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510(k) Data Aggregation
(217 days)
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 (<0.1 %)
- -SUBS (p-nitrophenyl phosphate in a stabilising buffer containing preservatives).
Calibrators A and B are buffered bovine protein matrix containing human BAP with sodium azide as preservative (<0.1 %).
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:
| Performance Characteristic | Acceptance Criteria (Implied / Comparator) | Reported Device Performance (IDS-iSYS Ostase® BAP) |
|---|---|---|
| Precision | Typically aims for low %CV (Coefficient of Variation) within and between runs, indicating reproducibility. Compared to predicate: - 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 <10% bias between test and control samples. | Non-significant interference (<10% bias) observed for: Acetaminophen, Alendronate, Bilirubin (Conjugated & Unconjugated), Biotin, Calcium Chloride, Cholesterol, Estradiol, Etidronate, Haemoglobin, HAMA, Ibuprofen, Pamidronate, Progesterone, PTH 1-34, PTH 1-84, Raloxifene, Red Blood Cells, Rheumatoid Factor (RF), Risedronate, Salicylic Acid (Asprin), Salmon Calcitonin, Total Protein, Triglycerides, 25-hydroxyvitamin D. Tested at specified high concentrations (e.g., Bilirubin 40 mg/dL, Biotin 400 ng/mL, Haemoglobin 300 mg/dL etc.). |
| Analytical Specificity (Cross-Reactivity) | Low percent cross-reactivity with structurally similar substances is desired to ensure specificity to BAP. | Low cross-reactivity observed for: - Liver ALP (745 µg/L spiked): 0.1% - Placental ALP (90 U/L spiked): 0.5% - Intestinal ALP (500 µg/L spiked): Undetectable Demonstrates high specificity to BAP. |
| Method Comparison | Strong correlation and agreement with the legally marketed predicate device (Ostase® BAP EIA) is required for substantial equivalence. A slope close to 1.0 and an intercept close to 0, with a high correlation coefficient (r) close to 1.0, are expected. - Predicate comparison to Tandem-R Ostase: slope 1.02, intercept 0.28, r = 0.97. | Comparison against Ostase® BAP EIA: - N: 150 samples - Slope: 0.99 (95% CI: 0.97 to 1.02) - Intercept: 0.17 µg/L (95% CI: -0.1 to 0.5) - Correlation Coefficient (r): 0.99 These results demonstrate excellent agreement and strong correlation, supporting substantial equivalence. |
| Stability | The device should maintain its performance over a defined shelf life. | Shelf Life: 12 months, determined based on real-time studies. |
| Expected Values / Reference Range | Established ranges for different populations. Consistency with established clinical understanding. | Population-specific BAP Concentrations (µg/L) for IDS-iSYS Ostase® BAP: - Males (N=140): Mean 13.7, Median 13.0, Observed Range 7.9 to 23.5 - Pre-menopausal (N=140): Mean 11.5, Median 11.1, Observed Range 5.9 to 20.5 - Post-menopausal (N=139): Mean 15.7, Median 14.3, Observed Range 7.9 to 34.2 These values are consistent with the general understanding of BAP levels in these populations, though laboratories are advised to establish their own ranges. |
Study Details (Based on the Provided Document)
As this is an IVD device, not an AI/ML system, many of the AI/ML-specific questions are not applicable. However, I will address what is implied or directly stated in the context of an IVD submission.
2. Sample Size Used for the Test Set and Data Provenance:
- Precision/Reproducibility:
- 10 native serum samples.
- Each sample assayed 80 replicates (in duplicate, twice per day for 20 days) on one system (representative lot) and 240 replicates (combined from 3 lots, 3 systems).
- Data provenance not explicitly stated (e.g., country of origin, retrospective/prospective), but implied to be laboratory-based analytical studies.
- Linearity:
- Not specified how many serum samples (a high and a low human serum sample were used to create 11 dilutions, but the N for testing these dilutions is not given).
- Detection Limits (LoB, LoD, LoQ):
- LoB: 60 replicates of blank per kit lot (total 180 over 3 lots).
- LoD & LoQ: 10 low BAP concentration samples tested per kit lot (details on number of replicates not fully clear, mentions tested in duplicate for 5 days per lot).
- Analytical Specificity (Interference/Cross-Reactivity):
- For interference: Two serum samples at two different BAP concentrations were spiked with potential interferents. For each condition, 26 replicate assays were performed for spiked and control samples.
- For cross-reactivity: Not explicitly stated, but substances were spiked into serum samples and measured.
- Method Comparison:
- N = 150 samples.
- Samples were "selected to represent a wide range of BAP concentrations [3.0 to 67.6 ug/L]".
- Data provenance not explicitly stated (e.g., country of origin, retrospective/prospective).
- Expected Values/Reference Range:
- N = 419 apparently healthy donors from the United States.
- 140 males (35 to 75 years of age)
- 140 pre-menopausal women (35 to 45 years of age)
- 139 post-menopausal women (55 to 75 years of age).
- This is a prospective collection of reference interval data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable in the AI/ML sense. For IVD tests measuring a biomarker like BAP, the "ground truth" is typically the quantitative value obtained from a reference method or the assigned values of traceable calibrator materials. No human expert "adjudication" or "ground truth labeling" of the BAP level in a sample is described as a part of establishing test set ground truth; rather, it’s about the measured BAP concentration.
- The calibrators for the new device are traceable to the predicate device via internal standards that were value-assigned using the predicate assay procedure. This method of traceability establishes the "truth" for calibration.
4. Adjudication Method for the Test Set:
- Not applicable. As above, for an IVD, the measurement itself is the "truth" within the context of the assay's analytical performance. No human adjudication is involved in determining the concentration of BAP in a blood sample for these types of studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. MRMC studies are specific to image-based diagnostic aids where multiple human readers' performance is evaluated and compared with and without AI assistance. This document describes an in vitro diagnostic assay that quantifies a substance in human serum, not an imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, in essence. For an IVD, the "standalone" performance is the analytical performance of the assay itself – its precision, linearity, detection limits, specificity, and comparison to a predicate device. The performance characteristics described in Section 1 (Precision, Linearity, Detection Limits, Analytical Specificity, Method Comparison) represent the standalone performance of the IDS-iSYS Ostase® BAP assay. It is designed to provide a quantitative result without direct human "interpretation" of the assay's output in the way an AI would assist a radiologist.
7. The Type of Ground Truth Used:
- Analytical Ground Truth (for analytical performance): For precision, linearity, detection limits, and specificity, the "ground truth" refers to:
- The known properties of control materials or spiked samples.
- The measured values from samples used in reproducibility studies.
- The established values/performance of the predicate device (for comparison studies).
- Reference Intervals (for clinical context): For expected values, the "ground truth" is derived from a defined cohort of apparently healthy individuals, and ranges are statistically determined (e.g., 2.5th to 97.5th percentile).
8. The Sample Size for the Training Set:
- Not applicable (in the AI/ML sense). This device is an IVD assay, not an AI/ML model that requires training on a vast dataset. The "training" for an IVD involves assay development, reagent optimization, and establishing manufacturing controls, not statistical model training based on patient data.
- The calibrators for the device are value-assigned using a method traceable to the predicate device. This process involves testing calibrators in multiple runs (minimum 20 assay runs on one system) to determine their assigned values. This could be considered analogous to "training" the assay system to accurately report concentrations based on known standards.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable (in the AI/ML sense). However, for an IVD, the "ground truth" for calibrator and control materials is established through:
- Traceability: The IDS-iSYS Ostase® BAP kit calibrators are value assigned against in-house secondary standards (IRs). These IRs are themselves value assigned against the predicate device (Ostase® BAP EIA assay) using the predicate assay procedure. This establishes traceability to a previously cleared, legally marketed device.
- Verification: The assigned kit calibrator values are then verified by running the assay on three different IDS systems and analyzing internal quality control (IQC) samples of known values across the range of the assay.
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