(88 days)
The Microsulis Tissue Ablation (MTA) System and accessories are for use in the intraoperative coagulation of soft tissue.
The MTA surgical applicator is inserted into soft tissue and coagulates a volume of tissue surrounding the active The MTA Suglicator tip. Temperature probes are included in the applicator kits to determine the temperature at area of the applicator up. Temperature probos are included in the applicator is to be used with the MTA Sulis™ V the penpher you the obegalate manually set at the desired power levels by the operator.
This document describes the Microsulis Tissue Ablation (MTA) System and its clearance by the FDA based on substantial equivalence to predicate devices, rather than a study demonstrating its performance against specific acceptance criteria. Therefore, directly answering the request with a table of acceptance criteria and device performance, and details of a clinical study, is not possible from the provided text.
However, I can extract the relevant information from the document that pertains to its clearance and the types of performance data that were considered.
General Information on Device Clearance:
The Microsulis Tissue Ablation System (K052919) received FDA clearance (JAN 13 2006) as a Class II device for the intraoperative coagulation of soft tissue. This clearance was based on demonstrating "substantial equivalence" to existing legally marketed predicate devices, not on meeting specific, pre-defined clinical acceptance criteria in a comparative outcome study.
The primary forms of "performance data" mentioned are related to engineering and safety standards, rather than direct clinical efficacy metrics against specific acceptance thresholds.
Information derived from the provided text:
1. A table of (implied) acceptance criteria and the reported device performance:
Since this is a 510(k) clearance based on substantial equivalence, there isn't a table of clinical acceptance criteria in the traditional sense, or reported device performance against those criteria. Instead, the "acceptance criteria" are compliance with established engineering, safety, and biocompatibility standards, and the "performance" is the demonstration of meeting these standards and functioning as intended.
| (Implied) Acceptance Criteria (Standards Compliance) | Reported Device Performance (Compliance Statement) |
|---|---|
| Medical Electrical Equipment Safety (EN 60601-1) | "The MTA System complies with the following standards: EN 60601-1:2003 Medical Electrical Equipment. Part 1: General requirements for safety" |
| Electromagnetic Compatibility (EN 60601-1-2) | "Meets EN 60601-1-2, EN55011, & IEC60601-1-2.2001" |
| Biocompatibility (ISO 10993) | "Biocompatibility ISO 10993, Biological Evaluation of Medical Devices" |
| Sterility Validation (EN550, ISO 11135) | "Sterilization validation requirements of EN550 and ISO 11135" |
| Shelf Life Distribution Validation (ASTM D4169) | "Shelf Life Distribution Validation Per ASTM D4169, Seal Strength Evaluation per ASTM F88" |
| Package Distribution Simulation (ISTA 2A, ASTM D4169) | "Package Distribution Simulation Per ISTA (International Safe Transit Association) Procedure 2A 2004, Package Distribution Simulation per ASTM D4169" |
| Material Suitability | "Patient contact materials used... are suitable for this use and have been used in numerous previously cleared products." |
| Functionality | "Performance testing was undertaken to ensure that the MTA System functions as intended and meets design specifications." |
| Substantial Equivalence | "The MTA System is equivalent to the predicate products. The indications for use, basic overall function, methods of operation, technological characteristics, and safety and effectiveness are substantially equivalent." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The clearance is based on engineering and bench testing, and substantial equivalence, not a clinical test set with human subjects. Thus, there's no "sample size for a test set" or associated data provenance in the clinical sense.
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. This device received 510(k) clearance based on engineering tests and substantial equivalence. There was no clinical ground truth established by experts for a test set described in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring expert adjudication 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 device is an ablation system, not an AI-assisted diagnostic tool. No MRMC study is mentioned or relevant to this type of device clearance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an ablation system requiring human operation, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the technical performance aspects, the "ground truth" would be the specifications and requirements defined by the referenced standards (e.g., proper electrical current output, successful sterilization, material compatibility, and overall functionality as designed). For the regulatory ground truth, it was the demonstration of substantial equivalence to predicate devices, meaning its characteristics were sufficiently similar in terms of safety and effectiveness.
8. The sample size for the training set
Not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.