(72 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 Solaris D890™ is an infrared therapy accessory probe for use with Solaris Series combination devices. The base Solaris devices provide the operational power and software. The D890 probe contains only an on/off switch and requisite software to drive the infrared energy source.
The provided FDA 510(k) summary for the Solaris D890™ Therapy Probe does not contain information about a study that establishes acceptance criteria or reports device performance in the way a clinical study would for a novel medical device.
Instead, this submission leverages the substantial equivalence pathway, which means the device's safety and effectiveness are established by demonstrating its similarity to a legally marketed predicate device, the Solaris D880 Infrared Probe (K031329).
Therefore, many of the requested fields regarding acceptance criteria, study design, sample size, ground truth, and expert involvement are not applicable or not explicitly detailed in this type of submission.
Here's how the provided information relates to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable (NA)
The 510(k) summary does not define specific performance acceptance criteria for clinical outcomes or efficacy endpoints. Instead, the acceptance is based on the device conforming to applicable regulatory standards for electronic and light-emitting products, and being substantially equivalent to the predicate device in terms of technology, intended use, and indications for use.
The "reported device performance" in this context refers to the device's technical specifications and how they align with regulatory requirements and the predicate device, rather than performance data from a clinical trial.
| Acceptance Criteria Type (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Conformance to 21 CFR sections 1010 (Electronic Products: General) | Device conforms to applicable requirements. |
| Conformance to 21 CFR sections 1040.10 & 1040.11 (Light-Emitting Products) | Device conforms to applicable requirements. |
| Technical Characteristics (similar to predicate) | "Shares the same or similar basic characteristics" as predicate. |
| Intended Use/Indications for Use (same as predicate) | "Identical to the cleared indications for the predicate device." |
| Safety & Effectiveness (similar to predicate) | "No substantive differences between the products... Similar to technologies used in other similar medical devices." |
| Quality Management System | Developed and documented under Dynatronics' mature Quality Management System (21 CFR Part 820). |
| Design/Change Control | Developed under design/change control, verified/validated to applicable standards. |
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable (NA)
No clinical test set or data provenance is detailed in this 510(k) summary. The submission relies on establishing substantial equivalence to a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable (NA)
No clinical test set requiring expert ground truth establishment is described in this 510(k) summary.
4. Adjudication Method for the Test Set
Not Applicable (NA)
No clinical test set requiring an adjudication method is described in this 510(k) summary.
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 (NA)
This device is an infrared therapy probe, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI-related effectiveness are not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable (NA)
This device is an infrared therapy probe and does not involve a standalone algorithm for performance testing.
7. The Type of Ground Truth Used
Not Applicable (NA)
As no clinical study or test set requiring ground truth is detailed, no specific type of ground truth is mentioned. The "ground truth" for this submission revolves around regulatory compliance and technical similarity to the predicate device.
8. The Sample Size for the Training Set
Not Applicable (NA)
No training set for an algorithm is described in this 510(k) summary as it is not an AI/algorithm-based device.
9. How the Ground Truth for the Training Set was Established
Not Applicable (NA)
As no training set is described, the method for establishing its ground truth is not applicable.
§ 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.