OMNIFLATOR 6630(6-630-00) by NORTHGATE TECHNOLOGIES, INC.

The Omniflator® Model 6630 CO₂ Gas Insufflator incorporates front panel controls similar to our current Omniflator® Model #6600. The 6630 has an adjustable gas flow rate from 0-30 LPM. The unit shall have direct patient pressure monitoring which can be used by attaching the direct patient monitoring tubing set to the Omniflator's® patient monitoring connector and subsequently into a cannula or trocar after initial insufflation has been achieved. The user has an option to utilize CO2 from a central supply or E-Cylinder tank.

AI/ML Overview

The provided documents describe a Laparoscopic Insufflator, Omniflator® 6630 (K973447), which received 510(k) clearance from the FDA in 1998. The primary purpose of this medical device submission is to demonstrate substantial equivalence to previously marketed devices, not to present a study proving the device meets acceptance criteria in the way this request typically defines it for AI/ML performance studies.

Therefore, many of the requested elements for an AI/ML performance study are not applicable to this traditional medical device submission. The focus here is on design, materials, and intended use as compared to existing technology, rather than on algorithm performance against a ground truth.

Here's an attempt to address the prompt based on the available information, noting where information is not present due to the nature of the submission:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (for substantial equivalence)	Reported Device Performance (as stated in submission)
Design: Similar to predicate devices.	Omniflator® Model 6630 incorporates front panel controls similar to current Omniflator® Model #6600.
Materials: Non-toxic and previously used in medical devices.	All materials are non-toxic and have been previously used to manufacture other medical devices.
Intended Use: Gas distention of the abdomen for diagnostic and/or operative laparoscopy.	Used for gas distention of the abdomen for diagnostic and/or operative laparoscopy.
Adjustable Gas Flow Rate: Within a specified range.	Adjustable gas flow rate from 0-30 LPM.
Patient Pressure Monitoring: Capability for direct monitoring.	Unit shall have direct patient pressure monitoring… by attaching direct patient monitoring tubing set.
CO2 Source Options: Central supply or E-Cylinder tank.	User has an option to utilize CO2 from a central supply or E-Cylinder tank.
Substantial Equivalence: Demonstrate equivalence to currently marketed devices (e.g., Snowden - Pencer).	Northgate's 6630 Insufflator/tubing sets are substantially equivalent in design, materials, and intended use to other currently marketed devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, not on a performance study using a test set of data.

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)

Not applicable. No ground truth for an AI/ML algorithm's performance is established or described in these documents. The "ground truth" equivalent would be the existing characteristics and performance of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set or expert adjudication is described for algorithm performance.

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 device is a laparoscopic 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. This relates to an AI/ML algorithm, which is not what this device is.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the purpose of substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate devices based on their historical use and regulatory clearances. This is assessed by the FDA against the new device's specifications.

8. The sample size for the training set

Not applicable. No training set for an AI/ML algorithm is described.

9. How the ground truth for the training set was established

Not applicable. No training set or associated ground truth is described.

Summary for this specific device (Omniflator® 6630):

The provided documents are for a 510(k) submission for a non-AI/ML medical device. The "acceptance criteria" discussed are related to demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than the performance metrics of a novel algorithm. The "study" proving these criteria are met is the comparison presented by the manufacturer (Northgate Technologies, Inc.) to the FDA, detailing the device's design, materials, and intended use in relation to established predicates. The FDA's review and clearance (K973447) signifies their agreement with the claim of substantial equivalence.

Summary

Regulation Number and Section

§ 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.