(61 days)
The SurgiQuest AirSeal Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments, and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization.
The SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") consists of the following major components: (1) a trocar, (2) a cannula, (3) tube sets, and (4) a micro-processor controlled insufflation, recirculation and filtration unit (the "DPIS 2000 Unit"). The cannula, trocar and tube sets are sterile, single-use products. The DPIS 2000 Unit is non-sterile and reusable.
The provided text is a 510(k) summary for the SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000. It describes the device, its indications for use, and some of the testing performed to demonstrate its safety and effectiveness.
However, the document does not contain specific acceptance criteria values or detailed study results (like sample sizes, ground truth establishment, expert qualifications, or MRMC study details) that would allow for a comprehensive answer to your request regarding acceptance criteria and performance studies. The "TESTING" section briefly mentions the device's ability to create and maintain a port of entry, maintain pneumoperitoneum, and aid in smoke evacuation, but it doesn't quantify these abilities with specific metrics or acceptable ranges.
The only specific performance detail mentioned is related to sterilization:
- Sterilization: Achieves a Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11137:2006 and AAMI TIR 27:2001.
Therefore, based only on the provided text, a complete table of acceptance criteria and device performance as requested, along with details about sample sizes, experts, adjudication, and specific study types (like MRMC or standalone), cannot be fully generated.
Here's what can be extracted and what is missing, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance (from text) |
|---|---|
| Sterility | Achieves a Sterility Assurance Level (SAL) of 10-6. |
| Pneumoperitoneum Maintenance | Tested to show its ability to maintain adequate pneumoperitoneum during laparoscopic surgery. |
| Smoke Evacuation | Tested to show its ability to aid in the evacuation of smoke. |
| Port of Entry creation/maintenance | Tested to show its ability to create and maintain a port of entry during simulated laparoscopic surgery. |
Note: The acceptance criteria for pneumoperitoneum maintenance, smoke evacuation, and port of entry are descriptive ("adequate," "aid in," "ability to create and maintain") rather than quantifiable metrics with specific thresholds. The document does not provide the numerical results or the specific acceptance thresholds for these aspects beyond stating that they were tested successfully.
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified in the provided text.
- Data provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The testing is generally referred to as "simulated laparoscopic surgery."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified in the provided text. The testing mentioned in the document appears to be primarily laboratory/technical testing rather than human-expert-driven ground truth establishment for a diagnostic algorithm.
4. Adjudication method for the test set
- Not applicable/Not specified in the provided text. (No diagnostic algorithm or expert review for ground truth described).
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/Not specified in the provided text. This is a medical device (trocar and insufflator), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not specified in the provided text. This is a medical device, not an algorithm. The device itself performs functions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For Sterility: Established based on compliance with ISO 11137:2006 and AAMI TIR 27:2001 standards.
- For Functional Performance (Pneumoperitoneum, Smoke Evacuation, Port of Entry): The text implies that the ground truth was based on the device's ability to perform these functions during "simulated laparoscopic surgery" in a manner deemed "adequate" or successful. No further details on how "adequacy" or "success" were quantitatively defined and measured are provided.
8. The sample size for the training set
- Not applicable/Not specified in the provided text. There is no mention of a "training set" as this device is not an AI/machine learning solution.
9. How the ground truth for the training set was established
- Not applicable/Not specified in the provided text. No training set is mentioned.
§ 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.