(59 days)
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.
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:
Here's an analysis of the provided text regarding the SensorMed CableCap™ 510(k) submission, outlining acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Test Objective) | Reported Device Performance |
|---|---|
| Prevent patient burns | Maximum device temperature of 95 °F after 60 minutes of contact. |
| Prevent igniting flammable items | Maximum device temperature of 95 °F after 60 minutes of contact. |
| Maintain temperature well below standard for patient contact | 95 °F is "well below the standard" (specific standard not provided but implied to be higher than 95°F for patient contact safety). |
| Safe for extended use (at least 30 minutes) | Tested for 60 minutes, remaining at 95 °F. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a numerical 'sample size' in terms of units tested. The text mentions "test runs" and a "report included in the testing section." It doesn't specify if one device was tested multiple times, or if multiple devices were tested.
- Data Provenance: The testing was conducted by "Materials, Engineering, and Testing Corp. located in Oak Ridge, TN." This indicates the data is from a U.S.-based, independent testing lab. The study appears to be prospective bench-top testing specifically designed to evaluate the safety of the CableCap.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. The ground truth for this device's performance is objective physical measurements (temperature). No human experts were used to establish a subjective "ground truth" for the test set. The acceptance criteria themselves (e.g., maximum safe temperature) would be derived from established medical device safety standards, which are developed by experts and regulatory bodies, but no specific number or qualification of experts is mentioned for this particular test.
4. Adjudication Method for the Test Set
- Not Applicable. As the ground truth was objective physical measurement (temperature), there was no need for expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This device (CableCap) is a physical accessory designed to reduce heat from a surgical light cable. Its performance is evaluated through objective physical measurements related to temperature, not through human interpretation of medical images or data. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, in essence. The performance testing described is of the device itself (the "algorithm" in this context being the device's physical heat-dissipating properties) without any human interaction influencing its core function or measurement during the test. The device's ability to absorb and diffuse light to prevent heat buildup was tested in a standalone, bench-top environment.
7. Type of Ground Truth Used
- Objective Physical Measurements: The ground truth was established by direct measurement of the device's temperature under simulated "extreme scenarios" (contact with skin for 60 minutes). This is a physical, measurable outcome, not expert consensus, pathology, or patient outcomes data directly from a clinical trial.
8. Sample Size for the Training Set
- Not Applicable. This device is a passive physical accessory, not an AI/ML algorithm that requires a training set. The performance is determined by its design and material properties, not learned from data. Therefore, there is no training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for this type of device, this question is not relevant.
§ 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.