(23 days)
The MALIS™ Irrigation Module 1000 is indicated for use with irrigating bipolar forceps with the CODMAN® / MALIS™ generators.
The MALIS™ Irrigation Module 1000 is an irrigation control system for use with the MALIS™ CMC-III Bipolar Electrosurgical Systems and the Synergy MALIS™ Precision System. This system provides controlled flow of irrigating fluid across the tips of bipolar irrigating forceps.
The provided document is a 510(k) summary for the MALIS™ Irrigation Module 1000. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information regarding detailed acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not available in this document.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (MALIS™ Irrigation System K854413) in terms of: | The modified system, MALIS™ Irrigation Module 1000, is stated to be substantially equivalent to the predicate MALIS™ Irrigation System (K854413). |
| * Intended Use | Met (same as predicate) |
| * Function | Met (same as predicate) |
| * Technical Specifications | Met (same as predicate) |
| * Operating Principles | Met (same as predicate) |
| Verification and Validation Tests: | "All testing passed." (No specific criteria or results provided beyond this general statement) |
| * System Functionality | Passed |
| * Software Functionality | Passed |
| Electrical Safety Testing: | "All testing passed." (No specific criteria or results provided beyond this general statement) |
| * Electrical Safety Standards Compliance | Passed |
Missing Information:
- No specific, quantifiable acceptance criteria (e.g., specific flow rates, pressure ranges, electrical parameters, software response times) are provided. The "acceptance criteria" are broadly defined by substantial equivalence to the predicate device and general statements of "all testing passed."
- No quantitative device performance metrics are reported.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document refers to "Verification and validation tests" and "Electrical safety testing" but does not detail the number of units tested or the duration/extent of testing.
- Data Provenance: Not applicable in the context of clinical data for AI models. The testing described is for device functionality and safety, not performance on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This document describes a medical device for irrigation, not an AI or diagnostic imaging device that uses expert-established ground truth from medical images/cases. The "ground truth" here is implied by engineering specifications and safety standards.
4. Adjudication Method for the Test Set:
- Not applicable. There is no mention of human-in-the-loop assessment or expert adjudication for the device's technical performance tests.
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 not an AI-powered diagnostic tool, and no MRMC study was performed or is relevant to this type of device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm. The "software" component mentioned would likely refer to embedded control software, for which standalone performance testing (i.e., verifying the software correctly controls the device) would have been part of the verification and validation, but this is not an AI algorithm in the common sense.
7. The Type of Ground Truth Used:
- For device functionality and safety: The "ground truth" would be established engineering specifications, performance standards (e.g., related to flow, pressure, electrical safety), and regulatory compliance requirements. These are typically defined internally by the manufacturer and by relevant industry standards (e.g., IEC standards for electrical safety).
8. The Sample Size for the Training Set:
- Not applicable. There is no "training set" in the context of this device. The device design and verification adhere to engineering principles and established performance specifications, not machine learning training.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. See point 8.
Summary of Device Acceptance and Study:
The MALIS™ Irrigation Module 1000 gained acceptance for marketing through the 510(k) pathway by demonstrating substantial equivalence to a previously cleared predicate device, the MALIS™ Irrigation System (K854413).
The "study" that proves the device meets acceptance criteria consists of:
- Verification and validation tests: These were conducted on the system and its software, and "all testing passed." The specific criteria for these tests were not detailed but would typically involve ensuring the device functions according to its design specifications regarding fluid flow, pressure, and control mechanisms.
- Electrical safety testing: Conducted to ensure compliance with relevant electrical safety standards, and "all testing passed."
The fundamental acceptance criterion for this 510(k) submission was that the new device, MALIS™ Irrigation Module 1000, is substantially equivalent to the predicate device (MALIS™ Irrigation System) in terms of its intended use, function, technical specifications, and operating principles. The safety and efficacy were substantiated by this similarity to the original device. No new clinical studies or detailed performance data comparing it to a standard of care were required or presented because the device was not deemed to represent a significant change in technological characteristics or indications for use.
§ 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.