(62 days)
The inorganic phosphorus reagents: product No. 112-01 and 112-02 are intended for Invitro The morganic phosphords reagence from the determination of inorganic phosphate in serum, or plasma.
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Here's an analysis of the provided text regarding acceptance criteria and study details for the Inorganic Phosphorus (IP) device:
The provided documents are a 510(k) clearance letter from the FDA and the "Indications for Use" statement for the device. These documents do not contain the specific details required to answer all your questions about acceptance criteria, detailed study design, and performance metrics.
The 510(k) process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring a detailed de novo clinical trial with explicit acceptance criteria and performance data as would be found in a Premarket Approval (PMA) application or a more extensive clinical study report for an in vitro diagnostic (IVD).
Therefore, many of your questions cannot be answered directly from the provided text. I will answer what is available and indicate where the information is missing.
Acceptance Criteria and Study for Inorganic Phosphorus (IP) Device (K991867)
Based on the provided documents, comprehensive details regarding acceptance criteria and the study that proves the device meets them are not fully available. The FDA clearance letter indicates a finding of "substantial equivalence" to a predicate device, which is the primary regulatory hurdle for a 510(k) submission. This suggests that the device's performance was compared to a known, legally marketed device, and found to be sufficiently similar.
The "Indications for Use" states: "The inorganic phosphorus reagents: product No. 112-01 and 112-02 are intended for Invitro quantitative determination of inorganic phosphate in serum, or plasma."
Here's an attempt to answer your questions based on the limited information:
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A table of acceptance criteria and the reported device performance
Acceptance Criteria Reported Device Performance Not explicitly stated in the document. The primary "acceptance criterion" for 510(k) clearance is demonstrating "substantial equivalence" to a predicate device. This would typically involve showing comparable accuracy, precision, and linearity to the predicate. Not explicitly stated in the document. Performance data (e.g., accuracy, precision studies) would have been submitted to the FDA to support substantial equivalence, but are not detailed in these public-facing letters. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided documents.
- Data Provenance: Not specified in the provided documents.
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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 / Not specified. For in vitro diagnostic assays like inorganic phosphorus, "ground truth" is typically established by comparing results to a reference method, a predicate device, or using certified reference materials, rather than expert consensus on images or interpretations. The concept of "experts establishing ground truth" in the way described for imaging studies is not directly relevant here.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not specified. Adjudication methods are typically used in studies involving subjective interpretations (e.g., medical imaging reads). For a quantitative IVD, direct comparison to a reference standard or predicate device is more common.
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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. This is an in vitro diagnostic (IVD) device for measuring a chemical analyte, not an AI-assisted diagnostic imaging tool. Therefore, MRMC studies and "human readers improve with AI" questions are not relevant to this device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in essence. An IVD device performs autonomously in a lab setting to generate a result. The "performance" assessed would be the analytical performance of the assay itself (e.g., accuracy, precision, linearity, interference). There isn't an "algorithm" in the typical sense of AI, but rather a chemical reaction and measurement process.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Likely a combination of:
- Reference Methods: Comparison against established, highly accurate laboratory methods for inorganic phosphorus.
- Predicate Device Comparison: Direct comparison of results from the subject device to results from the legally marketed predicate device using patient samples.
- Certified Reference Materials: Using materials with known, traceable concentrations of inorganic phosphate to verify accuracy.
- Likely a combination of:
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The sample size for the training set
- Not specified. This pertains to the analytical performance evaluation rather than a machine learning "training set". The development and validation of the chemical reagents and measurement system would involve various sample types and numbers, but it's not described as a "training set" in the context of typical AI/ML studies.
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How the ground truth for the training set was established
- Not applicable / Not specified in this context. As noted, this is not an AI/ML device with a "training set" in the modern sense. The "ground truth" for developing and validating the chemical assay would rely on established analytical chemistry principles, reference methods, and quality control materials.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle are three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG - 2 1999
A.P. Total Care, Inc. c/o Mr. Luis P. Leon Catachem, Inc. P.O. Box 6216 Bridgeport, Connecticut 06606
Re: K991867 Trade Name: Inorganic Phosphorus (IP) Regulatory Class: I reserved Product Code: CEO Dated: May 27, 1999
Received: June 1, 1999
Dear Mr. Leon:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Toutman
Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510 (k) NUMBER (IF KNOWN): 599 /84)
DEVICE NAME: INORGANIC PHOSPHORUS
(19)
INDICATIONS FOR USE:
The inorganic phosphorus reagents: product No. 112-01 and 112-02 are intended for Invitro The morganic phosphords reagence from the determination of inorganic phosphate in serum, or plasma.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
copy of Device Fuglustion (OFD)
Concurrence of CDRH, Office of Device Evaluation (OED)
Prescription Use (Per 21 CFR 801.109
OR
Over-The-Counter-Use (Optional Format 1-2-96)
§ 862.1580 Phosphorus (inorganic) test system.
(a)
Identification. A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.