(66 days)
PneuVIEW® XE VeryClear™ Gas Evacuation Cannula has applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to evacuate smoke and plume generated during minimally invasive surgery from the surgical cavity to aid visualization.
The PneuVIEW® XE VeryClear™ Gas Evacuation Cannula (Dual and Single Lumen Port) is an integral path of entry access port device with smoke evacuation mechanism intended for use in the surgical cavity during minimally invasive surgery. The PneuVIEW® XE VeryClear™ is a disposable single use device consisting of a path of entry access port device with filter and tubing with a multi-position stopcock valve. The PneuVIEW® XE VeryClear™ can be connected to a vacuum source for smoke evacuation. The integral path of entry access port device is designed and constructed similarly to the ' predicate Insuflow Synergy™ Port access device with a sealed instrument access lumen. Just as the Insuflow® Synergy™ Port, the PneuVIEW® XE VeryClear™ has a dual-lumen or single-lumen path of entry access device 5 mm configuration for surgical instrument manipulation and smoke evacuation.
The provided text describes the PneuVIEW® XE VeryClear™ Gas Evacuation Cannula and its 510(k) summary, aiming to demonstrate its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, detailed study designs, or performance metrics in the format requested.
The sections "Discussion of performance testing" and "Conclusion" broadly state that "Extensive performance testing has been conducted to assure that the PneuVIEW® XE VeryClear™ performs in accordance with its specifications and applicable standards. Flow/pressure performance and seal leak integrity testing were successfully completed. Since the access port device is the same size and configuration as the Insuflow Synergy™ Port 5 mm device, the insertion/removal testing previously submitted is directly applicable. In addition, biocompatibility per ISO 10993-1 was demonstrated."
This summary is insufficient to populate the requested table and answer the specific questions regarding acceptance criteria, sample sizes, expert qualifications, and study methodologies for an AI/device performance evaluation. The document focuses on demonstrating substantial equivalence to existing devices rather than a standalone performance study with quantifiable acceptance criteria against a defined ground truth.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's an attempt to answer based on the limited information and what cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Flow/Pressure Performance | Successfully completed (implied to meet specifications/standards) |
| Seal Leak Integrity | Successfully completed (implied to meet specifications/standards) |
| Insertion/Removal Testing | Directly applicable from predicate device (Insuflow Synergy™ Port 5 mm device) due to same size and configuration. |
| Biocompatibility | Demonstrated per ISO 10993-1 (meets standard) |
| Intended Use | Functions for establishing path of entry and evacuating smoke/plume in minimally invasive surgery. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified. The studies are referred to as "performance testing," but details on retrospective/prospective nature or country of origin are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not provided. The testing appears to be engineering/laboratory-based performance testing rather than expert-reviewed clinical ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided and is not applicable to the type of performance testing described (flow/pressure, leak integrity, biocompatibility).
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:
- No MRMC study was mentioned. This device is a physical medical device (cannula with smoke evacuation), not an AI diagnostic or assistance system. Therefore, this question is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is not an algorithm. This question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical tests:
- Flow/Pressure: Likely objective measurements against engineering specifications or established standards.
- Seal Leak Integrity: Objective measurements against engineering specifications or established standards.
- Biocompatibility: Conformance to ISO 10993-1, which involves standard materials testing.
- Insertion/Removal: Assumed based on equivalence to predicate device's prior testing, implying similar objective mechanical performance.
- No clinical "ground truth" (like pathology or outcomes data) is mentioned as part of the performance testing for this device's 510(k). The focus is on physical and material properties.
8. The sample size for the training set:
- This device is not an AI algorithm, so there is no training set in the AI sense. This question is not applicable.
9. How the ground truth for the training set was established:
- This device is not an AI algorithm, so there is no training set or ground truth for it in that context. This question is not applicable.
§ 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.