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510(k) Data Aggregation
(110 days)
The PK Cutting Forceps are indicated for electrosurgical coagulation, mechanical cutting, and grasping of tissue during the performance of laparoscopic and open general surgical procedures when used in conjunction with the general purpose ESG-400 workstation.
The PK Cutting Forceps are indicated for electrosurgical coagulation, mechanical cutting, and grasping of tissue during the performance of laparoscopic and open general surgical procedures when used in conjunction with the general purpose ESG-400 workstation. The device is a single use, sterile accessory, to be used in conjunction with the bipolar outputs of the Olympus workstation with PK software (ESG-400).
The proposed device is a modification of the Gyrus HALO PKS Cutting Forceps and includes an improved handle and improved jaw performance. The device handle has been redesigned with internal changes to improve ease of use. The jaws are identical as those found on the predicate Gyrus HALO PKS Cutting Forceps except that coatings have been added, and a mechanical bridge has been added inside the shaft.
The provided text is a 510(k) summary for the PK Cutting Forceps for the ESG-400 workstation. It outlines the device, its intended use, and substantial equivalence to a predicate device, but it does not contain acceptance criteria or a study that specifically proves the device meets such criteria in the context of AI/algorithm performance.
The document describes performance testing for the physical device itself (electrical, mechanical, functional, and preclinical ex-vivo tissue evaluations) to ensure it functions as intended and is substantially equivalent to a predicate device. This is typical for a medical device clearance, but not for an AI/algorithm-driven device's performance metrics.
Therefore, many of the requested items related to "device performance" in the context of AI/algorithm criteria (such as sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) cannot be extracted from this document as it's not relevant to the type of device being described.
However, I can provide what is available regarding general performance and testing, interpreting "acceptance criteria" as general performance requirements and "reported device performance" as the results of the non-clinical and preclinical testing.
Here's a breakdown of the information that can be extracted or inferred from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a table format for specific performance metrics like sensitivity/specificity. Instead, it states that the device was tested to perform as intended and meet design specifications, as well as demonstrate substantial equivalence to the predicate device.
| Performance Area | General "Acceptance Criteria" (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet ISO 10993-1 guidelines for external communicating, tissue/bone/dentin device for limited exposure (<24hrs.). | Full biocompatibility testing (Cytotoxicity, Sensitization, Irritation, Pyrogen Testing) completed; results considered passing and in accordance with ISO 10993-1. |
| Electrical Safety & EMC | Comply with applicable clauses of IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18 (safety) and IEC 60601-1-2 (EMC). | Testing conducted; device complies with applicable standards. |
| Sterilization Assurance | Provide a sterility assurance level of 10⁻⁶ | Sterilized using Ethylene Oxide, cycle validated in accordance with ISO 11135. |
| Shelf Life | Maintain functionality and meet specifications for determined shelf-life. | Accelerated shelf-life studies support an initial one-year shelf-life; real-time testing is ongoing to confirm, with plans for a three-year expiration date. Device maintains functionality. |
| Mechanical/Functional Performance | Function as intended, meet design specifications, and demonstrate substantial equivalence to the predicate device in aspects like torque strength, endurance, force, reliability, durability, grasping, thermal margin, cutting, coagulation, and general functionality. | Testing conducted (system testing, torque strength, endurance, force testing, reliability, ship testing, baseline performance testing, age testing, environmental conditioning, durability, dimensional verification, ergonomics, system compatibility, grasping, thermal margin, cutting, rotation, coagulation, and basic functionality). Results demonstrate the device performs as well as or better than the predicate device. Performance requirements were met, and the PK Cutting Forceps exhibited comparable performance characteristics to the predicate. |
| Preclinical (Ex-Vivo Tissue) Performance | Perform substantially equivalent to the predicate devices in usability, cutting, coagulation, and tissue grasping on biological tissue. | Evaluated ex-vivo using bovine and porcine tissue. Visual comparison of coagulation and thermal margin assessed. Testing demonstrated that the device performs as well as or better than the predicate device. |
Regarding AI/Algorithm-Specific Information (which is largely absent from this document):
Since this is a submission for an electrosurgical cutting and coagulation device, not an AI-powered diagnostic or therapeutic algorithm, the following information is not provided in the document:
- Sample size used for the test set and the data provenance: Not applicable as there's no algorithm test set. The preclinical testing used bovine and porcine tissue (ex-vivo).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device performance was established through physical measurements, engineering standards, and visual assessment in preclinical models.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For preclinical testing, the ground truth was based on direct observation of physical performance (cutting, coagulation, grasping, thermal margin) on animal tissues, often compared against the known performance of the predicate device.
- The sample size for the training set: Not applicable as there's no algorithm training set.
- How the ground truth for the training set was established: Not applicable.
In summary: The document pertains to the clearance of a physical medical device (forceps) and its electrosurgical function, not an AI or algorithm-driven component. As such, the performance criteria and studies described are related to the safety and physical/functional equivalence of the hardware, not the analytical performance of an algorithm.
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