(134 days)
- temporary relief of minor muscle and joint aches, pains and stiffness
- temporary relief of muscle spasm
- temporary relief of minor pain and stiffness associated with arthritis
- promoting relaxation of the muscle tissue
- temporary increase in local blood circulation
OptonPro is a topical heat lamp with laser light. It emits energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature. The OptonPro contents a Class IV laser unit with four simultaneously operating diodes with wavelengths of 810nm and 980mm transmitting their energy to an applicator through a flexible fibre optic cable. The applicator has an output spot size of 10 mm. The optimum ration of absorption and penetration depth quarantees efficient stimulation of tissue and pain receptors. The treatment effect of the OptonPro is achieved with 980nm and 810nm. Additionally the OptonPro contains an aiming beam with 650nm. Skin type, indication and desired depth of treatment define the operating mode and the required energy. Two operating modes are possible: continuous wave and serial pulse. The duty cycle can be adapted additionally (1:1 – 1:10). Patient feedback and direct access to the treatment parameters enable to adjust the application for individual requirements and to achieve treatment times of a few minutes. The OptonPro includes comprehensive safety features. In addition to multi-step activation of the laser by the software, with software security key lock and footswitch for starting treatment, protective glasses, an emergency off switch and a hardware interlock are included in the system. The performance of the laser unit can be tested with an integrated power control unit. A thermal threshold test offers a tool to assess the warmth sensitivity and the individual local absorption rate. Additionally the user is assisted with a special reminder function for a delivered particular amount of energy. OptonPro is an intuitive therapy system with touch screen and menu-quided operation. The maximum output power is 7 W. The adjustable output power corresponds with the chosen duty cycle. The OptonPro has a large colour display with 12 inch. A SD card is used as a memory, as a logbook and for updates. Individual adjustments can be made at any time and saved for easy access. A program menu with 3 fixed programs and a favourites and memory menu with 120 memory slots fur custom programs collects the most common settings and shows them when the OptonPro is started if required.
The provided document is a 510(k) premarket notification for the Zimmer MedizinSysteme OptonPro, an infrared lamp device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with acceptance criteria for a new device's performance.
Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not available in this document because they are typically required for demonstrating efficacy and safety of novel devices, or for AI/software devices, which this infrared lamp is not.
However, I can extract the information that is present concerning performance and testing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Therapeutic temperature range | 40 – 45°C |
| Maximum transition time to reach therapeutic temperature range | 5 minutes |
| Duration therapeutic temperature range is maintained | 10 minutes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "a few test candidates" (No specific number provided)
- Data Provenance: Not specified, but given it's a submission from Zimmer MedizinSysteme GmbH (Germany), it's likely originating from Europe.
- Retrospective/Prospective: The wording "temperature measurements were conducted" suggests a prospective measurement approach for the non-clinical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This information is not available in the document. The testing described is non-clinical performance measurement (temperature), not a diagnostic or clinical assessment requiring expert ground truth.
4. Adjudication Method for the Test Set
- This information is not applicable as the described testing involves physical measurements, not observational or diagnostic interpretations that would require adjudication.
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
- An MRMC study was not done. This device is an infrared lamp for therapeutic heating, not an AI or diagnostic imaging device that would typically involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- A standalone algorithm performance study was not done. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical tests was based on direct temperature measurements on test candidates, establishing whether the device could consistently reach and maintain a specified therapeutic temperature range.
8. The Sample Size for the Training Set
- Not applicable/Not provided. This document describes the 510(k) submission for a physical device, an infrared lamp, not an AI or machine learning model that would have a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not provided. As there is no training set for an AI model, there is no ground truth establishment for it.
In summary: The document is primarily a regulatory submission demonstrating substantial equivalence for an infrared lamp based on technological characteristics and non-clinical performance data (temperature output). It does not present clinical trial data or performance metrics common for AI/diagnostic devices that would involve human experts, large test sets, or ground truth derived from pathology or outcomes data.
§ 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.