(53 days)
AEONTM Laparoscopic Instruments is a family of instruments which includes forceps, scissors, and probes which are intended to be used in general laparoscopic surgical procedures requiring the use of monopolar electrosurgical cutting and/or coagulation.
The AEON Laparoscopic Instruments are sterile, disposable, single-use, individuallypackaged surgical instruments that are designed to cut, grasp, dissect, and coagulate selected tissue in laparoscopic surgery. The instruments are designed to be used with an electrosurgical generator (to be purchased separately).
There are 10 different instrument tip configuration variants. The only difference between the 10 variants is the geometry of the tip scissors/graspers in three shaft working lengths 22cm, 33cm, and 45cm.
Scissors and forceps have a handle with rotating wheel attached to an insulated shaft with different tips, which allows the shaft and tip to rotate. They include a male cautery connector when attached to standard monopolar cautery cables and generators. Probes/Electrodes have an insulated shaft with a thermally conductive metal tip electrode. The proximal end of the shaft is attached to a handle made of an injection molded, medical grade plastic.
The proposed device is provided Ethylene Oxide (ETO) sterilized to achieve the Sterility Assurance Level (SAL) of 10^-6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.
The provided text is a 510(k) summary for a medical device called "AEON Laparoscopic Instruments." It details the device's purpose, design, intended use, and a comparison to a predicate device to demonstrate substantial equivalence for FDA clearance.
Upon reviewing the document, it's clear that the information you're requesting regarding acceptance criteria and the study that proves the device meets them (specifically related to AI/ML or diagnostic performance) is not present in this submission.
Here's why, and what information is available:
- Device Type: The AEON Laparoscopic Instruments are surgical tools (forceps, scissors, probes) used in laparoscopic procedures for cutting, grasping, dissecting, and monopolar electrosurgical coagulation. They are not an AI/ML device, a diagnostic device, or a device that generates or analyzes medical images for interpretation.
- Performance Data: The "Performance Data" section (Section 9) focuses exclusively on:
- Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC 60601 series standards.
- Biocompatibility: Compliance with ISO 10993 series standards.
- Sterilization and Shelf Life: Compliance with ISO 11607, ASTM F1980, ASTM F1929, and ISO 11135 standards.
- Substantial Equivalence: The filing establishes substantial equivalence primarily based on the device's intended use, design, and technological characteristics being similar to an existing predicate device (Unimax Laparoscopic Instrument K103508). This is typical for Class II surgical instruments.
Therefore, since this device is not an AI/ML-driven diagnostic tool, the following information you requested is not applicable or cannot be extracted from this document:
- Table of acceptance criteria and reported device performance (for AI/diagnostic performance): Not applicable. The "performance" here relates to safety and functional specifications for a surgical instrument.
- Sample size for the test set and data provenance: No "test set" in the context of diagnostic performance or AI model evaluation. Sample sizes would refer to the number of instruments tested for physical performance, biocompatibility, sterility, etc.
- Number of experts and qualifications for ground truth: No expert human interpretation or "ground truth" establishment in the context of diagnostic performance.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This device does not involve human readers interpreting AI-generated output.
- Standalone (algorithm only) performance: Not applicable. There is no algorithm.
- Type of ground truth used: Not applicable. Ground truth for diagnostic performance is not relevant.
- Sample size for the training set: Not applicable. No AI model involved.
- How ground truth for the training set was established: Not applicable. No AI model involved.
In summary, the provided document describes a 510(k) submission for conventional surgical instruments, not an AI/ML-enabled medical device. As such, the requested information regarding AI/ML performance acceptance criteria and study details is irrelevant to this specific filing.
§ 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.