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The IDS Cortisol assay is an in vitro diagnostic device intended for the quantitative determination of cortisol in human serum and plasma on the IDS system. Results are to be used in conjunction with other clinical and laboratory data to assist clinicians in the diagnosis and treatment of disorders of the adrenal gland.

The IDS Cortisol assay consists of a reagent cartridge. The reagent cartridge contains multiple reagents:

• MPE1:Magnetic particles coated rat anti-mouse monoclonal antibody in a phosphate buffer with Proclin as preservative.
• CONJ: Cortisol coupled with an acridinium ester derivative in = phosphate buffer with Proclin as a preservative.
• mAb: Mouse anti-cortisol monoclonal antibody in phosphate buffer with Proclin as a preservative .;
• BUF: HEPES buffer containing Proclin as preservative .

This document describes the analytical performance of the IDS Cortisol assay, an in vitro diagnostic device, and demonstrates its substantial equivalence to a predicate device (Roche Elecsys Cortisol II). The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this in vitro diagnostic device are primarily based on demonstrating analytical performance that is comparable to, or meets specified standards relative to, established laboratory methods and a predicate device.

• 0.94 µg/dL: 7.8% CV
• 1.84 µg/dL: 4.6% CV
• 5.75 µg/dL: 2.4% CV
• 13.06 µg/dL: 2.4% CV
• 19.94 µg/dL: 1.8% CV
• 44.63 µg/dL: 1.9% CV
  |
  | | Intermediate Precision (Within-System/Total): Lower CV% | Within-System (n=80 per sample, 1 lot, 1 system):
• 0.94 µg/dL: 16.2% CV
• 1.84 µg/dL: 10.9% CV
• 5.75 µg/dL: 5.2% CV
• 13.06 µg/dL: 3.9% CV
• 19.94 µg/dL: 5.1% CV
• 44.63 µg/dL: 4.2% CV
  Total (Combind 3 lots, 3 systems, n=240 per sample):
• 0.88 µg/dL: 15.3% CV
• 1.78 µg/dL: 10.1% CV
• 5.75 µg/dL: 4.5% CV
• 13.09 µg/dL: 3.3% CV
• 20.22 µg/dL: 4.8% CV
• 44.48 µg/dL: 5.0% CV |
  | Linearity/Reportable Range | Data should demonstrate linearity across the claimed measuring range. | Measuring Range: 0.59 to 45.00 µg/dL.
  Regression: Observed = 1.01 * Expected + 0.01 µg/dL; R²: 1.00
  (Accepted based on R² close to 1 and slope ~1, intercept ~0) |
  | Detection Limits (LoB, LoD, LoQ) | Specific quantifiable low limits. | LoB: 0.10 µg/dL
  LoD: 0.24 µg/dL
  LoQ: 0.59 µg/dL |
  | Analytical Specificity (Interference) | Non-significant bias (

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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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The IDS SHBG assay is an in vitro diagnostic device intended for the quantitative determination of SHBG in human serum or plasma on the IDS System. Results are to be used as an aid in the diagnosis of androgen disorders

The IDS SHBG assay is an in vitro diagnostic device intended for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the IDS-iSYS Multi-Discipline Automated System. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the diagnosis of androgen disorders.

The assay is based on chemiluminescence technology. 5 uL of patient sample or calibrators are incubated with biotinylated monoclonal anti-SHBG antibody, an acridinium labelled monoclonal anti-SHBG conjugate and streptavidin labelled magnetic particles. The magnetic particles are captured using a magnet and a wash step performed to remove any unbound analyte. Trigger reagents are added; the resulting light emitted by the acridinium label is directly proportional to the concentration of analyte in the original sample.

The IDS SHBG assay is an in vitro diagnostic device consisting of ready to use reagents provided in individual compartments within the reagent cartridge.

The reagent cartridge contains:

• Magnetic particles magnetic particles coated with streptavidin in a phosphate buffer containing preservatives
• -Biotin antibody - monoclonal anti-SHBG labelled with biotin in a buffer containing proteins and preservatives
• Conjugate monoclonal anti-SHBG labelled with an acridinium ester derivative in a buffer containing proteins and preservatives The calibrators consist of:
• Calibrators A and B are included in the assay kit. The calibrators consist of a human serum matrix with defined concentrations of SHBG and preservatives. Together with a lot specific master calibration curve, the calibrators will be used to perform adjustment of the master calibration curve.

The provided document is a 510(k) summary for the IDS SHBG assay, an in vitro diagnostic device for the quantitative determination of Sex Hormone Binding Globulin (SHBG). The document details the device's performance characteristics and compares it to a predicate device to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Key Takeaway: This document describes the validation of an in vitro diagnostic (IVD) assay, not an AI/ML-based diagnostic device that typically involves human readers or image analysis. Therefore, many of the requested categories (e.g., number of experts, adjudication method, MRMC studies, human reader improvement with AI, standalone AI performance) are not applicable to this type of device and study. The ground truth in this context is established by reference methods or validated reference materials, typical for IVD assays.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several analytical performance characteristics that serve as "acceptance criteria" for the IDS SHBG assay. These are primarily related to the accuracy, precision, limits of detection, and specificity of the assay.

• Triglycerides: up to 3000 mg/dL
• Haemoglobin: up to 500 mg/dL
• Bilirubin (conjugated/unconjugated): up to 40 mg/dL
• Total Protein: up to 12 g/dL
• Biotin: up to 6000 ng/mL (and 1500 ng/mL)
• Rheumatoid Factor: up to 7000 IU/mL
• HAMA: up to 3000 ng/mL
• Cholesterol: up to 456 mg/dL
• Various common drugs (e.g., Acetaminophen, Ibuprofen, Ascorbic acid, Creatinine, Dopamine, Tetracycline, Tolbutamide, Tolazamide, Uric Acid). |
  | Analytical Specificity (Cross-Reactivity) | No significant cross-reactivity with structurally similar compounds or other biological substances up to tested concentrations. | Low/No significant cross-reactivity observed (50y:** 14.85 – 65.21 nmol/L (n=180)
  Premenopausal Females: 20.30 – 140.18 nmol/L (n=206)
  Postmenopausal Females: 11.30 – 127.31 nmol/L (n=120)
  (Based on 671 apparently healthy adults from the United States). |

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

• Precision/Reproducibility: 14 serum-based samples at different SHBG concentration levels covering the assay range. Tested across 21 days for one kit lot. (Table 11 shows individual sample IDs, CTLs, CALBs, IQCs)
• Linearity/Assay Reportable Range:
  • Linearity: A high human serum sample and a low human serum sample, plus 14 evenly spaced dilutions created by mixing high and low samples.
  • Automated Post-dilution Accuracy: 9 native samples with known SHBG concentrations obtained from the predicate device.
• Traceability of Calibrator:
  • Value assignment of Internal Reference Standards (IRs): At least 24 runs using three iSYS instruments, 2 kit lots, 3 replicates for each run. Serial dilutions of WHO 2nd international standard 08/266 used.
  • Value assignment of kit calibrators: At least 20 runs (14 runs using previous IR lot, 6 runs using international standard) using one iSYS instrument, 2 replicates for each run.
  • Value assignment verification: Internal quality controls at 3 SHBG levels tested in five replicates in one run and on each of three different iSYS instruments.
  • Correlation study (2-point calibration vs. IS 08/266 curve): 189 samples (139 serum, 50 K2 EDTA plasmas). Tested in two replicates using three lots (MB1, MB2, MB3) on one iSYS instrument.
• Detection Limit (LoB, LoD, LoQ):
  • LoB: LoB sample run in 12 replicates for each of 5 runs over 3 days, by one operator, on one different instrument for each of 3 manufacture batches (MB1, MB2B, MB3) = total 60 replicates per lot.
  • LoD: 7 LoD samples measured in duplicate. For each of 3 kit lots, 5 assays over 3 days by one operator on a different instrument = total 70 replicates per lot.
  • LoQ: Panel of 9 samples measured in singlicate two times per day. For each of 3 kit lots, 10 assays over 5 days by one operator on a different instrument = total 90 replicates per lot.
• Analytical Specificity (Interference): Two serum samples (low and high SHBG conc.) spiked with potential interferents. Control samples were also run. Number of replicates for each specific test not detailed but implied to be sufficient for statistical comparison.
• Analytical Specificity (Cross-Reactivity): Low and high SHBG samples spiked with various cross-reactants. Number of replicates for each specific test not detailed.
• Method Comparison: 136 samples, selected to represent a wide range of SHBG concentrations (2.54 - 172.12 nmol/L).
• Matrix Comparison: 69 samples (68 native, 1 diluted) covering a range of 0.51 to 238.45 nmol/L.
• Expected Values/Reference Range: 671 serum samples from apparently healthy adults (21-77 years old). Data Provenance: From the United States. Retrospective/Prospective: Not explicitly stated, but typically such studies for establishing reference ranges are retrospective collections of banked samples or a prospective study designed to collect samples from a healthy population.

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

Not Applicable (N/A).

This is an in vitro diagnostic (IVD) assay quantifying a biomarker (SHBG). "Ground truth" for an IVD assay is established through:

• Reference Methods: Such as the WHO 2nd international standard 08/266 for SHBG, against which the calibrators are standardized.
• Known Concentrations: Use of accurately prepared standards, spiked samples, or samples extensively characterized by reference methods.
• Clinical Data: For expected values, SHBG concentrations are measured in samples from defined healthy populations.

Therefore, the concept of "experts establishing ground truth" in the way it applies to image interpretation or AI-assisted diagnostics (e.g., radiologists labeling images) is not relevant here. The ground truth is analytical and based on metrological traceability to international standards.

4. Adjudication Method for the Test Set

N/A.

Adjudication methods (like 2+1, 3+1) are relevant for subjective interpretations (e.g., radiology reads) where discrepancies between readers need to be resolved to establish a definitive ground truth. For a quantitative IVD assay like IDS SHBG, the "reading" is a numerical output from the instrument based on chemical reactions. Accuracy is determined by comparison to reference materials or established methods, not by human adjudication of interpretations.

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

N/A.

This is an IVD assay, not an AI/ML diagnostic for human interpretation. No MRMC study or human reader improvement with AI assistance is applicable.

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

N/A.

This is not an AI/ML algorithm. The "device" is a fully automated immunoassay system (IDS-iSYS Multi-Discipline Automated System) that performs the biochemical analysis and reports a quantitative result without human "interpretation" of a signal beyond reading the numerical output. Its performance is evaluated as a standalone analytical system.

7. The Type of Ground Truth Used

The ground truth for the analytical performance studies (precision, linearity, detection limits, specificity, method comparison) is based on:

• International Reference Standards: Specifically, the WHO 2nd international standard for SHBG (IS 08/266) for traceability and calibration. This is the primary reference.
• Known Concentrations/Spiked Samples: Samples with defined, known concentrations of SHBG or interferents, prepared in a laboratory setting.
• Comparison to a Legally Marketed Predicate Device: The Siemens ADVIA Centaur SHBG assay (K151986) was used as a comparative method to assess agreement and accuracy (e.g., for method comparison and automated dilution accuracy).
• Healthy Population Data: For expected values/reference ranges, a large cohort of apparently healthy individuals were tested to establish population-specific normal ranges.

8. The Sample Size for the Training Set

N/A (for AI/ML 'training set' in the traditional sense).

For an IVD assay, the equivalent of a "training set" would be the samples and calibrators used during the assay's development and optimization phases to set parameters, establish reagent formulations, and fine-tune the system. This information is typically proprietary development data and is not explicitly detailed as a 'training set' in 510(k) summaries, which focus on the final validation/test data.

The closest analogous "training" or "calibration" process mentioned is the traceability and value assignment of calibrators:

• Value assignment of secondary standards (IRs) involves at least 24 runs (using 3 instruments, 2 kit lots, 3 replicates) comparing to the WHO international standard.
• Value assignment of IDS SHBG kit calibrators A and B involves at least 20 runs (1 instrument, 2 replicates) using the secondary standards and IS-08/266.
  These processes are used to establish the calibration curve for the assay.

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

N/A (for AI/ML 'training set').

As explained in point 8, the concept of a "training set" for an IVD assay is different from that for AI/ML. The "ground truth" for establishing the calibration and parameters of the assay is based on:

• Metrological traceability to the WHO 2nd international standard for SHBG (IS 08/266). This involved serial dilutions of the international standard in SHBG-depleted human serum to create reference points.
• Use of internal reference calibrators (IRs) that were themselves value-assigned against the WHO standard.

The goal is that the assay's measurements accurately reflect the true concentration of SHBG as defined by an international reference.

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The IDS-iSYS Intact PTH+ assay is an in vitro diagnostic device intended for the quantitative determination of intact PTH in human serum or plasma on the IDS-iSYS Multi-Discipline Automated System. Results are to be used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.

The IDS-iSYS Intact PTH" assay is based on chemiluminescence technology. 100 uL of patient sample is incubated with a biotinylated polyclonal anti-PTH (39-84) antibody and an acridinium labelled PTH (13-34) antibody. Streptavidin labelled magnetic particles are added prior to a second incubation step. The magnetic particles are captured using a magnet and a wash step performed to remove any unbound analyte. Trigger reagents are added; the resulting light emitted by the acridinium label is directly proportional to the concentration of Intact PTH in the original sample.

IDS-iSYS Intact PTH reagent kit consists of one (1) Immunoassay Cartridge, two (2) vials each of 2 concentration Calibrator levels and a mini-CD containing the Instructions For Use (IFU), CRY files and Certificate of Analysis.

IDS-iSYS Intact PTHN Cartridge, sufficient for 100 tests, consists of reagents provided in individual compartment within a plastic container called the Cartridge. The IDS-iSYS Intact PTHN Cartridge contains the following ready to use reagents:

• · Magnetic particles coated with streptavidin in a phosphate buffer containing sodium azide as preservative (1% (w/w%).
• · Calibrator B: Two vials of lyophilized porcine serum matrix buffer containing high level PTH and sodium azide as preservative >1% (w/w%).

The submission is due to a new source of antibody for the assay.

This document describes the performance characteristics of the IDS-iSYS Intact PTHN assay, an in vitro diagnostic device for quantitative determination of intact PTH.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets but are implicitly defined by the reported performance and the comparison to the predicate device. The information below summarizes the performance characteristics provided, which in a regulatory context, demonstrate the device meets its intended use and is substantially equivalent to the predicate.

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The IDS iSYS 25 VilD assay is intended for the quantitative determination of total 25-hydroxyvitamin D (125(OH)D) in hyman serum or plasma on the IDS iSYS Multi-Discipline Automated System. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in an adult population.

The IDS-iSYS 25 VitD Control Set is used for quality control of the IDS-iSYS 25 VitD assay on the IDS-iSYS Multi-Discipline Automated System.

The IDS-iSYS 25 VitDs reagent kit consists of one (1) Immunoassay Cartridge, one (1) vial each of 2 concentration Calibrator levels and a mini-CD containing the Instructions For Use (IFU), CRY files and Certificate of Analysis.

IDS-iSYS 25 VitDS Cartridge, sufficient for 100 tests, consists of reagents provided in individual compartment within a plastic container called the Cartridge. IDS-iSYS 25 VitDS Cartridge contains the following ready to use reagents:

• Magnetic particles coated with streptavidin in a phosphate . buffer containing sodium azide.
• . Sodium hydroxide solution.
• . 25(OH)D labelled with an acridinium ester derivative, in buffer containing bovine serum albumin with sodium azide.
• . Anti-25(OH)D sheep polyclonal antibody labelled with an biotin, in buffer containing bovine, sheep and mouse proteins and sodium azide.
• . Assay buffer containing proprietary displacing compounds, methanol and sodium azide.

The IDS-iSYS 25 VitD® Calibrators are included in the reagent kit. The ready to use calibrators contains human serum buffer matrix with two defined concentrations of 25(OH)D and sodium azide as preservative (

The provided document describes the IDS-iSYS 25VitD8 assay, a device for the quantitative determination of total 25-hydroxyvitamin D [25(OH)D] in human serum or plasma. Below is an analysis of its acceptance criteria and the studies performed.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for all performance characteristics in a single, consolidated table. However, it presents performance data for various analytical characteristics, and in some cases, implicitly defines acceptable ranges or desired outcomes for these studies. For instance, in the specificity study, an acceptance criterion of "

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IDS-iSYS 17-OH Progesterone Control Set
The IDS-iSYS 17-OH Progesterone Control Set is for in vitro diagnostic use, for the quality control of the IDS-iSYS 17-OH Progesterone on the IDS-iSYS Multi-Discipline Automated System.
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IDS-iSYS 17-OH Progesterone Calibration Verifiers
The IDS-iSYS 17-OH Progesterone Calibration Verifiers are an in vitro diagnostic device intended for medical purposes in the quantitative verification of assay calibration and measuring range of the IDS-iSYS 17-OH Progesterone assay, when performed on the IDS-iSYS Multi Discipline Automated System.
Rx Only.

The IDS-iSYS 17-OH Progesterone Control Set consists of Two sets of three vials, 1.0 mL each in liquid form. Human serum containing 17-OH Progesterone and sodium azide as a preservative (

The provided text describes the acceptance criteria and supporting studies for two in vitro diagnostic devices: the IDS-iSYS 17-OH Progesterone Control Set and the IDS-iSYS 17-OH Progesterone Calibration Verifiers.

1. Table of acceptance criteria and the reported device performance:

• Precision: CV ≤ 10% for low concentration, ≤ 8% for middle and high concentration | - Accelerated stability studies (CLSI guideline EP25-A) support a stability claim of 9 months when stored at 2-8°C.
• Real-time studies are ongoing. (No explicit statement if current readings meet the mean concentration and precision criteria for the 9-month claim, only that it "supports" it). |
  | Open Vial Stability | Percent recoveries within 10% of the reference material concentration. | Data supports the open vial stability claim of 49 days when stored at 2-8°C. (Implies the 10% recovery criterion was met). |
  | On-Board Stability | Compared to a reference material run at time 0. (Specific quantitative criteria not explicitly stated, assumes comparison ensures acceptable performance.) | The on-board stability data supports the claimed on-board stability of 4 hours. (Implies acceptable comparison results). |
  | Calibration Verifiers | | |
  | Value Assignment | Assigned target value defined as the mean of all runs for the IDS-iSYS 17-OH Progesterone assay and analyzer. | Expected values: Cal Ver 0: Undetectable, Cal Ver 1: 2.0 ng/mL, Cal Ver 2: 8.0 ng/mL, Cal Ver 3: 17.0 ng/mL. (Similar to control set, implies these were achieved.) |
  | Closed Vial Stability | - Mean concentration must be within QC ranges (as stated in Certificate of Analysis)
• Precision: CV ≤ 10% for low concentration, ≤ 8% for middle and high concentration | - Accelerated stability studies (CLSI guideline EP25-A) support a stability claim of 9 months when stored at 2-8°C.
• Real-time studies are ongoing. (No explicit statement if current readings meet the mean concentration and precision criteria for the 9-month claim, only that it "supports" it). |
  | On-Board Stability | Compared to a reference material run at time 0. (Specific quantitative criteria not explicitly stated, assumes comparison ensures acceptable performance.) | The on-board stability data supports the claimed on-board stability of 4 hours. (Implies acceptable comparison results). |

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

• IDS-iSYS 17-OH Progesterone Control Set - Value Assignment:
  • Sample Size: A minimum of 21 runs using cartridge batches (number of batches not specified) tested in triplicate on each of three IDS-iSYS Multi Discipline Automated Systems. Control solutions were prepared gravimetrically.
  • Data Provenance: Not explicitly stated as retrospective or prospective, nor country of origin. Given it's a device manufacturer's study to establish product characteristics, it's inherently prospective in nature.
• IDS-iSYS 17-OH Progesterone Control Set - Stability (All types):
  • Closed Vial (Real-time): Three lots of controls, tested in pentaplicate (5 replicates) at 2-month intervals for up to a minimum of 15 months. Each tested vial compared to reference material stored at -20°C.
  • Closed Vial (Accelerated): Performed according to CLSI guideline EP25-A.
  • Open Vial: Tested in duplicate at time points stated in the stability protocol (time points not detailed), against unopened vials.
  • On-Board: Three batches of controls, using three IDS-iSYS instruments. Tested at 0, 2, 4, 6, and 8 hours compared to a reference material at time 0.
  • Data Provenance: Same as above, likely prospective internal testing.
• IDS-iSYS 17-OH Progesterone Calibration Verifiers - Value Assignment:
  • Sample Size: Minimum of five runs for each cartridge batch (number of batches not specified) tested in triplicate on each of three IDS-iSYS Multi Discipline Automated Systems. Calibration Verifier solutions were prepared gravimetrically.
  • Data Provenance: Same as above, likely prospective internal testing.
• IDS-iSYS 17-OH Progesterone Calibration Verifiers - Stability (Closed Vial & On-Board):
  • Closed Vial (Real-time): Three lots of calibration verifiers, tested in pentaplicate (5 replicates) at 2-month intervals for up to a minimum of 15 months.
  • Closed Vial (Accelerated): Performed according to CLSI guideline EP25-A.
  • On-Board: Three batches of calibration verifiers, using three IDS-iSYS instruments. Tested at 0, 2, 4, 6, and 8 hours compared to a reference material at time 0.
  • Data Provenance: Same as above, likely prospective internal testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This device is an in vitro diagnostic (IVD) quality control material and calibration verifier for automated systems, not an imaging AI device. The "ground truth" here refers to the reference values established for the control and calibration materials themselves, rather than diagnosis or interpretation by human experts.

• Value Assignment: The "ground truth" (assigned target values) for both the control set and calibration verifiers is established by the mean of all runs from multiple tests on three IDS-iSYS Multi Discipline Automated Systems, using cartridge batches, and confirmed by immunologic analysis using the IDS-iSYS 17-OH Progesterone assay. The solutions themselves are prepared gravimetrically from intermediate stock solutions.
• There are no "experts" in the traditional sense (e.g., radiologists) involved in establishing the ground truth for this type of chemical/immunological assay. The ground truth relies on the precision and accuracy of the analytical methods and the instrument itself.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This is not a study involving human interpretation or subjective assessment of data that would require an adjudication method. The device's performance is determined by quantitative measurements and statistical analysis against predefined criteria.

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 device is an IVD quality control and calibration material, not an AI-powered diagnostic tool for human readers. No MRMC study was conducted or is relevant for this product.

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

Yes, the studies are inherently standalone as they evaluate the performance of the control and calibration materials on the IDS-iSYS Multi-Discipline Automated System. The system/assay performs the measurements without human intervention in the interpretation of the control/verifier results themselves beyond setting up the experiment and analyzing statistical compliance. The performance reported (e.g., mean concentration, CV, percent recovery) is that of the material as measured by the automated system.

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

The ground truth used is based on:

• Gravimetric preparation: For the initial stock solutions and preparation of control/calibration verifier samples.
• Immunologic analysis: Confirmation of concentrations using the IDS-iSYS 17-OH Progesterone assay itself.
• Statistical averaging: The mean of multiple runs on multiple instruments to establish the assigned target values, treated as the reference ground truth for quality control and calibration verification.
• Reference material comparison: For stability studies, comparison to a reference control material stored under optimal conditions (-20°C).

This is a form of analytical ground truth derived from established quantitative laboratory methods and statistical analysis rather than clinical consensus or pathological diagnosis.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set. The values and stability characteristics are determined through direct analytical testing, not model training.

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

Not applicable. As there is no training set for an AI/machine learning model, no ground truth needed to be established for it.

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The 25-Hydroxy Vitamin DS EIA assay is intended for the quantitative determination of 25-hydroxyvitamin D [25(OH)D] and other hydroxylated metabolites in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in an adult population.

The 25-Hydroxy Vitamin De EIA is a manual assay test and does not require the use of an automated system. The whole assay is performed in a microtitre plate and requires a user to perform each step. The 25-Hydroxy Vitamin De assay is an enzymeimmunoassay for the quantitation of 25(OH)D and other hydroxylated metabolites in serum or plasma. 25uL of each calibrators, controls and samples are diluted with biotin labelled 25(OH)D. The diluted samples are incubated in microtitre wells which are coated with a highly specific sheep 25(OH)D at room temperature before aspiration and washing. Enzyme (horseradish peroxidase) labelled avidin, is added and binds selectively to complexed biotin and, following a further wash step, colour is developed using a chromogenic substrate (TMB). The absorbance of the stopped reaction mixtures are read in a microtitre plate reader, colour intensity developed being inversely proportional to the concentration of 25(OH)D.

The provided document describes the performance characteristics of the 25-Hydroxy Vitamin D EIA assay, but it focuses on analytical and comparative performance rather than a study proving the device meets general acceptance criteria in a clinical setting with human readers. The document is for an in-vitro diagnostic (IVD) device, so the criteria and studies described are relevant to laboratory performance.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text, adapted for an IVD context where appropriate:

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

For IVD devices, "acceptance criteria" are usually internal performance goals set by the manufacturer to demonstrate analytical and clinical performance required for regulatory clearance. The document lists several performance characteristics and provides the corresponding measurements for the candidate device and, in some cases, the predicate device.

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The IDS-iSYS Aldosterone assay (IS-3300) is a device intended for use in clinical laboratories for the quantitative determination of Aldosterone in human EDTA plasma on the IDS-iSYS Multi-Discipline Automated System. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by excessive secretion of Aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hyperaldosteronism, edematous states and other conditions of electrolyte balance.

The IDS-iSYS Aldosterone Control Set (IS-3330) is intended for use as assaved quality control samples to monitor the accuracy of the IDS-iSYS Aldosterone assay on the IDS-iSYS Multi-Discipline Automated System.

The IDS-iSYS Aldosterone Calibration Verifiers (IS-3335) are intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS Aldosterone assay on the IDS-iSYS Multi-Discipline Automated System.

The IDS-iSYS Aldosterone assay is based on chemiluminescence technology. A biotinylated monoclonal anti-Aldosterone antibody is incubated with the sample, after an incubation step an Aldosterone acridinium conjugate is added and after a further incubation step streptavidin coated magnetic particles are added. Following a third incubation step the particles are "captured" using a magnet. After a washing step and addition of trigger reagents, the light emitted by the acridinium label is inversely proportional to the concentration of Aldosterone in the original sample.

Here's an analysis of the provided text to extract the requested information about acceptance criteria and the supporting study:

The provided document is a 510(k) Summary for the IDS-iSYS Aldosterone assay, control set, and calibration verifiers. It focuses on demonstrating substantial equivalence to a predicate device, as required for FDA clearance. The document details performance characteristics but does not explicitly state acceptance criteria in a pass/fail format typical of formal acceptance criteria documents. Instead, it reports performance values found during validation studies.

Here's the breakdown of the information you requested, based on what's available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit "acceptance criteria" are not listed in a single table. However, the performance characteristics are reported, and implicitly, these values are considered acceptable for demonstrating substantial equivalence. The table below compiles the reported performance data from the document.

Note: The document does not provide a column for "Acceptance Criteria" as a separate, pre-defined target. The "Reported Device Performance" is the outcome of the studies aiming to demonstrate acceptable performance.

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

• Precision/Reproducibility:

  • Sample Size: Six EDTA plasma samples (9 "samples" were run over 20 days, generating 80 replicates per sample concentration).
  • Data Provenance: Not explicitly stated, but clinical laboratory setting is implied. The phrase "two sites using three analyzers" could suggest multi-center testing, potentially from different locations/countries, but this is not specified. The studies were performed for the manufacturer for regulatory submission.

• Linearity/Assay Reportable Range:

  • Sample Size: One high plasma sample diluted with a low sample to create 11 dilution samples. Run in quadruplicate.
  • Data Provenance: Not specified, likely internal laboratory data for the manufacturer.

• Detection Limit (LoB, LoD, LoQ):

  • Sample Size:
    • LoB (Lot 1): One zero-aldosterone plasma sample, 10 replicates for 5 days (total 50 replicates).
    • LoD/LoQ (Lot 1): 7 samples, 2 replicates per sample, once per day for 8 days.
    • LoB (Lot 2): One zero-aldosterone plasma sample, 6 replicates for 5 days (total 30 replicates).
    • LoD (Lot 2): 8 samples, 2 replicates per sample, once per day for 5 days.
    • LoQ (Lot 2): 7 samples, 2 replicates per sample, once per day for 5 days.
  • Data Provenance: Not specified, likely internal laboratory data for the manufacturer. Two different sites and two different analyzers were used.

• Analytical Specificity (Interference and Cross-Reactivity):

  • Sample Size:
    • Interference: Two base plasma samples ("Low" and "High" Aldosterone concentrations), spiked with various potential interferents. For each interferent, 26 replicates for blank and spiked samples were compared.
    • Cross-reactivity: Stock solutions of various compounds diluted serially to create 7-point standard curves for each substance.
  • Data Provenance: Not specified, likely internal laboratory data for the manufacturer.

• Method Comparison:

  • Sample Size: 161 samples (including 12 altered samples).
  • Data Provenance: Not specified, implied to be clinical or patient samples. Whether these were retrospective or prospective, or their country of origin, is not mentioned.

• Reference Range Study (Expected Values):

  • Sample Size: 228 Caucasian adult samples.
  • Data Provenance: Collected in the US, prospective (samples collected under specific conditions: 7-10 am after overnight fasting, upright/supine positions).

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

This type of information is generally NOT applicable to in vitro diagnostic (IVD) devices like the Aldosterone assay described. For IVD assays, "ground truth" is typically established by:

• Reference methods/predicate devices (e.g., Diasorin Liaison Aldosterone assay for method comparison).
• Gravimetric preparation of standards and calibrators for traceability.
• Defined sample characteristics (e.g., "zero aldosterone plasma," "high plasma sample").

There were no human experts assessing images or making diagnoses that would require adjudication.

4. Adjudication Method for the Test Set

Not applicable, as this is an IVD assay, not a device requiring human interpretation of results in a diagnostic context that would call for adjudication of different interpretations.

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 IVD assay for quantitative determination of a biomarker; there are no "human readers" interpreting results in the way an MRMC study would be designed for an imaging AI device.

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

Yes, the studies conducted (Precision, Linearity, LoD/LoQ, Analytical Specificity, Method Comparison) represent the standalone performance of the IDS-iSYS Aldosterone assay system. The device quantifies aldosterone in plasma samples directly, without human interpretation of results being a variable in its core analytical performance.

7. The Type of Ground Truth Used

The ground truth used for various studies includes:

• Reference materials: Aldosterone (≥95% HPLC; A9477Sigma-Aldrich) dissolved in Dioxane, with concentration calculated by UV quantitation using molar extinction coefficient (for calibrators and traceability).
• Predicate device results: The Diasorin Liaison Aldosterone assay (K130321) for method comparison.
• Spiked samples: For linearity, interference, and cross-reactivity studies, known concentrations of analyte or interferents were added to base samples to create "true" concentrations.
• Patient samples: For method comparison and reference range studies, patient samples were used. Their "truth" for method comparison was established by the predicate device. For reference ranges, the "truth" was the measured value distributed among a healthy population.

8. The Sample Size for the Training Set

The document describes performance studies (validation) but does not explicitly mention a "training set" in the context of machine learning. For an IVD assay, the development process involves reagent optimization, calibration curve fitting, etc., which conceptually use data, but this is not typically termed a "training set" like in AI/ML.

However, the "Master curve" and "two-point calibration" system is mentioned. The "logistic parameters of the Master calibration curve" are generated using "data of 20 runs Internal Reference Calibrators" (p.9). This could be considered analogous to a training process for establishing the core measurement algorithm, but it's not a training set for an AI inference model.

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

If we consider the generation of the "Master calibration curve" as a "training" process:

• Ground Truth: The "Internal Reference Calibrators" referenced (p.9) would serve as the ground truth. These calibrators are traceable to gravimetrically prepared Aldosterone standards using high-purity Aldosterone and UV quantitation (p.9).
• Establishment Method: The "new kit calibrator sets are run as 'unknowns' in duplicate in at least 20 assays on one analyser" (p.9). "The data of 20 runs Internal Reference Calibrators are used to generate the logistic parameters of the Master calibration curve by using Prism software package" (p.9).

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The IDS-iSYS CTX-1 (CrossLaps ®) Calibration Verifiers is a device intended for the verification of the IDS-iSYS CTX-I (CrossLaps ®) Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer

The IDS-iSYS CTX-I (CrossLaps®) Calibration Verifiers consists of one set of four vials, 2.5 mL each in liquid form, containing horse serum with

The document is a 510(k) Summary for the IDS-iSYS CTX-I (CrossLaps®) Calibration Verifiers, a device intended for the verification of calibration of the IDS-iSYS CTX-I (CrossLaps®) Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.

Here's an analysis of the provided information to answer your request:

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

The document does not explicitly state "acceptance criteria" for the device's performance in a table format. Instead, it defines the "Target Range" for each Calibration Verifier level, derived from the mean ± 2 standard deviations during value assignment. This target range implicitly serves as the acceptance criteria for individual measurements when verifying calibration.

Note: The "Reported Device Performance" here is the target mean derived during the value assignment process, which aligns with the center of the acceptance range. The study ensures that the device can consistently achieve these target means and fall within the defined ranges.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes the "value assignment" process, which functions as the primary method for establishing the performance characteristics and implicitly, the "test set" for the verifiers.

• Sample Size: "Each lot-specific value assignment was tested in five runs on at least three different IDS-iSYS analyzers in triplicate, for a total of 45 replicates." This refers to 45 individual measurements for each calibrator verifier (Cal. Ver. 0, 1, 2, 3).
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given that Immunodiagnostic Systems Ltd is based in the United Kingdom, it's likely the studies were conducted there. The value assignment process described suggests a prospective study design for establishing lot-specific values.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of device. The device is a "Quality control material (assayed and unassayed)" for an in vitro diagnostic assay. Its "ground truth" (target values) is established through rigorous analytical testing and standardization against in-house reference standards, not by human expert interpretation of signals or images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As explained in point 3, the ground truth is established through analytical methods, not through expert adjudication.

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 not a study involving human readers or AI assistance. The device is a calibration verifier for an automated immunoassay.

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

This refers to the performance of the IDS-iSYS CTX-I assay on the IDS-iSYS Multi-Discipline Automated Analyzer when calibrated and verified using these verifiers. The "value assignment" study described is a standalone performance assessment of the verifiers themselves, demonstrating their ability to consistently produce expected concentration values within a statistically defined range. The objective of the verifiers is to ensure the assay's standalone performance is accurate.

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

The "ground truth" for the calibrator verifiers is their assigned concentration values, which are established through:

• Standardization against in-house reference standards (CTX-I in horse serum).
• Derivation from the mean of multiple replicates across multiple runs and instruments. The target ranges (e.g., 0.12 - 0.16 ng/mL for Cal. Ver. 1) are determined statistically (mean ± 2SD).

8. The sample size for the training set

This concept is not directly applicable to a calibration verifier in the same way it would be for an AI algorithm. The "training" here refers to the process of standardizing the manufacturing of the verifiers and establishing their lot-specific values. The "value assignment" study (45 replicates per verifier level) serves to establish these "ground truth" values and ranges.

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

For each lot, the "ground truth" (target mean values and ranges) was established through:

• Extensive testing: "Each lot-specific value assignment was tested in five runs on at least three different IDS-iSYS analyzers in triplicate," generating a substantial dataset for statistical analysis.
• Statistical analysis: The "assigned target value of each calibrator verifier was defined as the mean of all the runs for each calibrator verifier. The guideline target range is defined as the mean of all runs ± 2SD."
• Standardization: The IDS-iSYS CTX-I assay (for which these verifiers are used) is itself "standardized against in-house reference standards (CTX-I in horse serum)." This implies a chain of traceability to primary or secondary reference materials.

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The IDS iSYS 25-Hydroxy Vitamin DS Assay (IDS-iSYS 250HD*) is intended for the quantitative determination of 25-hydroxyvitamin D (25OHD) and other hydroxylated metabolites in human serum on the IDS iSYS Multi-Discipline Automated System. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in an adult population.

The IDS-iSYS 25-Hydroxy Vitamin DS (250HDS) Control Set is used for quality control of the IDSiSYS 25-Hydroxy Vitamin DS assay on the IDS-iSYS Multi-Discipline Automated System.

The IDS-iSYS 25-Hydroxy Vitamin DS assay consists of a reagent cartridge and one set of calibrators (Calibrators A & B or CAL A & CAL B). The reagent cartridge contains multiple reagents: MPV1 (Magnetic particles coated with 25-OH D in a phosphate buffer containing methanol with sodium azide as preservative), CONJ (Anti- 25-OH D sheep polyclonal antibody labelled with an acridinium ester derivative, in buffer containing bovine, sheep, rabbit and mouse proteins with sodium azide as preservative), NaOH (Sodium hydroxide solution

This is an analysis of a 510(k) summary for the IDS-iSYS 25-Hydroxy Vitamin Dˢ Assay and IDS-iSYS 25-Hydroxy Vitamin Dˢ Control Set.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by internal specifications of the manufacturer, often guided by CLSI (Clinical and Laboratory Standards Institute) guidelines or regulatory precedents. The document presents the reported performance without explicitly stating pre-defined acceptance criteria for each measurement, but rather implies acceptability by presenting results typically expected for such assays. For some sections, such as precision/reproducibility and interference, the acceptable range is mentioned within the text (e.g., ±10% bias for interference).

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