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SAGE Vitrification Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

SAGE Vitrification Warming Kit is intended for use in the thawing of virtified oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

SAGE Vitrification Kit (ART-8025 and ART-8026): This kit includes two solutions (Equilibration Solution and Vitrification Solutions in the kit consist of a MOPS-buffered media containing non-essential and essential amino acids. gentamicin sulfate, and human serum albumin. These solutions also contain the cryoprotectants ethylene glycol, dimethyl sulfoxide (DMSO) and sucrose as described below:

Equilibration Solution (ES): 7.5% (v/v) each of DMSO and ethylene glycol. Vitrification Solution (VS): 15% (v/v) each of DMSO and ethylene glycol, and 0.6 M sucrose

SAGE Vitrification Warming Kit (ART-8030 and ART 8031): This kit includes three solutions (1.0M Sucrose Warming Solution [1.0 M WS], 0.5M Sucrose Warming Solution [0.5 M WS], and MOPS Solution [MS]). All solutions in the kit consist of a MOPS-buffered media containing non-essential and essential amino acids, gentamicin sulfate, and human serum albumin. These solutions contain the cryoprotectant sucrose at the level described in their names (i.e., 1.0M, 0.5M, or no sucrose).

Solutions in the SAGE Vitrification Kit and SAGE Vitrification Warming Kit are aseptically-filtered and are provided to users in either 5 ml Type 1 borosilicate glass vials with a rubber closure and an aluminum seal (ART-8025 and ART-8030) or 2 ml polypropylene vials with cap (ART-8026 and ART-8031). The solutions in ART-8025 and ART-8030 are single-use only devices, whereas solution in ART-8026 and ART-8031 are to be used within 7 days after opening.

The provided text is a 510(k) summary for the SAGE Vitrification Kit and SAGE Vitrification Warming Kit. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study design with acceptance criteria for a new, AI/ML-driven medical device. Therefore, a direct response to your request, which implies an AI/ML device study, is not fully supported by the provided document.

However, I can extract the closest analogous information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" from this document as understood within the context of reproductive media and supplements, not AI/ML devices.

Here's a breakdown based on the provided document, interpreting "acceptance criteria" as product specifications and "study" as performance testing and literature review to support substantial equivalence:

1. Table of Acceptance Criteria (Product Specifications) and Reported Device Performance

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

The document does not describe a traditional "test set" in the sense of a dedicated, pre-defined dataset for a single study, as would be done for an AI/ML device. Instead, it relies on a summary of non-clinical performance testing (in-house lab tests) and clinical performance data from published journal articles.

• Non-Clinical Test Samples: Not explicitly quantified in terms of sample size (e.g., number of batches, number of media samples tested for pH, osmolality, endotoxin). The Mouse Embryo Assay (MEA) states "1-cell MEA" but doesn't specify the number of mouse embryos or replicate tests.
• Clinical Performance Data: This is derived from 9 cited journal articles. The sample sizes vary per study and are reported within the summaries:
  • Literature 1: 11 subjects, surplus MII oocytes (quantity not specified).
  • Literature 2: 6 subjects, surplus MII oocytes (quantity not specified).
  • Literature 3: General results/meta-analysis context, not a specific sample size.
  • Literature 4: 2353 MII oocytes.
  • Literature 5: 54 study subjects, 413 MII oocytes.
  • Literature 6: 37 subjects, 74 embryos.
  • Literature 7: 849 pronuclear-stage (PN) zygotes vitrified, 339 PN zygotes thawed over 103 cycles.
  • Literature 8: 24 warming cycles (after OHSS risk).
  • Literature 9: Control group of 102 warming cycles.
• Data Provenance: Not explicitly stated for all studies, but generally refers to clinical studies likely conducted in fertility clinics. The original journal articles (listed in Section XI) would contain this information. Given the context of the device and product development, it is likely these studies were retrospective or prospective clinical trials focusing on IVF outcomes. There is no mention of country of origin for the clinical data within this extract.

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

This concept is not directly applicable to this type of device (reproductive media). The "ground truth" for non-clinical tests is established by laboratory measurements against predefined product specifications. For the clinical performance, the "ground truth" relates to actual biological outcomes (survival, fertilization, pregnancy, live birth), which are typically reported by clinicians and embryologists involved in the treatment, not "experts establishing ground truth for a test set" in the AI/ML sense. No specific number of experts or their qualifications for establishing ground truth are mentioned.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" described as one would expect for an AI/ML device's test set. Clinical outcomes are reported as observed, not adjudicated by an independent panel.

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

Not applicable. This device is a media kit, not an interpretation tool for image data. Therefore, no MRMC study was performed or described.

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

Not applicable. This is not an AI/ML algorithm. The performance is of the media used by humans in a clinical setting.

7. The Type of Ground Truth Used

• Non-Clinical Performance:
  • Physical/Chemical Properties: Measured values (pH, Osmolality, Endotoxin) compared to defined ranges.
  • Biological Functionality: Mouse Embryo Assay (MEA) results (percentage blastocysts at 96h).
  • Sterility: Absence of microbial growth.
• Clinical Performance:
  • Clinical Outcomes Data: Survival rates, fertilization rates, clinical pregnancy rates, live birth rates following the use of the media in human oocyte/embryo vitrification and warming procedures. This is observational outcomes data from fertility treatments.

8. The Sample Size for the Training Set

Not applicable directly. This is not an AI/ML device that requires a "training set." The development of the media would involve research and formulation, but not in the sense of an AI model's training data.

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

Not applicable, as there is no "training set" for an AI/ML model for this device. The development of the media relies on cryobiology principles and empirical testing to achieve the desired cryoprotective properties and support oocyte/embryo viability.

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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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