(90 days)
The Oricare L2700 Series Surgical Lamps provide illumination at varying illumination levels to the patient surgical area and provide video-visual procedural support for medical staff during surgical procedures.
OL 2700 series Surgical Lamps are ceiling mounted Surgical Lamps, suitable for providing supplemental illumination, with reduced shadowing effects during surgical and non-surgical procedures. The lighting system utilizes LED's for illumination and is powered from a standard 115VAC voltage source. The head design is comprised of multiple LED's (Light Emitting Diodes). It provides a cool, color corrected light which is adjustable with 10 levels of intensity. The light path design provides an extended light depth so that the beam requires no manual focus. Light generated by the LEDs is focused by optical lens to achieve an ideal irradiance pattern. The OL 2700 series LED surgical light can be configured with one or two light heads, the primary light head is useful for major illumination while the secondary light head is for ancillary illumination. The lights can also provide low level background lighting for endoscopic surgery. Oricare L2700 series Operating Room Lamps can be easily used in conjunction with the optional SD or HD video systems, to document surgical procedures for training purposes, make use of live transmissions or consult with external surgeons during operations. The camera system is available in different versions and can be used with integrated OR systems. It delivers images in SD or HD quality straight to the TFT monitor.
The provided document is a 510(k) summary for a surgical lamp (Oricare L2700 Series OR Surgical Luminaires), not a medical imaging or AI-enabled diagnostic device. Therefore, the detailed information requested in the prompt regarding acceptance criteria and a study proving a device meets them (especially concerning AI performance, ground truth, expert adjudication, MRMC studies, etc.) is not applicable to this submission.
The document describes the device's technological characteristics, intended use, and performance testing, primarily focusing on compliance with recognized industry standards for medical devices and establishing substantial equivalence to predicate devices.
Here's a breakdown of the relevant information provided, framed as closely as possible to your request, but acknowledging the difference in device type:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of "acceptance criteria" for a diagnostic performance metric (like sensitivity or specificity) because it's a surgical light. Instead, it references compliance with various recognized industry standards. The reported "device performance" is implicitly that it meets these standards.
| Acceptance Criteria (Standards Adhered To) | Reported Device Performance (Compliance) |
|---|---|
| IEC 60601-1:2005 (3rd edition) | Compliant |
| IEC 60601-1-2:2007 | Compliant |
| IEC 60601-2-41:2009 | Compliant |
| ISO 14971:2009 | Compliant |
| IEC 60601-1-6 | Compliant |
| FDA Software Guidance Document | Compliant (for "Minor Level of Concern" software) |
The document states: "The combined testing and analysis of results provides assurance that the device meets the requirements for safety and essential performance and is effective for its intended use."
2. Sample Size Used for the Test Set and Data Provenance
This concept is not applicable. The device is a surgical lamp, not a diagnostic tool evaluated on patient data. Performance testing would involve engineering and electrical tests on the physical device itself, not a "test set" of patient cases.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. "Ground truth" in the context of diagnostic accuracy is not relevant for a surgical lighting system. Device performance (e.g., light intensity, color temperature, safety features) is typically established through engineering measurements and adherence to technical standards.
4. Adjudication Method for the Test Set
This is not applicable. No "test set" of patient cases or diagnostic results was used, so no adjudication method is relevant.
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
This is not applicable. The device is not an AI-assisted diagnostic tool, and no MRMC study was conducted. The document focuses on "Non-clinical Comparisons to Predicate Device" which are limited to "differences in design, material, and operational" aspects, and states these differences "do not raise any new issues of safety and efficacy."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This is not applicable. The device is not an algorithm or AI system.
7. The Type of Ground Truth Used
This is not applicable. The concept of "ground truth" (e.g., pathology, expert consensus) is for diagnostic accuracy studies, which are not relevant for a surgical lamp. The "truth" for this device lies in its physical performance characteristics meeting established engineering and safety standards.
8. The Sample Size for the Training Set
This is not applicable. The device is not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. No training set or associated ground truth was established for this device.
§ 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.