(60 days)
ALM X'Ten™ (X10) Surgical Light Systems with Energix™ Power Supply are intended to be used to provide visible illumination of the surgical area or the patient.
An optional "LEDinside" feature is available and produces lower intensity levels of illumination intended for minimally invasive surgeries, procedures and examinations.
The Energix™ Power Supply is intended for use with surgical light systems.
The ALM X'Ten'M Surgical Light System is a new product designation intended to identify a family of surgical lights that will use a similar set of design principals as the Angenieux (AX) Series Surgical Light Systems. The primary predicate device focuses on comparisons to the Angenieux® AX10, which is the medium sized lighthead within the Angenieux® (AX) Series.
The ALM X'Ten™ Surgical Light provides a broadened set of features and options that include video camera and flat screen display capabilities, bulb failure indicator(s), and an ambient light mode ("LEDinside") as results from this redesign effort. The user can toggie from the Surgical Light mode to the Ambient Light mode via use of a keypad switch mounted on the yoke of the lighthead. The "LEDinside" mode presents a ring of light mouthed from the bottom surface of the light, centered on the outer periphery of the sterile handle. Intensity can be adjusted to four levels: 30, 70, 110 and 150 Lux (@ 1m) and is sufficient to work on the patient in a dim or darkened operating room.
The ALM X'Ten™ Product Family currently has four configurations available, as shown within Table 1.
The provided text describes the ALM X'Ten™ Surgical Light System, but it does not contain a study section with acceptance criteria and a detailed analysis of how the device meets them. Instead, it lists the test data that supports conformance to various safety and performance standards.
Therefore, I cannot fulfill all parts of your request directly from the provided input. However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance:
The document states that the test data supports conformance to the following standards. These standards themselves contain the acceptance criteria, but the specific performance results from the testing are not reported in this document.
| Acceptance Criteria (Standards Conformed To) | Reported Device Performance |
|---|---|
| UL 60601-1 Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety | Conformance supported by test data |
| UL60601-2-41 Medical electrical equipment Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnostics | Conformance supported by test data |
| CSA C22.2 No. 601.1 Medical Electrical Equipment, Part 1: General Requirements for Safety | Conformance supported by test data |
| CSA C.22.2 No. 60601-2-41 Medical electrical equipment Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnostics | Conformance supported by test data |
| IEC 60601-2-41 Medical electrical equipment Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnostics | Conformance supported by test data |
| EN 60601-1-2 Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests | Conformance supported by test data |
| FCC Part 15 | Conformance supported by test data |
| Appropriate FDA Software Guidance Documents (for Minor Level of Concern software) | Tested according to these documents |
2. Sample size 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 text only states that "test data supports conformance" but does not detail the testing methodology, sample sizes, or provenance of the data.
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 in the document. The testing described is against engineering and safety standards, not clinical ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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 study was not done. This device is a surgical light system, and the filing indicates "No clinical data is required for this device classification submission." This type of study is typically associated with diagnostic AI systems.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a surgical light system, not an algorithm, and its performance is assessed against technical safety and performance standards rather than in a standalone diagnostic context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is defined by its adherence to established international and national safety and performance standards for medical electrical equipment and surgical luminaires (e.g., UL 60601-1, IEC 60601-2-41). It is not based on clinical "ground truth" like pathology or outcomes data, as clinical data was not required.
8. The sample size for the training set:
Not applicable. This device is a physical surgical light system, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, no training set is relevant for this type of 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.