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In the treatment of infertile couples by ICSI, PICSI is indicated for the selection of mature sperm for injection.

The PICSI™ Sperm Selection Device is a sterile, plastic culture dish with three microdots of hyaluronan hydrogel attached to the dish and three locating lines emoussed on the bottom exterior of the dish to aid the operator to find the microdots. Mature sperm attach themselves to hyaluronan through specific receptors on the sperm plasma membrane. At temperatures from 18-28° C, mature sperm attach firmly to the hyaluronan microdot and no longer exhibit progressive movement, although their tails beat and they are capable of motility. Such sperm are removed from the hyaluronan by micropipet for intracytoplasmic sperm injection (ICSI).

Here's an analysis of the provided information regarding the PICSI™ Sperm Selection Device, focusing on the acceptance criteria and the study that proves its performance:

Considering the device is an Assisted Reproduction Media Labware (a physical culture dish with hyaluronan hydrogel), the "acceptance criteria" here refer to the performance specifications of the product itself, primarily its chemical and physical properties, and its functional performance in a lab setting, rather than a diagnostic device's accuracy metrics (like sensitivity/specificity).

1. Table of Acceptance Criteria and Reported Device Performance

The document compares the PICSI dish to predicate devices (Sperm Catch™ and FALCON® IVF Round Dish) across several attributes. Since explicit "acceptance criteria" (numerical thresholds that must be met) are not directly stated, I will infer them from the comparison table as the performance of the predicate devices or general industry standards for such products where available.

2. Sample size used for the test set and the data provenance

• Sample Size for the test set: Not explicitly stated. The document mentions "a clinical trial involving side-by-side fertilization of oocytes by ICSI, using sperm selected on PICSI and in Sperm Catch." This suggests a comparative study, but the number of patients, oocytes, or sperm samples is not provided.
• Data Provenance: Not specified in terms of country of origin. The study is described as a "clinical trial," implying prospective data collection, though the timeframe or specific study design details are absent.

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

Not applicable. This is a medical device for use in an assisted reproduction laboratory, not a diagnostic imaging or AI device requiring expert interpretation for ground truth. The "ground truth" here is the biological outcome (fertilization rates, embryo quality, embryo disposition) observed in a clinical setting. The assessment of these outcomes would typically be done by trained embryologists and clinicians, but no specific number or qualifications are mentioned as "experts" for ground truth establishment.

4. Adjudication method for the test set

Not applicable. As a clinical trial assessing biological outcomes, there wouldn't typically be an adjudication method in the sense of resolving conflicting expert opinions on a diagnosis. The outcomes (e.g., fertilization rates, embryo morphology) are usually objectively measured and reported.

5. 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

Not applicable. This device is not an AI algorithm or an imaging device to be interpreted by human readers. It's a labware product used in an assisted reproduction procedure.

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

Not applicable. This device is not an algorithm. Its function is to facilitate sperm selection by laboratory personnel during ICSI.

7. The type of ground truth used

The ground truth used was clinical outcomes data related to fertilization and early embryo development. Specifically:

• Fertilization rates
• Average number of cells in 3-day embryos
• Number of 3-day embryos with 8 or more cells
• Morphological characterization of 3-, 5-, and 6-day embryos
• Disposition (outcomes) of 3- and 6-day embryos

8. The sample size for the training set

Not applicable. This device is a physical labware product, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

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• 1. As a component of the standard analysis of semen in the diagnosis of suspected male infertility,
• 2. As a component of analyses for determining the proper course of IVF treatment of infertility.

Not Found

This is an FDA 510(k) clearance letter, which means the device has been found substantially equivalent to a predicate device. It does not typically contain the detailed study results and acceptance criteria in the format requested. The letter primarily confirms regulatory approval based on the information submitted by the manufacturer.

However, based solely on the provided text, here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the FDA clearance letter. Acceptance criteria and specific performance metrics are typically detailed within the 510(k) submission itself, not in the clearance letter.

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

This information is not provided in the FDA clearance letter.

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

This information is not provided in the FDA clearance letter.

4. Adjudication method for the test set:

This information is not provided in the FDA clearance letter.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not provided in the FDA clearance letter. The device, "HBA Sperm-Hyaluronan Binding Assay," sounds like a diagnostic assay rather than an AI-assisted imaging device, so an MRMC study with human readers assisting AI (or vice-versa) is unlikely to be relevant.

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

This information is not explicitly provided in the FDA clearance letter. The device name "HBA Sperm-Hyaluronan Binding Assay" suggests a lab-based assay, which typically operates in a standalone manner to produce a result, which is then interpreted by a human. However, the details of its performance study, including whether it's standalone, are not in this document.

7. The type of ground truth used:

This information is not provided in the FDA clearance letter. For a "Sperm-Hyaluronan Binding Assay," ground truth would likely be established through other recognized methods of evaluating sperm functionality or infertility, but these methods are not detailed here.

8. The sample size for the training set:

This information is not provided in the FDA clearance letter.

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

This information is not provided in the FDA clearance letter.

In summary: The provided document is an FDA 510(k) clearance letter, which confirms that the device, HBA Sperm-Hyaluronan Binding Assay, is substantially equivalent to a legally marketed predicate device. It does not contain the detailed study information, acceptance criteria, sample sizes, or ground truth methodologies that would typically be found in the manufacturer's 510(k) submission or a peer-reviewed study publication. The letter focuses on the regulatory decision rather than the technical specifics of the validation study.

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