(57 days)
The Tandem-MP Ostase Immunoenzymetric Assay is an in vitro device indicated for the quantitative measurement of skeletal alkaline phosphatase (sALP), an indicator of osteoblastic activity, in human serum. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.
Tandem-MP Ostase is an in vitro device for the quantitative measurement of skeletal alkaline phosphatase (sALP) in human serum. The assay is a solid-phase, immunoenzymetric assay. Serum samples containing sALP are reacted in a microwell with the biotinylated capture antibody. Following binding of the biotinylated antibody/antigen complex to the streptavidin coated wells, the microwells are washed and incubated with an enzyme substrate. The captured sALP enzyme turns over the substrate and the amount of sALP bound to the microwell is determined colorimetrically by measuring the absorbance of the quenched reaction at 405 nm in a microplate reader. The calculation of the sALP concentration in the sample is based on concurrent testing of the Ostase Calibrators and Zero/Diluent.
The provided text describes the Tandem-MP Ostase Assay, an in vitro device for measuring skeletal alkaline phosphatase (sALP). However, it is a 510(k) premarket notification and focuses on demonstrating substantial equivalence to a predicate device (Tandem-R Ostase Immunoradiometric Assay, K961573) rather than a study providing acceptance criteria and performance data in the typical sense of a new device validation.
Therefore, many of your requested points cannot be directly extracted from this document, as it's not a performance study report for a novel AI device. This document is a regulatory filing for a laboratory assay.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the given text. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, not necessarily on presenting new, specific acceptance criteria and performance metrics for the new device in isolation. The document states that the Tandem-MP Ostase Assay "is substantially equivalent" to the predicate, implying its performance should be comparable.
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. The text mentions "human serum" as the specimen matrix, but no details about sample size, origin, or study design (retrospective/prospective) are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. This concept (experts establishing ground truth) is more relevant for diagnostic imaging AI studies or studies where subjective interpretation is foundational. For an in vitro diagnostic assay, "ground truth" would typically refer to a gold standard measurement or clinically established normal/abnormal ranges, not expert consensus interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically used in studies where multiple human readers are evaluating data, often for diagnostic imaging, and is not relevant to this type of in vitro diagnostic assay submission.
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 information is not provided. This is an in vitro diagnostic assay, not an AI-powered diagnostic imaging system that would involve human readers. Therefore, an MRMC study is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not explicitly detailed in the way it would be for an AI algorithm. The Tandem-MP Ostase Assay is an immunoenzymetric assay, which is a laboratory test. Its performance is inherent in its chemical and biological reactions and subsequent colorimetric measurement, not in an "algorithm" in the AI sense. The entire assay itself is "standalone" in that it produces a quantitative result from a serum sample without human interpretive assistance for the result itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For an in vitro diagnostic assay like this, "ground truth" would typically refer to:
- Reference Method/Predicate Device Comparison: The text implies comparison to the predicate device (Tandem-R Ostase Immunoradiometric Assay) is the basis for demonstrating equivalence in performance. This predicate device would serve as a de-facto "ground truth" for showing the new device measures the same analyte accurately.
- Clinical Correlation: The device is used as an aid in managing postmenopausal osteoporosis and Paget's disease. The ultimate "ground truth" for clinical utility would be disease progression, response to treatment, or bone mineral density measurements, but the device itself directly measures sALP, which is an indicator of osteoblastic activity. The document doesn't detail how the correlation with clinical outcomes was established for this specific device (Tandem-MP Ostase), but it relies on the predicate's established clinical utility.
Specific details about how "ground truth" was established for testing the new device are not explicitly provided beyond the substantial equivalence claim.
8. The sample size for the training set
This information is not provided. As an in vitro diagnostic assay, it doesn't typically have a "training set" in the machine learning sense. The development and optimization of such assays involve reagent formulation, antibody selection, and protocol refinement, which are different from supervised learning with a data set.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" in the AI/machine learning sense for this type of device.
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.