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The IDS-iSYS Ostase® BAP assay is an in vitro diagnostic device intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum on the IDS system. Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of postmenopausal osteoporosis and Paget's disease.

The IDS-iSYS Ostase® BAP assay consists of one reagent cartridge and one set of calibrators (CAL A & CAL B).

The reagent cartridge contains multiple reagents:

• MPM1 (Magnetic particles coated with streptavidin in a phosphate buffer with sodium azide as preservative);
• Ab-BIOT Monoclonal anti-BAP labelled with biotin, in buffer containing horse serum with bovine and mouse proteins and sodium azide as a preservative (

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "IDS-iSYS Ostase® BAP." This document is primarily concerned with demonstrating the substantial equivalence of the new device to a predicate device, rather than focusing on the acceptance criteria and study proving performance for an AI/ML-based medical device.

Therefore, the requested information regarding AI/ML-specific acceptance criteria and validation studies (like sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this document because it describes an in vitro diagnostic (IVD) test for quantitative determination of bone-specific alkaline phosphatase, not an AI/ML-driven imaging or diagnostic algorithm.

However, I can extract the relevant performance characteristics that are analogous to "acceptance criteria" for this type of IVD device and the study data proving it meets those.

Device Description

The IDS-iSYS Ostase® BAP assay is an in vitro diagnostic device intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum on the IDS system. Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of postmenopausal osteoporosis and Paget's disease.

1. Table of Acceptance Criteria (Performance Characteristics) and Reported Device Performance

For an in vitro diagnostic device, "acceptance criteria" are typically defined by various analytical performance characteristics that demonstrate the device's accuracy, precision, and reliability for its intended use. While explicit acceptance ranges are not always presented as a separate "criteria" table in a 510(k), the studies conducted implicitly aim to demonstrate performance within acceptable ranges for IVDs. The comparison to the predicate device and adherence to CLSI guidelines are key for demonstrating substantial equivalence.

Here's a table summarizing the analytical performance characteristics and the reported device performance, which serve as the "proof" that the device meets the implied acceptance criteria for an IVD:

• Predicate Within Run: 2.6% to 6.5% (7.4 to 79.5 μg/L)
• Predicate Between Run: 2% to 6.4% (8.4 to 81.1 µg/L) | Repeatability (Within Run):
  From 1.7% to 2.8% in the concentration range 6.2 to 59.8 µg/L (N=80 data points for each sample, for one representative lot).
  From 1.7% to 2.8% for combined 3 lots across samples 1-10 (6.2-59.8 μg/L).
  Within Laboratory (Between Run/Total Precision):
  From 3.0% to 7.6% in the concentration range 6.2 to 59.8 µg/L (N=80 data points for each sample, for one representative lot).
  From 3.0% to 7.2% for combined 3 lots across samples 1-10 (6.2-59.8 μg/L).
  Overall, shows robust precision comparable or improved relative to the predicate. |
  | Linearity / Reportable Range | The assay should demonstrate linearity across its claimed measuring range. Expected a high correlation coefficient (R²) close to 1.0.
• Predicate Range: 0.7 – 90 µg/L. | Linear Range: 0.9 to 78.5 µg/L.
  Measuring (Reportable) Range: 3 to 70 µg/L.
  Regression: Observed = 0.98 x (Expected) - 0.9 ng/mL.
  Regression coefficient R²: 1.00.
  The high R² demonstrates excellent linearity across the range. |
  | Detection Limits (LoB, LoD, LoQ) | Low values for LoB (Limit of Blank), LoD (Limit of Detection), and LoQ (Limit of Quantitation) are desirable to demonstrate the ability to detect very low concentrations of the analyte.
• Predicate: LoD 0.7 µg/L. Other values N/A. | LoB (Limit of Blank): 0.3 µg/L
  LoD (Limit of Detection): 0.4 µg/L
  LoQ (Limit of Quantitation): 0.5 µg/L
  Demonstrates improved or comparable sensitivity to the predicate. |
  | Analytical Specificity (Interference) | Bias due to common interfering substances should be non-significant, typically defined as

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