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Used to slow the motility of spermatozoa for the use in ICSI procedure.

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The provided text is a 510(k) clearance letter for a medical device called PVP (Polyvinylpyrrolidone), used to slow the motility of spermatozoa for ICSI procedures. However, the document does not contain information regarding the acceptance criteria, specific performance study results, sample sizes (training or test), expert qualifications, adjudication methods, or MRMC studies that would typically be detailed in a device's performance evaluation.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the device was cleared based on its substantial equivalence to a predicate device, rather than a detailed performance study against specific acceptance criteria. The FDA's 510(k) process often relies on demonstrating equivalence to an already approved device rather than requiring extensive de novo clinical trials with precise performance metrics and acceptance criteria.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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PVP is used for the intracytoplasmic sperm injection (ICSI) procedure to decrease the motility of spermatozoa, prevent their sticking to the injection pipette during the procedure and to give more control over the flow of fluid in the ICSI needle.

PVP, 10%, (W/V) in Hepes-HTF (Tissue Culture Media)

This document is a 510(k) clearance letter for "PVP, 10%, (W/V) in Hepes-HTF (Tissue Culture Media)" for use in ICSI procedures. It's a regulatory approval document and does not contain information about acceptance criteria or specific study details often found in scientific publications or clinical trial reports.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details from the provided text.

The closest information available is the "Indications For Use," which describes what the device is intended for: to decrease sperm motility, prevent sticking to the injection pipette, and provide more control over fluid flow during ICSI. This is a functional description, not a set of performance metrics or acceptance criteria as you've defined them.

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PVP (polyvinylpyrrolidone) is intended for use in assisted reproductive technology procedures involving the manipulation of gametes. Specifically, PVP is intended for use as a medium for the immobilization of sperm during intracytoplasmic sperm injection (ICSI) procedures.

PVP consists of polyvinylpyrrolidone that has been dissolved in ultra-pure water and Ivophilized.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Irvine Scientific PVP-Polyvinylpyrrolidone device.

Acceptance Criteria and Device Performance

The provided document describes the device, its intended use, and its technological characteristics. However, it does not explicitly list specific numerical acceptance criteria for performance. Instead, it relies on a historical review and the established use of the product.

Table of Acceptance Criteria and Reported Device Performance:

Note on Acceptance Criteria: The document references a "Notice of Final Rule" and "criteria outlined" within it, but these specific criteria are not detailed in the provided text. The submission primarily argues substantial equivalence based on the device's history of use and the fact it is considered a "standard" in the field.

Study Information:

The submission does not describe a specific clinical study with a test set, ground truth, or statistical analysis in the way a typical medical device study would. Instead, it relies on historical and widespread clinical adoption.

1. Sample sizes used for the test set and data provenance:
* Test Set Sample Size: Not applicable. No dedicated "test set" in the conventional sense is described.
* Data Provenance: The device's performance is supported by its "use in a variety of clinical settings" and its status as "one of the standard media" in the field over "a number of years." This implies broad, retrospective, and multi-country provenance, though specific countries or retrospective/prospective distinctions are not provided.

2. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
* Not applicable. No explicit "ground truth" establishment process for a test set is described. The "ground truth" seems to be established by consensus in the professional literature over time, reflecting widespread clinical acceptance and efficacy.

3. Adjudication method for the test set:
* Not applicable. No formal adjudication method is mentioned as there's no specific test set undergoing expert review.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
* Not applicable. This is not an AI-assisted device, and no MRMC study or comparison of human reader performance with/without AI is mentioned.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. This device is not an algorithm. Its performance is inherent in its chemical properties and how it aids human procedures (ICSI).

6. The type of ground truth used:
* The primary "ground truth" appears to be expert consensus and widespread clinical use/outcomes over time, as evidenced by the statement: "The conclusion from a review of the historical information contained in professional literature shows that PVP is suitable for its intended use..." and that it "has become one of standard media used for the immobilization and isolation of human sperm cells for use in ICSI procedures." This implies that successful clinical outcomes historically have validated its efficacy.

7. The sample size for the training set:
* Not applicable. This device is a chemical medium, not a machine learning algorithm requiring a training set.

8. How the ground truth for the training set was established:
* Not applicable. There is no training set mentioned.

Summary of Approach:

Irvine Scientific's 510(k) submission for PVP-Polyvinylpyrrolidone relies heavily on its historical use and established position as a standard product in the field of intracytoplasmic sperm injection (ICSI). The regulatory filing is for a device that has already gained significant clinical acceptance and is presenting this historical performance as evidence of its safety and effectiveness, rather than reporting on a new, specific clinical trial. This approach is common for devices seeking substantial equivalence where a strong predicate device or an extensive history of safe and effective use already exists. The "study" proving it meets acceptance criteria is effectively the accumulated body of professional literature and clinical experience over "a number of years."

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