(90 days)
The KSEA SCB Media Control provides remote control for overhead and surgical lights, cameras, telephones, pagers, CD-players, audio volume output, and teleconference equipment in the operating room.
The Karl Storz Media Control is a remote control unit.
The provided text is a 510(k) summary for the KSEA SCB Media Control device, which is a remote control unit. It does not contain information typically associated with studies proving acceptance criteria for AI/ML-driven medical devices.
Therefore, many of the requested fields cannot be extracted or are not applicable.
Here's a breakdown based on the available information:
1. Table of acceptance criteria and the reported device performance:
This device is a remote control unit, not an AI/ML diagnostic or measurement device. The 510(k) summary states, "The Karl Storz Media Control is substantially equivalent to the predicate device since the basic features and general intended uses are similar. The minor differences between the Karl Storz Media Control and the predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of these devices."
This implies that the "acceptance criteria" were met by demonstrating substantial equivalence to a legally marketed predicate device, rather than through specific performance metrics measured in a study. Therefore, there are no reported quantitative performance metrics in the document.
| Acceptance Criteria (Inferred from 510(k)) | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate device (KSEA SCB Media Control) | Basic features and general intended uses are similar to predicate. Minor differences have no effect on performance, function, or general intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is a remote control unit, and the 510(k) summary does not describe a test set or data for performance evaluation in the context of an AI/ML 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. Ground truth establishment is not relevant for this type of device according to the provided documentation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable.
8. The sample size for the training set:
Not applicable. This device does not involve a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.