(67 days)
The proposed Harmony LED-1 Surgical lighting System subjected in this submission is a variable pattern/ intensity surgical light designed to provide visible illumination of the surgical field and patient and to provide video-visual procedural support for the hospital staff during surgical procedures.
The proposed Harmony LED-1 Surgical Lighting System subjected in this submission is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures.
The proposed Harmony LED-1 Surgical Lighting System Lighthead is specifically designed to be the next generation lighthead which can be added to the existing center mounted suspension system supporting the horizontal arms, spring arms and yokes of the predicate device Amsco Harmony Surgical Lighting and Media System cleared for market on December 13, 2001 as K013242 (STERIS Corporation). Like the predicate device the system operates via an electronic controller.
The proposed Harmony LED-1 Surgical Lighting System accessories are as follows:
- . Ambient Light System.
- . IR remote control for camera module.
- DeepSite Fiber Optic Light. .
- Fiber Optic Video Enabled Video. ●
- . STERIS ACT Interface.
- Camera Module.
- . Dual or Single Flat Panel Monitors.
- . CRT.
- . 24VDC Battery Backup support.
- . Secondary Spindle Mount.
- . Low Profile Wall Control Unit.
- . Remote Power Module Unit.
- . Sterile Disposable Handle Covers.
Here's an analysis of the provided text regarding the STERIS Harmony LED-1 Surgical Lighting System, specifically addressing the requested information about acceptance criteria and performance studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document cites performance testing to verify compliance with safety standards, but does not explicitly list specific acceptance criteria or quantitative performance metrics (e.g., lux levels, color temperature, etc.) for the Harmony LED-1 Surgical Lighting System within the given text.
It makes a general statement: "Performance testing was conducted to verify that the proposed Harmony LED-1 Surgical Lighting System meet the requirements for Medical Electrical Equipment as defined in CEI/IEC 60601-1 and IEC 60601-2-41."
Therefore, based on the provided text, the table would look like this:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with CEI/IEC 60601-1 (General Requirements for Safety of Medical Electrical Equipment) | The device "meet[s] the requirements" of CEI/IEC 60601-1. |
| Compliance with IEC 60601-2-41 (Particular Requirements for the Safety of Surgical Luminaires and Light for Diagnosis) | The device "meet[s] the requirements" of IEC 60601-2-41. |
Important Note: To get actual numerical acceptance criteria (e.g., minimum illumination levels, maximum heat generation, color rendering index), one would need to refer to the specific clauses of the CEI/IEC 60601-1 and IEC 60601-2-41 standards, which are not detailed in this submission. This document focuses on demonstrating conformance to these standards rather than detailing the specific performance results against each criteria.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not mention any specific sample size for a "test set" in the context of clinical or performance data. The performance testing described refers to verification against technical standards, which typically involves testing the device itself, not a sample of patient data.
Therefore, this information cannot be extracted from the given document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable to the type of safety and performance testing described in the document. The "ground truth" here is established by the international safety standards (CEI/IEC 60601-1 and IEC 60601-2-41), and the testing verifies the device's adherence to these engineering and electrical safety requirements, not clinical efficacy or diagnostic accuracy that would require human expert adjudication.
4. Adjudication Method for the Test Set
This is not applicable for the reasons stated in point 3. The "test set" here is the physical device and its electrical/mechanical performance, which is assessed against objective technical standards, not through human adjudication of data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not conducted or mentioned in the provided text. This type of study is typically used for diagnostic or screening devices to assess the impact of AI on human reader performance for interpretation of images or other data. The STERIS Harmony LED-1 Surgical Lighting System is an illumination device, not a diagnostic tool that relies on human interpretation of outputs aided by AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable. The device is a surgical light, not an algorithm. Therefore, there is no "standalone" algorithmic performance to report.
7. The Type of Ground Truth Used
The "ground truth" used for performance assessment is the technical requirements and specifications outlined in the international safety and performance standards CEI/IEC 60601-1 and IEC 60601-2-41. These standards define what constitutes a safe and functional surgical light. The device is tested to ensure it meets these engineering and electrical safety criteria.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical hardware product (surgical light), not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8.
§ 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.