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510(k) Data Aggregation
(53 days)
The NTERO RF Sleeve is intended for use during laparoscopic surgery to maintain a port of entry and to coagulate tissue.
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The provided text describes a 510(k) submission for the NTERO RF Sleeve, a Class II electrosurgical device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new type of device.
Therefore, much of the requested information regarding acceptance criteria, specific test results, ground truth, and expert involvement is not present in the provided document. The device's safety and effectiveness were primarily established through comparison to legally marketed predicate devices.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document does not list specific numerical acceptance criteria. The "Reported Device Performance" is a general statement of positive test results and biocompatibility.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance: Results of in vitro and in vivo testing demonstrate that the NTERO RF Sleeve is safe and effective for its intended function. | |
| Biocompatibility: The materials used in the NTERO Probe have been shown to be biocompatible. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Results of in vitro and in vivo testing" but does not specify the sample sizes for these tests.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The document describes performance testing, but there is no mention of an expert panel establishing a "ground truth" for diagnostic or analytical performance, as would be typical for image analysis or AI devices. The evaluation focuses on the functional performance and safety of the surgical device.
4. Adjudication Method for the Test Set
Not applicable. As there's no mention of expert-established ground truth, there's no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The device is a surgical instrument, not an AI diagnostic tool that would typically involve a MRMC study to assess reader improvement with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a manual surgical tool and does not involve an algorithm with standalone performance.
7. Type of Ground Truth Used
Not applicable/Not specified in the context of diagnostic "ground truth." The testing focused on functional performance and biocompatibility through in vitro and in vivo methods, rather than establishing a diagnostic ground truth against which an algorithm would be measured. The "ground truth" for a surgical device would be its ability to perform its intended function safely and effectively within biological systems, observed during these tests.
8. Sample Size for the Training Set
Not applicable. This device is hardware (a surgical sleeve) and does not involve a "training set" in the context of machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, this query is irrelevant for this device.
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