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The IDS-iSYS Direct Renin assay is intended for the quantitative determination of Direct Renin in human EDTA plasma on the IDS iSYS Multi-Discipline Automated System. Renin measurements may aid in the diagnosis and treatment of certain types of hypertension.

The IDS-iSYS Direct Renin Control Set is used for quality control of the IDS-iSYS Direct Renin Assay on the IDS-iSYS Multi-Discipline Automated System.

The IDS-iSYS Direct Renin Calibration Verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS Direct Renin Assay when performed on the IDSiSYS Multi-Discipline Automated System.

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This document is a 510(k) premarket notification for an in vitro diagnostic device, specifically assays and controls for measuring Direct Renin. Such documents review the substantial equivalence of a new device to a predicate device, and the studies cited typically focus on analytical performance rather than clinical efficacy studies often associated with AI/ML devices. Therefore, a direct mapping to the requested information about AI model performance, expert ground truth adjudication, MRMC studies, or training set details is not possible based on the provided text.

However, I can extract information related to the acceptance criteria and performance as presented for this type of diagnostic assay.

Here's the breakdown based on the provided text:

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

The provided text (K123763) is a 510(k) clearance letter for the IDS iSYS Direct Renin Assay. It does not contain a table of acceptance criteria nor detailed performance data. This letter confirms that the FDA has reviewed the device and determined it to be "substantially equivalent" to legally marketed predicate devices. The full performance data and acceptance criteria would be in the original 510(k) submission, which is not provided here.

However, for in vitro diagnostic assays like this, typical acceptance criteria relate to analytical performance characteristics. While not explicitly stated with values, the Regulation Number: 21 CFR 862.1085 pertains to "Angiotensin I and renin test system." For such systems, acceptance criteria generally cover:

• Accuracy/Bias: Comparison to a reference method or predicate device.
• Precision/Reproducibility: Within-run, between-run, and total precision (CV%).
• Linearity/Measuring Range: The range over which results are proportional to the concentration.
• Limit of Detection (LoD) and Limit of Quantitation (LoQ): The lowest concentration that can be reliably detected and quantified.
• Interference: Evaluation of common endogenous and exogenous interfering substances.
• Specificity: Absence of significant cross-reactivity with related substances.

Since the FDA granted clearance based on substantial equivalence, it implies that the device's performance met the relevant acceptance criteria, demonstrating similar performance to a predicate device for these analytical characteristics.

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

The provided document (510(k) clearance letter) does not contain details about the sample size, data provenance, or study design (retrospective/prospective) for the test set. These details would be part of the full 510(k) submission.

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 type of information is not relevant for an in vitro diagnostic assay like the IDS iSYS Direct Renin Assay. The "ground truth" for such assays is established through analytical methods and scientific standards (e.g., reference methods, known concentrations of analytes, spiked samples), not through expert consensus on images or clinical interpretation.

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

Not applicable for an in vitro diagnostic assay. Adjudication methods are typically used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies.

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 for this in vitro diagnostic assay. MRMC studies and the concept of "human readers improving with AI assistance" are relevant to AI/ML medical devices that aid in interpretation or diagnosis by humans. This device is an automated laboratory assay for quantitative measurement.

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

This device, the IDS iSYS Direct Renin Assay, is an automated assay run on a "Multi-Discipline Automated System." Thus, its performance is inherently "standalone" in the sense that the measurement of Direct Renin concentration is performed by the instrument and reagents as an algorithm/system, without direct human cognitive input into result generation. A human interprets the final quantitative result. Performance studies for such devices evaluate the system's analytical capabilities directly.

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

For in vitro diagnostic assays, the "ground truth" for analytical performance evaluation typically involves:

• Reference Methods: Using a validated, often more complex or gold-standard, analytical method to determine true concentrations.
• Certified Reference Materials/Calibrators: Samples with precisely known concentrations of the analyte.
• Spiked Samples: Adding known amounts of the analyte to a matrix to assess recovery.
• Commutability/Traceability: Ensuring results are traceable to international reference standards if available.

The provided document does not specify the exact methods used to establish ground truth but these are the standard approaches for such devices.

8. The sample size for the training set

Not applicable in the context of AI/ML training data. For an in vitro diagnostic assay, there isn't a "training set" in the machine learning sense. The assay is developed through biochemical and engineering principles, and its performance is validated using experimental analytical studies.

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

Not applicable for an in vitro diagnostic assay. This concept is specific to AI/ML model development.

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A radioimmunoassay for the quantitative in vitro diagnostic measurement of the level of renin in plasma. Renin measurements are used in the diagnosis and treatment of certain types of hypertension.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a Renin RIA Test. This document does not describe acceptance criteria, device performance, or details of a study that proves the device meets specific acceptance criteria in the way described in the request (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies). It is a regulatory approval letter for an in vitro diagnostic device, not a technical report on its performance validation.

Therefore, I cannot extract the requested information from the provided text.

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The DSL ACTIVE™ Renin Coated Tube IRMA assay is intended for the quantitative determination of active renin in human serum or plasma. This assay is intended for in vitro diagnostic use. Renin measurements are used in the diagnosis and treatment of certain types of hypertension.

The DSL 25100 ACTIVE™ Renin Coated Tube IRMA Kit was developed for the quantitative measurement of active renin in human serum or plasma. This Coated Tube IRMA format is a capture assay. Anti-human renin mouse monoclonal antibody to renin is immobilized to the surface of the coated bead. Renin in the standards or samples is "sandwiched" between this monoclonal antibody and the anti-human Renin mouse monoclonal antibody radiolabeled for detection with I-125.

The DSL ACTIVE™ Renin Coated Tube IRMA kit was evaluated for its substantial equivalence to the Nichols Diagnostics ACTIVE Renin IRMA. The study involved comparing the results from both assays on patient samples to establish this equivalence.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implicitly defines substantial equivalence based on a high correlation and a linear relationship between the new device and the predicate device's measurements. Specific thresholds for the slope, intercept, or correlation coefficient for "acceptance" are not explicitly stated as numerical criteria, but the reported values were deemed sufficient for substantial equivalence by the FDA.

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

• Sample Size: 53 patient samples
• Data Provenance: The document states "patient samples were collected." No specific country of origin is mentioned, but the submitting company is based in Webster, Texas, USA. The data is retrospective in the sense that samples were collected and then assayed simultaneously by both methods, rather than being collected solely for future study. The samples were chosen based on expected Renin levels (low, intermediate, and high) to ensure a representative range.

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

There were no independent experts used to establish a new ground truth. Instead, the Nichols Diagnostics ACTIVE Renin IRMA served as the reference method, or "ground truth," for comparison. The performance of this predicate device itself would have been established through prior studies.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) was used for the test set. The comparison was direct between the new device and the predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was conducted, as this device is an in vitro diagnostic (IVD) kit for quantitative measurement and does not involve human reader interpretation in the same way imaging devices might. Therefore, there is no effect size reported for human readers improving with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This study is a standalone performance evaluation of the device (the kit itself), comparing its results directly to a predicate device. There is no "human-in-the-loop" aspect to the device's function or the comparative study described.

7. Type of Ground Truth Used

The "ground truth" for the test set was the results obtained from the Nichols Diagnostics ACTIVE Renin IRMA, which served as the predicate device and the reference standard for comparison. This is a form of comparative ground truth against an established and legally marketed device.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its size. The 53 patient samples were used for the comparative clinical study to demonstrate substantial equivalence, which is typically a validation or test set in the context of device approval. If a training phase was involved in the development of the DSL ACTIVE™ Renin Coated Tube IRMA kit, that information is not provided in this summary.

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

Since a dedicated training set is not explicitly mentioned, the method for establishing its ground truth is also not provided. For IVDs like this, the "training" (development and optimization) often involves internal testing against characterized samples or reference materials, which would have their values established through validated reference methods or inter-laboratory comparisons, but these details are not part of this 510(k) summary.

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