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The oocyte recovery needles are single use sterile devices provided for ultrasound guided transvaginal collection and recovery of oocytes from ovarian follicles for use during assisted conception procedures. The set consist of a single lumen, stainless steel needle attached to tubine. The needle is 33 cm in length and available in 16 Ga. or 17 Ga. Each device has 2 cm of echogenic markings at the distal tip for ultrasound reflection and a plastic hub at the proximal end for ease of guidance by hand. The tubing is attached to the proximal end of the needle and protrudes a total distance of 90 cm until it terminates in a silicone bung.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for CooperSurgical Oocyte Recovery Needles. This type of FDA submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials and performance metrics against specific acceptance criteria like an AI device would.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment typically associated with the evaluation of AI/ML-driven devices.

Instead, the submission focuses on comparing the new device to a predicate device based on its intended use, technological characteristics, and materials.

Here's a breakdown of why the requested information is absent and what the document does provide:

Table of acceptance criteria and reported device performance: This is not present. The submission's "Performance Data" section states that the device has undergone biocompatibility testing (equivalent to ISO 10993-1) and complies with ISO 594-1 1986 (luer taper requirements). These are standards for material safety and physical characteristics, not performance metrics like accuracy, sensitivity, or specificity.
Sample size used for the test set and data provenance: Not applicable. There was no "test set" in the context of AI/ML evaluation for this device. The biocompatibility and luer taper tests would have their own sample sizes for material/component testing, but these are not detailed in the summary.
Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. No "ground truth" was established by experts for performance evaluation in the AI/ML sense.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this was not done as it's not relevant for this type of medical device submission. The device is a needle, not an AI diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm or AI component in this device.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable as there is no AI/ML component.
How the ground truth for the training set was established: Not applicable.

What the document does state regarding the "device meeting acceptance criteria" (in the context of a 510(k) submission):

The "acceptance criteria" in this context are interpreted as demonstrating substantial equivalence to a predicate device and adherence to relevant safety and quality standards rather than clinical performance metrics.

Acceptance Criteria & Device "Performance" (as per the 510(k) document):

Acceptance Criteria (Demonstrated Equivalence/Compliance)	Reported Device Performance (as stated in submission)
Intended Use Equivalence	The subject device has the same indications for use as the predicate device: "ultrasound guided transvaginal recovery and collection of oocytes from ovarian follicles."
Material Composition Equivalence	The subject device states it is "composed of the same materials" as the predicate for most components. (Minor difference noted: needle hub is ABS vs. methyl pentene in predicate).
Sterilization Method Equivalence	"sterilized using the same method" (Ethylene Oxide).
Working Dimensions Equivalence	"similar dimensionally" to the predicate. (Minor difference noted: luer is slightly larger in diameter and length).
Biocompatibility (for patient-contacting materials)	Subjected to biocompatibility testing "equivalent to ISO 10993-1 Biocompatibility requirements."
Luer Taper Requirements (for fittings)	Complies with "ISO 594-1 1986 Conical fittings with a 6% (luer) taper requirements."
Technological Characteristics Equivalence (overall safety and effectiveness)	CooperSurgical Inc. believes the subject device is substantially equivalent to the predicate device, citing shared materials, sterilization, standards, and indications for use.
Conclusion of Safety and Effectiveness (relative to predicate)	"We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate devices."

Summary of missing information:

All points 1-9 regarding specific performance metrics, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details are not applicable to this 510(k) submission for a non-AI medical device. The submission focuses on demonstrating substantial equivalence to an already marketed predicate device, rather than proving de novo safety and efficacy through a performance study against specific clinical endpoints.

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