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The device Insufflator 50L FM134 is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, Pediatric and Bariatric operating modes of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is specifically indicated for pediatric laparoscopic procedures. The Vessel Harvesting operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery.

The Insufflator 50L FM134 is a microprocessor controlled CO2 insufflator that consists of the following major components and features: a casing, a world power supply, pressure reducers, a venting system, redundant pressure measurement, a fluid sensor, a gas heater, a software controlled graphical user interface (GUI) touch screen and various setting keys and display elements. The Insufflator 50L FM134 is not intended to enter the sterile field, and cannot be sterilized. The device is to be used with specially designed single-use tube sets that are delivered sterile. Specifically, the proposed device is to be used with a single-use tube set with heating wire and integrated filter or with a single-use tube set with integrated filter but without heating wire.

The provided text describes the 510(k) premarket notification for the Insufflator 50L FM134. However, it does not detail specific acceptance criteria or an overarching study proving the device meets acceptance criteria in the way one might expect for a diagnostic or prognostic AI/ML device (e.g., sensitivity, specificity, AUC thresholds).

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various tests and comparisons. The "acceptance criteria" can be inferred from the standards and comparisons performed.

Here's a breakdown based on the provided text, addressing the points where information is available and noting where it is not:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a medical device (CO2 insufflator) and not an AI/ML diagnostic, the acceptance criteria are not in terms of traditional metrics like sensitivity/specificity but rather compliance with safety, performance, and biocompatibility standards, and comparability to predicate devices.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not specify a "sample size" in terms of patient data or case numbers for the performance tests. The tests performed are primarily laboratory-based bench tests (e.g., electrical safety, EMC, software verification, comparative performance of insufflation characteristics, biocompatibility of materials, sterilization validation).
• Data Provenance: The tests were performed by "independent laboratories" (for electrical safety and EMC) and implicitly by the manufacturer or their designated testing facilities for others. The nature of the device (insufflator) means there wouldn't typically be "country of origin of the data" in the sense of clinical patient data, nor is it described as retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided. The "ground truth" for this device's evaluation is based on established engineering standards, physical performance measurements, and biological compatibility standards, rather than expert interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical evaluations where there might be disagreement among experts. The tests performed for this insufflator are objective measurements against predefined standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was it done?: No. An MRMC study is not relevant for this type of medical device (an insufflator). This type of study is typically performed for AI/ML diagnostic tools where human readers (e.g., radiologists) interpret images with and without AI assistance.
• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable.

6. Standalone Performance

• Was it done?: Yes, to the extent that an insufflator operates as a standalone device. The device's performance (e.g., flow rate, pressure regulation, leakage compensation) was tested independently against specifications and compared to predicate devices in bench testing. There is no "human-in-the-loop" performance as the device directly performs its function (insufflation).

7. Type of Ground Truth Used

The "ground truth" for the tests described is based on a combination of:

• International Standards: e.g., IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 10993 series, ISO 11135-1, ISO 14937, ISO 11607-1, ASTM-F-1980.
• Predicate Device Performance: The characteristics of the legally marketed predicate devices (45L Core Insufflator F114 and Nebulae™ I 50 LPM Insufflator) served as a benchmark for comparison to demonstrate substantial equivalence.

8. Sample Size for the Training Set

This information is not applicable and not provided. This device is an electro-mechanical insufflator, not an AI/ML system that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable.

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