(404 days)
The Carbodissecting Endoscope is designed for use in intraluminal tissue separation during a femoro-popliteal endarterectomy procedure intended to achieve vascular reconstruction. The device is an adjunctive aid in the separation of vessel layers.
The Carbodissecting Endoscope, sterile and single-use, consists of two components: The spatula is a surgical tool used with carbon dioxide (CO2) and saline for atherectomy using carbodissection. The scope is a flexible fiberscope intended for use with the Carbodissecting Endoscope Spatula to provide visual feedback.
The provided 510(k) summary for the "Carbodissecting Endoscope" does not contain information related to acceptance criteria or a study proving the device meets performance criteria in the context of an AI/ML medical device.
This document details the regulatory pathway for a surgical device (an intraluminal artery stripper) and focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. The "Performance Testing" section primarily refers to compliance with an electrical safety standard (IEC 601-2-18) and mentions "additional bench testing and biocompatibility testing," but provides no specifics on acceptance criteria or detailed study results for functional performance.
Therefore, for almost all the requested information, the answer will be "Not Applicable" or "Not Provided in the document" because the device is a physical surgical tool, not an AI/ML algorithm requiring performance metrics like sensitivity, specificity, or human-in-the-loop studies.
Here's a breakdown based on the provided text, indicating why most items cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria | Reported Device Performance |
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|
| Electrical Safety | Compliance with IEC 601-2-18 | Device meets the requirements of IEC 601-2-18 (Safety of Medical Electrical Equipment: Particular Requirements for Endoscopes). |
| Biocompatibility | Not explicitly stated, but implied as part of safety testing | Biocompatibility testing has been completed. |
| Bench Testing (Functional) | Not explicitly stated | Additional bench testing has been completed. (No specific functional criteria or results provided in this document). |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a physical surgical device, not an AI/ML algorithm that uses a test set of data. The document does not describe any clinical studies involving patient data for performance evaluation in a hypothesis-testing manner, but rather mentions "bench testing" and "biocompatibility testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No ground truth or expert review process as described for AI/ML models is mentioned in relation to proving the device's performance for this surgical tool.
4. Adjudication method for the test set
- Not Applicable. No test set or adjudication process as typically defined for AI/ML models is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a surgical instrument, not an AI-assisted diagnostic or interpretive device. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. Ground truth in the context of AI/ML performance evaluation is not relevant to this device's regulatory submission, which focuses on substantial equivalence based on prior predicate devices and safety testing.
8. The sample size for the training set
- Not Applicable. This is a physical device, not an AI/ML algorithm. There is no concept of a "training set."
9. How the ground truth for the training set was established
- Not Applicable. Consistent with item 8.
Summary regarding AI/ML related questions:
The provided 510(k) summary is for a traditional surgical device and predates the common regulatory framework for AI/ML medical devices. Therefore, the questions related to AI/ML specific performance criteria, data sets, ground truth, and human-in-the-loop studies are not applicable to the information contained within this document. The "Performance Testing" section primarily refers to compliance with an electrical safety standard, bench testing (without specifics), and biocompatibility testing, which are standard for physical medical devices.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).