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ISOCARE ONE-STEP Sperm Processing Medium is intended for use in assisted reproductive technology procedures that involve the isolation, processing and transfer of sperm. Specifically, ISOCARE ONE-STEP Sperm Processing Medium is intended for use as a sperm isolation and processing medium in the isolation and processing of sperm during intrauterine and other reproductive technology procedures.

ISOCARE ONE-STEP Sperm Processing Medium is a synthetic, defined culture medium composed of a mixture of salts and other physiologically compatible substances supplemented with 5mg/ml human serum albumin. ISOCARE ONE-STEP Sperm Processing Medium is intended for use in sperm processing procedures prior to intrauterine or other assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). ISOCARE ONE-STEP Medium uses a combined sodium bicarbonate/HEPES (J4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid () buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere.

The provided text describes the ISOCARE ONE-STEP Sperm Processing Medium, a medical device. Based on the given information, here's an analysis of its acceptance criteria and the study that proves its performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of a clinical study with a defined sample size for the ISOCARE ONE-STEP Sperm Processing Medium. The performance data primarily refers to lot release testing rather than a specific clinical trial.

• Sample Size for Lot Release Testing: Not explicitly stated as a number of samples/patients. It's implied that "each lot" is tested.
• Data Provenance: The document refers to "published historical information contained in the professional literature" and the device becoming "the standard media used for sperm isolation, washing and transport" over "a number of years." This suggests the data provenance is retrospective clinical experience and literature review, coupled with prospective in-vitro lot release testing. There is no specific country of origin mentioned for the historical data, but the submission is to the US FDA.

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

This information is not provided in the document. The performance data presented is based on objective laboratory assays (cytotoxicity, sperm motility/hyperactivation, mouse embryo assay, endotoxin, sterility) and a general reference to historical clinical usage, rather than expert-adjudicated ground truth from a test set.

4. Adjudication Method for the Test Set

This information is not applicable/provided. As there is no explicitly defined "test set" with expert review for adjudication, no adjudication method is mentioned. The assessment relies on the described laboratory test 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

An MRMC comparative effectiveness study is not applicable to this device. The ISOCARE ONE-STEP Sperm Processing Medium is a culture medium, not an AI-powered diagnostic or assistive technology for human readers. Therefore, there's no discussion of human reader improvement with or without AI assistance.

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

A standalone performance study, as typically understood for an AI algorithm (without human-in-the-loop), is not applicable to this device. The device is a physical medium used in laboratory procedures.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established through:

• In-vitro laboratory assays: Cytotoxicity testing, sperm motility/hyperactivation analysis, mouse embryo assay, endotoxin, and sterility testing. These provide objective measures of the medium's safety and functionality.
• Historical clinical usage/literature: The claim that the product has become "the standard media used for sperm isolation, washing and transport" implies that clinical outcomes and utility have been observed and documented over time, forming a practical "ground truth" of its effectiveness in real-world use.
• Predicate device comparison: The device is deemed substantially equivalent to a predicate device, implying that the established safety and effectiveness of the predicate forms a basis for evaluating the new device.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. It is a physical culture medium, not an algorithm that requires training data. The lot release testing and historical clinical observations serve as validation of the formulation.

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

This question is not applicable as there is no "training set" for this type of device.

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Q-HTF is intended for the retrieval, culture, transport, storage and transfer of human gametes and embryos.

Q-HTF Medium is intended for use in assisted reproductive technology procedures that involve the manipulation of gametes and embryos. Specifically, Q-HTF is intended for use a a culture medium for the embryo after fertilization, when used with an incubator, and as a nedim to support in vitro fertilization. Q-HTF is intended to simulate the substances fourd in the human to female reproductive system.

Q-HTF is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). Q-HTF uses a sodium bicarbonate buffering system and is appropriate for those procedures requiring the use of a carbon dioxide atmosphere during incubation.

Q-HTF is intended for use as a culture medium, with appropriate protein supplementation, for the support of fertilized embryos. Fertilization is also allowed to occur in Q-HTF when in vitro fertilization techniques are used. The fertilized gamete is then allowed to grow in the media and supplement, which are replenished as needed, until the desired state of development, usually up to three days post fertilization. Since Q-HTF utilizes a sodium bicarbonate buffer system, it is intended to be used in those procedures that require a carbon dioxide atmosphere, as is found in the incubators used by assisted reproductive laboratories. Therefore Q-HTF is primarily used as a medium to support embryo growth, development and culture in vitro.

The provided text describes the Q-HTF Medium, a synthetic culture medium for assisted reproductive technology procedures. Here's an analysis of the acceptance criteria and study as requested:

1. Table of acceptance criteria and the reported device performance:

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

• Test Set Sample Size: The text states, "Q-HTF medium is assayed by a mouse embryo assay prior to its release to market." However, it does not specify the number of mouse embryos or assays conducted for the performance testing described.
• Data Provenance:
  • Country of Origin: Not specified for the mouse embryo assay.
  • Retrospective or Prospective: Not explicitly stated, but "prior to its release to market" suggests a prospective, pre-market evaluation for each lot.

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

This information is not provided in the text. The mouse embryo assay is described as ensuring functionality and absence of toxicity, but details on how the "truth" of successful embryonic growth or toxicity is established (e.g., specific criteria or expert interpretation) are absent.

4. Adjudication method for the test set:

This information is not provided in the text. There is no mention of multiple reviewers or adjudication processes for the mouse embryo assay results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

A multi-reader, multi-case (MRMC) comparative effectiveness study is not applicable to this device. The Q-HTF Medium is a culture medium, not an AI-assisted diagnostic tool. Therefore, there is no discussion of human readers or AI assistance.

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

This is not applicable as the device is a culture medium and does not involve an algorithm or AI.

7. The type of ground truth used:

• For the performance testing (mouse embryo assay), the "ground truth" for functionality appears to be successful embryonic growth in the medium, and for safety, the absence of toxic effects. These are determined by the outcome of the biological assay itself, rather than external expert consensus, pathology, or outcomes data in the typical sense for diagnostic devices.
• The document also refers to a "review of published historical information contained in the professional literature" which supports the intended use and meets criteria, implicitly using historical clinical outcomes and scientific literature as a form of ground truth for the broader effectiveness of Human Tubal Fluid (HTF) media.

8. The sample size for the training set:

There is no mention of a "training set" in the context of this device. As a biological culture medium, it would not typically involve machine learning or AI models that require training data. The product's formulation is "defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498)" based on mimicking fallopian tube fluid, which represents a foundational scientific basis rather than a data-driven training process.

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

As there is no training set for this device, this question is not applicable.

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