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510(k) Data Aggregation
(198 days)
The intended use of the Laparoscopic Insufflator ALPHA DUO LAP is to establish and maintain a pneumoperitoneum with CO2 gas for diagnostic or operative Laparoscopy.
The Laparoscopic Insufflator ALPHA DUO LAP with the following model variants S.2916.00 II, S.2920.00 II, S.2925.00 II, S.2930.00 II, S.2945.00 II" is a microprocessor controlled device, designed to insufflate medical CO2 gas into peritoneal cavities during diagnostic and/or therapeutic laparoscopic procedures. The maximum flow delivery capability depends on the indexed ( performance ) type and ranges from 16 lpm to 45 lpm. The insufflation pressure is user adjustable between 3 and 30 mmHg. The safety features include acoustic and visual alarms for overpressure and low gas supply.
The provided document, K090652, is a 510(k) summary for a Laparoscopic Insufflator. This type of device is an electromechanical product, not an AI/ML-driven diagnostic tool. Therefore, the questions related to AI/ML specific acceptance criteria, study methodologies, ground truth, expert involvement, and sample sizes for training/test sets are not applicable.
The document indicates that the device's safety and effectiveness were evaluated through performance and physical tests against harmonized device standards.
Here's a breakdown of the available information regarding acceptance criteria and the study, while noting the irrelevance of AI-specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of acceptance criteria or quantitative performance metrics for the device itself. Instead, it states that:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Conformance to Standards | "All materials used in the composition of the laparoscopic insufflator and accessories were subject to performance and physical tests to evaluate safety, effectiveness and reliability of the devices. All results were in conformance with the cited harmonized device standards." |
| Substantial Equivalence | "This device is substantial equivalent to other SE-devices." |
| "The intended use, performance attributes, materials and basic design are identical/substantially equivalent to SE devices." | |
| Safety and Effectiveness | "Modifications in design and dimensions do not adversely affect the safety and effectiveness of these devices." |
| "A review of professional literature demonstrates the safety and effectiveness of CO2 insufflators." | |
| "The results of design validation raise no new issues of safety and effectiveness." |
2. Sample size used for the test set and the data provenance
Not applicable. The study involved physical and performance tests of the device itself and its components against standards, not analysis of a data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/ML studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for this device would be its ability to meet engineering specifications and safety standards, which are evaluated through testing.
4. Adjudication method for the test set
Not applicable. There was no "test set" in the context of expert review or data analysis, so no adjudication method was used.
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 not an AI-driven device, so an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The device operates as a standalone piece of medical hardware.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is conformance to established engineering standards, safety requirements, and performance specifications for medical devices. This is demonstrated through physical testing and adherence to recognized standards, rather than clinical outcome data or expert consensus on diagnostic tasks.
8. The sample size for the training set
Not applicable. There is no AI model, therefore no training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI model, therefore no training set or a ground truth for it.
Summary of the Study:
The study performed was a design validation and performance testing to demonstrate the device's conformance to cited harmonized device standards and its substantial equivalence to predicate devices already on the market. It involved:
- Testing of materials: To evaluate safety, effectiveness, and reliability.
- Performance and physical tests: Of the laparoscopic insufflator and accessories.
- Review against standards: All results were found to be in conformance with international and FDA-recognized standards.
- Comparison to predicate devices: The intended use, performance attributes, materials, and basic design were found to be identical/substantially equivalent to legally marketed predicate devices.
The conclusion drawn was that clinical data was not needed because the device was substantially equivalent and its safety and effectiveness were supported by adherence to standards and a review of professional literature concerning CO2 insufflators.
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