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PureCeption™ is for in vitro procedures involving sperm separation, washing and isolation.

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This document is a 510(k) premarket notification FDA approval letter for a medical device called "PureCeption™ Lower Phase, PureCeption™ Upper Phase, and PureCeption™ Sperm Washing Media with HEPES-buffered Ham's F-10 and HSA." This type of document declares that the device is "substantially equivalent" to a legally marketed predicate device.

Crucially, a 510(k) summary (or a 510(k) premarket notification as referenced here) typically does NOT contain detailed study data or acceptance criteria specifications in the format requested. The FDA's 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, which often relies on comparative performance rather than establishing new, standalone effectiveness or performance criteria through in-depth clinical studies as might be seen for a PMA (Premarket Approval) submission.

Therefore, based on the provided text, I cannot extract the specific information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications. The letter only confirms that the device is approved for marketing based on its substantial equivalence.

The "Indications For Use" state: "PureCeption™ is for in vitro procedures involving sperm separation, washing and isolation." This is the only performance-related statement that can be directly extracted.

To answer your request, if this were a document that contained the specific study information, it would typically look for sections detailing:

• Performance Data/Clinical Studies: Where the design, methodology, results, and statistical analysis of performance tests would be presented.
• Acceptance Criteria: Explicit numerical or qualitative targets the device performance needed to meet.
• Test Set/Training Set Details: Information about the data used for evaluation and development.
• Ground Truth: How the "correct" answers or references were determined.

Since this information is not present in the provided FDA letter, I cannot fulfill the request for those details.

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Pacific Andrology, Inc. Microtools are a family of precision pipettes that are used for assisted reproduction procedures. They are designed, for use to denude, micromanipulate, inject, hold or transfer human gametes or embryos for assisted hatching, ICSI, or other assisted reproduction methods.

ICSI micropipettes are used for the intracytoplasmic single sperm injection of oocytes.

Assisted hatching micropipettes are used to effect a hole in the zona pellucida by chemical means.

The Holding Micropipettes are used to hold the oocyte in position during single sperm injection with the Intracytoplasmic sperm injection (ICSI) Micropipette, to hold the embryo during the assisted hatching or during partial zona dissection procedures.

Partial zona dissection micropipettes are used to facilitate assisted hatching by mechanically creating a hole in the zona pellucida.

The Denuding Pipettes are used to remove cumulus cell layers from oocytes.

Microtools are a family of precision pipettes.

I am sorry, but based on the provided document, there is no information available regarding acceptance criteria, device performance results, study details (like sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods), MRMC studies, or standalone algorithm performance. The document is a 510(k) clearance letter for "Assisted Reproduction Microtools" and an "Indications For Use" statement. It does not contain the kind of technical performance study reporting that your request outlines.

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