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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.

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an indicator of osteoblastic activity which is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease

Tandem®-R Ostase® is an in vitro device for the quantitative measurement of skeletal alkaline phosphatase (sALP) in human serum. The assay is a solid-phase, two-site immunoradiometric assay. Samples containing sALP are reacted with a plastic bead (solid phase) that is coated with a monoclonal antibody directed toward a specific site on the sALP molecule and, simultaneously, with a second radiolabeled monoclonal antibody directed toward a different antigenic site on the sALP molecule. Following formation of the solidphase/sALP/radiolabeled antibody sandwich, the bead is washed to remove unbound labeled antibody. The radioactivity bound to the solid phase is measured in a gamma counter. The amount of radioactivity measured is directly proportional to the concentration of sALP in the test sample, which is determined from a standard curve. The standard curve is based on the concurrent testing of Tandem-R Ostase calibrators ranging from 0 to 120 µg sALP/L.

This looks like a 510(k) premarket notification for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trials with strict acceptance criteria found in PMA applications. As such, the provided text does not contain the detailed information you're requesting regarding quantitative performance metrics, study designs, sample sizes, expert involvement, and ground truth establishment in the traditional sense of a clinical validation study.

Here's an analysis based on the provided text, highlighting what can be extracted and what information is missing:

The core of this submission is to demonstrate "substantial equivalence" of the Tandem-R Ostase assay to a previously cleared predicate device (K930810), specifically regarding an expanded indication for use. This means the focus is less on proving absolute performance against a set acceptability standard, but rather showing that it performs as well as or identically to the predicate, and that the new indication does not raise new safety or effectiveness concerns.

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

Based on the provided text, specific quantitative acceptance criteria and detailed device performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard) are not explicitly stated. The primary "acceptance criterion" for this 510(k) is demonstrating substantial equivalence to the predicate device and that the expanded indication poses no new safety or effectiveness issues.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The text mentions "clinical data" but does not quantify the number of patients or samples included in this data.
• Data Provenance: Retrospective/Prospective: Not specified. Country of origin: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not specified. Since this is an in vitro diagnostic (IVD) assay measuring a biomarker (sALP), the "ground truth" would typically relate to accurately measuring sALP concentrations and correlating these with clinical conditions. The text implies the clinical utility of the assay for managing patients, rather than a diagnostic decision that requires expert interpretation of images or complex data. Therefore, there's no mention of experts establishing a ground truth in the way one would for diagnostic imaging.

4. Adjudication method for the test set

• Not applicable/Not specified. Adjudication methods (like 2+1, 3+1) are typically used when subjective interpretations or diagnoses from multiple experts need to be reconciled, such as in imaging studies. For an IVD measuring a quantitative biomarker, this would not be a standard requirement. The "clinical data" mentioned would likely involve correlations between sALP levels and patient management decisions or disease progression, rather than adjudicating diagnostic calls.

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 an in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers interpreting output. Therefore, an MRMC study is not relevant to this type of device.

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

• Partially applicable, but not framed as "standalone performance" in the AI sense. The Tandem-R Ostase assay itself is a standalone laboratory test. Its performance (e.g., analytical accuracy, precision, linearity) is inherent to the assay and doesn't involve a human-in-the-loop for its result generation. The "clinical data" would have been used to demonstrate that the results from this standalone assay are valuable for clinicians in patient management. The text confirms the assay's procedure is "unchanged" from the predicate, implying its standalone analytical performance is equivalent.

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

• Inferred Clinical Outcomes/Management Decisions. The text states that the "clinical data demonstrating that the Tandem-R Ostase assay provides the clinician with information that is of value in the management of patients with postmenopausal osteoporosis and Paget's disease." This suggests the ground truth was related to established clinical diagnoses of these conditions and how the sALP levels (measured by the assay) correlated with patient management strategies or clinical outcomes, rather than a single "ground truth" diagnosis established by pathology or expert consensus for each case. The "value in management" is the key here.

8. The sample size for the training set

• Not applicable/Not specified. This is not a machine learning or AI device that requires a training set in the conventional sense. The "training" for the assay itself would refer to its development and optimization, which isn't described in terms of a data set.

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

• Not applicable. As above, this is not an AI/ML device that uses training data with established ground truth. The "ground truth" for the assay's development would be analytical standards and known concentrations during its chemical and biological development.

In summary: The provided text is a 510(k) summary focused on demonstrating substantial equivalence and expanding an indication for use for an in vitro diagnostic test. It emphasizes that the device's technological characteristics and core intended use (analyte, matrix) are unchanged. The "study" mentioned refers to collecting "clinical data" to support the expanded indications for managing postmenopausal osteoporosis and Paget's disease, but it does not provide the granular detail typically associated with clinical validation studies for novel devices or AI algorithms. The lack of specific quantitative performance metrics, detailed sample sizes, and expert involvement for ground truth adjudication is typical for such a submission where the primary argument rests on equivalence to an already cleared device.

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