(114 days)
The Apollo Endosurgery Endoscopic Monopolar Scissors are designed to cut, dissect, and cauterize tissue during flexible endoscopic procedures.
The Endoscopic Monopolar Scissors is comprised of a flexible metal shaft with a distal mounted scissors which is operated by a proximal handle. The proximal handle also has connections for a monopolar electrocautery source. The scissor blades function as standard scissors for mechanical cutting and for standard electrosurgical cutting, as required.
The provided text describes the Endoscopic Monopolar Scissors and states that "Product testing was completed and met all of the acceptance criteria." However, it does not explicitly detail the acceptance criteria themselves or the specific results that demonstrate they were met. It only lists the types of testing performed.
Therefore, most of the requested information cannot be extracted from the provided document.
Here's what can be inferred/extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly detailed | Product testing was completed and met all of the acceptance criteria. |
| Dimensional | Met acceptance criteria (implied) |
| Visual | Met acceptance criteria (implied) |
| Atraumatic tip | Met acceptance criteria (implied) |
| Tortuous path | Met acceptance criteria (implied) |
| Handle pull strength | Met acceptance criteria (implied) |
| Resistivity | Met acceptance criteria (implied) |
| Electrocautery | Met acceptance criteria (implied) |
| Scissors performance | Met acceptance criteria (implied) |
2. Sample sized used for the test set and the data provenance
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as the testing described is performance-based on the device itself, not requiring expert ground truth in the traditional sense of diagnostic accuracy studies.
4. Adjudication method for the test set
- Not applicable.
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, this is a medical device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is a physical medical device.
7. The type of ground truth used
- The "ground truth" here would be the physical and electrical specifications/standards that the device needed to meet. The text doesn't specify these, but implies they exist (e.g., "acceptance criteria").
8. The sample size for the training set
- Not applicable, as this product is a physical device, not an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).