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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.

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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.

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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.

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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.

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Multipurpose Handling Medium™ (MHM™) is intended for use in assisted reproductive procedures which involve the manipulation of gametes or embryos. Specifically, Multipurpose Handling Medium™) is indicated for use as an oocyte retrieval medium during ovarian follicle aspiration procedures (not for flushing ovarian follicles), washing sperm prior to IVF and ICSI fertilization procedures, and for transport of the embryo to the uterus during embryo transfer procedures.

The Multipurpose Handling Medium™ (MHM™) is based upon the mHTF (K983586) formulation. The formula for the Multipurpose Handling Medium™ (MHM™) is based upon the composition of modified HTF, K983586. The medium uses a buffering system composed of HEPES (N-2-Hydroxyethylpiperazine-N1 - - 2 - - ethanesulfonic acid). MOPS . (3 Morpholinopropane - 1- sulfonic acid) and Sodium Bicarbonate. This buffering system provides pH maintenance over the physiologic range and does not require the use of a CO2 Incubator. - The product also contains 10 ug/mL gentamicin.

Multipurpose Handling Medium™ (MHM™) has utility as an oocyte retrieval medium, in procedures that aspirate oocytes from the patient's ovarian follicles. Multipurpose Handling Medium™ (MHM™) is used only in the oocyte collection vessel and is not for use in flushing oocytes from ovarian follicles. Once the oocyte has been retrieved, it is placed into a culture dish with an appropriate amount of a culture medium (does not include MHM™), as specified by the user's internal procedures, and fertilization is allowed to occur. Multipurpose Handling Medium™ (MHM™) can also be used to wash sperm in preparation for fertilization by conventional IVF or ICSI procedures. The fertilized oocyte (zygote) is allowed to grow in the culture dish, supported by a culture medium (does not include MHM™), as specified by the user's internal procedures, and an appropriate protein supplement, in a carbon dioxide incubator at 37°C until the desired stage of development is achieved. The embryo is removed from the culture dish, placed into an appropriate amount of Multipurpose Handling Medium™ (MHM™) for transfer into the uterus.

Multipurpose Handling Medium™ (MHM™) is supplied as a ready to use liquid, in 100 and 500 mL bottles.

Here's a breakdown of the acceptance criteria and the study details for the Multipurpose Handling Medium™ (MHM™) device, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample Sizes and Data Provenance

• Test Set (MEAs): The MEA testing was performed at three (3) different test facilities. The document does not specify the number of individual embryos or mouse embryos used per test, nor the country of origin of the data. The data is retrospective as it was performed as part of design validation prior to release.
• Test Set (HSSA): The HSSA was performed on donor specimens. The number of donor specimens is not specified. The data is retrospective as it was performed prior to release. The document does not specify the country of origin.
• Training Set: The sample size for the training set is not explicitly stated. This is likely because the MHM™ is a medium and its "training" or formulation development would involve biochemical and cell culture experiments rather than machine learning on a dataset in the traditional sense. The formulation is based on existing, predicate devices (mHTF and G-MOPS™/G-MOPS™ PLUS).

2. Number of Experts and Qualifications for Ground Truth (Test Set)

• The document does not explicitly state the number of experts used to establish the ground truth for the test set or their qualifications. For MEAs and HSSAs, the "ground truth" is typically the quantitative results of the assay (e.g., percentage of embryos reaching a certain stage, percentage of motile sperm), which are objectively measured by laboratory personnel, rather than through expert consensus on qualitative observations.

3. Adjudication Method for the Test Set

• The document does not mention an adjudication method. For quantitative assays like MEAs and HSSAs, adjudication is generally not applicable in the same way it would be for qualitative assessments (e.g., image interpretation). The results are based on objective measurement.

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

• No, an MRMC comparative effectiveness study was not conducted. This type of study is typically relevant for medical devices that involve human interpretation (e.g., diagnostic imaging AI). The MHM™ is a cell culture medium, and its performance is evaluated through biological assays.

5. Standalone Performance (Algorithm Only)

• Yes, standalone performance was done in the sense that the medium itself (the "device") was tested directly in the described assays (MEA, HSSA) without human intervention in the assay's outcome interpretation beyond standard laboratory procedures. There is no "algorithm" in the traditional sense for this device; its performance is intrinsic to its chemical composition and how it supports biological processes.

6. Type of Ground Truth Used

• Mouse Embryo Assay (MEA): The ground truth is established by the biological outcome of the assay, specifically the percentage of one-cell mouse embryos that develop to a specific stage (not explicitly stated, but typically blastocyst stage, or viability at 24/48/72 hours) after exposure to the medium. This is a direct measure of embryo toxicity/support.
• Human Sperm Survival Assay (HSSA): The ground truth is the percentage of motile human sperm after 24 hours at 37°C in ambient air, following exposure to the medium. This directly assesses sperm viability and function.

7. Sample Size for the Training Set

• As noted above, the sample size for a "training set" in the context of this biological medium is not applicable or explicitly stated in the document. The formulation was based upon existing predicate devices (mHTF and G-MOPS™/G-MOPS™ PLUS), implying an iterative development process informed by previous research and established formulations.

8. How Ground Truth for the Training Set Was Established

• The ground truth for the development of the MHM™ (the "training" equivalent) would have been established through pre-clinical research and development experiments focused on optimizing the medium's composition to support gamete and embryo viability and function. This includes:
  • Literature review and knowledge of existing formulations: The MHM™ is "based upon" the mHTF formulation, which itself has established efficacy.
  • Benchtop biochemical analysis: Measuring pH, osmolality, and sterility, and ensuring non-toxic component levels.
  • Pilot biological assays: Performing MEAs, HSSAs, and potentially other cell culture tests on various prototype formulations to identify those that yield optimal biological outcomes.
  • The document specifically mentions that MHM™ is assayed by MEA and HSSA prior to release, which serves as a final validation step to ensure consistency, not necessarily the ground truth establishment for training the initial formulation.

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Vit Kit® - Freeze, Vitrification Freeze Kit for Embryos (PN through Blastocyst Stage) is intended for use in the vitrification of pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Vit Kit® - Thaw, Vitrification Thaw Kit for Embryos (PN through Blastocyst Stage) is intended for use in the thawing and recovery of vitrified pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The five (5) media that comprise the two (2) kits, Vit Kit® - Freeze, Vitrification Freeze Kit for Embryos (PN through Blastocyst Stage) and the Vit Kit® - Thaw, Vitrification Thaw Kit for Embryos (PN through Blastocyst Stage) are all based upon the modified formulation of Medium 199. The Medium 199 is HEPES buffered and contains 20% (v/v) DSS, 35ug/mL gentamicin and varying concentrations of DMSO, EG and sucrose. The two (2) freeze, ES and VS, media in the Vit Kit® - Freeze, Vitrification Freeze Kit for Embryos (PN through Blastocyst Stage) are intended to be used sequentially, for the preparation for, and cryopreservation of, PN, day 3 cleavage stage embryos and blastocyst stage embryos. ES is used in preparation for freezing and contains 7.5 % (v/v) DMSO and EG. VS is to be used during cryostorage and contains 15% (v/v) DMSO and EG and 0.5M sucrose.

The three (3) thaw, TS, DS and WS, media in the Vit Kit®- Thaw, Vitrification Thaw Kit for Embryos (PN through Blastocyst Stage) are also intended for sequential use in the thawing and recovery of cryopreserved human embryo. The first medium used in the thawing process, TS, contains 1.0M sucrose. The second medium, DS, contains 0.5M sucrose. The third medium, WS, contains no sucrose.

The provided document is a 510(k) summary for the Vit Kit® - Freeze and Vit Kit® - Thaw products, which are media used for the vitrification and thawing of human embryos. The document focuses on demonstrating substantial equivalence to predicate devices rather than directly providing acceptance criteria and a rigorous study proving the device meets those specific acceptance criteria in the manner of a clinical trial for a diagnostic device.

However, based on the information provided, we can infer the acceptance criteria and the study design used to support the substantial equivalence claim. The primary acceptance criteria appear to be the successful outcome of assisted reproductive procedures (ARP) after using the vitrification and thawing kits, specifically focusing on births and ongoing pregnancies.

Here's an analysis based on the available text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the clinical outcomes presented to demonstrate substantial equivalence to predicate devices. The study results focus on successful pregnancies and live births following the use of vitrified/thawed embryos.

Note: The document presents clinical data in an aggregate form, citing various publications. It asserts that the proposed device is "substantially equivalent" to predicate devices based on this summarized clinical data, rather than presenting a direct comparative study of the new device against a predefined set of acceptance criteria. The underlying assumption is that if the predicate devices demonstrate these outcomes, and the new device is functionally and compositionally similar, it will achieve similar outcomes.

Study Information

The document describes clinical data that was "presented in the Comparison to Predicate Device summary presented on page 68" (which is not included in the provided text). This indicates a review of existing literature and clinical outcomes associated with the predicate devices and potentially similar vitrification technologies. It is not a prospective clinical trial specifically designed to test the new device against stringent acceptance criteria.

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

   • Test Set Sample Size: Not a single "test set" in the traditional sense. The data points mentioned are aggregated from various published clinical studies regarding vitrification techniques and predicate devices.
     • "thirty (30) births" from vitrified pronuclear stage zygotes and day 3 embryos.
     • "fifty-two (52) ongoing pregnancies" from 2PN embryos (37 from one study, 15 from another).
     • "one hundred-thirty seven (137) ongoing pregnancies" from blastocysts (136 from one study, 1 from another).
     • Specifically for the new device's intended use for pronuclear zygotes: "ten (10) healthy births (19 babies = 1 singleton and 9 deliveries = 18 babies)" and "fifty-two (52) ongoing pregnancies."
     • For the predicate device (RapidVit™ Cleave and RapidWarm™ Cleave K080446): "resulted in the births of two (2) sets of twins and six (6) singletons, a total of eight (8) births."
   • Data Provenance: Retrospective, as the data is summarized from existing published articles (e.g., Al-Hasani, Kumasako, Kuwayama, Oakes). The countries of origin are not specified for each study but are implied to be international given the nature of scientific publications in this field.

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

   • The document does not specify a number of experts or their qualifications for establishing ground truth for the summarized clinical data. The data is drawn from published scientific literature, where the ground truth (e.g., live birth, ongoing pregnancy) would have been established by the clinical teams conducting those studies (e.g., reproductive endocrinologists, embryologists).

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

   • No adjudication method is mentioned as this is a summary of existing clinical outcome data, not a prospective study where independent review of specific cases would be performed for the purpose of the 510(k). The "adjudication" would have occurred as part of the internal processes of the original studies cited.

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, an MRMC study was not done. This device is a medical media kit for embryo vitrification, not an imaging diagnostic device assisted by AI.

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

   • Not applicable. This device is a chemical media kit, not an algorithm.

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

   • The ground truth used is primarily outcomes data, specifically clinical outcomes such as live births and ongoing pregnancies, which are definitive endpoints in fertility treatments.

7. The sample size for the training set:

   • Not applicable in the context of device approval for a chemical media kit. There isn't a "training set" for an algorithm. The development of the media formulation would have involved internal R&D experiments and optimization, but not in the sense of a machine learning "training set".

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

   • Not applicable, as there is no "training set" in the context of an algorithmic device. The formulation of the media would have been based on scientific principles, prior research, and experimental validation in vitro to optimize cryoprotective properties, which are then ultimately validated by clinical outcomes data as presented.

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Single Step Medium is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. These procedures include the use of Single Step Medium as a culture medium from fertilization through day 5/6 of embryo development in vitro.

Single Step Medium is a synthetic, defined medium, composed of a balance mixture of salts, amino acids, minerals and other nutrient substances designed to be used during fertilization and culture of zygote/embryo through the desired development stage (up to 5/6 days) in vitro.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Irvine Scientific Single Step Medium (K072609):

Overall Assessment:

The provided document is a 510(k) summary for a reproductive media device. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a comprehensive clinical study with detailed acceptance criteria and performance metrics typically seen for high-risk devices or AI/software. The "performance data" section primarily describes a quality control assay and makes a general statement about the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For this type of device (in vitro embryo culture medium), the "acceptance criteria" are predominantly related to manufacturing quality control (sterility, endotoxin), general functionality as demonstrated by a biological assay (mouse embryo assay), and comparison to legally marketed predicate devices for substantial equivalence. The document does not provide specific numerical performance targets (e.g., embryo blastocyst rates, live birth rates) from a clinical study for K072609, but rather references a quality control test and general concordance with regulatory requirements.

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

• Sample Size for Test Set: Not specified for a discrete "test set" in the context of a clinical study. The performance data section refers to a "mouse embryo assay," which is a quality control test. The number of mouse embryos used in this assay is not provided.
• Data Provenance: The mouse embryo assay is an internal quality control measure. No information is given about the country of origin for any human clinical data because clinical studies, in the typical sense for a new device's primary efficacy, are not presented for K072609. The document mentions that the predicate device (MultiBlast Medium) "has been used in a variety of clinical settings." This implies real-world usage, but no specific study details are provided for K072609 itself.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. The document does not describe a study involving expert review for establishing ground truth, as it is not a diagnostic device or an AI/software product requiring human interpretation. The "ground truth" for this product is its biological efficacy in supporting embryo development, which is assessed via an in vitro mouse embryo assay, not expert consensus.

4. Adjudication Method

• Not Applicable. As no expert review or human interpretation study is described, there is no need for an adjudication method like 2+1 or 3+1.

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

• No. An MRMC study is not mentioned. This type of study is typically relevant for diagnostic imaging devices or AI systems that assist human readers in making diagnoses. This device is a culture medium.

6. Standalone Performance Study (Algorithm Only)

• Not Applicable. This is a physical biological medium, not an algorithm or AI product.

7. Type of Ground Truth Used

• The primary "ground truth" or performance assessment method described is the mouse embryo assay. This is an in vitro biological assay designed to assess the product's ability to support embryonic growth and its lack of toxicity. It's a form of biological assay outcome data.
• The overall "ground truth" for K072609's market clearance is substantial equivalence to legally marketed predicate devices, meaning it performs as expected for its intended use based on comparison rather than entirely novel clinical trial data.

8. Sample Size for the Training Set

• Not Applicable. This is not an AI/ML product, so there is no concept of a "training set" in the conventional sense for algorithm development.

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

• Not Applicable. (See point 8).

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Lyophilized MultiBlast Medium Kit is intended for use in the culture of human embryos from day three (3) to the blastocyst stage of development.

Lyophilized MultiBlast Medium Kit is a synthetic, defined medium, composed of a balance mixture of salts, amino acids, minerals and other nutrient substances designed to support embryonic growth and blastocyst development in vitro.

The provided document is a 510(k) summary for a medical device called the "Lyophilized MultiBlast Medium Kit," which is an in vitro embryo culture medium. This type of device is a consumable product used in assisted reproductive technology and not an AI/ML powered diagnostic device. Therefore, many of the requested fields regarding acceptance criteria and study parameters for AI/ML devices are not applicable.

Here's an analysis based on the information provided, specifically addressing the aspects that are relevant to this type of device:

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

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

The primary "testing" for this biological medium is through mouse embryo assay. The document doesn't specify a sample size for these assays, but states they are performed "prior to release to market" and "as a condition of release for this product." The data provenance is internal to Irvine Scientific (manufacturer). The nature of this testing is prospective, as it occurs for each lot of product before it is released.

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. The ground truth for a cell culture medium is its functional performance (supporting embryo development and being non-toxic), which is assessed by biological assays (mouse embryo assay) rather than expert interpretation of images or other data.

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

Not applicable. This is not an AI/ML diagnostic device requiring adjudication of human-interpreted 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 not an AI/ML diagnostic device, and therefore, no MRMC study was performed.

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

Not applicable. This is not an AI/ML algorithm.

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

The ground truth used is biological performance as demonstrated by mouse embryo assays, specifically the ability to support embryonic growth and blastocyst development, and the absence of toxic components. Additionally, historical clinical use data from the predicate device (MultiBlast Medium) contributes to the understanding of the intended use and expected outcomes.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary of the study that proves the device meets the acceptance criteria:

The primary study proving that the Lyophilized MultiBlast Medium Kit meets its acceptance criteria is a mouse embryo assay. This assay is performed on each lot of the product prior to market release. The purpose of this assay is to ensure that the medium is:

1. Functional for its intended use: capable of supporting embryonic growth and blastocyst development in vitro.
2. Non-toxic: free from components that could harm embryos.

Additionally, the submission relies heavily on the substantial equivalence to the predicate device, MultiBlast Medium (K034063). The predicate device has a long history of successful clinical use, being a "standard media used as the second, more complex stage of a sequential media protocol." This historical clinical performance of the predicate device provides strong supportive evidence for the new device's suitability for its intended use, assuming the new device performs equivalently in the mouse embryo assays and other specified release tests (endotoxin and sterility testing).

No large-scale human clinical trial data is presented for this specific device, as the biological assay and substantial equivalence to a clinically established predicate device are deemed sufficient for this product class.

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Lyophilized Early Cleavage Medium Kit is for use in assisted reproduction technology (ART) that involved the manipulation of gametes or embryos. Specifically, Lyophilized Early Cleavage Medium Kit is intended for use as a culture medium from fertilization through day three (3) of embryo development.

Lyophilized Early Cleavage Medium Kit is a synthetic, defined medium composed of a balanced mixture of salts and other nutrient substances designed to support early stages of embryonic growth (up to three days post-fertilization).

Here's a breakdown of the acceptance criteria and the study information for the Lyophilized Early Cleavage Medium (ECM) Kit, based on the provided document:

Acceptance Criteria and Device Performance

The document describes the performance of the Lyophilized Early Cleavage Medium Kit and its comparison to predicate devices, Early Cleavage Medium (K033462) and P-1 (K983589). The acceptance criteria are implicitly defined by the successful performance in the mouse embryo assay, demonstrating functionality and absence of toxicity comparable to the predicate devices.

Study Details

This submission describes a non-clinical study involving mouse embryo assays.

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

• Sample Size: The document does not explicitly state the numerical sample size (e.g., number of mouse embryos or assays) used for the test set. It mentions "parallel mouse embryo studies."
• Data Provenance: The studies were conducted by Irvine Scientific Sales Co., Inc., likely in their own facilities, to assess their product's performance prior to release to market. The data is prospective in relation to the submission date, as it was generated to support the 510(k) application. The country of origin is not explicitly stated but can be inferred as the USA, where Irvine Scientific is located and where the submission was made to the FDA.

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

• This is a non-clinical study involving a mouse embryo assay, not human expert interpretation of data. Therefore, the concept of human experts establishing ground truth for the test set is not applicable in the same way as it would be for, for example, an imaging device. The "ground truth" is based on the biological outcome of embryonic growth in the mouse models.

4. Adjudication Method for the Test Set:

• Not applicable. As a non-clinical, objective biological assay, human adjudication of results is not described. The outcome of the mouse embryo assay (e.g., successful embryonic development, absence of toxicity) is a direct biological observation.

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. This is a non-clinical study evaluating an in vitro culture medium, not an AI-assisted diagnostic or interpretative device that would involve human readers.

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

• Yes, in essence. The mouse embryo assay is a standalone test of the culture medium's biological performance. It evaluates the medium itself without human intervention in the interpretative process (though human observation and execution of the assay are required). There is no "algorithm" involved in the sense of a digital diagnostic tool.

7. The Type of Ground Truth Used:

• Biological Outcome (Mouse Embryo Development): The ground truth is the observable biological effect of the culture medium on mouse embryos – specifically, their ability to support embryonic growth and the absence of toxic effects, as determined by the mouse embryo assay. This is a direct measure of the product's intended function.

8. The Sample Size for the Training Set:

• This document refers to performance testing for market release and comparison to predicate devices, not a 'training set' in the machine learning context. The studies described are for validation and verification of the product's performance. The previous studies on the predicate devices (K033462 and K983589) could be considered historical data that informed the design and expected performance of the new device, but they are not a training set for an algorithm. The sample size for those historical studies is not detailed here.

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

• Not applicable as there is no "training set" in the machine learning sense. The ground truth for the performance testing (as described in point 7) was established through the direct biological observation of mouse embryo development in the assay.

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The AmnioStat-FLM-PG Kit is intended to be used for the immunological detection of phosphatidylglycerol (PG) in amniotic fluid to determine fetal lung maturity of the fetus collected from transabdominal or vaginal pool samples.

The AmnioStat-FLM-PG Kit is an immunological semi-quantitative agglutination test for determining the presence of phosphatidylglycerol in human amniotic fluid at concentrations indicative of fetal lung maturity. The AmnioStat-FLM-PG Kit is comprised of five (5) components and a disposable agglutination cards (cardboard with laminate). The five (5) components that comprise the kit include three (3) kit controls, Negative Control, Catalog #91013, Low Positive Control, Catalog #91027, High Positive Control, Catalog #91028, two (2) reagents, Reagent A, Catalog #91012 and Reagent B, Catalog #91029, and one (1) Buffer, Catalog #91011. The three (2) controls (negative, low positive, and high positive) in the AmnioStat-FLM-PG Kit are run with each test. The AmnioStat-FLM-PG Kit can be used to run six (6) patient test samples. Each patient sample is run on an individual agglutination card with a set of controls. The AmnioStat-FLM-PG Kit is a next generation kit based upon the same immunological agglutination test as AmnioStat-FLM (K822150) previously cleared for marketing. The immunological agglutination reaction is the same between the AmnioStat-FLM (K822150) and the AmnioStat-FLM-PG kit. The AmnioStat-FLM-PG Kit incorporates the use of Sudan Black B into one of the kit reagents which makes the differentiation of the three (3) kit controls more distinguishable. The AmnioStat-FLM (K822150) is performed on a glass slide that requires the use of a mirror to distinguish and differentiate the kit controls based upon clarity of the background and the size of the agglutinated particles. The AmnioStat-FLM-PG is performed on a disposable agglutination card that is white and does not require the use of a mirror to distinguish and differentiate the kit controls.

The provided text describes a 510(k) submission for the AmnioStat-FLM-PG Kit, an immunological semi-quantitative agglutination test for determining the presence of phosphatidylglycerol (PG) in human amniotic fluid to assess fetal lung maturity.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define quantitative acceptance criteria for the AmnioStat-FLM-PG Kit. Instead, the performance is described qualitatively and through a comparative study.

• Clinical comparison data for 73 patient samples yielded "no false positive test results" and "demonstrated that the AmnioStat-FLM-PG kit performs in accordance with the intended use of the product." This implies comparable accuracy to the predicate for determining the presence of PG. |
  | Ease of Use / User-Friendliness (Improvement over predicate) | - "The AmnioStat-FLM-PG Kit incorporates the use of Sudan Black B into one of the kit reagents which makes the differentiation of the three (3) kit controls more distinguishable."
• "The AmnioStat-FLM-PG is performed on a disposable agglutination card that is white and does not require the use of a mirror to distinguish and differentiate the kit controls."
• "The response and feedback from the laboratories that evaluated the kit indicates it was well received in terms of its application, ease of use..." |
  | Effectiveness in Determining Fetal Lung Maturity (as indicated by PG presence in amniotic fluid) | - "...effectiveness in the determining fetal lung maturity in human amniotic fluid."
• The comparative study with 73 patient samples reported "no false positive test results" and confirmed performance "in accordance with the intended use," which is to identify PG for fetal lung maturity assessment. |
  | Reliable Control Functionality | - "Functionality of the three (3) kit controls (negative, low positive, and high positive) in the AmnioStat-FLM-PG Kit with regards to differentiation in appearance is performed as a condition of release." (This is a manufacturing quality control, not a study outcome). |
  | Compliance with Regulation (21 CFR Section 862.1455) | - "meets the criteria as outlined in 21 CFR Section 862.1455, Lecithin/Sphingomyelin ratio in amniotic fluid test system." (This is a self-assessment statement). |

Summary of Acceptance: The acceptance is primarily based on demonstrating a substantially equivalent performance to the predicate device, with an improvement in ease of use and clarity of results. Specific quantitative performance metrics like sensitivity, specificity, or PPV/NPV are not provided in the summary.

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

• Sample Size for Test Set: 73 patient samples during the clinical comparison study.
• Data Provenance: The study involved two (2) clinical laboratories. The country of origin is not specified but implied to be the US given the submission to the FDA. The data is retrospective in nature, as indicated by "clinical comparison data was also generated for seventy-three (73) patient samples that were tested between the two (2) clinical laboratories." This suggests pre-existing samples or samples collected and analyzed for comparison, rather than a prospective study designed to evaluate the new device exclusively from scratch.

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

The document does not specify the number of experts used to establish ground truth or their qualifications. The "clinical comparison data" likely refers to results from the predicate device, AmnioStat-FLM (K822150), being used as the comparative "truth" or gold standard.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set. It describes a comparison between the new device and the predicate device's results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not explicitly performed or described. The study was a comparison of results between two devices on patient samples, not an evaluation of human readers' performance with and without AI assistance (as this is a diagnostic test kit, not an AI-based imaging interpretation tool). Therefore, no effect size for human reader improvement with AI assistance is applicable or reported.

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

Yes, this was a standalone performance evaluation of the diagnostic test kit itself. The AmnioStat-FLM-PG Kit is an in-vitro diagnostic device designed to provide a result directly, not an algorithm that assists a human in interpretation. The "performance data" section describes the kit's performance rather than human performance with the kit.

7. The Type of Ground Truth Used

The ground truth used was implied to be the results obtained from the predicate device, AmnioStat-FLM (K822150). The document states, "The results of the comparison study yielded no false positive test results and demonstrated that the AmnioStat-FLM-PG kit performs in accordance with the intended use of the product." This indicates the predicate device's findings were used as the reference to assess the new device's accuracy (specifically, in terms of false positives). The ultimate ground truth relates to the presence of phosphatidylglycerol, which the predicate device is also designed to detect.

8. The Sample Size for the Training Set

The document does not mention a separate training set. This is not an AI/machine learning device that typically requires distinct training, validation, and test sets. It's a chemical/immunological diagnostic assay. The samples mentioned (73 patient samples) are for the clinical comparison study, analogous to a test or validation set.

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

Since no training set is described for this type of device, this question is not applicable.

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