(206 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (Dynatronics Solaris Model 708 and 709 - K031329) | The HF54 "shares the same or similar basic characteristics including waveforms, operating frequencies and the same use in physical medicine and neurology as the predicate device." "The methods of application and intended use/indications for use are the same and the same patient population is intended to be treated by the new device and the predicate device." "The measured parameters for the proposed HF54 are the same as those displayed on the predicate devices." |
| Compliance with Mandatory Standards | The HF54 "complies with this mandatory standard" (21 CFR 1050.10 for therapeutic ultrasound). |
| Compliance with Consensus Standards (Safety and EMC) | The HF54 "is designed to comply with" IEC 60601-1 (+A1, +A2), UL 60601-1, IEC 60601-1-2, IEC 60601-2-5, and IEC 60601-2-10. |
| Consistency with FDA Guidance and International Standards (Ultrasound Output and Electrical Stimulation) | "The ultrasound output and electrical stimulation currents are consistent with FDA guidance and international standards." |
| Infrared Therapy Probe Equivalence | "The light wavelengths (visible and infrared) and output intensities for the HF023 Infrared therapy probe are the same as the predicate device's Infrared therapy probe cleared under K031239." |
| Materials Used | "The materials used in construction of the device...are similar" to the predicate. |
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.
§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.