Search Results

Ask a specific question about this device

cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrification procedures to contain and maintain human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The cryo-GO Vitrification Device is a sterile, single-use, closed assisted reproduction storage device for use in vitrification procedures to contain and maintain oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The cryo-GO Vitrification Device is composed of an injection molded body with an extended loading tip (4.45 inches long with a 0.65 inch loading tip), an injection molded cap (1.76 inches), and a total device combined length of 5.05 inches. Visible marks are on the distal loading tip, body, and at the opening of the cap, to indicate the location of the tip, the upright orientation of the device and the opening of the cap, respectively. The body and cap include a taper design that create a seal when assembled prior to plunging the device in liquid nitrogen for vitrification and for subsequent storage. The device is provided in five different colors: red, yellow, green, blue, and purple. The subject devices are radiation sterilized to a sterilization assurance level of 10-6 and have a one-year shelflife.

A detailed response outlining acceptance criteria and device performance based on the provided text for the cryo-GO Vitrification Device (K241341):

Acceptance Criteria and Device Performance for cryo-GO Vitrification Device (K241341)

The provided documentation, a 510(k) Summary, focuses on demonstrating substantial equivalence to a predicate device (VitriGuard, K200815) rather than explicitly stating pre-defined, quantitative acceptance criteria for all aspects of performance with a dedicated clinical study. However, some functional performance criteria are implicitly accepted through comparison with the predicate device or established standards. The non-clinical performance data section presents the studies undertaken to support the device's safety and effectiveness.

Here’s a breakdown based on the categories requested:

1. Table of Acceptance Criteria and Reported Device Performance

Summary of the Study Proving Device Meets Acceptance Criteria:

The "cryo-GO Vitrification Device" underwent non-clinical performance testing to demonstrate its safety and effectiveness, supporting its substantial equivalence to the predicate device. The studies were primarily bench testing and in-vitro biological assays.

2. Sample Size and Data Provenance for Test Set:

The provided document describes non-clinical performance testing rather than a "test set" in the context of AI/machine learning or a clinical trial with patient data. Therefore, the concept of sample size and data provenance as typically applied to such studies does not directly align.

• Sample Size: Not explicitly stated as a single "test set" sample size. The testing involved multiple units of the device for various engineering and biological tests (e.g., numerous devices for sterility validation, package integrity, shelf-life testing, and a sufficient number of mouse embryos for the MEA).
• Data Provenance: The data comes from laboratory testing performed by the manufacturer, FUJIFILM Irvine Scientific, Inc. The nature of the studies implies that they were prospective bench and in-vitro experiments designed to evaluate the device's physical, chemical, and biological performance. There is no indication of country of origin of "data" in the sense of patient data, as this was a non-clinical submission.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This was a submission for a physical medical device (cryopreservation device), not an AI/software device requiring expert human readers to establish ground truth for image interpretation or diagnosis. The "ground truth" for performance was established through standardized laboratory testing methods (e.g., ISO, ASTM, USP, FDA guidance documents).

4. Adjudication Method for Test Set:

Not applicable. As noted above, this was non-clinical bench and in-vitro testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI performance evaluations to reconcile discrepancies among human readers or expert panels.

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

Not applicable. This device is not an AI algorithm or a diagnostic imaging tool that would involve human readers interpreting cases. Therefore, an MRMC study and analysis of AI assistance improving human readers were not performed.

6. Standalone (Algorithm Only) Performance:

Not applicable. The "cryo-GO Vitrification Device" is a physical medical device for cryopreservation, not a software algorithm.

7. Type of Ground Truth Used:

The ground truth for evaluating the device's performance was based on:

• Standardized Laboratory Test Results: Measurements and observations against established industry standards (e.g., ISO 11137 for sterility, ASTM standards for package integrity and accelerated aging, USP for endotoxin).
• Biological Activity/Functionality: The Mouse Embryo Assay (MEA) provides a biological "ground truth" for the device's non-toxicity and suitability for embryo culture, as defined by the "≥ 80% expanded blastocyst within 96 hours" criterion endorsed by the FDA guidance.

8. Sample Size for Training Set:

Not applicable. This is a physical device, not an AI/machine learning model, so there is no concept of a "training set."

9. How Ground Truth for Training Set Was Established:

Not applicable, for the same reason as point 8.

Ask a specific question about this device

SSS-NX is intended for use in assisted reproductive technology (ART) procedures which include gamete and embryo manipulation and culture. These procedures include the use of SSS-NX as a supplement for ART media.

SSS-NX (Serum Substitute Supplement-NX) is an assisted reproduction media supplement consisting of a combination of human serum proteins (approximate protein content 50 mg/mL, 5% w/v) in a saline solution. Of this, ≥83% is albumin and ≤17% is globulins. The product is supplied as a ready to use liquid in 10 mL containers distributed in a twelve (12) x 10 mL kit and a 100 mL liquid packaged in a 125 mL container.

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

Device: SSS-NX (Serum Substitute Supplement-NX)
Device Type: Assisted reproduction media supplement
Predicate Device: Serum Substitute Supplement (SSS)
510(k) Number: K233764

1. Table of Acceptance Criteria and Reported Device Performance

Note: While the "Indications for Use" statement differs between the subject and predicate devices, the "Intended Use" is considered the same: for manipulation of gametes and embryos and for culture use. The differences in device materials do not raise different questions of safety and effectiveness. The subject device has a more stringent endotoxin limit than the predicate, which is considered an improvement and does not raise different safety and effectiveness concerns. The shorter shelf life for the subject device is noted but not presented as a failure of acceptance criteria, as it was supported by testing.

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

The provided document describes testing for a reproductive media supplement, not a diagnostic or AI-powered device. Therefore, the concept of a "test set" in the context of imaging or algorithm performance is not applicable here.

• Sample Size: The document does not specify the exact sample size for each test (e.g., how many batches for sterility, how many embryos for MEA). It implies that testing was performed on sufficient samples to meet the specified criteria.
• Data Provenance: Not applicable in the traditional sense for this type of product. The data is generated through laboratory testing of the manufactured product (SSS-NX). There is no mention of country of origin of data or retrospective/prospective clinical data for human subjects because it is a manufacturing component, not a device directly used in a patient.

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

Not applicable. As this is a reproductive media supplement, the "ground truth" is established through standardized laboratory assays and physical/chemical property measurements, not clinical expert consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable. Ground truth for this product is determined by objective laboratory tests and adherence to specified ranges (e.g., pH, osmolality, sterility) and biological performance (MEA). There would be no expert adjudication in the manner of diagnostic interpretation.

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

Not applicable. This type of study is relevant for AI-assisted diagnostic devices involving human readers interpreting medical images or data. SSS-NX is a laboratory reagent.

6. Standalone Performance Study (Algorithm Only)

Not applicable. SSS-NX is a physical product (a liquid supplement), not an algorithm or software. Its performance is measured directly by laboratory tests.

7. Type of Ground Truth Used

The ground truth for this device is based on:

• Laboratory Assay Results:
  • Sterility (absence of microbial growth per USP )
  • Endotoxin levels (per USP )
  • pH (per USP )
  • Osmolality (per USP )
  • Mouse Embryo Assay (MEA) performance (percentage of 1-cell embryos developing to expanded blastocyst at 96 hours). This is a biological performance test to ensure the media supports embryo development.
• Physical/Chemical Properties: Clarity and Color.
• Standards Adherence: ISO 13408-1:2008, ISO 13408-2:2018, ASTM F1980-21, ASTM D4169-22.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of algorithm development.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this product.

Ask a specific question about this device

PRIME-XV FreezIS DMSO-Free MD is for use in human ex vivo tissue and cell culture processing applications.

PRIME-XV Freez/S DMSO-Free MD is a liquid medium intended for use in human ex vivo tissue and cell culture processing applications.

It is a chemically defined cryogenic preservation solution for human cells for use in a professional Healthcare Facility that performs cell culture and cell handling. It has comparable post-thaw cell viability as solutions containing dimethyl sulfoxide (DMSO), maintains potency of stem cells throughout cryopreservation, eliminates the risk of DMSO in stem cell therapy applications, is animal componentfree, enables cell preservation at -80°C to -196°C environments and is manufactured under cGMP conditions.

The provided text describes a medical device, PRIME-XV FreezIS DMSO-Free MD, which is a tissue culture medium. It presents the device's indications for use, technological characteristics, and a comparison to predicate devices, but it does not contain information about an AI-powered device or a study involving human readers or a test set to establish ground truth for performance metrics like sensitivity or specificity.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance data for an AI device. The document is a 510(k) summary for a biological/chemical product, not a software device or an AI diagnostic tool.

The acceptance criteria provided in the document relate to the quality and performance of the tissue culture medium itself, such as:

• High cell viability, robust cell expansion post-cryopreservation, maintenance of cell function, phenotype and differentiation potential: To demonstrate lack of potential toxicity and support of tissue/cell growth.
• **Endotoxin testing per USP , mycoplasma testing per USP **: To demonstrate lack of endotoxin or pyrogen contamination.
• Compliance with GMP requirements regarding aseptic processing: For validation of Aseptic Processing and Sterility Assurance Level (SAL).
• Incoming raw materials are of high quality and are lot-tested for identity and purity: To demonstrate chemical purity.
• 24-month shelf life when stored at 2 – 8 °C: Based on stability testing confirming pH, osmolality, non-cytotoxicity, and protection against microbial contamination.

These are established through laboratory testing directly on the medium and its interaction with cells, not through studies involving expert readers or ground truth adjudication as would be relevant for an AI diagnostic device.

Ask a specific question about this device

Vit Kit - Freeze NX (Vitrification Freeze Kit) is intended for use in the vitrification of oocytes (MI) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Vit Kit - Warm NX (Vitrification Warm Kit) is intended for use in the thawing of vitrified occytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The five media products that comprise the two kits, Vit Kit - Freeze NX and Vit Kit -Warm NX, consist of a basal media of Continuous Single Culture Medium (CSCM) which utilizes MOPS, HEPES and sodium bicarbonate buffers, 20% (v/v) DSS, 10μg/mL gentamicin and varying levels of cryoprotectants, including dimethyl sulfoxide (DMSO), trehalose, and ethylene glycol (EG).

The two freeze media in the Vit Kit – Freeze NX are intended to be used sequentially for the preparation and cryopreservation of oocytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The three media in the Vit Kit - Warm NX are intended for sequential use in the thawing and recovery of cryopreserved oocytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

This document describes a 510(k) premarket notification for Vit Kit - Freeze NX and Vit Kit - Warm NX, which are reproductive media for vitrification (freezing) and thawing of oocytes and embryos.

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 acceptance criteria are implicitly defined by the non-clinical performance data and the comparison to the predicate device. The document states that "The subject device passed the predefined acceptance criteria for these tests," confirming that the reported device performance met these criteria.

Note: The document only states "The subject device passed the predefined acceptance criteria for these tests" without providing specific numerical results for each test for the subject device. The table above uses the predicate's specifications or general qualitative criteria as a proxy for the acceptance criteria, which the subject device is stated to have met.

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

• Sample Size: The document does not specify the exact sample sizes used for each non-clinical test (e.g., number of vials tested for pH, number of embryos for MEA).
• Data Provenance: The document does not explicitly state the country of origin. The study appears to be a lab-based non-clinical performance evaluation, not involving human subjects or patient data. It is a non-clinical performance data study, retrospectively conducted for the 510(k) submission.

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

This information is not applicable to this type of device and study. This 510(k) pertains to reproductive media, not an AI or imaging device requiring expert interpretation of results to establish ground truth. The "ground truth" for media performance is established through standardized laboratory assays (pH, osmolality, endotoxin, sterility, mouse embryo assay).

4. Adjudication Method for the Test Set

This information is not applicable as the tests are objective, laboratory-based measurements, not subjective human interpretations requiring adjudication.

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

No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, often with and without AI assistance. This 510(k) is for IVF media, which does not involve human reader interpretation in its intended use or performance evaluation.

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

No, a standalone algorithm performance study was not done. This concept is specific to AI/machine learning devices where the algorithm's performance is evaluated independently. This product is a biological medium, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance evaluations was established through objective laboratory measurements and standardized biological assays:

• Chemical assays (pH, Osmolality)
• Microbiological assays (Endotoxin, Sterility)
• Biological assays (Mouse Embryo Assay - MEA)

These are empirical measurements against predefined quality control specifications, rather than expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/machine learning device that requires a "training set." The device is a manufactured chemical product.

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

This information is not applicable given that the device is not an AI/machine learning product and does not have a "training set."

Ask a specific question about this device

Arctic™ Sperm Cryopreservation Medium is intended for use in assisted reproductive procedures involving the cryopreservation and storage of human sperm.

The Arctic™ Sperm Cryopreservation Medium is a modified version of the predicate device (K991337). It is a defined medium consisting of salts, buffering materials, cryoprotectants, vitamins, amino acids, minerals, carbohydrates, surfactant, energy source, and human serum albumin. The Arctic™ Sperm Cryopreservation Medium is a single-use device that is aseptically filled into sterilized vials and has a sterility assurance level (SAL) of 10-3. This medium is supplied in a fill volume of 5 mL. and twelve (12) 5mL vials are included in a package, The product is tested for pH, osmolality, sperm cyrosurvival, endotoxin and sterility before lot release, and has a shelf-life of 18 months.

This document describes the Arctic™ Sperm Cryopreservation Medium, a device intended for use in assisted reproductive procedures involving the cryopreservation and storage of human sperm. The regulatory submission (K171224) demonstrates its substantial equivalence to a predicate device (Sperm Maintenance Medium with Glycerol, K991337).

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific number of samples for each test (e.g., pH, osmolality, endotoxin, sterility). For the Sperm Cryosurvival Assay, it states "Donor semen was mixed with the test medium and control (predicate device)". This suggests a comparative test using an unspecified number of donor semen samples. The data provenance is not specified regarding country of origin or whether it's retrospective or prospective; however, it is part of a regulatory submission for a medical device, implying prospective testing for the purpose of demonstrating substantial equivalence.

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

Not applicable. This device is a cryopreservation medium, and its performance is assessed through laboratory tests (e.g., pH, osmolality, microbiological growth, sperm motility), not through expert interpretation of images or clinical outcomes that require human ground-truthing in the typical sense of diagnostic AI.

4. Adjudication method for the test set

Not applicable. The tests are laboratory-based and yield objective measurements (e.g., pH values, osmolality values, presence/absence of growth, percentage motility) which do not require an adjudication method.

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-assisted diagnostic device for human readers.

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

The device itself is a standalone medical product (a cryopreservation medium). The performance tests described (e.g., pH, osmolality, sperm cryosurvival) are standalone evaluations of the product's physical, chemical, and biological properties, not an algorithm's performance.

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

The 'ground truth' for this device's performance is established by objective, quantitative laboratory measurements and established scientific standards/methods (e.g., USP for sterility, USP for endotoxin, specified pH and osmolality ranges, and a minimum percentage of control motility for cryosurvival).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that involves a "training set." The product is a chemical formulation.

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

Not applicable. As noted above, this device does not involve a training set.

Ask a specific question about this device

The Continuous Single Culture®-NX (CSCM-NX) is intended for use as a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro.

The Continuous Single Culture®-NX (CSCM-NX) is a culture medium using a formulation modified from the predicate device. It is intended for culture of embryos from fertilization to blastulation. This medium consists of salts, energy substrates, amino acids, buffering agents, nutrients supplements, and antibiotics. This product is a single-use device supplied in a fill volume of 20 mL and 60 mL. It is aseptically filled into sterilized bottles and has a sterility assurance level (SAL) of 10⁻⁶. The product is tested for pH, osmolality, embryotoxicity, spermtoxicity, endotoxin, and sterility before lot release. The product has a four-month shelf-life and remains stable for four weeks after opening/closing of the bottle when it is stored at 2-8°C.

This document describes the Continuous Single Culture®-NX (CSCM-NX), a culture medium for human gametes and embryos. The information provided is from a 510(k) premarket notification.

Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are primarily focused on ensuring the new device (CSCM-NX) performs comparably to its predicate device (Continuous Single Culture Complete) and meets safety and quality standards for reproductive media.

Table of Acceptance Criteria and Reported Device Performance:

The study supporting these claims are a series of non-clinical performance tests designed to demonstrate the substantial equivalence of the CSCM-NX to its predicate device.

Additional Information on the Study:

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

• Test Set Sample Size: The document does not specify exact sample sizes for the individual tests (MEA, HSSA, endotoxin, sterility, pH, osmolality). For the Mouse Embryo Assay, it mentions "One-cell mouse embryos were exposed to subject devices," indicating a biological sample rather than a human data set. For other tests, specific batch or replicate numbers are not provided.
• Data Provenance: The studies were internal non-clinical performance tests conducted by Irvine Scientific. The data is prospective as it was generated specifically for the 510(k) submission. No country of origin for external data is mentioned, as the studies appear to be proprietary.

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

• This is a product performance study for a culture medium, not a diagnostic device relying on expert interpretation of results. Therefore, no experts were used to establish ground truth in the sense of clinical decision-making. The "ground truth" for these tests are objective, measurable laboratory parameters (e.g., pH, osmolality, blastocyst development rates, sperm motility percentages, endotoxin levels, sterility absence).

4. Adjudication method for the test set:

• Not applicable. As described above, there is no expert interpretation or adjudication involved in determining the outcome of these objective laboratory tests. The results are quantitative measurements or observation of biological phenomena against predefined criteria.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The CSCM-NX is a culture medium, and its effectiveness is determined by objective laboratory assays, not by human interpretation of its "output" in a clinical setting. Therefore, there is no effect size presented for human readers improving with or without AI assistance.

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 an AI system. It is a biological culture medium. Performance is assessed through specific biological and chemical assays.

7. The type of ground truth used:

• The ground truth for this device's performance relies on objective, verifiable laboratory measurements and biological outcomes established through standardized assays. This includes:
  • Chemical properties (pH, osmolality).
  • Biological response (mouse embryo development to blastocyst, human sperm motility).
  • Contaminant levels (endotoxin).
  • Absence of microbial growth (sterility).
  • These measurements are compared against pre-established acceptance criteria, which were likely derived from industry standards, historical performance of the predicate device, or biological necessity for successful embryo culture.

8. The sample size for the training set:

• Not applicable. This device is a culture medium, not a machine learning model. Therefore, there is no "training set" in the context of algorithm development.

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

• Not applicable. As there is no training set for an algorithm, there is no ground truth established for such a set.

Ask a specific question about this device

The Continuous Single Culture®-NX Complete (CSCM-NXC) is intended for use as a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro. This device can be used for transfer of embryos to the uterus.

The Continuous Single Culture®-NX Complete (CSCM-NXC) is a culture medium using a formulation modified from the predicate device. It is intended for culture of embryos from fertilization to balstulation and transfer of embryos to the uterus. This medium consists of salts, energy substrates, amino acids, buffering agents, nutrients supplements, antibiotics, and human serum albumin.

This product is a single-use device supplied in a fill volume of 20 mL. It is aseptically filled into the sterilized bottle and has a sterility assurance level (SAL) of 10-3. The product is tested for pH, osmolality, embryotoxicity, spermtoxicity, endotoxin, and sterility before lot release. The product has a four-month shelf-life and remains stable for four weeks after open/close of bottle, when it is stored at 2-8°C.

This document describes the Continuous Single Culture®-NX Complete (CSCM-NXC), a culture medium for human gametes and embryos, and outlines the non-clinical performance testing conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the provided text to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists acceptance criteria for various tests but does not explicitly provide the reported device performance values for each test. It states that the "performance data also demonstrate that the subject device is substantially equivalent to the predicate device," implying the criteria were met. For some tests (pH, Osmolality, Endotoxin, Sterility), it states "Same as predicate" or provides a pass/fail criterion without a specific measured value from the study.

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

• Sample Size for Test Set: The document does not specify the sample size for the biological assays (MEA, HSSA) or the chemical/physical tests. It mentions "One-cell mouse embryos" were exposed for MEA, but not the number of embryos or replicates.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that it's a premarket notification for a medical device in the US, it's highly likely the studies were conducted to US regulatory standards, but the geographical origin of the samples (e.g., human gametes for HSSA) is not detailed.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable or not provided in the context of this device. The tests described are laboratory-based, quantitative assays (e.g., pH, osmolality, embryo development percentages, bacterial growth, endotoxin levels). These are typically assessed by trained laboratory technicians against defined quantitative acceptance criteria, rather than by human experts establishing a "ground truth" through interpretation (as would be the case for an imaging AI device).

4. Adjudication Method for the Test Set:

Not applicable. The tests are objective, quantitative measurements or established pass/fail biological assays, not subjective assessments requiring adjudication.

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

No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance to assess diagnostic performance. This document concerns an in vitro culture medium, and such a study design is not relevant here.

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

Not applicable. This is a medical device (culture medium), not an AI algorithm. Its performance is evaluated through direct laboratory testing of its effect on biological samples (mouse embryos, human sperm) and its physical/chemical properties.

7. Type of Ground Truth Used:

The ground truth used for performance evaluation is objective laboratory measurements and established biological outcomes.

• For MEA: Percent development to expanded blastocyst stage.
• For HSSA: Percent of original motility at 24 hours.
• For chemical/physical tests: Measured values (pH, osmolality) compared to specified ranges.
• For sterility/endotoxin: Absence of growth/LAL assay results compared to limits.

These are not "expert consensus," "pathology," or "outcomes data" in the clinical sense, but rather quantifiable and verifiable laboratory results.

8. Sample Size for the Training Set:

Not applicable. This is a manufactured product (culture medium), not an AI/machine learning model that requires a training set. The "formulation modified from the predicate device" implies chemical engineering and biological optimization, not algorithm training.

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

Not applicable, as there is no training set for this type of device. The formulation would have been developed and optimized through R&D experiments guided by scientific principles and previous experience with culture media, evaluated against biological performance targets.

Ask a specific question about this device

Vit Kit® - Freeze (Vitrification Freeze Kit) is intended for use in the vitrification of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Vit Kit® - Thaw (Vitrification Thaw Kit) is intended for use in the thawing of vitrified oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The five media that comprise the two kits, Vit Kit® - Freeze and the Vit Kit® - Thaw are all based upon a modified formulation of Medium 199 is HEPES buffered and contains 20% (v/v) dextran substitute supplement (DSS), 35μ.g/mL gentamicin and varying concentrations of dimethyl sulfoxide (DMSO), ethylene glycol (EG), and sucrose. The two freeze media in the Vit Kit® - Freeze are intended to be used sequentially, for the preparation and cryopreservation of PN, day 3 cleavage stage, and blastocyst stage embryos and oocytes.

The three thaw media in the Vit Kit®- Thaw are intended for sequential use in the thawing and recovery of cryopreserved human PN, cleavage stage, and blastocyst embryos and oocytes.

The provided text describes the acceptance criteria and a clinical study conducted for the Vit Kit® - Freeze and Vit Kit® - Thaw products, specifically to support the expanded indication for use to include oocytes (MII).

Here's an analysis of the provided information to address your request:

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

The document presents product specifications that act as acceptance criteria for the manufacturing release of the media, and then discusses clinical performance.

Product Specifications (Acceptance Criteria & Reported Performance):

Note: The table above reflects the identical specifications for both the predicate and proposed device, implying these are the acceptance criteria that the device meets "prior to their release for sale." The document states "Results of all release assays performed are reported on a lot-specific certificate of analysis, and are indicated on the labeling," confirming they meet these criteria.

Clinical Performance (Acceptance Criteria & Reported Performance for Oocyte Vitrification):

The clinical study aimed to demonstrate comparability between frozen oocyte transfers (using the Vit Kit) and fresh oocyte transfers. The implicit acceptance criteria are that the performance metrics for frozen oocytes are acceptable and comparable to fresh oocytes, and generally align with established ART success rates.

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

• Test Set Sample Size: "up to 400 patients" volunteered.
• Data Provenance:
  • Type: Prospective, multicenter clinical study.
  • Country of Origin: Not explicitly stated, but given FDA submission, it's highly likely to be primarily US-based, potentially with international centers typical for multicenter studies. However, this is an inference, not directly stated.

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 study is a clinical trial involving patients and the outcomes of IVF procedures (fertilization, implantation, pregnancy, live birth). The "ground truth" for these metrics (e.g., successful fertilization, confirmed pregnancy, live birth) is established through standard medical procedures and clinical observation, not through expert consensus on image review or similar subjective assessments. Therefore, the concept of "experts establishing ground truth for the test set" in the context of radiologists or similar is not directly applicable here. The outcomes are objective clinical endpoints.

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

Not applicable. This is a clinical trial assessing device performance on biological samples and patient outcomes, not an imaging study requiring expert adjudication of interpretations. The clinical outcomes are observed and recorded.

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/imaging study, but rather a study of a medical device (vitrification media) and its clinical effectiveness. No human "readers" or AI assistance are involved in the assessment of the outcomes.

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

Not applicable. This is not an algorithm-based device. The "performance" is the efficacy of the media in cryopreservation and its impact on subsequent clinical outcomes.

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

The ground truth is outcomes data directly observed in human patients undergoing IVF:

• Fertilization rates
• Implantation rates
• Pregnancy rates
• Live birth rates

8. The sample size for the training set

Not applicable. This is a medical device (chemical media), not an algorithmic or AI model. Therefore, there is no "training set."

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

Not applicable, as there is no training set for this type of device. The product formulation is based on scientific principles of cryopreservation. The product's consistent performance is validated through non-clinical assays (Part 1, Table 1) and clinical performance (Part 1, Table 2).

Ask a specific question about this device

Continuous Single Culture™ Complete is intended for use as a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro.

The Continuous Single Culture™ Complete is based upon the Single Step Medium™ (K072609) formulation that is supplemented with Human Serum Albumin, H.S.A. The Continuous Single Culture™ Complete is composed of a balanced mixture of salts, amino acids and other nutrients that have been shown to support embryo development. The Continuous Single Culture™ Complete is designed to be used as a culture media for fertilization and for development of embryos until the desired developmental stage (up to 5/6 days). Selected embryos are then moved to an embryo transfer media prior to transfer to the uterus.

The Continuous Single Culture™ Complete is supplied in liquid form, and contains gentamicin sulfate as a preservative and a therapeutic grade of Human Serum Albumin (K983584). Liquid Continuous Single Culture™ Complete is supplied in a fill volume of 20 mL.

Continuous Single Culture™ Complete has utility as a culture medium from fertilization through day 5/6 of development. The fertilized oocyte (zygote) is allowed to grow in the culture dish, supported by a culture medium and an appropriate protein supplement, in a carbon dioxide incubator at 37°C until the desired stage of development is achieved. Selected embryos are then moved to an embryo transfer media prior to transfer to the uterus.

Continuous Single Culture™ Complete is supplied as a ready to use liquid in 20 mL bottles.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the product specifications comparison between the proposed device (Continuous Single Culture™ Complete) and the predicate device (Single Step Medium™ K072609). The performance for the proposed device is the criteria it must meet.

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

• MEA (Mouse Embryo Assay): The study states that one (1)-cell MEA was performed as part of design validation. It was conducted at three (3) different test facilities. The sample size for embryos or individual tests is not specified beyond "one (1)-cell MEA." The data provenance is not explicitly stated (e.g., country of origin), but it is implied to be non-clinical laboratory testing. The study is prospective in nature, as it is part of design validation and pre-market release testing.
• HSSA (Human Sperm Survival Assay): Performed on donor specimens at three (3) different test facilities. The number of donor specimens is not specified. The donor specimens were "initially processed by gradient separation and resulting motile specimens were equally divided." Data provenance is not explicitly stated, but it is implied to be non-clinical laboratory testing using human donor samples. The study is prospective, as it is part of design validation and pre-market release testing.
• Other tests (pH, osmolality, sterility, endotoxin, albumin recovery, appearance): These are described as routine quality control tests performed "prior to release to the market" and "as a condition of release." The sample sizes for these tests (e.g., how many batches, how many units per batch) are not specified. The data provenance is internal laboratory testing.

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

• This document describes non-clinical performance testing for a cell culture medium. It does not involve human interpretation of medical images or patient diagnoses that typically require expert adjudication for ground truth.
• The "ground truth" for the MEA and HSSA is an objective biological outcome (embryo development to blastocyst, sperm motility) measured by laboratory assays. The document doesn't mention expert review for establishing ground truth as it would for, say, a diagnostic imaging device. The "field evaluations" where the product was found "equal" to the control medium imply expert handling and perhaps informal assessment, but not formal "ground truth" adjudication.

4. Adjudication Method for the Test Set

• Not applicable. As noted above, this study evaluates a cell culture medium through objective laboratory assays, not a diagnostic device requiring expert adjudication of results.

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 a 510(k) summary for a cell culture medium, not an AI-assisted diagnostic device. There are no "human readers," "AI assistance," or "cases" in the context of an MRMC study.

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

• Not applicable. This is a cell culture medium, not an algorithm or AI system.

7. The Type of Ground Truth Used

• For the MEA, the ground truth is biological outcome data: achievement of ≥ 80% expanded blastocyst development at 96 hours.
• For the HSSA, the ground truth is biological outcome data: ≥ 70% of original sperm motility at 24 hours.
• For pH, osmolality, sterility, and endotoxin, the ground truth is instrumental measurement data compared against defined numerical ranges or a "Pass" criterion.

8. The Sample Size for the Training Set

• Not applicable. As a non-AI/ML device, there is no "training set." The product's formulation was developed and validated, but not "trained" in the machine learning sense. The development likely involved iterative testing and refinement, but this is distinct from an AI training set.

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

• Not applicable, as there is no training set for this type of device.

Ask a specific question about this device