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The SOPRO 640 Laparoscopic Insufflator may only be used by qualified physicians for building up a pneumoperitoneum with CO2 Gas for diagnostic or operative Laparoscopy.

The SOPRO 640 insufflator supplies CO2 gas from cylinders to build up a pneumoperitoneum with CO2 Gas for diagnostic or operative Laparoscopy with a maximum flow rate of 20, 30 or 45 liters per minute dependent on the model selected. The insufflation pressure is user adjustable between 0 and 24 mmHg. The safety features include acoustic and visual alarms for overpressure and low gas supply.

The provided text is a 510(k) Summary for the SOPRO 640 Laparoscopic Insufflator. This type of document is for a medical device that the manufacturer seeks to market by demonstrating "substantial equivalence" to a predicate device already legally on the market.

Crucially, a 510(k) submission for a non-diagnostic device like an insufflator does not typically involve the type of clinical studies and performance metrics (sensitivity, specificity, accuracy) that would be applicable to AI-enabled diagnostic tools.

Therefore, most of the requested information (items 1-9) cannot be extracted or inferred from this document because it describes a different kind of regulatory process and device. This document focuses on comparing the new device's technical specifications and intended use against a legally marketed predicate device to establish equivalence, rather than proving performance against specific acceptance criteria through a clinical study.

Here's what can be addressed based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Cannot be provided based on the document. The document does not describe specific numerical acceptance criteria (e.g., minimum flow rate accuracy, pressure stability within a certain range) or quantitative performance data from a clinical trial for the SOPRO 640. Its approval is based on substantial equivalence to a predicate device, meaning its performance characteristics are considered comparable to an already approved device.

2. Sample Size Used for the Test Set and Data Provenance

• Not applicable/Not provided. This device is an insufflator, not an AI-powered diagnostic tool. There is no "test set" of patient data in the context of an algorithm's performance. The "study" for this device is the demonstration of substantial equivalence to its predicate.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Not applicable/Not provided. Ground truth is not established in this context as there's no diagnostic algorithm being evaluated against clinical findings.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. No test set or expert adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. This is not an AI-enabled diagnostic device that would typically undergo an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• No. This is a hardware medical device with automated functions, not a standalone algorithm.

7. The Type of Ground Truth Used

• Not applicable/Not provided. Ground truth, in the AI diagnostic sense, is not relevant here. The "truth" for this device's approval is its technical similarity and equivalent safety/effectiveness to its predicate device.

8. The Sample Size for the Training Set

• Not applicable/Not provided. This device does not use an AI algorithm that would require a "training set."

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

• Not applicable/Not provided. No training set exists for this device.

Summary of Device and Approval Process from the Document:

• Device: SOPRO 640 Laparoscopic Insufflator
• Intended Use: "The SOPRO 640 Laparoscopic Insufflator may only be used by qualified physicians for building up a pneumoperitoneum with CO2 Gas for diagnostic or operative Laparoscopy."
• Predicate Device: HI-FLO THERME PNEU 45, WISAP #7083, 7083V (K031014)
• Basis for Approval: Substantial equivalence to the predicate device. The document explicitly states: "Differences that exist between the devices relating to technical specifications, performances, and intended use are minor and do not affect the safety and effectiveness of the SOPRO 640 Laparoscopic Insufflator."
• Key Technical Specifications (from Device Description):
  • Supplies CO2 gas
  • Maximum flow rate: 20, 30, or 45 liters per minute (dependent on model)
  • Insufflation pressure: User adjustable between 0 and 24 mmHg
  • Safety features: Acoustic and visual alarms for overpressure and low gas supply.

The "study" for this 510(k) submission is a comparative analysis demonstrating that the SOPRO 640 is as safe and effective as the predicate device by meeting similar technical and performance characteristics. It does not involve a clinical trial to establish quantitative performance metrics as one would expect for a diagnostic or AI-driven device.

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