(29 days)
The Disposable Irrigation Bipolar Cord Assembly is a single-use product sold sterile, and is intended for use with standard bipolar irrigating forceps, and the Codman & Shurtleff, Malis™ CMC - Bipolar System. This device is to be used to deliver electrical energy from a Malis™ CMC®-III (or equivalent) Generator to the bipolar forceps (handpiece), as well as, provide the system with an integrated delivery conduit, for carrying an irrigating solution from its collapsible reservoir to the forceps, via gravity feed.
The Disposable Irrigation Bipolar Cord Assembly is a single-use product sold sterile, and is intended for use with standard bipolar irrigating forceps, and the Codman & Shurtleff, Malis™ CMC -Bipolar System. This device is to be used to deliver electrical energy from a Malis ™ CMC -III (or equivalent) Generator to the bipolar irrigating forceps (handpiece), as well as, provide the system with an integrated delivery conduit, for carrying an irrigating solution from its collapsible reservoir to the forceps, via gravity feed.
The provided text describes the regulatory clearance for a medical device, the "Disposable Irrigation Bipolar Cord Assembly for Malis™ System CMC®-II." However, it does not contain a study that demonstrates the device meets specific acceptance criteria in the way a clinical or performance study would for a novel AI/software device. Instead, it details the testing performed to assure safety and substantial equivalence to predicate devices.
Therefore, many of the requested elements for an AI device study (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable or cannot be extracted from this document, as it pertains to a physical medical device and its predicate comparison for regulatory approval.
Here's an analysis based on the provided text, focusing on the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance / Compliance |
|---|---|---|
| Biological Safety | Biocompatibility | Selection of irrigating lumen materials demonstrating appropriate levels of biocompatibility. Tested in accordance with ISO Standard 10993-1 (external communicating device, blood path indirect, contact duration category "A"). |
| Sterilization Safety | Sterility Assurance Level (SAL) of 10⁻⁶ | Sterility validated in accordance with and in compliance with AAMI/ISO 11137 and EN 552 (current editions) for radiation sterilization. |
| Performance Safety | Electrical Safety, High Frequency Surgical Equipment Safety, Electrosurgical Devices Standards | Testing in accordance with and in compliance with IEC 601-1-2 (1988), IEC 601-2-2 (1991), and ANSI/AAMI HF 18 (1993). |
| Substantial Equivalence | Function & Intended Use Equivalent to Predicate Devices | Determined to be substantially equivalent in function and intended use to: |
- 80-1163, Malis™ Integrated Irrigation Tubing and Bipolar Cord Set
- NU1060, Irrigation / Bipolar Set, for Malis System CMC-II |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This document refers to engineering and quality assurance testing of a physical device, not an AI model requiring a test set of data. The "test set" here would refer to the physical units tested for biocompatibility, sterility, and electrical performance. The exact number of units tested is not specified but would typically follow established standards for medical device validation (e.g., n=3 for certain types of testing, or larger batches for sterility validation).
- Data Provenance: Not applicable in the context of clinical/imaging data. The "provenance" here relates to the manufacturing process, material sourcing, and lab conditions under which the safety and performance tests were conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device does not involve expert-labeled ground truth for an AI algorithm. The "ground truth" for the device's performance is defined by adherence to established ISO, IEC, and ANSI/AAMI standards, which are determined by technical specifications and material properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study assessing human or AI diagnostic performance. Compliance with standards is determined by objective measurements and validated procedures rather than expert adjudication of cases.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an irrigation bipolar cord assembly, not an AI or imaging diagnostic tool.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance aligns with technical standards and validated test procedures.
- For biocompatibility: ISO 10993-1 defines the accepted methods and criteria.
- For sterility: Sterility Assurance Level (SAL) of 10⁻⁶ as per AAMI/ISO 11137 and EN 552.
- For performance: Compliance with IEC 601-1-2, IEC 601-2-2, and ANSI/AAMI HF 18 through specific electrical and functional tests.
- For substantial equivalence: Comparison of functional and intended use specifications against existing legally marketed predicate devices.
8. The sample size for the training set
- Not applicable. This device documentation does not involve a training set for an AI model.
9. How the ground truth for the training set was established
- Not applicable. There is no training set mentioned in this document.
§ 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.