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The Disposable Biopsy Valve is used to cover the biopsy/suction channel of Olympus® and Fujinon® or Pentax® gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.

The Disposable Biopsy Valve is provided non-sterile, and is composed of a cylindrical base and a connected cap. The Disposable Biopsy Valve provides sealable access via the working channel port of an endoscope for surgical instruments. The valve consists of an attached cap and valve body with a circular opening. The cap is pre-perforated, and ensures instrument access and removal is tight and leak-free. The valve is designed with a hollow body with a distal end that releasably attaches to the inlet port of the working channel. The valve body provides a flexible diaphragm seal that separates the body into a proximal chamber and distal chamber. The distal chamber secures onto the endoscope, while the proximal chamber secures the cap. Instruments are inserted through the cap and chambers, through the diaphragm seal, and into the endoscope. The diaphragm seal is configured such that a seal is formed due to deformation of the elastomer around an instrument when it is inserted through the opening, preventing fluids from passing through the biopsy valve. The cap serves two primary functions. One function of the cap is to provide an additional seal around surgical instruments to prevent leakage. The second function is to allow modification of pressure during insufflation by opening the cap, allowing gasses to flow from the endoscope, and out of the biopsy valve.

The provided document is a 510(k) premarket notification for a medical device: the Disposable Biopsy Valve. It outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence.

However, the document does not contain any information regarding the acceptance criteria for a study proving the device meets those criteria, nor details of such a study.

Specifically, the document states under "7. Non-Clinical Testing":
"The device has undergone both bench testing of performance and laboratory biocompatibility testing for cytotoxicity, sensitization, intracutaneous injection test, and system injection test, in accordance with 21 CFR, Part 58. The Single Use Biopsy Valve results in no safety or efficacy concerns regarding biocompatibility or performance. Likewise, in conformance with 21 CFR 807.92(b)(3), the device performs as well as the predicate in all testing performed."

And under "Performance testing" in the comparison table (pages 7 and 8):
"Design verification Pressure test with valve closed - the device holds pressure for 1 Min at 10 PSI"
"Design verification Pressure test with instrument inserted - the device holds pressure for 1 Min at 10 PSI"
"Design verification Pressure test: Following removal of instrument the device holds pressure for 1 Min at 10 PSI"

While these are performance tests, they are described as "Design verification" and do not provide:

1. A table of acceptance criteria and reported device performance. The document lists the tests performed (pressure tests) and states the device "holds pressure for 1 Min at 10 PSI", but it doesn't explicitly state quantitative acceptance criteria (e.g., "must hold pressure for minimum of X minutes at Y PSI") against which a reported performance would be quantitatively compared.
2. Sample size used for the test set and data provenance: Not specified.
3. Number of experts used to establish ground truth and their qualifications: Not applicable for these types of physical performance and biocompatibility bench tests.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: No such study described. The device is a physical component (biopsy valve), not an AI/imaging device that would typically involve human reader studies.
6. Standalone (algorithm only) performance: Not applicable as this is a physical device, not an algorithm.
7. Type of ground truth used: For these bench tests, ground truth would be the physical measurements and observations of the device's performance under test conditions.
8. Sample size for the training set: Not applicable; this is a physical device, not a machine learning model.
9. How ground truth for the training set was established: Not applicable.

In summary, the document refers to "bench testing of performance" and "design verification pressure tests" but does not provide the detailed study information requested, such as specific acceptance criteria tables, sample sizes, or details typically associated with clinical or AI/imaging performance studies.

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