(175 days)
The LevaLap Laparoscopic Access Device is intended for use in the peri-umbilical region of the abdominal wall prior to the establishment of a pneumoperitoneum to aid in the insertion of a Veress needle during gynecologic (pelvic) and general surgical (intra-abdominal) laparoscopic procedures.
The LevaLap Laparoscopic Access Device is a sterile single-use device, consisting of a clear hemisphere-shaped housing containing a port for connection to a standard operating room (OR) vacuum system and a septum for introduction of a Veress needle. The LevaLap Laparoscopic Access Device is intended to raise the abdominal wall above critical organs and vessels by means of negative pressure, thus creating an initial space prior to insufflation in preparation for laparoscopic access. The device includes a vacuum bypass plug positioned in the vacuum intake port.
The provided text describes the LevaLap Laparoscopic Access Device, but it does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a study proving device performance as it would typically be described for an AI medical device.
The product described is a laparoscopic access device, which is a physical instrument, not an AI algorithm. Therefore, many of your questions, such as those related to AI assistance, human readers, ground truth establishment for AI, and training sets, are not applicable in this context.
However, I can extract the available information related to the device's performance through non-clinical testing.
Here's a breakdown of what can be derived from the text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Specification) | Reported Device Performance |
|---|---|
| Device maintains consistent negative pressure at -0.8 Bar for a minimum of 1 minute, with a 14G needle inserted in the septum (under simulated use conditions). | Testing successfully demonstrated that these specifications are met (non-clinical bench tests for vacuum draw and vacuum hold). |
2. Sample size used for the test set and the data provenance
The text mentions "representative functional testing against specified requirements for vacuum draw and vacuum hold at T=0 and after accelerated aging simulating 2 years." However, it does not specify the sample size for these tests or the data provenance beyond "simulated use conditions." Given it's a physical device's mechanical performance, "data provenance" in the sense of patient data is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is a mechanical instrument, and its performance criteria are based on physical measurements (negative pressure maintenance) rather than expert interpretation of medical images or other data that would require "ground truth" established by experts.
4. Adjudication method for the test set
This question is not applicable, as there's no expert interpretation or consensus-building process described for evaluating the device's mechanical performance.
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
This question is not applicable. This is a physical medical device, not an AI algorithm that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance appears to be physical measurements of vacuum pressure and hold time under simulated conditions, compared against defined performance specifications.
8. The sample size for the training set
This question is not applicable. The device is a physical instrument, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable.
Summary of Relevant Information:
- Acceptance Criteria: Maintains consistent negative pressure at -0.8 Bar for a minimum of 1 minute with a 14G needle in the septum.
- Study Proving Performance: Non-clinical bench tests were performed successfully for vacuum draw and vacuum hold, and also after accelerated aging simulating 2 years.
- Sample Size/Provenance: Not specified beyond "representative functional testing" under "simulated use conditions."
- Ground Truth Type: Physical measurements against defined performance specifications.
- Biocompatibility: Also tested successfully in accordance with ISO 10993-1.
- Additional Testing: Sterilization, packaging integrity, and shelf-life testing were also performed.
§ 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.