(105 days)
The CableCap device attaches to the distal end of high intensity light cables. The device absorbs and diffuses the light transmitted through the cable in order to prevent patient burns and igniting flammable items in the surgical suite. It is necessary to check each light cable to determine which CableCap model (STZ, ACM, WLF) to use. See product instructions for cleaning and sterilization protocols.
The device is not intended to be used to illuminate the surgical field.
The CableCap device attaches to the distal end of high intensity light cables. The device absorbs and diffuses the light transmitted through the cable in order to prevent patient burns and igniting flammable items in the surgical suite.
There are three separate models made for the three types of light cables: WLF, STZ, ACM.
Here's an analysis of the provided text regarding the CableCap™ device, focusing on the acceptance criteria and the study performed:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text only details one explicit performance criterion related to temperature.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maximum device temperature below a "standard" | Maximum temperature was 101 °F |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text mentions "test runs" and "bench-top physical testing," implying multiple tests were done, but the exact number of units tested or runs performed is not provided.
- Data Provenance: The testing was conducted by Materials, Engineering, and Testing Corp. in Oak Ridge, TN. This indicates the testing was likely performed in the USA. The text does not specify if the tests were performed on retrospective or prospective data/scenarios; it describes simulating "an extreme scenario" for prospective product safety.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to the type of testing described. The performance testing for the CableCap™ device was a physical bench-top test measuring temperature, not a diagnostic or interpretive task that would require expert consensus for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. Since the testing involved physical measurements (temperature), there was no need for expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. The CableCap™ is a physical accessory designed to prevent burns and ignition, not a diagnostic or interpretive tool that would involve human readers or AI assistance in decision-making. Therefore, an MRMC study is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. The CableCap™ is a passive mechanical device, not an algorithm or software. Its performance is inherent in its physical properties and design, not in an algorithmic output.
7. Type of Ground Truth Used
The ground truth used for the performance testing was a physical measurement benchmark (a "standard" for safe temperature) against which the device's measured temperature was compared.
8. Sample Size for the Training Set
This information is not applicable. The CableCap™ is a hardware device; it does not involve machine learning or AI, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set was Established
This information 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.