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Stimulator Mode: The Stellar Model HS-04 stimulator mode is indicated for use in repeatedly contracting muscles using pulsed electrical currents for muscle reeducation, maintaining or increasing range of motion, relaxing muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, and immediate post-surgical prevention of venous thrombosis in the calf.

Interferrential Mode: The Stellar Model HS-04 interferrential mode is indicated for use in post-surgical acute pain and edema, post-traumatic acute pain and edema, reduction of inflamation, increasing local blood circulation, maintaining or increasing range of motion, and relaxing muscle spasms.

Heating Mode: The Stellar Model HS-04 heating mode is indicated for heating of a body region for the relief of minor muscular or joint pain.

The Stellar Model HS-04 is a device that combines the functionality of two devices that have been classified by FDA, the powered muscle stimulator and the powered heating pad. Heat and muscle stimulation are often used at the same time by physical therapists and others to treat patients, and the HS-04 provides both therapies with a single combination device for convenience. The heating elements are contained in the same applicators that hold the stimulation electrodes.

The provided document is a 510(k) summary for the Stellar Model HS-04, a combined powered electrical stimulator and heating pad. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study for a diagnostic AI/ML device would. Instead, the focus is on demonstrating substantial equivalence to legally marketed predicate devices through technological characteristics and safety testing.

Here's a breakdown of the requested information based on the provided text, and where gaps exist because the document is a 510(k) summary for a physical medical device, not an AI/ML algorithm:

Acceptance Criteria and Device Performance

The document does not explicitly define acceptance criteria in the typical numerical performance metric sense (e.g., sensitivity, specificity, AUC) for an AI/ML device. Instead, acceptance for the Stellar Model HS-04 is based on substantial equivalence to predicate physical devices and compliance with safety standards.

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance:

   • N/A. The document does not describe a "test set" in the context of evaluating an AI/ML algorithm's performance on a dataset of patient cases. The evaluation is focused on the physical device itself.

2. 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):

   • N/A. This type of expert review for establishing ground truth on a dataset is not relevant to a 510(k) submission for a physical medical device like the Stellar Model HS-04.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • N/A. Not applicable as there is no "test set" in the AI/ML sense.

4. 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:

   • No. An MRMC study is not mentioned. This type of study is specifically designed for evaluating the impact of AI on human reader performance, which is not applicable to a physical stimulator/heating pad.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • N/A. The device is a physical, user-operated therapeutic device, not a standalone algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • N/A. "Ground truth" in the context of a dataset for an AI/ML algorithm is not applicable here. The "truth" for this device's efficacy and safety is implicitly assumed by its substantial equivalence to previously cleared devices for similar indications and by compliance with electrical safety standards.

7. The sample size for the training set:

   • N/A. The concept of a "training set" is not relevant for this type of device submission.

8. How the ground truth for the training set was established:

   • N/A. Not applicable, as there is no training set mentioned.

Summary of the "Study" (or Testing) that Proves the Device Meets Criteria:

The "study" or testing described in the K973223 submission is primarily focused on electrical safety testing and comparison of technological characteristics to predicate devices to establish substantial equivalence.

• Testing Information (Section F):

  • The Stellar Model HS-04 is undergoing electrical safety testing by an independent laboratory to assure compliance with UL-2601.
  • The manufacturer (KMC Systems) committed to not marketing the device until these electrical safety certifications are successfully completed.

• Substantial Equivalence (Section D & E):

  • The core of the submission is a detailed comparison of the HS-04's technological characteristics (power, stimulation waveforms, heating elements, pulse rate, intensity, pulse width, applicator pad design) with those of the predicate devices (RS Medical Model RS-4M, Staodyn EMS + 2, and PT-PAC Portable Heating Pad).
  • The argument is that these characteristics are "the same as those of the predicate devices" or "precise enough to ensure equivalence," thus demonstrating that the new device is as safe and effective as the legally marketed predicate devices.

Conclusion:

This 510(k) submission relies on a combination of demonstrating substantial equivalence to previously cleared devices based on technological characteristics and committing to successful completion of electrical safety testing (UL-2601) rather than a formal performance study with acceptance criteria and ground truth in the manner of an AI/ML device.

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