Specific 510(k) numbers are cited where indicated in the second comparison chart.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. The submission does not describe a clinical "test set" in the traditional sense, but rather a comparison of technical specifications. No human subjects or patient data are presented.
Data Provenance: The data provenance is from the technical specifications of the XH-1 device itself, and the comparison is made against the technical specifications of the Myopulse Neuromuscular Stimulator (a preamendment device) and other 510(k) cleared devices (K840346, K850013, K893878, K893879, K926510). This is not retrospective or prospective clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable. No "ground truth" for a test set was established by experts in this submission. The comparison is based on published technical specifications and claims of equivalence made by the submitter (Dr. Laiyin Yan).
Qualifications of Experts: Dr. Laiyin Yan (alias Fa Lin) from the California Medical Research Institute is the signatory of the submission. The submission references "the Federal Engineering department associated with the National Electric Code and according to the State of California OSHA Consultation Group" as sources for the "Equivalent*" notation for average output current, suggesting consultation with these bodies. However, these are not "experts establishing ground truth for a test set" in the context of clinical performance.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There was no test set or clinical data requiring adjudication. The comparison is a direct technical feature-by-feature evaluation against predicate devices.

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

MRMC Study: No. This submission pertains to a neuromuscular stimulator and does not involve imaging or AI assistance for human readers.

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

Standalone Performance: Not applicable. The XH-1 is a physical medical device (neuromuscular stimulator), not an algorithm or AI system. Its "performance" is based on its electrical output characteristics.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" in this context refers to the established technical specifications and performance characteristics of the predicate device (Myopulse) and other cleared 510(k) neuromuscular stimulators. These are official device clearances and product specifications rather than expert consensus, pathology, or outcomes data. The claim of "equivalence" is the primary "truth" being established based on these technical comparisons.

8. The Sample Size for the Training Set

Sample Size: Not applicable. There is no concept of a "training set" for this type of device submission. The device's design and manufacturing are presumably based on established engineering principles for neuromuscular stimulation.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable. As there is no training set, there is no ground truth for a training set to be established.

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