(86 days)
The OrthoGold 100 is intended for the activation of connective tissue.
The OrthoGold 100™ is a pulsed acoustic wave device. It includes an electrically powered generator to generate transient compressed air that rapidly expands to create the acoustic waves, which in turn are propagated through a water-filled coupling membrane attached to the hand-held applicator. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.
This document is a 510(k) summary for the OrthoGold 100™ therapeutic massager. It does not provide information specific to an AI/ML device, therefore, many of the typical acceptance criteria and study details for such devices are not applicable.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in the typical sense of a human-in-the-loop or standalone AI performance study (e.g., specific sensitivity, specificity, or AUC thresholds). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through various performance tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device meets design specifications. | Verification and validation testing was performed and demonstrated that the OrthoGold 100™ meets the design specifications. |
| Device is safe and effective for its intended use. | All tests required by the verification and validation plan were completed and passed. |
| Software is validated to an appropriate level of concern. | The OrthoGold 100™ software was validated and demonstrated to be of a Moderate level of concern. |
| Risks are mitigated to an acceptable level. | Hazard analysis / risk management was performed and demonstrated that all risks are mitigated to an acceptable level. |
| Conformance to general safety requirements. | The OrthoGold 100 was tested and demonstrated to conform to the general safety requirements of IEC 60601-1:2005. |
| Conformance to electromagnetic compatibility requirements. | The OrthoGold 100 was tested and demonstrated to conform to the electromagnetic compatibility requirements of IEC 60601-1-2:2014 (4th Ed.) and 60601-2-36. |
| Applicator displacement, force, and penetration depth are equivalent to predicate device. | In-vitro testing was performed to determine applicator displacement, force and penetration depth and was demonstrated to be equivalent to the AW module of the Dermablate predicate device. Maximum penetration depth of 25.4 mm at energy level 16 (predicate: 30mm). Energy flow density PIIT [mJ/mm2] 0.00017 - 0.04403 at energy level 1 - 16 (predicate: 0.018-0.25). Peak compressional acoustic pressure pc [MPa] 9.27 at energy level 16 (predicate: 13.4). Other parameters shown to be "Similar" or "Equivalent" to predicate. |
| Probe cover and transport verification/validation performed. | Probe cover testing and transport verification and validation was also conducted. |
| Overall substantial equivalence to predicate device. | The performance testing demonstrated that the OrthoGold 100 is substantially equivalent to the predicate device. |
2. Sample size used for the test set and the data provenance
Not applicable. This device is a therapeutic massager, not an AI/ML diagnostic tool that would typically use a "test set" of patient data for performance evaluation. The testing involved in-vitro performance measurements, electrical safety, and electromagnetic compatibility.
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 diagnostic device, there was no need for experts to establish ground truth on a test set of medical images or patient data.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication of ground truth was used.
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
Not applicable. This is not an AI/ML assisted device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (therapeutic massager), not a standalone algorithm.
7. The type of ground truth used
For the in-vitro performance testing, the "ground truth" was established by objective measurements against known physical standards and comparison data from the predicate device. For example, measurements of applicator displacement, force, and penetration depth would have physical accuracy.
8. The sample size for the training set
Not applicable. This product is a physical device, not an AI/ML model that requires a training set. The "training" for such a device would refer to its engineering, design, and manufacturing processes.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML device.
§ 890.5660 Therapeutic massager.
(a)
Identification. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.