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The Seal Single Use Biopsy Valve is intended to provide access for endoscopic device passage and exchange, help maintain insufflation, minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provide access for irrigation.

The Seal™ Single-Use Biopsy Valve is provided non-sterile, and is composed of a cylindrical base and a connected cap. The Seal™ Single Use 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 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 text does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding study design elements such as sample sizes, expert involvement, or ground truth establishment.

The text is a 510(k) summary for the Boston Scientific Seal Single Use Biopsy Valve, outlining its intended use, technological characteristics, and a statement that bench testing was performed.

Here's what can be extracted:

• Device Name: Seal Single Use Biopsy Valve
• Intended Use: To provide access for endoscopic device passage and exchange, help maintain insufflation, minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provide access for irrigation.
• Performance Data Mentioned:
  • Bench testing for air and water leak testing, device insertion and removal, and scope compatibility.
  • Biocompatibility testing (cytotoxicity, sensitization, and irritation testing).
• Result of Performance Data: The device "passed all Bench testing" and "passed all Biocompatibility testing."

However, none of the specific details requested in your prompt regarding acceptance criteria values, performance metrics, study design specifics (sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types and establishment, training set details) are present in the provided document.

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The Single-Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from biopsy port throughout the endoscopic procedure, and provides access for irrigation.

The Seal "Single-Use Biopsy valve is provided non-sterile, and is composed of a cylindrical base and a connected cap. The Single-Use 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 text is a 510(k) summary for a medical device (Seal Biopsy Valve) and does not contain information about acceptance criteria for a study or the study details you are asking for. It focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information. The document details administrative information, the intended use of the device, its description, and a comparison to a predicate device to confirm substantial equivalence, rather than a performance study with acceptance criteria.

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The Single-Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.

The Seal Single-Use Biopsy valve is provided non-sterile, and is composed of a cylindrical base and a connected cap. The Single-Use Biopsy Valve provides surgical instruments with sealable access to the working channel port of an endoscope. 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Seal Single-Use Biopsy Valve:

The provided text (K133734) is a 510(k) Summary for a Seal Single-Use Biopsy Valve device, which is a modification of a previously cleared device (K111821). The document primarily focuses on demonstrating substantial equivalence to the predicate device, rather than detailed performance studies with clinical outcomes or human-in-the-loop assessments.

Therefore, many of the requested criteria in your prompt are not applicable or cannot be extracted from this type of regulatory submission. This document highlights bench testing and biocompatibility testing to demonstrate that the modified device performs as well as the predicate device.

Acceptance Criteria and Reported Device Performance

Study Details (Based on provided text)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated for each test (e.g., how many biopsy valves were pressure tested). However, "bench testing" was performed.
   • Data Provenance: The testing appears to be conducted in a laboratory setting ("bench testing," "laboratory biocompatibility testing"). No country of origin is specified, but given the submission to the FDA, it's likely relevant to US regulatory standards. It is a retrospective analysis in the sense that the results are being presented after the tests were conducted.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. This document describes performance and biocompatibility testing of a medical device, not a diagnostic or AI-assisted device where expert ground truth is typically established for image or data interpretation. The "ground truth" here is the physical measurement or chemical reaction in the bench and biocompatibility tests.

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

   • Not Applicable. Adjudication methods like 2+1 are used for establishing ground truth in clinical studies involving interpretation of data (e.g., radiology reads). This document focuses on physical and biological performance tests.

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. This is a single-use biopsy valve, not an AI-assisted diagnostic device. Therefore, no MRMC study was conducted or is relevant to this submission.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This device is a mechanical component (biopsy valve), not an algorithm or AI system.

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

   • Established physical and biological testing standards. For pressure tests, the "ground truth" is a pass/fail criterion based on maintaining pressure at 10 PSI for 1 minute. For biocompatibility, the ground truth is determined by established laboratory protocols and thresholds for cytotoxicity, sensitization, etc., as per 21 CFR Part 58.

7. The sample size for the training set:

   • Not Applicable. This device does not involve a training set as it is not an AI/ML-based device.

8. How the ground truth for the training set was established:

   • Not Applicable. See point 7.

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