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The Osteomark NTx Point of Care (POC) Controls are assayed for the verification of device performance when using the Osteomark NTx POC for the quantitative measure of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine (nM Bone Collagen Equivalents/mM creatinine). The controls are used as consistent test samples of known nM BCE/mM creatinine concentration that may be measured over time as a means of evaluating analytical precision, as well as device performance.

The Osteomark® NTx Point of Care Control Set is a human urine-based, liquid, 2-level control set to be used in quality control procedures with the Osteomark® NTx Point of Care test. The assayed control set is used for evaluating precision and systematic analytical deviations that may arise from reagent or device variations.

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and the study that proves the device meets those criteria:

Device: Osteomark® NTx Point of Care (POC) Control Set

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state numerical acceptance criteria in terms of precision or accuracy targets. Instead, it describes the purpose of the controls and the method used to demonstrate their functionality. The acceptance criteria can be inferred from the study's objective: to demonstrate the control set's ability to evaluate the quality of day-to-day performance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The study used three manufactured lots of the Osteomark® NTx POC Control Set. For each control lot, each of the two control levels was tested six times a day for five days.
  • This equates to: 3 lots * 2 control levels/lot * 6 tests/day * 5 days = 180 data points (measurements).
• Data Provenance: Not explicitly stated, but it is a premarket submission for a medical device in the US, so the study was likely conducted by the manufacturer (Metrika, Inc.) or a contracted lab under their supervision. It appears to be prospective data collection as it describes an evaluation study performed for regulatory submission. Country of origin is not specified for the data itself, but the applicant and reviewer are US-based.

3. Number of Experts Used to Establish Ground Truth for the Test Set and their Qualifications

• This device is a quality control material, not a diagnostic device that requires expert interpretation of results. Therefore, the concept of "ground truth" established by experts in a diagnostic context (like radiologists) does not directly apply here.
• The "ground truth" for a control material is its assigned value (concentration). How these assigned values were originally established for the control lots is not detailed in this 510(k) summary, but it would typically involve rigorous analytical methods and calibration traceable to reference materials.

4. Adjudication Method for the Test Set

• Adjudication methods (e.g., 2+1) are typically used in studies where multiple human readers interpret results and discrepancies need to be resolved.
• Since this study involves the analytical performance of an in vitro diagnostic control, there is no human adjudication method described or typically applicable. The results are quantitative measurements from an instrument.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance?

• No, an MRMC comparative effectiveness study was not done.
• This device is an in vitro diagnostic quality control material. It does not involve human readers interpreting images or data for diagnostic purposes, nor does it incorporate AI. Therefore, concepts like human reader improvement with or without AI assistance are not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• This device is a physical control material, not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not applicable.
• The study does evaluate the device (control set) in a standalone analytical context, meaning its performance characteristics are assessed independently to verify its utility in controlling the main diagnostic assay.

7. The Type of Ground Truth Used

• For the Osteomark® NTx POC Control Set, the "ground truth" for the controls themselves are their known or assigned quantitative concentrations of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine. These values are pre-assigned to the control lots.
• The study then assessed how well the Osteomark® NTx POC device measured these known values from the control set to demonstrate the control set's utility for evaluating the device's performance.

8. The Sample Size for the Training Set

• The 510(k) summary does not mention a "training set" in the context of device development. This is because the Osteomark® NTx POC Control Set is a control material, not an algorithm that requires machine learning training data. There is no algorithm being trained here.
• The study mentioned (testing three lots, etc.) served as the validation/verification study for the control product itself.

9. How the Ground Truth for the Training Set was Established

• As there is no training set for an algorithm, this question is not applicable.
• The ground truth (assigned values/concentrations) for the control materials themselves would be established through a characterization process, including:
  • Analytical testing using established reference methods.
  • Calibration against traceable standards.
  • Statistical analysis to assign a target value and acceptable range.
  • This process is not detailed in the provided summary.

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