(24 days)
The CODMAN Integrated Bipolar Cord and Tubing Sets are intended to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation.
The CODMAN Integrated Bipolar Cord and Tubing Set consists of an inlet spike with protective cap, an on/off clamp, silicone tubing and fittings, a male luer connector, two plugs, and a female socket connector. The set is packaged sterile for single use with a nonpyrogenic fluid pathway.
The provided documentation is a 510(k) Premarket Notification for a medical device called the "Codman Integrated Bipolar Cord and Tubing Set." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies, especially for Class II devices.
Therefore, the information regarding acceptance criteria and a "study that proves the device meets the acceptance criteria" will be focused on the performance testing conducted to demonstrate substantial equivalence, rather than a clinical effectiveness study. The "acceptance criteria" here refer to the passing criteria for the various technical and safety tests performed.
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bench Testing | |
| Electrical Functionality Test - Continuity and Resistance | Pass |
| Irrigation Functionality Test - Leak (Dry) | Pass |
| Mating Part - Part 1: Pins | Pass |
| Mating Part - Part 2: Socket | Pass |
| Mating Part - Part 3: Luer | Pass |
| Mating Part - Part 4: Spike | Pass |
| Pull Testing | Pass |
| Irrigation Simulated Use Test | Pass |
| Simulated Use Pull Test | Pass |
| Electrical Safety and EMC per IEC 60601 | |
| High Frequency Leakage Current - 60601-1 and 60601-2-2 | Pass |
| High Frequency Dielectric Strength - 60601-1 and 60601-2-2 | Pass |
| Main Frequency Dielectric Strength - 60601-1 and 60601-2-2 | Pass |
| Cable Flexing - 60601-1 and 60601-2-2 | Pass |
| Electromagnetic Compatibility - 60601-1-2 | Pass |
| Sterilization | |
| Bioburden Validation | Pass |
| Bioburden Test | Pass |
| EO/ECH Residuals | Pass |
| LAL Validation | Pass |
| Sterility Assurance Level (SAL) | 10⁻⁶ (Pass) |
| Shelf Life - Functionality Testing Complete after One Year Accelerated Aging | |
| Electrical Functionality Test - Continuity and Resistance | Pass |
| Irrigation Functionality Test - Leak (Dry) | Pass |
| Mating Part - Part 1: Pins | Pass |
| Mating Part - Part 2: Socket | Pass |
| Mating Part - Part 3: Luer | Pass |
| Mating Part - Part 4: Spike | Pass |
| Pull Testing | Pass |
| Device and packaging remain functional and maintain sterility for 1 year | Achieved through accelerated aging |
| Biocompatibility | |
| Cytotoxicity - ISO MEM Elution | Pass |
| Delayed Type Sensitization - ISO Maximization in Guinea Pigs | Pass |
| Intracutaneous Reactivity - ISO Intracutaneous Study in Rabbits | Pass |
| Acute Systemic Toxicity - ISO Systemic Toxicity in Mice | Pass |
| Pyrogenicity Testing - USP Rabbit Pyrogen Study, Material Mediated | Pass |
| Hemolysis - ASTM F756 (Extract only) | Pass |
| Chemical Characterization of Extractables (ISO 10993-18) | Low level of extractables |
| Toxicology Risk Assessment | Extractables do not represent a significant toxicological risk to patients |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document consistently refers to "final sterile devices" being tested across various performance categories. However, it does not specify the exact sample sizes (e.g., number of units, batches) used for each individual test (Bench, Electrical Safety, Sterilization, Shelf Life, Biocompatibility).
The data provenance is internal testing performed by the manufacturer (Medos International SARL, based in Le Locle, Switzerland, or its affiliate Codman & Shurtleff, Inc. in Raynham, MA, USA). The testing is prospective as it was conducted specifically to support this 510(k) submission.
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)
This information is not applicable and therefore not provided in the document. This is a medical device for electrosurgical cutting and coagulation, and the testing performed is technical and safety-related (e.g., electrical, mechanical, biological). It does not involve human interpretation or expert evaluation to establish a "ground truth" in the way a diagnostic AI device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided in the document. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations, typically in diagnostic studies. As mentioned above, the testing involved in this 510(k) is technical and objective.
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. The device is an accessory (bipolar cord and tubing set) for electrosurgical equipment. Its evaluation for substantial equivalence relies on physical, electrical, and biological safety and performance testing, not on human reader performance with or without AI assistance. The document explicitly states: "No clinical studies were performed as appropriate verification and validation of the modified device was achieved from the results of the bench testing."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. This is a physical medical accessory, not an AI algorithm. Therefore, there is no "standalone algorithm only" performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by objective engineering specifications, material standards, and compliance with recognized industry standards (e.g., ISO, IEC, ASTM, ANSI/AAMI, USP). For example:
- Bench Testing: Mechanical integrity, electrical continuity, leak-free operation, proper mating, pull strength are measured against predetermined engineering specifications.
- Electrical Safety: Compliance with specific limits defined in IEC 60601 standards.
- Sterilization: Achievement of a specified Sterility Assurance Level (SAL) of 10⁻⁶ validated against microbiological standards (ISO 11135, ISO 11737-1).
- Biocompatibility: Absence of toxic effects and compliance with ISO 10993 standards and specific biological response criteria in animal models (e.g., no sensitization, no systemic toxicity).
8. The sample size for the training set
This information is not applicable. This is a physical medical device, not an AI or machine learning model. Therefore, there is no "training set" in the context of data used to train an algorithm.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
§ 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.