This submission is not for an AI/ML powered device, but rather for a medical device called SpermGrad™, which is an assisted reproduction medium. Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable.

However, I can extract and present the information relevant to this medical device submission.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of medical device (assisted reproduction media), acceptance criteria typically relate to demonstrating substantial equivalence to a predicate device, primarily through technological characteristics and intended use. Performance is often measured indirectly by showing comparable or equivalent functionality.

Acceptance Criteria (Inferred from 510(k) Process)	Reported Device Performance
Intended Use Equivalence: Device has the same intended use as legally marketed predicate device.	"Médium for In Vitro Fertilization Procedures" and "For gradient sperm separation." - Identical to predicate.
Technological Characteristics Equivalence: Device has identical technological characteristics to the predicate device in all material respects.	"The technological characteristics of SpermGrad™ are identical to the predicate device in all material respects."
Safety and Effectiveness: Demonstration that the device is as safe and effective as the predicate device.	Achieved via substantial equivalence determination based on identical technological characteristics and intended use. No specific performance metrics for this type of device are presented in the provided text, as safety and effectiveness are inferred by the substantial equivalence to a legally marketed predicate with a known safety and effectiveness profile.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This is a 510(k) submission for an assisted reproduction media (SpermGrad™) where substantial equivalence is claimed based on identical intended use and technological characteristics to a predicate device (ISolate® - K991341). The information provided does not indicate a clinical study with a "test set" in the context of device performance data generation. Clinical data is typically not required for device classifications like this where substantial equivalence can be demonstrated through other means.

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)

Not Applicable. See point 2.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. See point 2.

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

Not Applicable. This device is an assisted reproduction media, not an AI/ML-powered diagnostic or assistive tool for human readers.

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

Not Applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable. No explicit "ground truth" as would be defined for an AI/ML device needing validation against a gold standard is mentioned or implied for this submission. Substantial equivalence relies on comparison to a predicate device.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device requiring a training set.

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

Not Applicable. See point 8.

Summary

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PREMARKET NOTIFICATION SUMMARY X.

Submitted by:	Vitrolife Sweden ABMölndalsvägen 30SE-412 63 GothenburgSWEDEN
Contact Person:	Ms. Nina ArvidssonVitrolife Sweden ABMölndalsvägen 30SE-412 63 GothenburgSWEDEN
	Mr. Gary L. YinglingMr. Michael H. HinckleKirkpatrick & Lockhart, LLP1800 Massachusetts Avenue, NWWashington, DC 20036-1800
Date Prepared:	October 07, 2002
Trade Name:	SpermGrad™
Common Name:	Assisted Reproduction Media
Classification Name:	Reproductive Media and Supplements(21 C.F.R. § 884.6180)
Predicate Device:	ISolate® (510(k) # K991341)
Description of the Device:	Physiological salt buffer containing silane-coated,colloid silica particles. For use after appropriatedilution.
Intended Use:	Medium for In Vitro Fertilization Procedures
Indications for Use:	For gradient sperm separation.
Technological Characteristics:	The technological characteristics of SpermGrad™are identical to the predicate device in all materialrespects.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Nina Arvidsson RA Officer Vitrolife Sweden AB Mölndalsvägen 30 SF-412 63 Gothenburg SWEDEN

Re: K023403

Trade/Device Name: SpermGrad™ Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II

Product Code: 85 MQL Dated: October 7, 2002 Received: October 10, 2002

Dear Ms. Arvidsson:

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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snigdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number:

K023403

Device Name:

Indications For Use:

SpermGrad™ Assisted Reproduction Media

For gradient sperm separation.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 C.F.R. § 801.109)

()R

( )ver-the Counter Use______

David C. Tilling

(Division Sign-Off)
Division of Reproductive, Abdominal
3 and Radiological Devices
510(k) Number
K123403

Regulation Number and Section

§ 884.6180 Reproductive media and supplements.

(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.