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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

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.

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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.

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.

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