(75 days)
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of amylase in human serum. It is intended for in vitro diagnostic use only. The determination of amylase in serum is most commonly performed for the diagnosis and treatment of diseases of the pancreas.
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The document provided is a premarket notification (510(k)) letter from the FDA to Pointe Scientific, Inc. regarding their Amylase EPS-G7 (Liquid) Reagent Set. This type of document declares "substantial equivalence" to a predicate device, which allows the product to be marketed, but does not typically include detailed studies proving performance against acceptance criteria in the way a clinical trial for a novel AI device would.
Therefore, many of the specific details requested in the prompt, such as sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, or MRMC studies, are not applicable to this 510(k) submission for an in vitro diagnostic reagent kit.
However, I can extract the relevant information about the device and its intended use, and explain why other sections are not present:
1. A table of acceptance criteria and the reported device performance
This document (a 510(k) clearance letter) does not typically contain a table of detailed performance characteristics and acceptance criteria in the way a clinical study report for an AI device might. For in-vitro diagnostic products like this, the demonstration of "substantial equivalence" to a legally marketed predicate device is the primary regulatory hurdle. This means the device is shown to perform as well as, or comparably to, an existing device on the market.
While the letter doesn't explicitly state "acceptance criteria," the intended performance of the device is for the "quantitative determination of amylase in human serum" for the "diagnosis and treatment of diseases of the pancreas." Substantial equivalence implies that its performance (e.g., sensitivity, specificity, accuracy, precision, linearity, interfering substances) is comparable to, and not worse than, the predicate device.
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 510(k) clearance letter. For in vitro diagnostic reagents, performance studies are conducted, but their detailed results (including sample sizes, study design, and data provenance) are typically submitted to the FDA in a separate dossier and summarized or referenced in the 510(k) submission, rather than being fully reproduced in the publicly available clearance 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 information is not applicable/provided in this context. For a reagent test determining a quantitative analyte (amylase), the "ground truth" is typically established by reference methods, standard assays, or certified reference materials, not by expert consensus in the way a diagnostic imaging interpretation would be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are relevant for subjective interpretations (like radiology reads) where multiple experts might disagree. For quantitative assays, the "ground truth" is determined by objective laboratory measurements, not expert consensus requiring adjudication.
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 is not applicable. This device is a reagent set for laboratory testing, not an AI-assisted diagnostic tool that aids human readers. Therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a laboratory reagent kit, not an algorithm. Its performance is inherent to the chemical reaction and analytical equipment, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For an amylase reagent test, the "ground truth" would typically be established through:
- Reference methods: Highly accurate and validated analytical methods.
- Standardized calibrators: Materials with known, certified concentrations of amylase.
- Interlaboratory comparisons: Performance against other established and trusted assays.
The specific type of ground truth used is not detailed in this 510(k) clearance letter.
8. The sample size for the training set
This information is not applicable/provided. This device is a chemical reagent, not a machine learning model, so there is no "training set" in the AI sense. Performance validation involves testing the reagent's characteristics (e.g., linearity, precision, accuracy, reproducibility) across a range of samples and conditions, but this is distinct from training an AI model.
9. How the ground truth for the training set was established
This information is not applicable/provided for the reasons stated in point 8.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the address of the Food and Drug Administration. The address is 2098 Gaither Road, Rockville MD 20850. The text is black and the background is white. The text is left-aligned.
Mr. Ron Jamison Technical Service Manager Pointe Scientific, Inc. 1025 John A. Papalas Drive Lincoln Park, MI 48146
Re:
K023396 Trade/Device Name: Amylase EPS-G7 (Liquid) Reagent Set Regulation Number: 21 CFR 862.1070 Regulation Name: Amylase Test System Regulatory Class: Class II Product Code: CIJ Dated: December 3, 2002 Received: December 4, 2002
Dear Mr. Jamison:
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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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K023396 510 (k) Number (if known):
Device Name: Amylase EPS-G7 (Liquid) Reagent se
Indications for use:
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of amylase in human serum. It is intended for in vitro diagnostic use only. The determination of amylase in serum is most commonly performed for the diagnosis and treatment of diseases of the pancreas.
Division Sion-Off vices Division of 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Counter Use (Per 21 CFR 801.109)
OR
Over the
(Optional Format 1-2-96)
§ 862.1070 Amylase test system.
(a)
Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).(b)
Classification. Class II.