(70 days)
Infrared therapy to provide topical heating for: Temporary increase in local blood circulation Temporary relief of minor muscle and joint aches, pains and stiffness Relaxation of muscles Muscle spasms Minor pain and stiffness associated with arthritis
The Dynatron® Solaris™ model numbers X3, Dynatron Xp, and D405) provide infrared (IR) therapy. Components: System console, model Dynatron X3, containing software and control electronics with alpha-numeric displays. Infrared pad, model Dynatron Xp, for administering IR therapy. Hand-held infrared probe, model D405, for administering IR therapy. Accessories such as power cord.
The provided text is a 510(k) premarket notification for the Dynatron® Solaris™ Series of infrared therapy devices. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing new clinical study data to prove safety and effectiveness. Therefore, the information requested regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details will not be found in this document.
The document explicitly states:
- "There are no substantive differences between the products defined in this 510(k) submission and the predicate devices."
- "They are similar to the technologies that are currently used in other similar medical devices."
- "They were developed and documented under Dynatronics' mature Quality Management System, under the Quality System Regulation, 21 CFR Part 820, under design/change control, and are verified/validated to applicable standards/guidance documents."
This indicates that the manufacturer is relying on the established safety and effectiveness of the predicate device (Dynatron® Solaris™ D705 and accessory D880 IR Probe, cleared under K031329) and adherence to general performance standards and regulations.
Therefore, I cannot extract the requested information as it is not contained within this 510(k) submission.
What can be extracted is information related to the device itself and its regulatory status:
| Category | Description / Response |
|---|---|
| 1. A table of acceptance criteria and the reported device performance | Not applicable. This document is a 510(k) submission for substantial equivalence. It does not present specific acceptance criteria or new clinical performance data for the device. Instead, it asserts the device's substantial equivalence to a predicate device, implying that its performance is comparable to that already accepted for the predicate device. The performance standard mentioned is general: "The Dynatron Solaris Series of devices conform to the applicable requirements of 21 CFR sections 1010 (Performance Standards for Electronic Products: General)." |
| 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) | Not applicable. No clinical test set data is presented or referenced to demonstrate performance, as this is a 510(k) submission relying on substantial equivalence to a predicate device. |
| 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) | Not applicable. No clinical test set data is presented, and therefore, no expert-established ground truth is mentioned. |
| 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set | Not applicable. No clinical test set data is presented, and therefore, no adjudication method is mentioned. |
| 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 device is an infrared therapy device, not an AI-based diagnostic or assistive technology for human readers. No MRMC study was conducted or is relevant to this type of device. |
| 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done | Not applicable. This device is an infrared therapy device, not an AI algorithm. Its performance is related to its physical function of providing topical heating. |
| 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc) | Not applicable. No new clinical ground truth development is presented for this substantial equivalence submission. The effectiveness is based on the known therapeutic effects of infrared therapy and the predicate device. |
| 8. The sample size for the training set | Not applicable. No machine learning or AI training set is relevant or mentioned for this device. |
| 9. How the ground truth for the training set was established | Not applicable. No machine learning or AI training set is relevant or mentioned for this device. |
Summary of Device and Regulatory Context (from the provided text):
- Device Name: Dynatron® Solaris™ Series (models Dyntron X3, Xp, D405); Infrared therapy.
- Intended Use/Indications For Use: Topical heating via infrared therapy for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, relaxation of muscles, muscle spasms, and minor pain and stiffness associated with arthritis.
- Predicate Device: Dynatron® Solaris™ D705 and accessory D880 IR Probe (cleared under K031329).
- Basis for SE: The devices share the same or similar basic characteristics, features, and intended use as the predicate.
- Safety and Effectiveness Rationale: No substantive differences from the predicate, similar to other currently used medical devices, developed under Dynatronics' Quality Management System, and verified/validated to applicable standards/guidance documents.
- Regulatory Class: Class II, Product Code ILY.
- FDA Determination Date: July 25, 2005.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.