(174 days)
The labeling for the Ultratherm 908i limits its intended uses to those accepted by FDA for class II shortwave diathermy devices.
The Ultratherm 908i is a shortwave diathermy device intended to generate deep heat in body tissues for the treatment of medical conditions such as the relief of pain, muscle spasms and joint contractures.
This document describes a 510(k) premarket notification for the Ultratherm 908i, a shortwave diathermy device. This submission focuses on demonstrating substantial equivalence to a predicate device (Ultratherm 808i) and highlights changes that enhance safety and effectiveness, rather than presenting a formal clinical study with acceptance criteria and performance data as would be expected for a novel AI/medical imaging device.
Therefore, many of the requested categories for a study proving device performance are not applicable (N/A) in this context. The core argument for acceptance here relies on:
- Substantial equivalence to a predicate device.
- Technological changes that improve safety and effectiveness (e.g., reduced operating voltage and leakage, enhanced safety features, improved output control).
- Prior marketing history of a "similar" device in Europe and Canada without significant adverse events or recalls.
Here's how to address your request based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Safety: | |
| - Reduced operating voltage & leakage | Operating voltage and leakage are significantly reduced. |
| - Enhanced electrical safety | Impulse peak reduced to 400 watts. Symmetrical/asymmetrical output sockets. |
| - Use of non-flammable materials (electrodes) | Use of non-flammable silicon rubber field electrodes. |
| - Sheltered coil field electrodes | Sheltered coil field electrodes. |
| Effectiveness: | |
| - Max effective output does not exceed 200 watts | Maximal effective output does not exceed 200 watts. |
| - Consistent selected output | Selected output is kept constantly in the scope of the patient's coupling conditions. |
| - Indication of output (LED display) | Electronically indicated by an LED display and luminous band. |
| - Treatment of pain, muscle spasms, joint contractures | Intended for treatment of pain, muscle spasms, and joint contractures (as per predicate). |
| Reliability/User Interface: | |
| - Improved control/selection of operating mode | Mechanical switches replaced by touch-sensitive contacts with LED control. |
| - LED display of output intensity | LED display of output intensity. |
| Regulatory: | |
| - Substantial equivalence to predicate (Ultratherm 808i) | Basis of 510(k) submission. |
| - Indications limited to FDA-accepted for Class II shortwave | Labeling limits intended uses to those accepted by FDA for Class II shortwave diathermy. |
| - No significant adverse events/recalls in prior marketing history | Manufacturer's successful marketing of a similar device in Europe (4-5 years) and Canada (1 year) without recall or significant adverse experience reports. |
2. Sample size used for the test set and the data provenance
- Sample Size: N/A (No specific "test set" or clinical trial data is presented in this 510(k) summary for device performance.)
- Data Provenance: N/A. The claims rely on engineering specifications, comparisons to a predicate device, and a qualitative statement about the manufacturer's marketing experience with a "similar device" in Europe (4-5 years) and Canada (1 year).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. This submission does not involve an expert-adjudicated test set in the context of typical AI/imaging device evaluations. The ground truth for device function and safety is based on engineering design, adherence to standards (implied by reduction in leakage/voltage, etc.), and the predicate device's established safety/effectiveness.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No test set requiring expert adjudication 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
- N/A. This is not an AI-assisted device. It's a medical device (shortwave diathermy) that generates heat.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. As it's not an AI/algorithm-based device, this concept does not apply. The device operates independently for therapy delivery.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering Specifications & Predicate Device Performance: The "ground truth" for the claims made is primarily based on:
- Engineering design and testing to confirm features like reduced voltage/leakage, max output, constant output, and impulse peak.
- The established safety and effectiveness of the predicate device (Ultratherm 808i).
- Regulatory compliance with recognized indications for Class II shortwave diathermy devices.
- Post-market surveillance data (or lack thereof) for the "similar device" in Europe and Canada (absence of recalls/adverse events).
8. The sample size for the training set
- N/A. This device does not use a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- N/A. No training set is applicable.
§ 890.5290 Shortwave diathermy.
(a)
Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz 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)
Nonthermal shortwave therapy —(1)Identification. A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification: Class II (special controls). The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible.
(ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:
(A) Peak output power;
(B) Pulse width;
(C) Pulse frequency;
(D) Duty cycle;
(E) Characteristics of other types of modulation that may be used;
(F) Average measured output powered into the RF antenna/applicator;
(G) Specific absorption rates in saline gel test load or other appropriate model;
(H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and
(I) Characterization of the deposited energy density in saline gel test load or other appropriate model.
(iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use.
(v) Labeling must include the following:
(A) Output characteristics of the device;
(B) Recommended treatment regimes, including duration of use; and
(C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications.
(vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.