Para-Pro™ fc50 is a unique, patent pending device for the separation of fecal debris from the appropriate preserved specimen (10% buffered formalin; SAF sodium acetate acetic acid formaldehyde; and Proto-fix™ CLR) for the concentration of eggs, larvae, protozoa and juvenile nematodes associated with intestinal infections.

Device Description

AI/ML Overview

This is a 510(k) premarket notification for a Class I microbiology specimen collection and transport device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study data, ground truth, and training sets for an AI/ML algorithm is not present in this document.

The document states that the device is "substantially equivalent" to legally marketed predicate devices. This means that a direct comparison against a predicate device was performed, rather than an independent study with acceptance criteria and statistical analysis of performance as would be expected for an AI/ML device.

Here's what can be extracted from the document relevant to a traditional medical device submission:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria and reported device performance in the manner of an AI/ML device study. Instead, the FDA determined the device is "substantially equivalent" to legally marketed predicate devices. This typically implies that the device performs comparably to the predicate device for its intended use. For
a microbiology specimen collection and transport device, acceptance criteria would likely relate to its ability to:

Effectively separate fecal debris.
Preserve eggs, larvae, protozoa, and juvenile nematodes for subsequent analysis.
Be compatible with specified preservatives (10% buffered formalin; SAF sodium acetate acetic acid formaldehyde; and Proto-fix™ CLR).
Maintain the viability or integrity of the parasites within the specified timeframes.

2. 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 document as it's a 510(k) summary focused on substantial equivalence. A detailed study protocol with sample sizes, data provenance, and study design (retrospective/prospective) would be part of the supporting documentation submitted to the FDA, but is not included in this letter.

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)

This concept of "ground truth" established by experts is typically relevant for diagnostic devices that produce an output requiring expert interpretation (e.g., imaging devices, AI algorithms). For a specimen collection and transport device, the "ground truth" would be established by laboratory methods assessing the recovery and preservation of parasites, which is distinct from expert consensus on an interpretation. The document does not provide details on such a study or expert involvement in establishing performance benchmarks.

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

Not applicable in the context of this device and the information provided. Adjudication methods are typically for resolving discrepancies in expert interpretations, which is not the primary evaluation method for a specimen collection and transport device.

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 is a traditional medical device, not an AI/ML driven diagnostic.

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

Not applicable. This is a physical device, not an algorithm.

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

The "ground truth" for this type of device would likely be based on laboratory-confirmed presence and condition of parasites. This would typically involve microscopic examination by trained laboratory personnel after processing the samples and comparing results from the device against a gold standard method. The document does not specify this type of detail.

8. The sample size for the training set

Not applicable. This is a traditional medical device, not an AI/ML device that requires a training set.

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

Not applicable. This is a traditional medical device, not an AI/ML device.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 12 2006

Mr. Richard Williams President/CEO Alpha-Tec Systems, Inc. 12019 NE 99th Street Building 17, Mail Stop 1780 Vancouver, WA 98682

Re: K053257

Trade/Device Name: Para-Pro™ fc 50 Regulation Number: 21 CFR 866.2990 Regulation Name: Microbiology Specimen Collection and Transport Device Regulatory Class: Class I Product Code: LKS Dated: April 11, 2006 Received: April 13, 2006

Dear Mr. Williams:

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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sally, a Toy

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):____ K053257

Device Name:__________________________________________________________________________________________________________________________________________________________________ Para-Pro™ fc50

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Freddutu Poole
Division Sign-Off

vision Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K053257

Regulation Number and Section

§ 866.2900 Microbiological specimen collection and transport device.

(a)
Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.