(15 days)
The surgical light M3 is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow-free, "cold" light.
The M3 Surgical Light is suitable for all types of of surgical procedures. With its advanced technology of R96 light technology, the M3 realizes a high illumination intensity with a lower heat radiation. The light incorporates easy-to-move swivel arms, three halogen bulbs, and an easy-to-exchange lamp cartridge. Also an optional Video camera or video preparation is available. The lamp can be combined with other lights provided by MAVIG.
This section will describe the acceptance criteria and the study that proves the M3 Surgical Light meets the acceptance criteria.
The provided 510(k) summary for the MAVIG M3 Surgical Light does not contain a study explicitly designed to "prove" the device meets specific acceptance criteria in the way a clinical or performance study for a diagnostic AI device would. Instead, this 510(k) submission establishes substantial equivalence to a predicate device (CHROMOPHARE X 65, K024132).
For a surgical lamp, acceptance criteria typically fall under performance standards outlined in recognized standards (e.g., IEC standards for medical electrical equipment) or internal company specifications related to illumination intensity, shadow reduction, heat radiation, color temperature, mechanical stability, and safety. The 510(k) process focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Given the nature of the provided document, the "acceptance criteria" can be inferred from the comparison made to the predicate device and the general performance characteristics expected of a surgical light. "Reported device performance" would be derived from the description of the M3 and its comparison to the predicate.
Here's an attempt to structure the information based on the provided document, acknowledging the limitations for a device of this type in a 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a surgical lamp, the "acceptance criteria" are implicitly tied to the performance of the predicate device and general safety/effectiveness requirements for surgical lights. The "reported device performance" is descriptive rather than quantitative, focusing on features and comparative benefits.
| Acceptance Criteria (Inferred from Predicate Equivalence & Device Type) | Reported M3 Device Performance |
|---|---|
| Illumination Intensity (High) | Realizes a high illumination intensity (with its advanced technology of R96 light technology). |
| Shadow-free Illumination | Intended to illuminate locally the operating site... with a high intensity, shadow-free, "cold" light. |
| Reduced Heat Radiation | Realizes a high illumination intensity with a lower heat radiation. |
| Operability / Maneuverability | Incorporates easy-to-move swivel arms. |
| Light Source Type & Redundancy | 3 halogen bulbs 24V/50W (Predicate: 2 discharge lamps with automatic switch-over function). This difference is presented as not negatively affecting safety/effectiveness. |
| Reflector System | Multi-reflector system with 3 glass reflectors, specially coated heat protection filter (Predicate: One-reflector system with polygon reflector). |
| Lighting Field Size Adjustment | Duo-Focus Technology: Allows a bigger setting range of the light field size (suitable for very small and deep wound areas). (Predicate: Not available). This is highlighted as an enhancement to usefulness. |
| Modularity / Expandability | Optional video camera or video preparation is available. Can be combined with other lights provided by MAVIG. |
| Safety and Effectiveness | Substantially equivalent to the surgical light CHROMOPHARE X 65. Any difference has no negative effect on safety or effectiveness and actually enhances the usefulness. |
Since this is a 510(k) for a medical device (surgical lamp) and not an AI or diagnostic device, the subsequent requested points regarding study details are largely
not applicable or cannot be determined from the provided 510(k) summary document directly because it focuses on substantial equivalence rather than a detailed performance study with human readers or AI algorithms.
Here's an analysis for each point:
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 / Not Provided: For a surgical light, there isn't a "test set" in the context of diagnostic data or images. Performance is typically assessed through engineering tests, adherence to standards, and user feedback, not data analysis with a test set. The 510(k) does not mention any specific test set data provenance.
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 / Not Provided: As there is no "test set" in the diagnostic sense, there were no experts establishing ground truth for data for this device type within the scope of a 510(k) summary of this nature. Performance validation for medical devices like surgical lamps involves technical specifications and compliance with recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: There is no diagnostic "test set" or adjudication method described.
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 / Not Provided: This device is a surgical lamp, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers or AI assistance would not be relevant or performed for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided: This device is a surgical lamp, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: For a surgical light, "ground truth" isn't established in the same way as for diagnostic devices. Performance is typically validated against technical specifications, optical measurements (e.g., illuminance, color rendering, depth of field), and safety standards. The document doesn't detail these validation methods but implies they were performed to support substantial equivalence.
8. The sample size for the training set
- Not Applicable / Not Provided: This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: This device is not an AI/ML algorithm, so there is no training set or associated ground truth.
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.