(87 days)
The Unimax Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
The Unimax Veress Needle is a sterile and single-use product. It incorporated a spring loaded blunt stylet mechanism similar to the needle. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Veress Needle, available in 120mm and 150mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.
The Unimax Veress Needle is not an AI/ML device, but rather a traditional medical device (a surgical instrument). Therefore, the provided document does not contain the information typically associated with AI/ML device evaluations, such as studies on algorithm performance, human-in-the-loop performance, ground truth establishment for training/test sets, or sample sizes related to AI model development.
The document describes the non-clinical testing performed to demonstrate the safety and effectiveness of the Unimax Veress Needle and its substantial equivalence to a predicate device.
Here's the information extracted from the document based on the provided categories, with "N/A" for criteria not applicable to a non-AI/ML device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (What was tested) | Reported Device Performance (Test Results) |
|---|---|
| Tip Pull Test | Meets pre-defined acceptance criteria |
| Switch Operation | Meets pre-defined acceptance criteria |
| Spring Obturator Operation | Meets pre-defined acceptance criteria |
| Needle Puncture Force Test | Meets pre-defined acceptance criteria |
| Cytotoxicity Test | Complies with ISO 10993-5 |
| Intracutaneous Reactivity Test | Complies with ISO 10993-10 |
| Maximization Sensitization Test | Complies with ISO 10993-10 |
| EO Sterilization Validation Study | Complies with ISO 11135-1 |
| Ethylene Oxide Sterilization Residuals Study | Complies with ISO 10993-7 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists "A series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests" but does not specify the sample sizes (e.g., number of needles tested for each physical/mechanical test) or the exact provenance of the data (e.g., where the in vivo tests were conducted). It is indicated that the manufacturer is based in Taipei, Taiwan. The tests are non-clinical (preclinical), not clinical data, and appear to be prospective testing of the device itself rather than data collection from a population.
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)
N/A. This is a non-AI/ML device. Ground truth, in the context of AI, refers to expert-labeled data. For a physical medical device, performance is evaluated against engineering specifications and international standards, not against expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Adjudication methods are relevant for resolving discrepancies in expert labeling for AI ground truth. For this device, performance is measured against technical specifications and standard compliance.
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
N/A. This is a non-AI/ML device. MRMC studies are used to evaluate diagnostic performance of AI-assisted systems.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a non-AI/ML device. "Standalone performance" refers to the performance of an AI algorithm without human involvement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this medical device, the "ground truth" or standard for acceptance is adherence to recognized international standards (e.g., ISO 10993 series, ISO 11135-1) and demonstrating performance at least equivalent to the predicate device through physical and mechanical testing (e.g., Tip Pull Test, Switch Operation, Spring Obturator Operation, Needle Puncture Force Test). There is no "ground truth" in the AI sense for this type of product.
8. The sample size for the training set
N/A. This is a non-AI/ML device, so there is no training set for an algorithm.
9. How the ground truth for the training set was established
N/A. This is a non-AI/ML device, so there is no training set for an algorithm.
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.