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The Precision Capillaries for Micromanipulation are microcapillaries intended for the following uses in assisted reproduction procedures:

• Holding human oocytes, blastocysts, or other suspension cells .
• Transferring and injecting sperm (or cells of a similar size) using the ICSI . (Intracytoplasmic Sperm Injection) technique

The proposed Precision Capillaries for Micromanipulation (Precision Capillaries) product line contains the following types of microcapillaries:

• VacuTips Holding Capillary, used for holding human oocytes, blastocysts, or ● other suspension cells
• TransferTips® (ICSI), used for transferring sperm and perforating oocytes . using the ICSI (Intracytoplasmic Sperm Injection) technique
  The Precision Capillaries and the substantially equivalent devices are borosilicate glass microcapillaries designed for use in assisted reproduction procedures. The proximal end of the shaft is inserted into the capillary holder of the micromanipulator or microinjector. The distal end is drawn to a narrow tip that contacts the gamete for transfer and/or perforation. The distal end of the VacuTips is blunt for cell transfer. The TransferTips (ICSI) have spiked tips for perforation of the gamete. Three forms of the TransferTips (ICSI) are described in the 510(k), TransferTips-F, TransferTips-R, and TransferTips-RP. The TransferTips vary in shaft length, tip length, and flexibility of the flange.
  Each Precision Capillary is mounted in a "Capillary Safe" consisting of a holder and protective tube to protect the capillary and the user during transport and handling. The Precision Capillary mounted in the Capillary Safe is sealed in a foil pouch to maintain sterility. The packaged devices are sterilized by gamma irradiation.

The provided text describes a 510(k) premarket notification for "Precision Capillaries for Micromanipulation." This document is focused on demonstrating substantial equivalence to predicate devices for assisted reproduction microtools, rather than detailing a study proving device performance against specific, quantifiable acceptance criteria in the way one might see for an AI/software device.

Therefore, many of the requested sections (sample sizes for test sets, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable or not provided in the context of this type of submission.

However, I can extract the relevant information regarding performance testing and acceptance, even if not presented in a typical AI/medical device performance study format.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the document. The performance testing section mentions "biological and functional testing" and "application testing," but does not provide details on the number of capillaries, samples (e.g., sperm, oocytes), or replicates used for these tests.
• Data Provenance: Not explicitly stated. Given the context of a 510(k) submission by a U.S.-based sponsor (Brinkmann Instruments, Inc., Westbury, NY), it's highly probable the testing was conducted in a laboratory setting, likely within the U.S. The testing is reported retrospectively for this submission.

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

Not applicable. The ground truth for functional tests (sperm aspiration, oocyte perforation) would be based on direct observation or laboratory measurements, not expert consensus in the typical sense of radiological or pathological interpretation. For biological safety tests, it would be based on established laboratory protocols and assays. No "experts" are mentioned for establishing ground truth.

4. Adjudication Method for the Test Set

Not applicable. This is not a study assessing human reader performance or diagnostic accuracy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a medical device (microcapillary), not an AI algorithm, and therefore, no MRMC study was conducted.

6. Standalone Performance (Algorithm Only without Human-in-the Loop Performance)

Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

• Laboratory Assay Results: For bioburden, endotoxin, and embryotoxicity testing.
• Direct Observation/Demonstration of Functionality: For successful sperm aspiration and oocyte perforation during "application testing."

8. Sample Size for the Training Set

Not applicable. This is a manufactured physical device, not a machine learning algorithm. There is no "training set" in this context. The product is manufactured and tested based on established design specifications.

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

Not applicable. As above, there is no "training set." The device design and manufacturing processes are likely informed by predicate devices and engineering principles to ensure functionality and safety.

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