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The Single Lumen Ovum Aspiration Needles are used for laparoscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.

Single Lumen Ovum Aspiration Needles consist of a stainless-steel needle with a manipulating handle which may be connected to a fluorinated ethylene-propylene (FEP) or polytetrafluorethylene (PTFE) tube, which in turn is connected to a Silicone stopper (bung). The stopper has a Luer lock fitting directly to the stopper or connected to a length of tube to allow connection to a vacuum pump which provides aspiration suction. The stopper is placed in a 14mL test tube which acts as a collection reservoir. Needles are available in 16 to 21 gauge sizes and lengths from 25 to 35 cm. Needles have an echogenic tip that enhances the visualization of the needle tip under ultrasound. The Single Lumen Ovum Aspiration Needles are sterile and single-use devices.

Here's an analysis of the provided FDA 510(k) summary, specifically addressing the acceptance criteria and the study that proves the device meets them:

The document is a 510(k) premarket notification for the "Single Lumen Ovum Aspiration Needles." This is a medical device, and the focus of the regulatory claim is substantial equivalence to a predicate device, not necessarily a demonstration of clinical superiority or a deep dive into AI performance. Therefore, many of the typical AI/ML acceptance criteria and study details you'd expect are not present.

The "acceptance criteria" here largely refer to the performance standards and modifications made to demonstrate that the new device is as safe and effective as the predicate device.

1. Table of acceptance criteria and the reported device performance

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

The document does not specify exact sample sizes for each test set beyond mentioning "device extracts" for the Mouse Embryo Assay. The studies are pre-clinical/design verification and validation studies rather than clinical trials with human participant data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" as relevant to patient data provenance do not directly apply here. These studies are conducted by the manufacturer (William A. Cook Australia Pty Ltd).

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

This information is not applicable to this type of regulatory submission. For a medical device like an ovum aspiration needle, "ground truth" is established through standardized laboratory testing and engineering specifications to confirm physical and biological properties, not expert clinical interpretation of data.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical imaging studies or other diagnostic assessments involving multiple human readers, which is not the nature of the studies described here.

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

There was no MRMC study conducted. This device is a physical medical instrument (needle) and does not involve AI or human readers in the context of diagnostic interpretation.

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

This information is not applicable. The device is not an algorithm or an AI product.

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

The "ground truth" for the performance data presented is derived from standardized laboratory testing, engineering specifications, and established biological assays. For example:

• Biocompatibility: Conformity to ISO 10993 standards.
• Mouse Embryo Assay: Direct observation of embryo development under controlled conditions.
• Endotoxin testing: Quantitative measurement against USP <85> limits.
• Mechanical testing: Measurements against predefined engineering specifications for strength, leak resistance, and stiffness.

8. The sample size for the training set

This information is not applicable. The device is not an AI/ML system and therefore does not have a "training set" in the computational sense. The design verification and validation tests are performed on representative samples of the manufactured device.

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

This information is not applicable as there is no training set for an AI/ML algorithm.

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