(268 days)
The Curapuls 670 is indicated to be used for applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as:
- Relieving pain;
- Reducing muscle spasm;
- Increasing range of motion of contracted joints using heat and stretch techniques; and
- Increasing blood flow to tissues in the treatment area.
The Curapuls 670 is a two-channel microprocessor-controlled unit for pulsed shortwave therapy. Through inductive electrodes (Circuplodes), high-frequency electric currents are produced within the body. Pulsed energy at 27.12 MHz is absorbed by soft tissues. Three sizes of Circuplodes (140mm, 90mm and elliptical) are available to accommodate different size treatment areas.
Deep heating of tissue is achieved with ease by means of inductive electrodes. The user can connect two applicators. Activation of each applicator can be controlled from the console menu.
This device is a prescription equipment. Use by any persons other than physicians is prohibited.
This document is a 510(k) clearance letter for a medical device called Curapuls 670, a shortwave diathermy unit. It details the device's characteristics, its comparison to a predicate device (BTL-703), and the non-clinical testing performed to establish its substantial equivalence.
However, the provided text does not contain information related to an AI/ML-driven device or a study involving human-in-the-loop performance, such as a multi-reader multi-case (MRMC) study. It describes a physical therapy device used for applying therapeutic deep heat. Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML evaluation (e.g., sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable to this document.
The "acceptance criteria" and "study" described in this document are focused on demonstrating the safety and effectiveness of the Curapuls 670 as a medical device for therapeutic deep heating, primarily through non-clinical testing and comparison to a predicate device.
Let's extract what is available regarding acceptance criteria and the "study" (non-clinical testing) from the provided text:
Acceptance Criteria and Study for Curapuls 670 (Non-AI Device)
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a formal table of quantitative acceptance criteria for performance in the way one might expect for an AI model (e.g., specific sensitivity/specificity thresholds). Instead, the "acceptance criteria" for this device are primarily met by demonstrating compliance with recognized medical device safety and performance standards and showing substantial equivalence to a legally marketed predicate device.
The reported "device performance" is primarily qualitative and centered around its stated indications for use and its electrical/thermal properties.
| Acceptance Criteria (Implied by Standards & Equivalence) | Reported Device Performance / Compliance |
|---|---|
| Safety & Essential Performance (Electrical, Mechanical) | Complies with IEC 60601-1, ANSI AAMI ES60601-1. Full electrical safety testing performed. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2. EMC testing done to evaluate emissions and immunity. |
| Software Life Cycle Processes | Complies with IEC 62304. |
| Risk Management | Complies with ISO 14971. |
| Biocompatibility | Complies with ISO 10993-1, ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (irritation and skin sensitization). |
| Usability | Usability assessments done to verify user interface, safety features, and satisfactory performance. |
| Therapeutic Efficacy (Heat Generation) | Demonstrated ability to maintain tissue temperature in the range of approximately 40-45°C in vivo. |
| Substantial Equivalence to Predicate Device | Indications for Use are identical. Technological characteristics (working frequency, energy type, user interface, firmware control) are mostly identical. Minor differences (power source, mode of operation, applicator attachments, dimensions) are discussed and deemed not to raise new questions of safety or effectiveness. |
| Ability to achieve stated Indications for Use | "Used for applying therapeutic deep heat in body tissues in adults for the treatment of selected medical conditions such as: 1. Relieving pain; 2. Reducing muscle spasm; 3. Increasing range of motion of contracted joints using heat and stretch techniques; and 4. Increasing blood flow to tissues in the treatment area." The thermal effect on tissue testing supports this. |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not applicable in the context of a dataset for an AI model. The document refers to "final, finished devices" undergoing testing. The number of physical devices tested isn't specified, but it's a small manufacturing sample for validation, not a large patient data sample.
- Data Provenance: Not applicable for an AI dataset. The "data" here refers to test results from physical devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML device requiring expert labeling of data. The ground truth for performance is based on established engineering and medical device standards (e.g., temperature measurements, electrical safety parameters, usability assessments).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human reader interpretations that require adjudication.
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:
- No. An MRMC comparative effectiveness study was not done. This is not an AI-assisted diagnostic or interpretative device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm. The device's performance is inherently "standalone" in the sense that it performs its physical function (producing heat) independently, but it is operated by a human user (a physician).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is based on:
- Engineering specifications and regulatory standards: Compliance with IEC, ISO, and ANSI/AAMI standards for electrical safety, EMC, biocompatibility, and software quality.
- In vivo thermal measurements: Direct measurement of tissue temperature increase (40-45°C) to validate the therapeutic heating capability.
- Usability assessments: Evaluation of the user interface and safety features by presumably qualified personnel to ensure satisfactory operation.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device trained on a dataset.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for an AI model.
In summary, the provided FDA 510(k) clearance letter pertains to a non-AI medical device (Shortwave Diathermy). Therefore, the detailed questions appropriate for an AI/ML device's validation study are largely irrelevant to this document. The "acceptance criteria" are met by demonstrating compliance with established safety and performance standards relevant to physical therapy equipment and showing substantial equivalence to a predicate device.
§ 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.