(161 days)
The Matreneu® Percutaneous Balloon Compression Kit is intended to the Percutaneous Balloon Compression (PBC) procedure for primary trigeminal neuralgia.
The Matreneu® Percutaneous Balloon Compression Kit is intended to be used to the Percutaneous Balloon Compression (PBC) procedure for primary trigeminal neuralgia.
The subject device consist of five parts, such as the balloon catheter, puncture needle, svringe, connector, and pressure gauge. Through a sheath under X-ray fluoroscopy. a micro-balloon is introduced into the meniscus of the trigeminal nerve in Meckel's cavity to assist in retraction and establishment of a pathway. Then inject the contrast agent to fill the balloon to relieve the compression of the nerve fibers that cause trigeminal neuralgia. And through the expansion of the micro-balloon compression injury to treat trigeminal neuralgia.
The Kit is supplied sterile and is intended for single use.
The provided text is a 510(k) summary for the Matreneu® Percutaneous Balloon Compression Kit. It outlines the device's intended use and compares it to a predicate device, but it does not include information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML powered device.
The document states: "No clinical tests were performed." and primarily focuses on non-clinical performance testing related to physical and chemical properties, sterilization, shelf-life, and biocompatibility.
Therefore, many of the requested details, particularly those related to AI/ML powered device evaluation, are not present in the provided text.
Here is an attempt to answer the questions based only on the information provided, with many entries indicating that the information is not available:
Acceptance Criteria and Device Performance Study for Matreneu® Percutaneous Balloon Compression Kit
This document, a 510(k) summary, primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe acceptance criteria in the context of clinical performance or a study proving the device meets these criteria for an AI/ML powered device. The device described, Matreneu® Percutaneous Balloon Compression Kit, is a non-powered surgical instrument, not an AI/ML driven one.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria Description | Reported Device Performance and Study Findings |
|---|---|---|
| For AI/ML Powered Device | Not Applicable: The Matreneu® Percutaneous Balloon Compression Kit is a non-powered neurosurgical instrument and not an AI/ML powered device. Therefore, no acceptance criteria or performance metrics related to AI/ML (e.g., sensitivity, specificity, AUC) are discussed in this document. | |
| Non-Clinical Testing | ETO Residuals: Meet criteria defined in ISO 11135 Second edition 2014 and ISO 10993-7:2008. | Passed: EO residual was measured and met the specified criteria. |
| Shelf-Life: Maintain essential performance for three years, meeting ISO 11607-1:2006 requirements. | Passed: Shelf-life for three years "had been validated in real-time aging test" and met packaging requirements. Essential performance achieved before and after shelf-life test. | |
| Biocompatibility: Demonstrated in accordance with 2020 FDA Guidance document Use of International Standard ISO-10993-1. | Passed: Cytotoxicity, sensitization, intracutaneous irritation, system toxicity, In Vitro Hemolytic Properties Test, and pyrogen tests were performed to demonstrate biocompatibility. | |
| Electromagnetic Compatibility (EMC) & Electrical Safety: Meet requirements per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-1-2 Edition 3: 2007-03. | Passed: Tests on Electromagnetic Compatibility and Electrical Safety were performed in accordance with the cited requirements. | |
| Clinical Performance | Not specified as clinical tests were not performed. | Not performed: The document explicitly states: "No clinical tests were performed." |
Note: The "acceptance criteria" here are inferred from the non-clinical tests conducted to support the marketing claims and confirm safety and effectiveness equivalent to the predicate device. They are primarily engineering and material performance specifications rather than diagnostic or treatment efficacy metrics typically associated with AI/ML systems.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable: No test set in the context of an AI/ML algorithm is mentioned or implied, as the device is a physical, non-powered surgical instrument. The non-clinical tests used samples of the device itself (e.g., for EO residuals, aging, biocompatibility tests). The number of such samples is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable: No expert-established ground truth for an AI/ML algorithm's test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable: No test set for an AI/ML algorithm requiring adjudication is mentioned.
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
- No: The document states, "No clinical tests were performed." Furthermore, this device is a physical instrument, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: This device is a physical instrument. There is no algorithm mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable: No ground truth in the context of an AI/ML algorithm is mentioned. For the non-clinical tests, the "ground truth" would be established by the standards themselves (e.g., ISO 11135 for EO residuals, ISO-10993-1 for biocompatibility).
8. The sample size for the training set
- Not applicable: No training set for an AI/ML algorithm is mentioned.
9. How the ground truth for the training set was established
- Not applicable: No training set or associated ground truth establishment is mentioned for this device.
§ 882.4535 Nonpowered neurosurgical instrument.
(a)
Identification. A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.