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The Flex-THOR System is indicated for use in providing access to, and visualization of, the thoracic and abdominal cavities, to allow for the performance of various diagnostic and therapeutic surgical procedures.

The Flex-THOR System includes two main components: (1) the Flex-THOR Scope (Part Number: 11292VS(U)A-THOR), and (2) the Camera Control Unit (CCU). The insertion shaft of the Flex-THOR Scope (Part Number: 11292VS(U)A-THOR) has an outer diameter of 2.9 mm and a working length of 675 mm with 8.5 Fr elliptical shaped distal tip (major diameter of 3.2 mm and minor diameter of 2.4 mm). Users can access the 1.2 mm working channel through the Luer ports.

This FDA 510(k) summary for the KARL STORZ Flex-THOR System does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to diagnostic accuracy or clinical effectiveness.

Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (electrical safety, EMC, and reprocessing validation) and a comparison of technological characteristics.

Therefore, I cannot fulfill the request to provide details about acceptance criteria and a study that proves the device meets them in the context of clinical performance or diagnostic accuracy.

Here's what can be extracted from the provided text:

Acceptance Criteria and Device Performance (Not applicable for clinical performance/diagnostic accuracy)

As mentioned, there are no specific acceptance criteria for clinical performance or diagnostic accuracy provided in this document. The focus for this 510(k) submission is on demonstrating safety and effectiveness through substantial equivalence, primarily via non-clinical testing.

The document does report performance against safety and reprocessing standards:

Study Information (Primarily Non-Clinical)

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

   • Test Set Sample Size: Not applicable. The document discusses non-clinical bench testing for electrical safety, EMC, and reprocessing. These types of tests typically involve devices/prototypes and simulated conditions, not a "test set" of patient data in the sense of clinical performance or diagnostic accuracy.
   • Data Provenance: Not specified, but generally, bench testing is performed in a controlled laboratory environment. It is not patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in the context of clinical expert consensus is not part of this 510(k) submission for this device. The non-clinical tests rely on established engineering and microbiological methodologies.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for expert review of images or data, which is not described here.

4. 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 done, as this device (an endoscope) does not involve AI or image interpretation for diagnostic assistance that would require such a study.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an endoscope, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests:

   • Electrical Safety & EMC: Compliance with international standards.
   • Reprocessing: Verification based on microbiological testing (reduction of microbial load) and visual inspection against established reprocessing protocols outlined in the standards.

7. The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for an AI algorithm.

Summary of what the document does provide:

• Clinical Performance Data: The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications."
• Purpose of Non-Clinical Data: The non-clinical data covered electrical safety, electromagnetic compatibility (EMC), and reprocessing validation, all to demonstrate the device is as safe and effective as the predicate device.
• Conclusion: The submission concludes that based on non-clinical performance data and comparison of device characteristics, the Flex-THOR System is substantially equivalent to the predicate device, and the differences do not raise new questions of safety and effectiveness.

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This instrument has been designed to be used with Olympus XLTF-VAW Laparo-Thoraco Videoscope and other ancillary equipment for CO₂ gas and water feeding to clean the distal lens during endoscopic surgery.

The subject UCR Endoscopic CO2 Regulation Unit feeds either CO2 gas and water to clean the distal end of the XLTF-VAW Laparo-Thoraco Videoscope. The UCR unit is similar to the predicate Olympus device, the MAJ-1203 Air/Water Supply Pump unit, with the following being the major differences:

• The UCR is designed for CO2 gas and water feeding to clean the distal end of . the XLTF-VAW, whereas the predicate device MAJ-1203 was designed for air and water feeding for the XLTF-VAW.
• The UCR utilizes a decompression valve mechanism for gas dispensing, . whereas the design for the predicate device MAJ-1203 employs a diaphragm pump.

The provided text describes a 510(k) summary for the "ENDOSCOPIC CO₂ REGULATION UNIT UCR". This document serves as a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. For such submissions, a "study that proves the device meets acceptance criteria" in the traditional sense of a clinical trial with specific performance metrics and statistical analyses is often not required, especially for accessories and devices demonstrating equivalence rather than novel efficacy.

Instead, the submission focuses on comparing the new device's technical characteristics and intended use to a predicate device. The acceptance criteria here are implicitly met by demonstrating that the new device is as safe and effective as the predicate, without raising new questions of safety or effectiveness.

Therefore, the response below will interpret "acceptance criteria" as the critical characteristics compared for substantial equivalence and "study that proves the device meets the acceptance criteria" as the comparison table provided in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are typically defined by the characteristics of the predicate device, and "reported device performance" is the comparison of the new device against these characteristics. The key "performance" here is demonstrating sufficient similarity or equivalence.

Summary of the "Study" (Comparison for Substantial Equivalence):

The document provides a comparative analysis (Table 1) between the subject device (UCR Endoscopic CO₂ Regulation Unit) and the predicate device (MAJ-1203 Air/Water Supply Pump Unit). This comparison serves as the "study" demonstrating that the UCR is substantially equivalent to the predicate, even with noted differences. The conclusion is that the UCR "does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device" when compared to the predicate.

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

• Sample Size for Test Set: Not applicable. This type of 510(k) relies on a comparison of device specifications and intended use against a legally marketed predicate device, not on a clinical test set with a specific number of cases or patients. The "test set" implicitly comprises the technical specifications and existing knowledge/history of the predicate device.
• Data Provenance: Not applicable for a traditional test set. The data provenance for the predicate device's established safety and effectiveness would be its long-standing market presence and regulatory clearance (K053382).

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

• Number of Experts: Not applicable. "Ground truth" in this context refers to the established characteristics, safety, and effectiveness of the predicate device. This is determined by its prior FDA clearance (K053382) and general medical acceptance, rather than a specific panel of experts for this submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no "test set" requiring adjudication in the clinical sense. The "adjudication" is implicitly performed by the FDA reviewer(s) who assess the substantial equivalence claim based on the provided technical and comparative data.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an accessory (Endoscopic CO₂ Regulation Unit), not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was Done

• Standalone Performance: Not applicable. This device is a mechanical/electronic accessory for medical procedures, not an algorithm. Its function is to feed CO₂ gas and water, not to provide diagnostic interpretations or automated decisions.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety, effectiveness, and functional characteristics of the predicate device (MAJ-1203 Air/Water Supply Pump Unit) as cleared by the FDA under K053382. This is based on regulatory precedent and the understanding of its intended use in medical practice.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is not developed using machine learning or AI that would require a "training set."

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

• How Ground Truth Was Established: Not applicable, as there is no training set for this type of device.

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