(102 days)
ALM Prismalix (PRX) Surgical Lights are intended to provide visible illumination for the surgical field or for the examination of the patient. PRX is designed to eliminate shadows, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures. Use.is by surgeons and other medical care givers.
The ALM PRX Surgical Lights will be used in indications which are the same as indications for other surgical lights currently offered for commercial distribution in the United States.
The new product known as "Prismalix™" is of similar technology to surgical lights covered under D.C. Number K882613 issued on June 29, 1988. The differences between the new Prismalix™ models and models previously sold are cosmetic along with the addition of a tilting mechanism (in selected models) which allows variations in pattern size.
The surgical light consists of single or multiple lightheads attached to suspension arms supported from hospital installed mounting plates. Light heads can be positioned for optimal illumination of the surgical site by grasping sterilizable handles or non-sterile handles on the lighthead.
Low voltage power is supplied to the light bulb by way of a remote mounted transformer similar to those used by other surgical lighting manufacturers. Light intensity is controlled by a dimmer system, mounted remotely at a wall location.
Illumination is measured in footcandles or lux (1 footcandle equals 10.764 lux). Reference publication RP-29-95 Lighting for Hospitals and Health Care Facilities chapter 4, section 11, page 18. Illuminating Engineering Society of North America. New York, NY 1995. IES recommends a minimum illumination level at the surgical site of 2,500 footcandles when the light is positioned one meter above the site. The Prismalix™ series meets and exceeds this recommendation.
The previous range of lighting covered under K882613 is referenced by the three sizes of light heads; 500 mm or 5000 series, 700mm or 7000 series, and 900mm or 9000 series. The Prismalix™ series will be referenced by three sizes of light heads; 400mm or 4000 series, 600mm or 6000 series, and 800mm or 8000 series.
It is possible to provide a fixed focus video camera in selected 4000 series light heads. This Prismavision camera is similar in overall design and construction to the current ALM fixed focus camera, and other surgical/endoscopic video cameras offered for commercial distribution in the United States.
The provided document describes the ALM Prismalix™ Surgical Light and its substantial equivalence to predicate devices, rather than a study with acceptance criteria and device performance in the context of an AI/ML device. Therefore, many of the requested categories for AI/ML device evaluation (like sample size for test/training sets, data provenance, expert ground truth, MRMC studies, or standalone performance) are not applicable to this submission.
However, I can extract information related to the device's technical specifications and how its performance is compared to established standards and predicate devices.
Here's the relevant information based on the provided text:
Acceptance Criteria and Device Performance (for a Traditional Medical Device)
1. Table of Acceptance Criteria and Reported Device Performance
For this traditional medical device (surgical light), "acceptance criteria" are implied by industry standards and performance metrics of predicate devices. The primary acceptance criterion identified is illumination level.
| Acceptance Criterion (Implied) | Reported Device Performance (ALM Prismalix™) | Reference/Basis |
|---|---|---|
| Minimum Illumination Level at Surgical Site | Meets and exceeds 2,500 footcandles (at 1 meter) | IES RP-29-95 Lighting for Hospitals and Health Care Facilities (minimum recommendation) |
| Illumination Range | 100,000 to 120,000 lux | Comparison with predicate devices (ALM Prismatic, Berchtold, Steris, Midmark/Chick) |
| Compliance with Safety Standards | Designed to meet IEC 601-2-41; UL and C-UL Marks received | IEC 601-2-41 (safety criteria), Underwriters Laboratories (safety testing) |
| Substantial Equivalence to Predicate Devices (overall design, function, materials) | Substantially equivalent to 4 listed predicate devices (K882613, K922836, K943288, K860739) | FDA 510(k) review process |
2. Sample Size Used for the Test Set and the Data Provenance
Not applicable. This is a submission for a traditional medical device (surgical light), not an AI/ML device that uses test sets or training sets from patient data. The "test" in this context refers to engineering and safety testing of the physical product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Ground truth for AI/ML models is not relevant here. Device performance is measured against established engineering standards and specifications.
4. Adjudication Method for the Test Set
Not applicable for a traditional medical device submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
Not applicable. This is not an AI/ML device and human reader performance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
For this device, the "ground truth" is based on:
- Engineering Specifications and Standards: Such as IES RP-29-95 for illumination levels and IEC 601-2-41 for safety.
- Performance of Legally Marketed Predicate Devices: The device's features and performance are directly compared to existing, cleared surgical lights to demonstrate substantial equivalence.
- Safety Testing Certifications: UL and C-UL marks from Underwriters Laboratories confirm adherence to safety standards.
8. The sample size for the training set
Not applicable. This is a traditional medical device, not an AI/ML system requiring a training set of data.
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.