(22 days)
For In Vitro Diagnostic Use
The AQC™ Sperm Count and AQC™ Post-vasectomy Quality Controls are intended for monitoring sperm counts performed either manually using commercially available counting chambers or using computer assisted semen analysis (CASA) instruments. The AQC™ Sperm Count and AQC™ Postvasectomy Quality Controls are intended for use as Quality Control materials having known sperm concentrations. Daily monitoring of the control values establishes intra-laboratory parameters for accuracy and precision of the cell counting methods. These products are also available for external laboratory quality control and proficiency testing and as such are sold under the proprietary trade names, AQC™ Spenn Count and AQC™ Post-Yasectomy Proficiency Challe Challenges.
AOC™ Sperm Count and AQC™ Post-Vasectomy Quality Controls are supplied in two levels, 0.3mL per vial. AQC™ Sperm Count and AQC™ Post-Vasectomy Proficiency Challenges are supplied in two levels, 0.15mL per vial. Each control is a ready-to-use liquid requiring no reconstitution or dilution. The liquid is prepared in a solution fortified to target levels with purified chemicals and stabilized human sperm cells and semen. Preservatives, including formalin, have been added to inhibit microbial growth and inactivate potential infectious agents.
Here's a breakdown of the acceptance criteria and the study details for the AQC™ Sperm Count and AQC™ Post-vasectomy Quality Controls, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Closed Vial Stability (2-8°C): Recovery of cell counts within 2 Standard Deviations (SDs) of the original cell counts. | The closed vial stability is 1 year when stored at 2-8°C. |
| Open Vial Stability (2-8°C, with daily warming to room temperature): Recovery of cell counts within 2 SDs of the originally established control limits. | The open vial stability is 6 weeks when stored at 2-8°C with daily opening. |
Study Information
2. Sample size used for the test set and the data provenance:
-
Closed Vial Stability (Test Set):
- Sample Size: "A total of 10 samples from each lot were counted at each interval." (Multiple lots were tested, but the total number of lots is not specified).
- Data Provenance: Not explicitly stated, but implies retrospective testing of manufactured lots over time. No information on country of origin of the data is provided, but given the applicant is in Cleveland, OH, it's likely US-based.
-
Open Vial Stability (Test Set):
- Sample Size: "Testing was done on one product lot of each level of control initially and after 2 months of daily opening." (This means at least two lots were tested, one for each level).
- Data Provenance: Similar to closed vial, implies retrospective testing. Likely US-based.
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 summary. The study involved determining sperm sample concentration using "manual microscopy and sperm counting chambers," but it doesn't specify who performed these counts or their qualifications, nor how many individuals were involved in establishing a "ground truth" for each specific sample.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. The summary only states that counts were performed. There is no mention of multiple readers or an adjudication process.
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. An MRMC comparative effectiveness study was not performed. This device is a quality control material intended to monitor sperm counts, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical quality control material, not an algorithm or software. It is used to validate the performance of manual counting or computer-assisted semen analysis (CASA) instruments.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for stability testing was established by repeatedly measuring the sperm sample concentration using "manual microscopy and sperm counting chambers" at specific time intervals. The initial cell counts at day 0 served as the baseline for comparison. This represents an observed physical property measurement.
8. The sample size for the training set:
- This concept is not applicable as this is a physical quality control device, not an AI/ML algorithm that requires a training set. The "samples" referred to in the performance characteristics section are lots of the control material being tested for stability.
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.
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.