(291 days)
Oil For Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.
Gradient System is used for separation and purification of human sperm for assisted reproduction procedures.
SpermFreeze is intended to be used as a cryopreservation medium for human sperm.
Oil For Tissue Culture is a colorless liquid paraffin.
Gradient System is a solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%.
SpermFreeze is a HEPES buffered freezing medium for use with human Sperm. It contains 0.4 % human serum albumin.
The provided document is a 510(k) Pre-market Notification for a "FertiPro Reproductive Media Bundle" which includes "Oil for Tissue Culture," "Gradient System," and "SpermFreeze." The document does not describe acceptance criteria or a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to previously marketed predicate devices based on technological characteristics and performance testing.
Here's a breakdown of why the requested information cannot be extracted and what the document does provide:
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A table of acceptance criteria and the reported device performance: This information is not present in the document. The document states that "The predicates and these devices were compared in the following areas and found to have exact technological characteristics and to be equivalent: Formula, Special controls, Packaging, Performance Testing." However, it does not provide specific acceptance criteria or detailed performance data from these comparisons.
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Sample size used for the test set and the data provenance: This information is not present. The submission is based on demonstrating substantial equivalence, not on clinical performance testing with a specific test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present. Ground truth establishment by experts is relevant for studies validating a diagnostic or AI device's accuracy, which is not the nature of this 510(k) submission.
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Adjudication method for the test set: This information is not present.
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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: This information is not present. An MRMC study is relevant for AI-assisted diagnostic tools, which these reproductive media products are not.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present. The devices are reproductive media, not algorithms.
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The type of ground truth used: This information is not explicitly stated as a ground truth in the context of a diagnostic study is not applicable here. The comparison is based on "exact technological characteristics" and "performance testing" against predicate devices, implying analytical performance rather than clinical ground truth.
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The sample size for the training set: This information is not present. The devices are not AI or machine learning models that require training sets.
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How the ground truth for the training set was established: This information is not applicable as there is no training set for these products.
In summary, the provided document is a 510(k) premarket notification for reproductive media. It asserts substantial equivalence to predicate devices based on technological characteristics and performance testing but does not detail specific acceptance criteria or provide the results of any clinical or diagnostic performance studies that would utilize the concepts of "test sets," "ground truth," or "expert adjudication," as these products are not diagnostic devices or AI algorithms.
§ 878.5070 Air-handling apparatus for a surgical operating room.
(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.