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Intended for flushing and/or aspiration of oocytes from ovarian follicles.

The Follicle Aspiration Set. Reduced Single Lumen proposed in this submission is intended for ultrasound-guided transvaginal aspiration and flushing of oocytes from ovarian follicles. This product is comprised of the following components:

• A stainless steel needle .
• A silicone cork to be pushed into the opening of a sampling tube .
• A length of TPE-O tubing for aspiration and flushing ●
• An adapter for flushing .
  The subject device is provided sterile and is for single use only. It comes in four versions with the same design but different dimensions, as described below.

The provided text is a 510(k) summary for the Vitrolife Sweden AB Follicle Aspiration Set, Reduced Single Lumen. This document demonstrates the device's substantial equivalence to a predicate device, rather than providing a detailed study report for meeting specific performance criteria typically associated with AI/ML-enabled devices.

Therefore, many of the requested categories (such as sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, and ground truth establishment for training set) are not applicable to this type of device and submission. This is a medical device clearance based on engineering performance and material compatibility, not on diagnostic accuracy derived from AI analysis of data.

However, I can extract the acceptance criteria and reported performance for the engineering and biological tests conducted.

Acceptance Criteria and Device Performance for Vitrolife Sweden AB Follicle Aspiration Set, Reduced Single Lumen

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test set (e.g., number of devices for endotoxin testing, number of embryos for MEA). The tests are typically laboratory-based engineering and biological assessments compliant with recognized standards. Data provenance is not described in terms of geographical origin or retrospective/prospective study design as would be relevant for clinical data. These are intrinsic performance tests of the device itself.

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

Not applicable. The "ground truth" for these types of tests is generally defined by the specific test method, instrument calibration, and adherence to international standards (e.g., ISO, ASTM, USP). There are no human "experts" establishing ground truth in the context of diagnostic interpretation for these performance evaluations. Qualified laboratory personnel perform and interpret the results according to the established protocols.

4. Adjudication Method for the Test Set

Not applicable. These are quantitative and qualitative laboratory tests with defined pass/fail criteria from international standards. There is no ambiguous "case" interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is an aspiration set, primarily a mechanical and sterile instrument, not an imaging or diagnostic device that involves human interpretation of results.

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

Not applicable. This device is not an algorithm or AI-enabled system. Its performance is entirely mechanical, material-based, and biological compatibility.

7. The Type of Ground Truth Used

The ground truth is based on established international and national standards and methodologies for medical device performance, sterility, material safety, and biocompatibility. Examples include:

• Sterilization: ISO 11137-2:2013
• Endotoxin: USP
• Needle Properties: ISO 9626:2016
• Embryo Toxicity: Mouse Embryo Assay (MEA), a recognized biological test.
• Packaging Integrity: ASTM F1886/F1886M-09, ASTM F1929-12, ASTM F88/F88M-09

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning, so there is no "training set."

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

Not applicable. As there is no training set, this question is irrelevant to the device submission.

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Follicle Aspiration Set, Reduced Single Lumen is intended for flushing and/or aspiration of oocytes from ovarian follicles

The Follicle Aspiration Set, Reduced Single Lumen device is a modification of the current Vitrolife Follicle Aspiration Set (K991273). The Follicle Aspiration Set, Reduced Single has the same intended use as the predicate device technological characteristics related to safety and effectiveness. A thinner type of needle end is being introduced, and the last 40-60 mm close to the tip of a standard needle is reduced from an inner diameter of 1.2 mm to an inner diameter of 0.6 mm.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Vitrolife Follicle Aspiration Set, Reduced Single Lumen.

Important Note: The provided document is a 510(k) Premarket Notification Summary, which focuses on demonstrating substantial equivalence to a predicate device. It primarily details the safety and effectiveness testing required to prove this equivalence, rather than setting and meeting formal "acceptance criteria" in the way a clinical trial for a novel device would. Therefore, the "acceptance criteria" here are inferred from the safety tests performed.

Acceptance Criteria and Device Performance

Study Details

Given the nature of the 510(k) submission and the device (a modification of an existing medical instrument), the "study" is primarily focused on bench testing to demonstrate the safety of the design change. It's not a clinical study with human participants or a traditional AI/software efficacy study.

1. Sample sizes used for the test set and data provenance:
* Test Set Sample Size: Not explicitly stated as a number of individual needles. The testing is described as occurring "according to ISO 9626" and also an "extended angle test." ISO standards typically define sample sizes for such tests, but the specific number used by Vitrolife is not reported here.
* Data Provenance: Not applicable in the context of a clinical study. This is a report on internal bench testing conducted by the manufacturer, Vitrolife Sweden AB.

2. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
* This is not applicable as the "ground truth" for mechanical component testing is defined by engineering standards (e.g., ISO 9626) and passing specific physical tests, not by expert consensus on clinical data.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable. Adjudication methods like 2+1 are used for interpreting clinical data, not for bench testing. The passing or failing of these mechanical tests is objective.

4. 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:
* No. This is a physical medical device (a needle), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is irrelevant.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* No. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The "ground truth" for the safety tests is based on engineering standards and specifications (specifically ISO 9626 for resistance to breakage and an "extended angle test"). The device passing these prescribed mechanical tests constitutes the "ground truth" for demonstrating its structural integrity.

7. The sample size for the training set:
* Not applicable. This device is a modified physical instrument, not an AI model, so there is no "training set."

8. 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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