(150 days)
The Laparo CO2-Pneu generates and maintains pneumoperitoneum CO3 gas and can be used in diagnostic and operative laparoscopy
The Laparo CO2-Pneu 2232 supplies CO2 gas from cylinders or central gas supplies to dilate the abdomen by CO2 gas insufflation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Laparo CO₂ Pneu 2232:
Based on the provided 510(k) summary (K981334), no acceptance criteria or studies proving device performance were detailed or reported.
The document explicitly states:
- "Performance data not generated." (Section 5.0 Performance Data)
- "No clinical tests performed." (Section 6.0 Clinical Tests)
The manufacturer, Richard Wolf Medical Instruments Corp., relies on substantial equivalence to previously cleared devices to establish the safety and effectiveness of the Laparo CO₂ Pneu 2232. They state, "The differences [between this device and predicates] do not affect the safety or effectiveness of the device."
Therefore, for the information requested in your prompt, the answers derived from this document are as follows:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | No performance data generated or reported in this document. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable, as no test sets or performance studies were conducted.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: 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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a laparoscopic insufflator, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: No, a standalone performance study was not done. This device is a hardware medical instrument, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: Not applicable, as no performance studies were conducted.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
Summary of Conclusions from the Device Submitter:
The manufacturer concluded that the "Laparo CO₂-Pneu 2232 was designed and tested to guarantee the safety and effectiveness during the expected lifetime of the device if it is used according to the instruction manual." This conclusion is based on design and internal testing, not on reported performance data or clinical trials in the provided 510(k) summary. The FDA's clearance is based on the determination of substantial equivalence to predicate devices already on the market.
§ 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.