(184 days)
The Snowden-Pencer Computerized High Flow Insufflator is intended to provide intra-abdominal distention during laparoscopic surgery.
The Snowden-Pencer Computerized High Flow Insufflator is intended to provide intra-abdominal distention during laparoscopic surgery. The device is software controlled and provides numerous features intended to optimize the process of establishing and maintaining pneumoperitoneum during laparoscopic surgery. These features include selection of operating modes, a CO2 tank volume display, flow control mode selections, selectable flow rates and pressure setting, continual monitoring of the patient's abdominal pressure, automatic venting of excess patient pressure, and a video screen interface for display of insufflation parameters/data.
This 510(k) summary (K962683) describes a high-flow insufflator which is a non-AI device. The questions listed in the prompt are designed for AI/ML-driven medical devices. Therefore, the information required to answer these questions is not present in the provided text.
Here's why each question cannot be answered:
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A table of acceptance criteria and the reported device performance: The document states "Performance testing conducted on the Snowden-Pencer Computerized High Flow Insufflator includes software verification and validation, UL 544 testing and certification, VDE 0871/0876/0877 and CISPR 11:1990/EN55011 testing/certification for radiated emissions (EMI/EMC)." It also mentions conformity to "ECRI Test Criteria for High-flow Laparoscopic Insufflators." However, it does not provide specific acceptance criteria values (e.g., minimum flow rates, pressure accuracy) nor the reported device performance against these criteria.
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Sample sized used for the test set and the data provenance: Not applicable. This is a hardware/software device validation, not a data-driven AI model. There is no "test set" in the context of diagnostic performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth establishment in the context of diagnostic assessment for an insufflator.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for a non-AI device.
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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 for a non-AI device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable for a non-AI device. While software is involved, it controls the physical insufflation process, not an AI algorithm making diagnostic interpretations without human oversight.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The device's "truth" is its physical performance parameters (flow, pressure, safety standards), not a diagnostic ground truth.
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The sample size for the training set: Not applicable. There is no "training set" for this type of device. Software validation involves testing against specifications, not training on data.
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How the ground truth for the training set was established: Not applicable. There is no training set.
§ 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.