(207 days)
The ENDOPATH Endoscopic Instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.
The ENDOPATH Endoscopic Instruments are sterile, single patient use instruments designed for use through appropriate ENDOPATH Surgical Trocars and FLEXIPATH® Flexible Surgical Trocars. The instruments have a rotating insulated shaft with a diameter of either 3mm, 5mm or 10mm. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. The ring handles are compressed and released to activate the instrument jaws or scissor blades. Each of the curved scissors and dissectors has a monopolar cautery connector that extends from the top of the handle. The connector is used for electrosurgery when properly attached to a standard cautery cable and a proper generator.
The provided 510(k) summary for the ENDOPATH® Endoscopic Instruments describes a medical device and its substantial equivalence to a predicate device. However, it does not contain detailed acceptance criteria, a specific study with quantitative performance metrics, or information relevant to AI/ML or extensive clinical trials as implied by many of your requested categories.
This device is a surgical instrument from 1999, and the regulatory submission approach for such devices
is typically based on demonstrating substantial equivalence through design comparisons and pre-clinical bench testing, rather than the rigorous performance studies often associated with AI/ML-driven diagnostics where the requested details would be highly applicable.
Therefore, I cannot fulfill most of your request as the information is not present in the provided text. I will address what can be extracted or inferred.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria. Instead, it states:
- Acceptance Criteria (Implied): Acceptable performance equivalent to the Predicate Device in reliability and design.
- Reported Device Performance: "The studies demonstrated acceptable performance to the Predicate Device in reliability and design. The performance evaluated are ergonomics of the handle and rotating knob tissue trauma, grasping, dissecting, cauterizing ability and cutting ability. From the date generated, it can be concluded that the New Device performs equivalent to the Predicate Device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The performance evaluation refers to "pre-clinical data" and "studies" but gives no details on sample size, data provenance, or whether the studies were retrospective or prospective. Given the nature of a surgical instrument, these tests would likely be in-vitro or ex-vivo bench tests, possibly animal models, rather than human clinical trials for a 510(k) submission focused on substantial equivalence.
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 provided. It's unlikely that "experts" in the sense of clinicians establishing ground truth for diagnostic accuracy (as would be relevant for AI) were involved in a way that would require detailed reporting for this type of device. The evaluations would more likely involve engineers or technicians assessing mechanical and functional performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically relevant for complex diagnostic interpretations, not for the functional testing of a surgical instrument.
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 such study was done. This is a surgical instrument, not an AI-based diagnostic tool. "Human readers" and "AI assistance" are not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document states performance was evaluated on "ergonomics of the handle and rotating knob tissue trauma, grasping, dissecting, cauterizing ability and cutting ability." The "ground truth" would be objective measurements or qualitative assessments of these physical properties and functions against pre-defined engineering specifications or performance of the predicate device. It would not be expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
§ 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.