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510(k) Data Aggregation
(236 days)
MENICON CO., LTD. NEW BUSINESS DIVISION
The Qualis is intended for preparing motile human sperm for use in the treatment of infertile couples by intracytoplasmic sperm insertion (ICSI) fertilization.
The Qualis is a sterile, disposable, plastic laboratory dish that contains four chambers connected through micro-channels and is designed to be used in conjunction with commercially available culture medium to selectively separate motile spermatozoa (sperm) for non-motile spermatozoa and cellular debris.
The provided text describes the "Qualis" device, a sterile, disposable, plastic laboratory dish designed to separate motile spermatozoa from non-motile spermatozoa and cellular debris for use in intracytoplasmic sperm insertion (ICSI) fertilization. The document evaluates the device's substantial equivalence to a predicate device, the "Research Instruments Migration Sedimentation Chamber."
The acceptance criteria are not explicitly listed in a table format within the provided text. However, the functional and safety testing paragraph and the substantial equivalence discussion highlight key performance and safety aspects that were evaluated.
Here's an attempt to parse the acceptance criteria and performance based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Performance: Effectiveness in separating motile sperm (presumably for ICSI fertilization) | "The final design validation study demonstrated that the subject device is effective." (This suggests the device successfully achieved its intended function, likely assessed by the quality and quantity of separated motile sperm.) |
| Safety: Biocompatibility with human sperm | "The result of HSSA testing demonstrated that the subject device is safe." (Indicates the device does not adversely affect sperm viability or function.) |
| Human Sperm Survival Assay (HSSA) Requirement | Passed HSSA testing. |
| Human Sperm Motility/Morphology Assessment | Testing included human sperm motility/morphology. (While a specific pass/fail isn't stated, the overall conclusion of "functional performance and safety requirements" implies satisfactory results.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document states: "To verify that device design met its functional performance and safety requirements, representative sample of the device underwent testing including human sperm survival assay (HSSA) and human sperm motility/morphology."
- Sample Size: The exact sample size used for the test set (i.e., the number of Qualis devices tested, or the number of sperm samples used for testing each device) is not specified in the provided text. It mentions "representative sample of the device."
- Data Provenance: The provenance of the data (country of origin, retrospective or prospective) is not specified.
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)
The document does not mention the use of experts to establish ground truth for the test set in the context of the device's functional or safety testing. The evaluation primarily relies on laboratory assays (HSSA, motility/morphology) which typically have objective measures. The ground truth for these assays would generally be the predetermined laboratory standards or comparison to controls, rather than expert consensus on interpretation of complex data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not mention any adjudication method, as the tests described (HSSA, motility/morphology) are typically objective laboratory measurements rather than subjective assessments requiring multiple reviewers.
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
This section is not applicable as the Qualis device is for sperm preparation in assisted reproduction, not an AI-assisted diagnostic imaging device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable as the Qualis device is a physical laboratory instrument for sperm processing, not an algorithm or software. It is a standalone device in the sense that its functional performance and safety were evaluated independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the functional and safety testing appears to be based on objective laboratory measurements and established biological assays.
- For "functional performance" in sperm separation, the ground truth would likely be the quantitative analysis of enriched motile sperm populations (e.g., count, motility percentage, morphology) compared to established benchmarks or predicate device performance.
- For "safety" (HSSA), the ground truth is the survival and viability of human sperm after exposure to the device, measured against controls and established safety limits for cell viability.
8. The sample size for the training set
This section is not applicable. The Qualis device is a physical product, not a machine learning model, so there is no concept of a "training set" in the context of its development and validation.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as above (no training set for a physical device).
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