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Sydney IVF Blastocyst Cryopreservation Kit is intended for use in assisted reproduction technologies for cryopreservation of blastocysts.
Sydney IVF Blastocyst Thawing Kit is intended for use in assisted reproduction technologies for thawing of cryopreserved blastocysts.

The Sydney IVF Blastocyst Cryopreservation and Thawing Kits are intended for cryopreservation and thawing of human blastocysts. The Sydney IVF Blastocyst 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 Blastocyst Cryopreservation Kit consists of three solutions containing increasing concentrations of cryoprotectant (both glycerol 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 Blastocyst Cryopreservation Kit is designed for use with Sydney IVF Blastocyst Thawing Kit.

The Sydney IVF Blastocyst Thawing Kit consists of four solutions with decreasing concentrations of cryoprotectants (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 Blastocyst Cryopreservation Kit.

Sydney IVF Blastocyst Cryopreservation and Thawing Kits are provided in glass vials with Fluorotec® coated rubber stoppers held in place with a tamper evident seal. Sydney IVF Blastocyst Cryopreservation Kit is packaged in a carton box containing 3 x 20mL solutions per kit. The Sydney IVF Blastocyst Thawing Kit is packaged in a carton box containing 4 x 20mL solutions per kit.

The provided text describes a Special 510(k) submission for the Sydney IVF Blastocyst Cryopreservation Kit and Sydney IVF Blastocyst Thawing Kit (K152717). This submission is for reproductive media, not an AI/ML medical device. Therefore, many of the requested categories pertaining to AI/ML device studies (e.g., sample size for test set, data provenance, ground truth experts, adjudication methods, MRMC studies, standalone performance) are not applicable to this document.

However, I can extract information related to the device's performance, stability, and comparison to its predicate.

Here's the information that can be extracted:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The stability studies and MEA tests would have involved specific sample sizes, but these are not disclosed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is reproductive media, not an AI/ML diagnostic tool requiring expert ground truth in the context of image interpretation or similar.

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

Not applicable.

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

Not applicable.

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

Not applicable.

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

For the MEA, the "ground truth" is the observation of embryo development to blastocyst stage, compared to a control group. For the chemical and physical properties (pH, osmolality, endotoxin, sterility), the ground truth is established by standard laboratory testing and measurements.

8. The sample size for the training set

Not applicable; this is not an AI/ML device with a 'training set'.

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

Not applicable.

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Sydney IVF Embryo Biopsy Medium is intended for use in assisted reproduction technologies to facilitate the aspiration of blastomeres for pre-implantation genetic diagnosis.

Sydney IVF Embryo Biopsy Medium is bicarbonate based, free of calcium and magnesium to facilitate the aspiration of blastomeres for pre-implantation genetic diagnosis of the embryo. Embryos are placed in this medium for approximately five minutes to break down gap junctions between blastomeres. One or two blastomeres are removed, and the embryo is then returned to Cleavage Medium or Blastocyst Medium for further culture.

Sydney IVF Embryo Biopsy Medium contains Human Serum Albumin (5 mg/mL) and Gentamicin (0.01 mg/mL). The device is available as a 20 mL fill only.

The Sydney IVF Embryo Biopsy Medium is provided in glass vials with Fluorotec® coated rubber stoppers held in place with a tamper evident seal. These products are single use, sterile (aseptic filtration) devices.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Sydney IVF Embryo Biopsy Medium, incorporating the requested information where available:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on the comparison to a predicate device and stability studies. Specific, quantified acceptance criteria for clinical performance are not explicitly stated in a typical format (e.g., sensitivity, specificity). Instead, the performance is demonstrated through meeting established specifications and validating shelf-life.

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

The document describes stability studies as the primary performance validation.

• Sample Size for Test Set: Not explicitly stated for each specific test (e.g., number of vials tested for endotoxin, number of MEAs performed). However, stability studies typically involve multiple samples tested at various time points.
• Data Provenance: Not explicitly stated. The manufacturer is William A. Cook Australia Pty Ltd, so the testing likely occurred in Australia or through their designated testing facilities. The study appears to be prospective with regard to the shelf-life validation, as the product's performance was evaluated over time to determine its stability.

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

• This information is not provided in the document. The device is a culture medium, and its performance is assessed against physical, chemical, and biological specifications rather than through expert interpretation of clinical outcomes directly from the medium's use. The "ground truth" for the tests (e.g., what constitutes an acceptable osmolality reading) would be based on established scientific and regulatory standards for reproductive media.

4. Adjudication Method for the Test Set

• This information is not provided and is generally not applicable to this type of device and testing. Performance appears to be assessed against predefined quantitative specifications (e.g., numerical ranges for pH, osmolality, endotoxin).

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or interpretive devices that assist human readers. The Sydney IVF Embryo Biopsy Medium is a laboratory reagent, not an AI or diagnostic tool.

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

• Not applicable. This device is a culture medium, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the performance validation relies on:
  • Validated laboratory methods and established specifications: For chemical (pH, osmolality, proline, pyruvate, ammonia), physical (sterility), and biological (endotoxin, Mouse Embryo Assay for embryo toxicity) tests.
  • Predicate device characteristics: The similar chemical formulation and performance specifications (osmolality, endotoxin, MEA) of the previously cleared predicate device K023850 served as a benchmark for comparison.

8. The Sample Size for the Training Set

• Not applicable. As this is a biological/chemical product evaluated through laboratory testing and stability studies, there is no "training set" in the context of machine learning or AI models. The testing involved samples of the manufactured medium.

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

• Not applicable. (See point 8).

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Blastocyst Vitrification Kit is intended for the vitrification of human blastocysts for assisted reproduction technologies (ART). This kit is designed for use with Blastocyst Warming Kit (K-SIBW-5000).

Blastocyst Warming Kit is intended for the warming of human blastocysts that have undergone vitrification using COOK Sydney IVF Vitrification Kit (K-SIBV-5000) for ART procedures.

COOK Sydney IVF Blastocyst Vitrification and Warming Kits are intended for the vitrification and warming of human blastocysts as part of human ART procedures. The COOK Sydney IVF Blastocyst Vitrification and Warming Kits provide users with the ability to cryopreserve supernumerary embryos created during the in vitro fertilization procedure and then to re-warm them for use at a future point in time.

The COOK Sydney IVF Blastocyst Vitrification Kit (K-SIBV-5000) consists of a series of 2-[4-(2-hydroxyethyl)piperazin1-yl] ethanesulfonic acid (HEPES)-buffered, physiological solutions containing increasing concentrations of functional cryoprotectants to which the embryo is sequentially exposed during cryopreservation. The first three solutions in the kit are all based upon the same formulation (known as "Cryobase buffer"), which is a 10 mM HEPES buffered media containing 20 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin. The fourth solution in the kit is dimethyl sulfoxide (DMSO) and does not contain HSA or Gentamicin. The DMSO is provided for the practitioner to add to Solution 2 and Solution 3 of the vitrification kit, as described in the Instructions for Use.

COOK Sydney IVF Blastocyst Warming Kit (K-SIBW-5000) consists of three solutions which are used sequentially throughout the warming process. The three media in the kit are all based upon the same formulation of Cryobase buffer, a 10 mM HEPES buffered media containing 20 mg/mL HSA and 0.01 mg/mL Gentamicin.

The COOK Sydney IVF Blastocyst Vitrification and Warming Kits are single use, sterile (aseptic filtration) devices.

These solutions contact the blastocyst during the vitrification and re-warming process. The solutions are removed by washing prior to embryo transfer back to the patient and are therefore non-patient contacting.

The provided document describes the COOK Sydney IVF Blastocyst Vitrification Kit and COOK Sydney IVF Blastocyst Warming Kit, and its comparison to a predicate device (K082363). The primary purpose of the submission is to justify an extended shelf-life from 8 weeks to 20 weeks for the updated device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance specifications that are considered acceptance criteria for the device. The reported performance of the proposed device is stated to be the same as the predicate device for these parameters.

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

The document mentions that the shelf-life was validated "in stability studies." However, it does not provide any specific sample sizes for these stability studies (e.g., number of batches, number of vials tested per time point).

Regarding data provenance, the document does not explicitly state the country of origin for the data or whether the study was retrospective or prospective. Given that the manufacturer is William A. Cook Australia Pty Ltd and the submission is to the US FDA, it's likely the studies were conducted by the manufacturer, potentially in Australia or in collaboration with other labs. The nature of stability studies (testing products over time) inherently makes them prospective in terms of data collection from manufactured lots.

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

This information is not provided in the document. For device components like reproductive media, the "ground truth" for performance parameters (pH, osmolality, endotoxin, MEA) is typically established by laboratory testing against defined scientific standards and biological assays, not by expert consensus in the way a diagnostic imaging device might use radiologists. The MEA (Mouse Embryo Assay) is a biological test performed by trained embryologists or laboratory technicians, but the document doesn't specify the number or qualifications of these individuals involved in establishing the "ground truth" (i.e., the control performance).

4. Adjudication Method for the Test Set:

This information is not applicable to the type of device and testing described. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or performance evaluations where human interpretation of medical images or patient outcomes requires reconciliation among experts. For laboratory performance characteristics and stability testing of media, the results are quantitative and directly measured (e.g., pH, osmolality) or rely on established biological assay endpoints (e.g., MEA, sterility), not subjective expert judgment that requires adjudication.

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:

This information is not applicable and not present in the document. MRMC studies are relevant to diagnostic imaging devices or AI-assisted interpretation where human readers (e.g., radiologists) are involved in making decisions, and the AI's impact on their performance is being evaluated. The COOK Sydney IVF Blastocyst Vitrification and Warming Kits are reproductive media, not an AI diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This information is not applicable as the device is not an algorithm or AI. The performance evaluation focuses on the chemical and biological integrity of the media itself.

7. The Type of Ground Truth Used:

For the performance parameters and stability studies, the "ground truth" is established through:

• Laboratory measurements: For physical and chemical properties like pH, osmolality.
• Microbiological testing: For endotoxin and sterility.
• Biological assays: Specifically, the Mouse Embryo Assay (MEA), which is a standard biological control test to ensure that culture media and components are non-toxic and support embryonic development.
• Chemical assays: For concentrations of specific components like amino acids, pyruvate, ammonia, and HSA.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. "Training set" refers to data used to train machine learning models. This device is not an AI/ML product. The document describes laboratory testing for product quality and stability.

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 model for this device. The ground truth for the device's characteristics (as outlined in point 7) is established through established laboratory methods and specifications.

In summary of the study proving the device meets acceptance criteria:

The primary study detailed (though without specific numerical sample sizes) is a stability study designed to validate the extended shelf-life of 20 weeks. This study involved testing critical device characteristics—pH, osmolality, endotoxin, MEA, sterility, and concentrations of specific chemical components (amino acids, pyruvate, ammonia, HSA)—over time at the specified storage conditions (2-8°C). The "conclusion" section states that "The results of the testing provide reasonable assurance that the COOK Sydney IVF Blastocyst Vitrification Kit & COOK Sydney IVF Blastocyst Warming Kit is as safe and effective as the predicate device and supports a determination of substantial equivalence." This implies that the measured values for these parameters remained within acceptable limits for the entire 20-week period, demonstrating that the device maintains its performance specifications for the extended shelf life.

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The Cook Otrieva™ Tapered Ovum Aspiration Needles are used for laproscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles.

This device is intended for laparoscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles.

The needle is passed through a transvaginal ultrasound transducer or placed through a cannula for a laparoscopic procedure to advance into the ovarian follicle.

The main body of the cannula is 17 gage, which tapers to 20 gage at the distal tip. Although the outer diameter of the needle tapers, a constant 0.60 mm internal diameter is maintained.

The Otrieva™ needles are available in two lengths: 30cm and 35cm. The needles are provided with an aspiration tube of 90 cm length and a vacuum tube with a length of 50 cm. The tubing is connected to a silicone bung.

The materials used in the device include: stainless steel, polycarbonate, PTFE, silicone, FEP and copolyester.

The provided text describes a 510(k) premarket notification for the Otrieva™ Tapered Ovum Aspiration Needle, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a standalone study with clinical performance metrics as typically expected for algorithmic-based devices.

Therefore, many of the requested sections (2-6, 8-9) are not applicable as this document does not describe an AI/algorithmic device or a study designed to establish clinical performance against predefined acceptance criteria for such a device. Instead, it describes engineering and pre-clinical tests to support substantial equivalence.

Here's the information that can be extracted and inferred from the document:

1. A table of (implied) acceptance criteria and the reported device performance

Since this is a submission to demonstrate substantial equivalence, the "acceptance criteria" are implicitly the performance specifications of the predicate device. The new device must perform at least as well as the predicate device or demonstrate that modifications do not introduce new safety/effectiveness questions.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document describes pre-clinical (bench) testing and biocompatibility verification, not a clinical test set from human data for an AI/algorithmic device. The "test set" here refers to device samples used in the non-clinical testing. The document does not specify the number of units tested for each non-clinical test (e.g., how many needles were subjected to "Resistance to breakage testing"). The manufacturer is William A. Cook Australia.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth as typically understood for AI/algorithmic devices does not apply to this type of medical device submission. Biocompatibility and engineering tests do not rely on expert consensus for "ground truth" in the same way.

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

Not applicable. No human adjudication is described for the non-clinical tests performed.

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

Not applicable. This is not an AI/algorithmic medical device.

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

Not applicable. This is not an AI/algorithmic medical device.

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

For the non-clinical tests, the "ground truth" implicitly refers to objective measurements and pass/fail criteria defined by engineering standards, biocompatibility regulations (e.g., ISO standards), and internal quality controls. For the Mouse Embryo Assay (MEA), the "ground truth" is the observed blastocyst rate in the tested embryos, which is a biological outcome.

8. The sample size for the training set

Not applicable. This is not an AI/algorithmic medical device, so there is no "training set."

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

Not applicable. This is not an AI/algorithmic medical device.

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'Cook Sydney IVF Blastocyst Vitrification Kit' is intended for the vitrification of Human blastocysts for ART procedures. This kit is designed for use with Cook Sydney IVF Blastocyst Vitrification Warming Kit

'Cook Sydney IVF Blastocyst Warming Kit' is intended for the recovery of Human blastocysts that have undergone vitrification using Cook Sydney IVF Blastocyst Vitrification Kit for ART procedures.

Blastocyst Warming Kit is intended for the recovery of human blastocysts that have Diastooyst Warming This Internet Sydney IVF Blastocyst Vitrification Kit (K-SIBV-5000) for ART procedures.

Blastocyst Vitrification Kit is intended for the vitrification of human blastocysts for assisted Diastooyot . This sit is designed for use with Blastocyst Warming Kit (K-SIBW-5000)

Cook Sydney IVF Blastocyst Vitrification and Warming Kits are intended for the vitrification, containment and re-warming of human blastocysts as part of human ART procedures. Vitrification involves the rapid freezing of the embryo and is defined as the solidification of a solution at a temperature below its glass transition temperature by extreme elevation in viscosity using high cooling rates (15 000 to 30 000 °C/min) rather than crystallisation. The Cook Sydney IVF Vitrification and Warming Kits are comprised of HEPES buffered solutions containing physiological salts and the cryoprotectants ethylene glycol, DMSO and trehalose.

The provided document describes the Cook Sydney IVF Blastocyst Vitrification Kit and the Cook Sydney IVF Blastocyst Warming Kit. It is a 510(k) summary for these devices, which are reproductive media and supplements. The document focuses on demonstrating substantial equivalence to a predicate device, Vit Kit Freeze/Vit Kit Thaw (K060168) manufactured by Irvine Scientific Sales.

The document does not detail specific acceptance criteria with quantifiable metrics (e.g., minimum percentage of viable blastocysts, maximum contamination levels) that the device must meet, nor does it present a formal study report with detailed device performance statistics against such criteria. Instead, it relies on a comparison to a predicate device and mentions "satisfactory safety" determined through bench testing and "clinical efficacy" supported by clinical practice at Sydney IVF, but without specific data.

Therefore, much of the requested information cannot be extracted from this document as it is not a performance study report in the typical sense for a medical device with measurable outcomes like accuracy or sensitivity.

Here's an attempt to answer the questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for any of the tests mentioned (bench testing or clinical practice).
• Data Provenance:
  • Bench testing (pH, osmolality, MEA, LAL): The location where these were conducted is not specified, but the manufacturer is Cook Australia.
  • Clinical Efficacy: "Clinical practice at Sydney IVF, Sydney, Australia." This indicates retrospective clinical data from Australia.

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

• This information is not provided. The "clinical practice at Sydney IVF" suggests that experts (e.g., embryologists, reproductive specialists) were involved in the ART procedures and assessment of outcomes, but their specific role in establishing a formal "ground truth" for a study is not described.

4. Adjudication method for the test set

• No formal adjudication method is described for either the bench tests or the clinical efficacy claims.

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

• No MRMC comparative effectiveness study was conducted. This device is a medical product (vitrification/warming kits), not an AI-based diagnostic or assistive device that would involve human readers/interpreters. Therefore, this question is not applicable.

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

• This question is related to AI/software performance. This device is not an algorithm or AI-based system. Therefore, this question is not applicable.

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

• For bench testing, the "ground truth" or reference was likely established by standard laboratory methods and specifications for pH, osmolality, MEA, and LAL assays.
• For clinical efficacy, the "ground truth" for "safety and efficacy" and "suitable pregnancy rate" would be based on clinical outcomes data from human ART procedures, as assessed by the clinicians and embryologists at Sydney IVF.

8. The sample size for the training set

• This device does not involve a "training set" in the context of machine learning or AI. The product's formulation and protocols were developed based on scientific understanding of cryopreservation and clinical experience, not through a data-driven training process.

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

• This question is not applicable as there is no "training set" for this type of medical device. The "ground truth" for the development of such media is typically based on fundamental biological and chemical principles, previous research in cryopreservation, and iterative refinement through laboratory and eventually clinical testing.

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