(125 days)
THE PRODUCT WILL BE USED TO ILLUMINATE SURGICAL PROCEDURES WITH COLOR CORRECTED WHITE LIGHT AND HEAT FILTERING (IR). DESIGNED TO ELIMINATE SHADOWS AND ILLUMINATE DEEP CAVITY WOUNDS WITH ADEQUATE PENETRATION. IT IS INTENDED TO BE USED BY SURGEONS AND OTHER MEDICAL CARE PRACTITIONERS IN A SURGICAL SETTING. THERE ARE NO CONTRA-INDICATIONS FOR USE.
The Getinge/Castle OptiView® surgical lights are designed to provide the high quality light required in an operating room setting. There are four major considerations that the lights have been designed for: 1. Shadow Elimination. 144 radial dioptric lenses, disposed equally on the lens glass, are used to broaden the light beam such that a 10 X 20 cm patch of light is produced on the surgical site from each lens. Should one or several of the lenses become obstructed by the surgeon or from equipment, a constant quantity of light is subtracted from each point of the light field. This virtually eliminates shadows and provides for optimum visibility. 2. Optimal Depth of Field. A central toric lens and conic mirror is used to produce very broad beams whose intersection are not points but are volumes. In some cases the volume can measure up to 70 cm in height and 20 cm across the center. The design also allows the volume of light to be moved in the axis of the beam, this is called variable focusing. 3. Heat Elimination and High Color Rendition. Through the use of a special type of glass, the emitted light is corrected for color (towards the model for broadband sunlight) and filtered for infrared. This eliminates the thermal effect of the beam and allows a color rendition index of Ra = 95 or greater. 4. Electromagnetic and Bacteriologic Neutrality. The product have been designed and tested to comply with the strictest electromagnetic compatibility standards. Also, the sealed optical unit, the flat, smooth surfaces and sensitive touch-controls provide for an extremely aseptic environment. The mechanical aspects of the lights are that they are constructed of specifically designed steel load-bearing drop tubes, yokes and suspension assemblies that are coated with a strong epoxy resin paint. These structures are mechanically connected at pivot points that incorporate counter-balances for ease of movement as well as specially designed wire-runs and fully pivoting electrical connectors. The electrical aspects of the lights are designed to comply with international safety standards such as: Low Voltage Directive (LVD) 72/23/CEE, Decree No. 95-1081 Electromagnetic Compatibility Directive (EMC) 89/336/CEE, Decree No. 95-587 Medical Device Directive (MDD) 93/42/CEE. Power Supply Units, NF EN 60-4391 (IEC 433-1), NF EN 60-439-Operating Theatre Lighting, NF EN 60-601-1 (IEC 601). The design will also be examined to UL 544 and certified by either Underwriters Laboratory or Intertek Testing Services (ITS) which should result in the UL or ETL mark. The lights were previously CE marked, while marketed in Europe, by the original manufacturer: Scialityque Industrie. The lights are electrically controlled via pressure sensitive touch controls that may be located on the lights or at remote locations. The controls allow the lights to be energized, the light level to be adjusted and the focus mechanisms to be operated. The light beam is achieved through the use of one or two (dependent upon model) tungsten-halogen 24 VDC bulbs that are contained in a sealed optical unit. The emitted light is focused through a toroidial lens and is reflected off of a conic, polished aluminum reflector and through 144 radial dioptric lenses which allows for a radial-focused broad-beam light pattern on the surgical surface. This eliminates shadows while concurrently extending the true depth of field of the beam.
The provided document is a 510(k) premarket notification for the Getinge/Castle OptiView® Surgical Light. It details the device's description, intended use, and a comparison to predicate devices to establish substantial equivalence. However, it does not include a formal study with acceptance criteria and reported device performance in the way a clinical trial or performance validation study would typically present it for an AI/ML device.
Instead, the "acceptance criteria" can be inferred from the comparison tables which demonstrate that the OptiView® surgical lights meet or exceed the specifications of the predicate devices for key performance characteristics. The "study" proving this is implicitly the comparison itself, showing that the new device's specifications are within acceptable ranges relative to already-marketed and cleared devices.
Here's an analysis based on the provided text, addressing the requested points:
Acceptance Criteria and Device Performance for Getinge/Castle OptiView® Surgical Light
The "acceptance criteria" for this device are implicitly defined by its substantial equivalence to predicate devices, particularly in key performance specifications relevant to surgical lighting. The study proving conformance is a direct comparison of these specifications.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for a non-AI surgical light, formal acceptance criteria as typically seen for AI/ML devices (e.g., sensitivity, specificity thresholds) are not explicitly stated. Instead, the acceptance criteria are satisfied by demonstrating that the OptiView® series lights perform comparably or better than the predicate devices across relevant technical specifications.
The tables below present selected specifications for the OptiView® 500 series and 700 series alongside their predicate devices. The "Acceptance Criteria" column represents the range or value observed in the predicate devices within which the new device should fall to demonstrate substantial equivalence. The "Reported Device Performance" column shows how the OptiView® series lights meet these implicit criteria.
OptiView® 500 series vs. Predicate Devices (ALM PRC 7001 series, Berchtold C-570 series)
| Specification | Acceptance Criteria (Predicate Range/Value) | Reported Device Performance (OptiView® 500 series) |
|---|---|---|
| Illumination Level, max ft-candles (lux) | 9,300 (100,000) - 13,530 (145,000) ft-candles (lux) | 12,300 (130,000) ft-candles (lux) |
| Color Temperature, °K | 3,500 - 4,500 °K | 4,300 °K |
| Field Size, Diameter, cm (in) | 18-28 (7-11) cm | 10-15 (3.9-5.9) cm |
| Depth of Field, cm (in) | 70 (27.6) - 80 (31) cm | 40 (15.7) cm |
| Bulb Life, hr | 1000 hr | 500 (min) hr |
| Heat Filtering, % | 99% | 99% |
| Controls | Continuous/Adjustable Dimmer, Adjustable Focus, Adjustable Field Size | Variable intensity Dimmer, Adjustable Focus, Adjustable Field Size |
Note on Field Size and Depth of Field for OptiView® 500 series: While the reported values are sometimes outside the predicate range, the narrative emphasizes benefits like "optimal depth of field" (up to 70cm in some cases) and variable focusing, suggesting these differences are part of an equivalent or improved design aimed at specific functional benefits such as shadow elimination and deep cavity penetration.
OptiView® 700 series vs. Predicate Devices (ALM PRC 9001 series, AMSCO SQ240)
| Specification | Acceptance Criteria (Predicate Range/Value) | Reported Device Performance (OptiView® 700 series) |
|---|---|---|
| Illumination Level, max ft-candles (lux @ 1 m) | 10,000 (107,640) - 12,000 (129,170) ft-candles (lux) | 11,200 (120,000) ft-candles (lux) |
| Color Temperature, °K | 3,500 - 4,400 °K | 4,300 °K |
| Field Size, Diameter, cm (in) | 16.5 (6.5) - 21.6 (8.5) cm | 17-24 (6.7-9.4) cm |
| Depth of Field, cm (in) | 66 (26) - 70 (27.6) cm | 50 (19.7) cm |
| Bulb Life, hr | 1000 hr | 500 (min) hr |
| Heat Filtering, % | 98% | 99% |
| Controls | Continuous/Variable intensity Dimmer, Fixed/Adjustable Focus, Adjustable Field Size | Variable intensity Dimmer, Adjustable Focus, Adjustable Field Size |
Note for OptiView® 700 series: similar to the 500 series, specific values like bulb life (500 min hrs vs 1000 hrs for predicates) might differ, but the overall functional equivalence and safety are argued through the 510(k) process, emphasizing design features like "true depth of field of the beam."
2. Sample Size Used for the Test Set and Data Provenance
This is not a study involving a "test set" in the context of AI/ML. The "test" consists of comparing the specifications of the new device to existing predicate devices. The data provenance is from the technical specifications provided by Getinge/Castle and the manufacturers of the predicate devices. The data is based on engineering specifications and likely internal testing, not patient data.
- Sample Size for Test Set: Not applicable in the context of an AI/ML device test set. The "test" is a comparison of product specifications.
- Data Provenance: Technical specifications of manufactured surgical lights (OptiView series and predicate devices). Implicitly, this data is from the respective manufacturers, likely based on engineering designs and performance testing. The country of origin for Getinge/Castle is the USA (North Charleston, SC). For predicate devices, ALM, AMSCO, and Berchtold are mentioned, which are international manufacturers. The data is retrospective in the sense that it reflects established specifications of existing devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. "Ground truth" in this context is established by the documented technical specifications of the surgical lights themselves, which are derived from engineering and manufacturing standards, not expert medical opinion on a dataset.
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication method" as this is not a diagnostic device with ambiguous outputs requiring clinical interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a medical device (surgical light), not a diagnostic algorithm, and therefore an MRMC study is not relevant or performed in this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is a physical surgical lighting device, not an AI algorithm. "Standalone" performance testing would refer to the device's technical specifications and functionality (e.g., light intensity, color temperature, heat dissipation) as reported in the tables, independent of human interaction during those measurements. The information provided demonstrates this by listing the device's inherent performance characteristics.
7. The type of ground truth used
The "ground truth" implicitly used for comparison is the published performance specifications of legally marketed predicate surgical lights, which represent accepted performance benchmarks for such devices in a clinical setting.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that uses a "training set."
9. How the ground truth for the training set was established
Not applicable.
Summary of the "Study" (510(k) Premarket Notification):
The "study" in this submission is the comprehensive comparison of the Getinge/Castle OptiView® Surgical Light (including its 200, 500, and 700 series) with predicate devices (ALM Prismatic models, AMSCO SQ240, Berchtold Chromophare models). This comparison is based on detailed technical specifications across numerous parameters, including:
- Physical dimensions (diameter, weight)
- Electrical specifications (supply voltage, power, bulb type, volts, life)
- Optical performance (color temperature, field size, depth, focal length, illumination level)
- Control features (dimmer, focus, field size, rotation)
- Material composition (heat filtering, filter material, reflector material)
- Mounting types and ceiling height requirements
The premise of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use, and either has the same technological characteristics as the predicate, or has different technological characteristics but does not raise new questions of safety and effectiveness and is as safe and effective as the predicate device.
The provided tables and descriptive text fulfill this requirement by showing that the OptiView® series lights meet or exceed the performance metrics of the predicate devices for critical elements like illumination, color rendition, heat filtering, and shadow elimination, indicating that they are at least as safe and effective. The narrative explicitly states: "We are not introducing new technology. The OptiView® lights and the predicate devices use very similar technology to achieve the same basic goal..." and "We are not introducing any new indications for use." These statements, backed by the comparative data, serve as the "proof" that the device meets the implicit acceptance criteria of substantial equivalence.
§ 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.