(526 days)
Adjunctive treatment of musculoskeletal pain related to: (1) plantar fasciitis of the heel; and (2) osteoarthritis of the knee.
The ActiPatch® device is a pulsed shortwave therapy device. The circuitry consists of low voltage (3 V) digital/analog electronics that control all timing functions to produce the therapeutic radiofrequency (RF) field, where the antenna is placed directly above the therapeutic site. This closed loop system of the antenna, low energy signal generator circuit, and battery power supply, transfers the RF energy to the target tissue as a localized therapy with no far field effects.
The provided document is a 510(k) premarket notification for the ActiPatch® device. This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness. Therefore, the information provided focuses on comparative performance and safety rather than establishing acceptance criteria as would be seen for a new medical device. The document does not explicitly state "acceptance criteria" but rather presents clinical study results as evidence of comparable safety and effectiveness to predicate devices.
Here's an attempt to extract and organize the requested information based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document doesn't define explicit "acceptance criteria" in the traditional sense of pre-defined thresholds. Instead, it presents clinical study results to demonstrate effectiveness and safety comparable to predicate devices. The "reported device performance" below summarizes these clinical findings.
| Criterion Type (Implicit) | Acceptance Criteria (Not explicitly stated, but implied by study results) | Reported Device Performance (ActiPatch®) |
|---|---|---|
| Effectiveness - Knee OA | Improvement in pain levels (VAS and WOMAC scores) comparable to or better than placebo/no treatment, and potentially supporting reduction in pharmacological therapy for osteoarthritis of the knee. | Osteoarthritis of the knee study: |
- 36% of the treatment group reported a >30% decrease in VAS pain, compared to 9% for the placebo group.
- 18% of the treatment group reported a >30% decrease in total WOMAC pain, compared to 3% for the placebo group.
- 26% of the treatment group stopped pharmacological therapy, whereas 33% of the placebo group started new pharmacological therapy. |
| Effectiveness - Plantar Fasciitis | Reduction in pain levels (daily morning VAS score) comparable to or better than placebo/no treatment for plantar fasciitis. | Plantar fasciitis study: - Average reported pain reduction (day 1 AM to day 7 AM VAS) for the treatment group was 40%, compared to 7% for the control group. |
| Safety | No significant adverse events related to the device. | Osteoarthritis of the knee study: No adverse events were recorded.
Plantar fasciitis study: Primary safety endpoint was all treatment-related adverse events; the document does not explicitly state if any were recorded but implies a positive safety profile through the "safe and effective as its predicate devices" conclusion. |
| Usability (OTC Use) | Lay users must understand how to use the device safely and effectively for pain relief in the specified indications. | Usability testing: - 46 men and women (age >17, wide education levels) demonstrated understanding of indications for use, contraindications, how to turn on, correct placement, and duration of use. |
| Non-Clinical Performance | Conformity to relevant electrical safety, electromagnetic compatibility, and biocompatibility standards. Performance as intended under anticipated conditions of use regarding output power, pulse characteristics, absorption rates, and electromagnetic fields. | Non-Clinical/Performance Data: - Conformed to IEC/EN 60601-1-2:2012, IEC 60601-1:2005+A1:2012, EN 60601-1:2006.
- Biocompatibility testing (ISO 10993-10:2010 for sensitization and irritation, ISO 10993-5:2009 for cytotoxicity) showed no evidence of sensitization, irritation, or in vitro cytotoxicity.
- Special controls testing (per October 13, 2015 Final Reclassification Order) demonstrated intended performance, characterizing peak output power, pulse characteristics, duty cycle, average output power, specific absorption rates, and electrical/magnetic fields in a saline gel test load. |
2. Sample Size Used for the Test Set and the Data Provenance
- Osteoarthritis of the knee study:
- Sample size: 66 intent-to-treat patients, with 60 patients completing the four-week study.
- Data Provenance: Not explicitly stated (e.g., country of origin, specific locations), but described as "double-blind randomized controlled study" implying a prospective design.
- Plantar fasciitis study:
- Sample size: 70 patients completed the study.
- Data Provenance: Described as "double-blind, multicenter, randomized, placebo-controlled study," implying a prospective design. Country of origin not specified.
- Usability testing:
- Sample size: 46 men and women.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective), but the description ("These subjects demonstrated use...") implies a prospective, interactive study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" for the test set in the context of image interpretation or diagnostic accuracy studies. The clinical studies evaluated patient-reported outcomes (VAS and WOMAC scores) and adverse events, which are direct measures from the participants themselves, rather than interpretations by experts.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
The document describes the clinical studies as "double-blind and placebo-controlled randomized controlled trials." This implies that blinding was used for both participants and researchers/assessors regarding treatment allocation. However, it does not specify an adjudication method for outcome measures like VAS or WOMAC scores, which typically do not require such adjudication as they are direct patient responses. For adverse events, it states "No adverse events were recorded" for the knee study; the method for reviewing or adjudicating AEs in the plantar fasciitis study is not detailed beyond "primary safety endpoint was all treatment-related adverse events."
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. The ActiPatch® is a physical medical device for pain relief, not an AI or imaging interpretation device that would typically involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The ActiPatch® is a physical device, not an algorithm. Its performance is inherent in its physical and electrical characteristics and its interaction with the patient's body. The clinical studies evaluate the device's effect directly on patients.
7. The Type of Ground Truth Used
For the clinical studies, the "ground truth" was primarily based on patient-reported outcomes:
- Pain levels: Measured using validated scales like the Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores.
- Adverse events: Self-reported by patients or observed during the study.
For usability testing, the "ground truth" was established by observing lay user comprehension and ability to perform tasks (turn on, place correctly, understand indications/contraindications).
For non-clinical testing, the "ground truth" was conformance to established engineering and biological standards (e.g., IEC, ISO standards for electrical safety, biocompatibility, and specific power output measurements).
8. The Sample Size for the Training Set
The document does not describe the use of a "training set" as it would for an algorithm or AI model development. The clinical studies described are for evaluating the final device's performance, not for training a model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was explicitly mentioned or used in the context of algorithm development. The document describes clinical trials and usability studies of a physical medical 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.