(233 days)
Apply stationary use of ultrasound to:
Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.
Apply continuous movement of ultrasound for:
- Pain.
-
- Pain relief, muscle spasms, and joint contractures.
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- Relief of pain, muscle spasms, and joint contractures that may be associated with:
- · Adhesive capsulitis,
- · Bursitis with slight calcification,
- · Myositis,
- · Soft tissue injuries, and
- · Shortened tendons due to past injuries and scar tissues.
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- Relief of pain, muscle spasms, and joint contractures resulting from:
- · Capsular tightness, and
- · Capsular scarring.
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- Localized increase in blood flow.
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- Increased range of motion of contracted joint using heat and stretch techniques.
The ManaSport+ is an adaptation of the previously cleared ManaSport device, which was cleared under K210284. A wireless control option was added to the ManaSport+ and the subject device was evaluated for home use. As a portable and rechargeable prescriptive device in the home or clinical/hospital setting, the subject device is intended to apply ultrasound to the patient's treatment site for selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation. Ultrasound can be used to apply therapeutic deep heat for the treatment of selected medical conditions such as soft tissue injuries, shortened tendons due to past injuries and scar tissues, relief of pain, muscle spasms and joint contractures.
The provided text is a 510(k) summary for the ManaSport+ device, an ultrasonic diathermy device. It discusses the device's substantial equivalence to predicate devices, focusing on its technical characteristics and indications for use. However, it explicitly states that "Clinical testing was not provided in support of this 510(k) application," and therefore, there is no study described that proves the device meets specific performance acceptance criteria via clinical data, nor is there information on ground truth establishment, expert consensus, or MRMC studies.
The document primarily relies on non-clinical testing and comparison to predicate devices, demonstrating substantial equivalence rather than proving performance against quantified clinical acceptance criteria.
Therefore, many of the requested details about acceptance criteria, the study proving the device meets them, sample sizes for test sets, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided text.
The document focuses on demonstrating that the ManaSport+ is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective as those devices, and does not require a new Premarket Approval Application (PMA). This is achieved through non-clinical testing and a comparison of technical specifications.
Here's what can be extracted based on the provided text, while noting the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of clinical performance acceptance criteria and reported device performance against those criteria. Instead, it provides a "Summary of Substantial Equivalence" comparing the ManaSport+ (Subject Device) to its primary predicate (ManaSport) and another predicate (sam 2.0 Long Duration Ultrasound System) based on various technical parameters. The "Equivalence" column in this table indicates if the subject device's parameter is identical, similar, or different, and explains why any differences do not affect safety or effectiveness.
Below is a partial example of how the provided table could be structured to show the comparison, but it's crucial to understand these are technical specifications for substantial equivalence, not clinical performance metrics against acceptance criteria.
| Parameter & Predicate Device(s) | Subject Device (ManaSport+) Reported Value | Primary Predicate Device (ManaSport) Reported Value | Predicate Device (sam 2.0) Reported Value | Equivalence (as stated in document) |
|---|---|---|---|---|
| Product Code | IMI, PFW | IMI, PFW | PFW | Identical |
| Indications for Use | (Detailed list provided in text) | (Detailed list provided in text) | (Detailed list provided in text) | Identical |
| Power Source(s) | 120/240 Vac with 5Vdc Input and rechargeable 3.7Vdc battery | Not Publicly Available | 120/240 VAC with 5V DC Input Power Jack and Lithium Battery Powered | Identical |
| Frequency (MHz) | 1.5 | Not Publicly Available | 3 | Identical or small. The frequency of the subject device is identical to that of the primary predicate device, and smaller than that of the predicate device. Therefore, the frequency does not affect the safety or effectiveness. |
| Maximum Value of the Output Power (W ± 20%) | 0.60 | Not Publicly Available | Single Applicator: 0.65W ± 20% Dual Applicator: 1.3W ± 20% | Identical or similar. Therefore, the maximum power does not affect the safety or effectiveness. |
| Compliance with Voluntary Standards? | Yes (lists IEC standards) | Not Publicly Available | Yes (lists IEC standards) | Identical |
| Wireless Control via Bluetooth App | Yes | Not Publicly Available | No | Different. Although the primary predicate and predicate devices do not have the wireless option, such a wireless option is optional to the subject device. Just like the primary predicate device, the subject device can be operated independently to realize all its features, and completely does not rely on the optional wireless communication to realize any of its features. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. The document states, "Clinical testing was not provided in support of this 510(k) application." The testing primarily involved non-clinical, bench testing to verify compliance with electrical safety, EMC, and biocompatibility standards, and software verification. There are no "test sets" in the context of clinical or AI performance evaluation.
- Data Provenance: Not applicable for a clinical test set. The document refers to compliance with ISO and IEC standards, which are international standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. As no clinical testing was performed, no ground truth was established by experts for a test set.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC study was not done. The document explicitly states "Clinical testing was not provided."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The ManaSport+ is a physical device (ultrasonic diathermy), not an AI algorithm. Its performance is related to its physical outputs (e.g., ultrasound frequency, power, temperature rise in tissue), which were evaluated through non-clinical bench testing for compliance with standards.
7. The Type of Ground Truth Used
- Not applicable for clinical ground truth. For the non-clinical tests, the "ground truth" refers to the established requirements and specifications of the cited voluntary standards (e.g., IEC 60601-1, ISO 10993) which the device's measured performance was compared against.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/algorithm device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. No training set for an AI algorithm.
Summary of Device Performance and Acceptance Criteria (Based on Non-Clinical Data):
The ManaSport+ device demonstrated performance primarily through non-clinical tests to ensure compliance with recognized voluntary standards for medical devices. The "acceptance criteria" here are the requirements outlined in these standards for:
- Electrical Safety: IEC 60601-1, IEC 60601-2-5 (for ultrasonic physiotherapy equipment)
- Electromagnetic Compatibility (EMC): IEC 60601-1-2
- Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and skin sensitization)
- Home Healthcare Environment Requirements: IEC 60601-1-11
- Usability: IEC 60601-1-6
- Software Verification: FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The document asserts that the device conformed to or complied with these standards. For example, regarding temperature rise, it states "Meets IEC 60601-2-5, section 201.11 Protection against excessive temperature and other HAZARDS." Specific values for temperature rise in tissue are also given (e.g., "7.6°C at 1 cm / 3.3°C at 2 cm / 1.4°C at 3 cm / Max treatment time: 20 min"), and these are compared to the predicate devices as "Identical or similar. This value of the subject device is identical to that of the primary predicate device, and smaller than that of the predicate device. Therefore, it does not affect the safety or effectiveness."
In conclusion, for the ManaSport+ device, its "acceptance criteria" were primarily defined by compliance with a comprehensive set of international electrical safety, EMC, biocompatibility, and usability standards, and its "performance" was demonstrated through non-clinical testing against these standards, as well as by showing substantial equivalence to existing cleared devices with similar indications for use. No clinical trial data was submitted or required for its 510(k) clearance.
§ 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.