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K Number
K021472
Device Name
HMS-DHR-3 NEUROMUSCULAR STIMULATOR
Manufacturer
HOME MEDICAL SERVICES
Date Cleared
2002-08-06

(90 days)

Product Code
IPF
Regulation Number
890.5850
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

THE INDICATIONS FOR USE OF THIS DEVICE FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS :

  • Relaxation of muscle spasms
  • Prevention or retardation of disuse atrophy
  • Increasing local blood circulation
  • Muscle re-education
  • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
  • Maintaining or increasing range of motion
Device Description

Not Found

AI/ML Overview

This FDA 510(k) clearance letter for the HMS-DHR-3 Neuromuscular Stimulator is for a Class II medical device (Powered Muscle Stimulator, 21 CFR 890.5850). The letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

Crucially, this document is a regulatory clearance letter and does not contain the detailed study information typically found in a clinical trial report or a scientific publication. As such, I cannot extract the information required to answer your questions about acceptance criteria and the study that proves the device meets those criteria from this text alone.

The information you are requesting would typically be found in the 510(k) submission itself, or in supplementary documents referenced within it. This letter primarily confirms the regulatory status and allowed indications for use.

Therefore, many of your specific questions about study design, sample sizes, ground truth establishment, and expert qualifications cannot be answered based on the provided text.

Here is what I can infer from the document and general 510(k) understanding:

  1. A table of acceptance criteria and the reported device performance: This information is not present in the provided letter. 510(k) submissions typically involve demonstrating that a new device is "substantially equivalent" to a predicate device. This often involves showing comparable performance, safety, and efficacy, which might include specific performance metrics, but these are not enumerated here.

  2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in the provided text.

  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): Not available in the provided text.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in the provided text.

  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: Not applicable. This device is a neuromuscular stimulator, not an AI-powered diagnostic imaging device. Therefore, MRMC studies involving human readers and AI assistance would not be relevant.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is hardware, not a standalone algorithm.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available in the provided text. For a neuromuscular stimulator, ground truth might relate to objective physiological measurements (e.g., muscle contraction force, nerve conduction studies, range of motion improvements) or patient-reported outcomes, but the specifics are not detailed here.

  8. The sample size for the training set: Not applicable and not available. This is not an AI/machine learning device that would typically have a "training set."

  9. How the ground truth for the training set was established: Not applicable and not available.

Conclusion:

This FDA 510(k) clearance letter details the regulatory approval of the HMS-DHR-3 Neuromuscular Stimulator for specific indications based on substantial equivalence to a predicate device. It does not contain the detailed performance data, study design, or ground truth methodologies that are requested. This information would be found in the full 510(k) submission, which is not provided here.

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).