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

Follicle Aspiration Sets included in this submission are intended for ultrasound-guided transvaginal aspiration and flushing of oocytes from ovarian follicles. Four types of Follicle Aspiration Sets are included in this submission, and are described in more detail below.

The Follicle Aspiration Sets are radiation sterilized and are for single use only. The materials used in these devices include: stainless steel, TPE-O tubing, silicone, medical grade adhesive, polypropylene, and methyl methacrylate acrylonitrile butadiene styrene.

Follicle Aspiration Set, Single Lumen: This device consists of a single-lumen stainless steel needle, aspiration tubing, and a silicone rubber cork for attachment to a collection tube. One version (17132) also includes vacuum tubing attached to the silicone rubber cork for attachment to the vacuum pump used for aspiration. This device also includes an adapter for flushing of ovarian follicles and removal of blockages. The needles for the majority of the versions of this device type include echogenic markings at the tip of the needle to aid in visualization during aspiration procedures.

Follicle Aspiration Set, Double Lumen: This device consists of a double lumen stainless steel needle, tubing for flushing of ovarian follicles and removal of blockages, tubing for aspiration, and a silicone rubber cork for attachment to a collection tube. One version (17129) also includes vacuum tubing attached to the silicone rubber cork for attachment to the vacuum pump used for aspiration. The needles for these versions of the device include echogenic markings at the tip of the needle to aid in visualization during aspiration procedures.

Follicle Aspiration Set, Single Lumen Luer with Tubing: This device consists of a single lumen stainless steel needle, and aspiration tubing with a luer connection at the end. The needle is provided with echogenic markings at the tip of the needle to aid in visualization during aspiration procedures.

Follicle Aspiration Set, Single Lumen, Luer: This device consists of a single lumen stainless steel needle with a luer connection at the base of the needle. The needle is provided with echogenic markings at the tip of the needle to aid in visualization during aspiration procedures.

The provided text describes the Follicle Aspiration Set, outlining its design, intended use, and comparison to a predicate device. It also includes information about performance testing to establish substantial equivalence.

Here's a breakdown of the requested information:

Acceptance Criteria and Reported Device Performance

• Sterilization Validation (ISO 11137-2:2013): International standard for radiation sterilization.
• Mechanical Testing (ISO 9626:2016, Tensile Strength): International and industry standards for needle properties and material strength.
• Biocompatibility Testing (ISO 10993-5, 10, 1): International standards for evaluating the biological effects of medical devices.
• Packaging Testing (ASTM F88/F88M, F1929, F1886/F1886M): American Society for Testing and Materials standards for package integrity.

These are objective, quantitative, and qualitative measures against defined standards or biological responses, rather than subjective ground truths established by human experts or outcomes data in a clinical trial.

8. The sample size for the training set

This information is not applicable. The device is a manufactured medical instrument, not a machine learning model, so there is no "training set."

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

This information is not applicable, as there is no "training set" for this physical device.

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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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The Swemed Follicle Aspiration Sets are intended to be used to obtain gametes from the body. The Swemed Follicle Aspiration Sets are indicated for use in flushing and/or aspiration of oocytes from ovarian follicles.

The Swemed Follicle Aspiration Sets are designed with either a single lumen which is capable for aspiration from the follicle or a double lumen which is capable of aspiration and flushing of sterile medium through the outer lumen up to the follicle. The needle has a beveled tip provided with shallow grooves to improve ultrasound image enhancement. The needle are supplied with a protective tube on the tip, which must be removed before use. The needles have inner diameters of 0.8 - 1.2 mm and outer diameters of 1.47 - 1.65 mm, which approximates a 16 and 17 gauge needle, respectively. The needle length ranges from 25 to 35 cm. The set is packed in an inner and outer wrapping, and steam sterilized.

The provided text focuses on the 510(k) summary for the Swemed Follicle Aspiration Set, demonstrating its substantial equivalence to a predicate device. This type of submission relies on comparisons to existing legally marketed devices rather than extensive new clinical studies with detailed acceptance criteria and performance metrics. Therefore, many of the requested details about acceptance criteria, specific studies, ground truth establishment, and expert involvement are not present in this document.

Here's a breakdown of the information that can be extracted and a clear indication of what is not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) submission for the Swemed Follicle Aspiration Set is based on demonstrating substantial equivalence to a predicate device (Cook OB/GYN Ovum Pick-Up Aspiration Needles). Substantial equivalence means the device is as safe and effective as a legally marketed predicate device, not that it met specific quantitative performance criteria in a de novo study with acceptance thresholds. The document states:

"The Swemed Follicle Aspiration Sets and the Cook Ovum Pick-Up Needles share the exact same intended use: to obtain oocytes from the body and the exact same indication for use: flushing and/or aspiration oocytes from ovarian follicles. Except for four minor features, the Swemed Follicle Aspiration Sets and the Cook Ovum Pick-Up Needles are nearly identical. ... These minor differences do not affect the safety or effectiveness of the device."

This implies that the "acceptance criteria" were met by demonstrating that the device's technological characteristics and intended/indications for use are sufficiently similar to a device already deemed safe and effective, and that the minor differences do not negatively impact safety or effectiveness. No specific performance metrics (e.g., aspiration efficiency, follicle retrieval rate) are provided or compared.

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

This information is not provided. The document describes the device's features and its proposed equivalence to a predicate device, but it does not detail any specific clinical testing or studies with a "test set" in the context of typical AI/diagnostic device validation. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not provided. As no specific test set or study is detailed, there's no mention of experts establishing a ground truth.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC study and, crucially, this device is a medical instrument (needles), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

This is not applicable as the device is a medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

This information is not provided. Since the submission relies on substantial equivalence and not a de novo performance study, there's no detailed discussion of ground truth. The "ground truth" implicitly references the established safety and effectiveness of the predicate device.

8. The Sample Size for the Training Set

This information is not provided. As this is not an AI/algorithmic device, there would be no "training set."

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

This information is not provided and is not applicable for this type of device and submission.

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