SQA, SPERM QUALITY ANALYZER by MEDICAL ELECTRONIC SYSTEMS, LLC

The provided documents are an FDA 510(k) clearance letter and an Indications for Use statement for the Medical Electronics Systems, LLC, Sperm Quality Analyzer (SQA). The documents confirm the device's substantial equivalence to a predicate device and its intended uses. However, they do not contain detailed information regarding acceptance criteria or the specific study that proves the device meets those criteria.

The FDA clearance letter primarily focuses on regulatory approval based on substantial equivalence and does not elaborate on the specific performance studies. The Indications for Use statement outlines the parameters the SQA measures but does not provide performance metrics or study details.

Therefore,Based on the provided documents:

A table of acceptance criteria and the reported device performance: This information is not provided in the given documents. The documents refer to the device's ability to provide calculated measurements for various sperm parameters, but not the specific performance metrics (e.g., accuracy, precision) or acceptance criteria established for those metrics.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not provided in the given documents.
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): This information is not provided in the given documents.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided in the given documents.
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 provided in the given documents. The SQA is described as an "electro-optical device for semen analysis" providing calculated measurements, implying it automates measurements rather than assisting human readers in interpreting images.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The SQA is presented as an automated device that provides "calculated measurements," which suggests a standalone performance. However, specific study details to confirm this or its performance metrics are not provided in these documents.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided in the given documents.
The sample size for the training set: This information is not provided in the given documents.
How the ground truth for the training set was established: This information is not provided in the given documents.

To obtain the detailed information requested, one would typically need to refer to the full 510(k) submission summary or a separate technical report/clinical study report submitted to the FDA, which are not included in the provided snippets.

Summary

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10903 New Hampshire Avenue Silver Spring, MD 20993

Medical Electronics Systems, LLC c/o Ms. Erika B. Ammirati, RAC, MT(ASCP) Regulatory Consultant 575 Shirlynn Court Los Altos, California 94022

DEC 2 1 2012

Re: K012352

Trade/Device Name: Medical Electronics Systems, LLC, Sperm Quality Analyzer (SQA) Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Date: July 23, 2001 Received: July 25, 2001

Dear Ms. Ammirati:

This letter corrects our substantially equivalent letter of September 21, 2001.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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Page 2 - Ms. Erika Ammirati

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

m chan

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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July 23, 2001

Medical Electronic Systems, LLC SOA, Sperm Quality Analyzer 510(k) Modification for K894949

STATEMENT OF INTENDED USE

Kola352 510(K) Number (if known): __

Device Name: SQA, Sperm Quality Analyzer

Indications for Use:

The SQA is a point-of-care, easy-to-use, electro-optical device for semen analysis. The SQA provides calculated measurements for:

total cell concentration (millions/mL) t
. percent (%) motility
% normal morphology .
motile sperm concentration (MSC), (millions/mL) ●
functional sperm concentration (FSC), (millions/mL) .
sperm motility index (SMI) ●

Aruseline Bautista

Clinical Laboratory Devices

510(k) Number K012352

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE AS NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)
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Over-the-Counter Use
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Regulation Number and Section

§ 864.5220 Automated differential cell counter.

(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”