(294 days)
The Provant System is intended for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.
Much like the predicate Regenesis Model 42 device, the new Provant System includes a Control Unit and Treatment Applicator. Disposable Applicator Covers are provided for the Treatment Applicator for infection control and to provide appropriate contact surfaces for the patient. The predicate Provant System contains the same components. The Control Unit for the Provant System is housed in a UL-compliant injection-molded case made of high-impact ABS plastic. The case contains a lockable hinge to prevent accidental closure of the lid. Upon opening the Provant case, the user sees the control panel of the Control Unit. The main electronics of the Control Unit are housed beneath its control panel. The device also includes a Treatment Applicator that is attached to the Control Unit. When not in use, the Treatment Applicator is stored inside the carrying case. The Treatment Applicator is removed from the case prior to administration of therapy, inserted into its Disposable Applicator Cover, and placed directly over the area to be treated. Device labeling is also located inside the case cover. Four pre-drilled holes in the underside of the case allow for attachment of the device to the optional roller stand (sold separately). The Disposable Applicator Covers of the Provant System are single-use-only and are intended to minimize contagion and help protect the Treatment Applicator from biological contamination. The Disposable Applicator Covers contain a Radio Frequency Identification Device (RFID) tag which guards against reuse of used Disposable Applicator Covers.
The provided text is a 510(k) summary for the Provant System, a shortwave diathermy device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study specifically proving the device meets acceptance criteria. As such, the information needed to fully answer your request regarding acceptance criteria and a study demonstrating performance against those criteria is largely absent.
Here's an breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary explicitly states: "Performance standards have not been established by the FDA under section 514 of the Federal, Food, Drug and Cosmetic Act."
Instead of performance against specific acceptance criteria, the submission focuses on demonstrating "substantial equivalence" to a predicate device (Regenesis Model 42) for the adjunctive use in the palliative treatment of postoperative pain and edema.
The device performance described is primarily the delivery of: "the same amount of energy to the subject and is therefore as safe and as effective as its predicate."
2. Sample size used for the test set and the data provenance
This information is not provided in the document. The submission states, "Although the reusable portions of the Provant System have extensive clinical experience, this 510(k) Notice does not rely upon clinical data." Instead, it relies on "Bench testing data." The sample size for this bench testing is not specified, nor is the provenance of that data detailed beyond being "bench testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the submission explicitly states it does not rely on clinical data, therefore, no expert review for a test set ground truth would have been established.
4. Adjudication method for the test set
This information is not applicable as there was no test set involving human interpretation of clinical data that would require an adjudication method.
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
This information is not applicable. The device is a "shortwave diathermy device" used for therapeutic purposes, not for aiding "human readers" in diagnostic tasks. Therefore, an MRMC study related to AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This device is a therapeutic physical medicine device, not an algorithm-based diagnostic tool. Performance is evaluated based on its physical characteristics and energy delivery, not as a standalone algorithm.
7. The type of ground truth used
The "ground truth" for demonstrating substantial equivalence was based on bench testing data showing similar energy delivery capabilities between the new device (Provant System) and its predicate (Regenesis Model 42). There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this 510(k) submission.
8. The sample size for the training set
This information is not provided and is largely irrelevant, as the submission relies on bench testing and not a machine learning model trained on a dataset.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" in the context of this device and submission type.
§ 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.