(28 days)
The DeRoyal Disposable Rigid Light Handle and Adapter are indicated for use as accessories to a surgical lamp. The adapter is to be used, when necessary, to attach the light handle to the surgical lamp. The light handle is to be used to position the light without contaminating the gloved hand.
The DeRoyal Disposable Rigid Light Handle and Adapter function in the same manner as predicate devices in that they are intended to be used as accessories to a surgical lamp which are used to position the light for illumination in various areas of the surgical field. The DeRoyal Disposable Rigid Light Handle and Adapter are made of materials commonly used for their purposes. The light handle contains a protective shield at the base which is used to prevent the gloved hand from contaminated surfaces. The protective shield may be folded and attached to the light handle to reduce space needed for packaging and storage.
This 510(k) summary for the DeRoyal Disposable Rigid Light Handle and Adapter focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study. As such, much of the requested information regarding detailed study design and results is not present in the provided document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define quantifiable acceptance criteria with corresponding performance metrics from a specific study. Instead, it relies on a qualitative comparison to predicate devices, asserting that the new device functions "in the same manner" and shares similar characteristics.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance |
|---|---|---|
| Material (Light Handle) | Plastic Polymers | Plastic Polymers |
| Protective Shield | Yes | Yes |
| Rigid | Yes | Yes |
| Universally Adaptable | Yes | Yes |
| Sterility | Sterile | Sterile |
| Disposable | Yes | Yes |
| Packaged | 1 or 2 per Pack | 1 or 2 per Pack |
| Material (Adapter) | Aluminum (or similar) | Aluminum |
| Functionality | Position light without contaminating gloved hand; attach to surgical lamp | Position light without contaminating gloved hand; attach to surgical lamp |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The submission does not describe a formal "test set" or a performance study with a defined sample size for evaluating the device against acceptance criteria. The comparison is based on the inherent design features and intended use of the device relative to existing products.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This type of information is typically relevant for studies involving subjective assessments or complex diagnostic imaging, which is not the case for this device.
4. Adjudication Method for the Test Set
Not applicable, as there was no formal "test set" requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is not relevant for this type of device (a surgical light handle accessory). MRMC studies are typically used to assess the comparative diagnostic performance of readers using different methods or technologies, often in medical imaging.
6. Standalone (Algorithm Only) Performance Study
No. This device is a physical, mechanical accessory, not an algorithm or software-based system. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
The "ground truth" for this submission is the established design and functionality of the legally marketed predicate devices (Charles Polo & Co. and Devon Industries). The claim of substantial equivalence is based on the new device having the same technological characteristics and intended use as these predicates. There is no external "ground truth" like pathology or outcomes data sought.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-driven device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set 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.