(128 days)
The MI-750 is a fixed pattern / three level intensity procedural/minor surgical light designed to provide visible illumination of the surgical field and the patient during minor surgical and non-surgical procedures.
The proposed MI-750 is a first generation fix pattern / three level intensity procedural/minor surgical light designed to provide visible illumination of the surgical field and the patient during minor surgical and non-surgical procedures.
This document is a 510(k) summary for the Medical Illumination International MI-750 Minor Surgical Light. It contains information related to the regulation, intended use, and substantial equivalence to predicate devices, but it does not contain a study that proves the device meets specific acceptance criteria in the context of diagnostic or AI performance.
Instead, the "Performance Testing" section states: "Performance testing was conducted to verify that the MI-750 meets the requirements for Medical Electrical Equipment as defined in CEI / IEC 60601-1 and IEC 60601-2-41." These are general safety and performance standards for medical electrical equipment and surgical luminaires, not performance metrics like sensitivity, specificity, or reader improvement typically seen in studies for AI/diagnostic devices.
Therefore, many of the requested points in the prompt (e.g., sample size for test set, number of experts, MRMC study, standalone performance) are not applicable or cannot be answered from the provided text, as this document is not reporting on such a study.
However, I can extract the relevant information about the acceptance criteria and how "performance" was assessed based on the provided text.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Meets general requirements for safety as defined in CEI/IEC 60601-1 | "The performance of the MI-750 meets the general requirements for safety as defined in CEI/IEC 60601-1" |
| Meets requirements for Medical Electrical Equipment as defined in IEC 60601-2-41 | "The performance of the MI-750 meets the general requirements for safety as defined in... IEC 60601-2-41" |
| Verifies that the MI-750 meets the requirements for Medical Electrical Equipment as defined in CEI / IEC 60601-1 and IEC 60601-2-41 (Performance Testing) | "Performance testing was conducted to verify that the MI-750 meets the requirements for Medical Electrical Equipment as defined in CEI / IEC 60601-1 and IEC 60601-2-41." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The performance testing refers to compliance with safety standards for medical electrical equipment, not a study involving human subjects or data sets in the typical sense of AI/diagnostic device evaluation.
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 information is not provided as the document describes a safety and performance compliance testing for a medical light, not a study evaluating human interpretation or diagnostic accuracy where expert ground truth would be established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as it's not relevant to the type of compliance testing 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
No, an MRMC comparative effectiveness study was not done as this device is a surgical light, not an AI or diagnostic tool designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a surgical light, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable. The "ground truth" for compliance testing of a surgical light would be the specifications and requirements outlined in the CEI/IEC 60601 standards.
8. The sample size for the training set
This is not applicable. The device is a surgical light, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This is not applicable. The device is a surgical light, not an AI model.
In summary, the provided document is a 510(k) premarket notification for a medical device (a surgical light). The "study" mentioned refers to performance testing against established international electrical safety and performance standards (CEI/IEC 60601-1 and IEC 60601-2-41) for medical electrical equipment, rather than a clinical trial or AI performance study typically associated with the detailed criteria requested in your prompt.
§ 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.