(78 days)
The OrthoGold 100 is intended for:
- Relief of minor muscle aches and pains
- · Temporary increase in local blood circulation
- · 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.
The provided FDA 510(k) summary for the OrthoGold 100 device does not describe a study involving an artificial intelligence (AI) component or its acceptance criteria.
Instead, this document is a premarket notification for a Class I therapeutic massager, which is a physical device (a pulsed acoustic wave device). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance testing of the physical device to ensure it meets design specifications, safety standards, and is substantially equivalent to a predicate device.
Therefore, many of the specific questions you asked about AI-related acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and training sets are not applicable to the information provided in this document.
Here's an analysis based on the document, focusing on the engineering and performance testing described for a Class I medical device, and explaining why the AI-related questions are not relevant here:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with corresponding performance results in the way one might see for an AI model's clinical endpoints. Instead, it describes various performance tests and compliance with standards as evidence of meeting design specifications and safety requirements.
Here's a summary of the performance claims:
| Acceptance Criteria Category/Test | Reported Device Performance/Conclusion |
|---|---|
| General Performance & Design Specifications | "Verification and validation testing was performed and demonstrated that the OrthoGold 100™ meets the design specifications and is safe and effective for its intended use. All tests required by the verification and validation plan were completed and passed." (Page 5) |
| Software Validation | "The OrthoGold 100™ software was validated and demonstrated to be of a Moderate level of concern." (Page 5) |
| Hazard Analysis / Risk Management | "Hazard analysis / risk management was performed and demonstrated that all risks are mitigated to an acceptable level." (Page 5) |
| General Safety (Electrical Medical Equipment) | "The OrthoGold 100 was tested and demonstrated to conform to the general safety requirements of IEC 60601-1:2005 (AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012)." (Page 5-6) |
| Electromagnetic Compatibility (EMC) | "The OrthoGold 100 was tested and demonstrated to conform to... the electromagnetic compatibility requirements of IEC 60601-1-2:2014 (4th Ed.)." (Page 5) |
| Particular Requirements for Extracorporeally Induced Lithotripsy | "The OrthoGold 100 was tested and demonstrated to conform to... IEC 60601-2-36 Edition 2.0: 2014-04." (Page 5-6) |
| Applicator Displacement, Force, and Penetration Depth (Invitro) | "Invitro testing was performed to determine applicator displacement, force and penetration depth and was demonstrated to be equivalent to the AW module of the D-Actor 200 predicate device." (Page 5) Specific values are provided in the comparison table on page 7, showing characteristics like: |
- Max penetration depth: 25.4 mm at energy level 16
- Energy flow density: 0.00017 - 0.04403 mJ/mm2 at energy level 1-16
- Peak compressional acoustic pressure: 0.43 - 9.27 MPa at energy level 1-16. |
| Probe Cover Testing & Transport Verification/Validation | "In addition, probe cover testing and transport verification and validation was also conducted." (Page 5) – No specific results detailed, but implied successful. |
| Substantial Equivalence | "The performance testing demonstrated that the OrthoGold 100 is substantially equivalent to the predicate device." (Page 5) "The bench testing demonstrates that the performance characteristics of the OrthoGold 100 are equivalent to those of other legally marketed therapeutic massagers, and therefore supports a determination of Substantial Equivalence for the proposed indications for use." (Page 9) |
| Clinical Data | "Clinical performance data is not relied upon to establish the substantial equivalence of the subject and predicate device." (Page 6) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document describes engineering and laboratory performance testing, not a clinical trial or AI model validation using patient data. Therefore, the concept of "sample size for the test set" (referring to patient data) and "data provenance" (country, retrospective/prospective) is not applicable. The "test set" would be the device itself and its components undergoing various mechanical, electrical, and physical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable as the document describes physical device testing for safety and performance, not diagnostic AI. "Ground truth" here relates to physical measurements and engineering specifications, established by standard test methods and calibrated equipment, not by medical experts interpreting data for diagnostic purposes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable for the same reasons as above. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI model validation when multiple human readers assess data and their consensus forms the ground truth for comparison. This document describes physical device testing.
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 is not applicable. An MRMC study is relevant for assessing the impact of a diagnostic AI tool on human clinician performance. The OrthoGold 100 is a therapeutic massager, not a diagnostic AI device, and the document explicitly states clinical data was not relied upon for substantial equivalence (Page 6).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This question refers to the performance of a diagnostic algorithm without human interaction. The OrthoGold 100 is a physical therapeutic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is based on engineering specifications, verified physical measurements (e.g., force, penetration depth, acoustic pressure), and compliance with recognized industry standards (e.g., IEC 60601-1, IEC 60601-1-2). These are objective measurements and adherence to established safety and performance benchmarks for therapeutic medical devices, not clinical outcomes or expert consensus for diagnostic interpretation.
8. The sample size for the training set
This is not applicable. The OrthoGold 100 is a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as there is no AI training set.
§ 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.