(104 days)
The Articulating Hook Knife is a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.
The Ethicon Endo Surgery (EES) Articulating Hook Knife is a monopolar instrument intended for use in endoscopic electrosurgical procedures where cutting, dissecting, and cauterizing soft tissue are desired. The device consists of a flexible wire cable and hook knife electrode, which can be extended, rotated, and articulated from the flexible outer shaft using two handle control knobs. In addition, the hook electrode can be rotated independently of the end effector. When connected to an electrosurgical generator and activated, the hook knife delivers a monopolar electrical current to the surgical site. This device passes through endoscopes having a 3.7 mm or larger working channels. This device is supplied sterile for single-patient use.
The provided text describes the Ethicon Endo Surgery® Articulating Hook Knife, a monopolar electrosurgical instrument. However, the details provided are primarily for a 510(k) submission, which focuses on demonstrating substantial equivalence to predicate devices rather than a detailed performance study with acceptance criteria and specific performance metrics like those found in a comparative effectiveness study or a standalone algorithm study.
Here's a breakdown of the requested information based on the provided text, and where the information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics against those criteria. It mentions "bench testing was performed to demonstrate that the EES device performs as intended" and lists compliance with several electrical safety and medical electrical equipment standards. Compliance with these standards implies meeting their embedded acceptance criteria, but the specific numerical results are not provided.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use | "device performs as intended" (verified through bench testing) |
| Biocompatibility | "comply with the requirements of ISO 10993-1" |
| Electrical Safety Standard | "Tested to demonstrate compliance with AAMI HF18, 2001/01/01" |
| High Frequency Surgical Equipment Safety | "Tested to demonstrate compliance with IEC 60601-2-2, 2006/07/01" |
| Endoscopic Equipment Safety | "Tested to demonstrate compliance with IEC 60601-2-18, 1996/08/01" |
| General Medical Electrical Equipment Safety | "Tested to demonstrate compliance with IEC 60601-1:1995" |
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 does not mention a "test set" in the context of clinical data, as this is a 510(k) for an electrosurgical instrument that relies on engineering bench testing and compliance with standards rather than clinical performance studies. Therefore, there's no information about sample size for a test set, data provenance, or whether it was retrospective or prospective.
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)
Not applicable. The product is a surgical instrument, and its performance is evaluated through engineering and biocompatibility testing, not through expert-reviewed "ground truth" derived from clinical images or similar data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no mention of a "test set" or human review/adjudication process for establishing ground truth in the provided text.
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
Not applicable. This is a surgical instrument, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a non-AI surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance data mentioned (bench testing, biocompatibility, and standards compliance), the "ground truth" is established by the specifications defined in those standards and engineering requirements, which are typically objective and measurable. There is no clinical "ground truth" in the sense of expert consensus or pathology mentioned.
8. The sample size for the training set
Not applicable. This is a non-AI surgical instrument undergoing engineering and biocompatibility testing. There is no concept of a "training set" as would be used for machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this 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.