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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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Sydney IVF Cryopreservation Kit is intended for use during in vitro fertilization procedures for cryopreservation of 1-cell to 8-cell embryos.

Sydney IVF Thawing Kit is intended for use during in vitro fertilization procedures for thawing of 1-cell to 8-cell embryos.

The Sydney IVF Cryopreservation and Thawing Kits are intended for cryopreservation and thawing of 1-cell to 8-cell human embryos. The Sydney IVF Cryopreservation and Thawing Kits provide users with the ability to cryopreserve supernumerary embryos created during the in vitro fertilization procedure and then to thaw them for use at a future point in time.

The Sydney IVF Cryopreservation Kit consists of three solutions containing increasing concentrations of cryoprotectant (both propanediol and sucrose are used). These buffers were designed to be used sequentially in order to remove water from embryos prior to cryopreservation. The removal of water prevents ice crystal formation inside the embryo thereby limiting damage and improving viability. It contains 12 mg/mL Human Serum Albumin (HSA) and 0.01mg/mL Gentamicin. Sydney IVF Cryopreservation Kit is designed for use with Sydney IVF Thawing Kit.

The Sydney IVF Thawing Kit consists of four solutions with decreasing concentrations of cryoprotectants (propanediol and sucrose) which are used sequentially throughout the thawing process. It contains 12 mg/mL Human Serum Albumin (HSA) and 0.01mg/mL Gentamicin. It is designed for use with Sydney IVF Cryopreservation Kit.

Sydney IVF Cryopreservation and Thawing Kits are provided in glass vials with Fluorotec coated rubber stoppers held in place with a tamper evident seal. Sydney IVF Cryopreservation Kit is packaged in a carton box containing 2 x 10mL and 1 x 20mL solutions per kit. The Sydney IVF Thawing Kit is packaged in a carton box containing 4 x 10mL solutions per kit.

The document provided is a 510(k) premarket notification for the Sydney IVF Cryopreservation Kit and Sydney IVF Thawing Kit. It outlines the similarities and differences with a predicate device and provides performance data primarily related to stability and shelf life, rather than clinical performance or a comparative effectiveness study.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the product specifications for sterility, pH, osmolality, and endotoxin are the same for the proposed device and the predicate. The MEA test assay and specification have changed, as noted in the table.

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

The document does not detail a specific "test set" for clinical performance. The studies mentioned are primarily stability studies and Mouse Embryo Assays (MEA).

• Sample Size: Not specified for the MEA or stability tests. The MEA mentions "control", but the number of embryos or replicates isn't provided.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The submitting company is William A. Cook Australia Pty Ltd. The studies appear to be laboratory-based rather than clinical trials with human subjects.

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

Not applicable. The document describes laboratory testing (MEA, stability) with defined endpoints and specifications, rather than a clinical study requiring expert assessment for ground truth.

4. Adjudication Method for the Test Set

Not applicable, as there's no mention of a human expert test set or adjudication process for the described studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "The results of the testing provide reasonable assurance that the Sydney IVF Cryopreservation Kit & Sydney IVF Thawing Kit is as safe and effective as the predicate device and supports a determination of substantial equivalence." This indicates a non-clinical comparison for substantial equivalence, not a comparative effectiveness study with human readers/users. Therefore, no effect size for human readers with/without AI assistance is provided.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Not applicable. This device is a medical kit (media and reagents) used in IVF procedures, not an algorithm or AI-driven diagnostic device.

7. Type of Ground Truth Used

For the Mouse Embryo Assay (MEA), the "ground truth" is defined by the objective outcome measure: the percentage of control embryos that develop to blastocyst. For stability studies, it involves objective measurements of pH, osmolality, endotoxin, sterility, and concentrations of specific substances.

8. Sample Size for the Training Set

Not applicable. This device is a medical kit, not a machine learning model that requires a training set.

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

Not applicable. As above, this is not a machine learning device.

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