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The HF54 interferential therapy and premodulated therapy is indicated for: Pain relief for: Symptomatic relief of chronic intractable pain and/or management of traumatic or post surgical pain.

Ultrasound therapy is available from the HF54 and indicated for: Applying therapeutic deep heat within body tissues for the treatment of selected chronic and sub-chronic medical conditions such as: Relief of pain joint contractures This can be done using One or two ultrasound applicators. The second ultrasound applicator is optional. Ultrasound therapy, either alone or in combination with interferential therapy or premodulated therapy can be used in a scanned manner (where the therapist moves the applicator) or for specific treatment areas identified in the operator's manual, the applicator can be used in a hands-free manner (where the applicator remains stationary).

An Infrared Therapy Probe is available as an optional accessory (HF023) for use with the Hill Laboratories HF54 Combination Ultrasound Interferential and premodulated stimulation system or for stand-alone use with an optional external medical grade, isolated power supply. It is used to provide topical heating for: Temporary increases in local blood flow and circulation. Temporary relief of minor muscle and joint aches Temporary relief of pain and stiffness Relaxation of muscles. Temporary relief (or relaxation) of muscle spasms. Temporary relief of minor pain and stiffness associated with arthritis

The HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with optional hands-free operation is a device that provides ultrasonic diathermy, interferential current therapy, and infrared lamp therapy. It can be used with one or two ultrasound applicators, and the ultrasound therapy can be applied in a scanned or hands-free manner. An optional infrared light probe is also available.

The provided 510(k) summary for the Hill Laboratories HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with optional hands-free operation (K072256) does not describe a study involving a test set, expert adjudication, MRMC comparative effectiveness, or stand-alone algorithm performance in the typical sense of a clinical trial or algorithm validation study for diagnostic devices.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K062256) by affirming compliance with mandatory and consensus standards, and by performing risk analysis for the expanded indication of "hands-free" operation for ultrasound. The "acceptance criteria" here refer to safety thresholds and compliance with established performance standards for similar medical devices.

Here's an breakdown based on the provided text, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a "test set" in the context of clinical data or images. The "tests" mentioned are primarily engineering and electrical safety measurements (e.g., thermal measurements, pulsed output analysis) for the device itself.

• Sample Size: Not applicable in the context of a clinical test set. The measurements were likely performed on a single or a small number of device units.
• Data Provenance: The measurements related to thermal output and standing waves were conducted internally by Hill Laboratories, likely in a laboratory setting. This is a technical validation, not clinical data from patients.

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

Not applicable. Ground truth, in the sense of expert consensus on clinical diagnoses or outcomes, is not described as part of this submission. The "ground truth" for the engineering performance aspects would be the physical laws and measurement standards.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This submission is for an expanded indication for a physical therapy device, focusing on safety and technical equivalence rather than a diagnostic or screening efficacy study involving human readers.

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

Not applicable. This device is a physical therapy equipment, not an AI algorithm for diagnosis or image analysis. Its operation inherently involves a human operator (therapist). The "hands-free" aspect refers to the applicator staying stationary on the patient, but the therapist still monitors the patient.

7. The Type of Ground Truth Used

The "ground truth" here is based on:

• Engineering and physical measurements: For thermal output, acoustic properties (standing waves), and electrical safety.
• Compliance with established standards: Mandatory (21 CFR 1050.10) and consensus standards (IEC 60601 series, UL 60601-1).
• Risk analysis: Identifying potential hazards and mitigation strategies (e.g., operator manual instructions).

8. The Sample Size for the Training Set

Not applicable. There is no training set in the context of machine learning or AI algorithms described in this submission.

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

Not applicable. As there is no training set, there's no ground truth established for one.

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The HF54 is indicated for: Pain relief for: Symptomatic relief of chronic intractable pain and/or management of traumatic or post surgical pain. Ultrasound therapy is available from the HF54 and indicated for: Applying therapeutic deep heat within body tissues for the treatment of selected chronic and sub-chronic medical conditions such as: Relief of pain Muscle Spasms Joint contractures The combination ultrasound & electrotherapy modes offer deep heat for pain management (ultrasound therapy) at the same time that electrical stimulation for either pain management or muscle stimulation is being delivered. Two electrotherapy modes utilizing Premodulated IFC can be utilized at a time in conjunction with the ultrasound mode. These are using One or two ultrasound applicators. The second ultrasound applicator is optional. An Infrared Therapy Probe is available as an optional accessory (HF023) for use with the Hill Laboratories HF54 Combination Ultrasound Interferential and premodulated stimulation system or for stand-alone use with an optional external medical grade, isolated power supply. It is used to provide topical heating for: . Temporary increases in local blood flow and circulation . Temporary relief of minor muscle and joint aches Temporary relief of pain and stiffness Relaxation of muscles . Temporary relief (or relaxation) of muscle spasms . Temporary relief of minor pain and stiffness associated with arthritis

The HF54 Combination Ultrasound Interferential and Premodulated Stimulation System is a device that offers electrical stimulation, ultrasonic therapy and/or combination of the two. It also has an optional Infrared light probe accessory (HF023).

Here's an analysis of the provided text regarding the Hill Laboratories HF54 Combination Ultrasound Interferential and Premodulated Stimulation System, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on presenting a comprehensive study of the new device's performance against specific acceptance criteria in a clinical setting. Therefore, many of the requested categories, especially those related to clinical study design, will likely be absent or inferable rather than explicitly stated.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary for a substantial equivalence determination, the "acceptance criteria" here primarily refers to the device meeting the same fundamental characteristics and performance safety standards as the predicate device, as well as adherence to relevant consensus standards. There isn't a table of clinical performance metrics (e.g., sensitivity, specificity) because this type of device is not typically evaluated in that manner for 510(k) clearance.

Study Details (Based on available information)

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

• Sample Size: Not applicable. This 510(k) summary does not describe a clinical "test set" in the sense of patient data. The evaluation for substantial equivalence is based on engineering specifications, compliance with standards, and comparison to the predicate device's design and indications for use.
• Data Provenance: Not applicable. No clinical data or patient data is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No ground truth based on expert review of clinical data is described.

4. Adjudication method for the test set:

• Not applicable. No clinical test set or adjudication process is described.

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 physical therapy apparatus, not an AI-assisted diagnostic or interpretative tool. No MRMC study was performed.

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

• The device is a physical therapy system requiring direct human application (qualified therapist). It does not involve an algorithm for standalone performance evaluation in the context of diagnostic or interpretive AI. Its standalone performance would relate to its electrical/ultrasound/infrared output characteristics, which are checked against standards.

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

• The concept of "ground truth" as typically used in diagnostic study evaluations (e.g., pathology for cancer detection) is not directly applicable here. For this device, the "truth" is established by:
  • Compliance with published standards: Mandatory (21 CFR 1050.10) and Consensus (IEC 60601 series, UL 60601-1).
  • Consistency with FDA guidance and international standards for ultrasound and electrical stimulation outputs.
  • Direct functional and performance comparison to the legally marketed predicate device (Dynatronics Solaris Model 708 and 709).

8. The sample size for the training set:

• Not applicable. This device does not use machine learning or AI algorithms requiring a training set.

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

• Not applicable. No training set is used.

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