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The Elecsys PTH CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys PTH quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.

Device Description

The Elecsys PTH CalCheck 5 is a lyophilized product consisting of human PTH in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

AI/ML Overview

The provided text describes the Elecsys PTH CalCheck 5, an assayed control used for calibration verification and assay range verification. It is not an AI/ML-driven medical device, but rather a control material for laboratory instruments. Therefore, many of the requested criteria related to AI/ML device testing (e.g., sample sizes for test/training sets, expert consensus, MRMC studies, ground truth establishment for AI models) are not applicable to this product.

The performance evaluation described focuses on "value assignment and stability" of the control material, and its substantial equivalence to a predicate device.

However, I can extract information relevant to the acceptance criteria and the study proving it meets these criteria, interpreting them within the context of a laboratory control product rather than an AI/ML diagnostic tool.

Acceptance Criteria for Elecsys PTH CalCheck 5 (Implicit via Comparison to Predicate):

The acceptance criteria for the Elecsys PTH CalCheck 5 are primarily established by demonstrating its substantial equivalence to the predicate device, Elecsys PTH CalCheck (K993642). This means the new device must perform comparably for its intended use, analyte, format, and matrix, and meet or exceed the performance characteristics of the predicate, particularly regarding stability and the ability to serve its control function.

While explicit numerical acceptance criteria are not provided in the text for performance, the comparison table implies that the new device's characteristics must align well with the predicate.

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is the performance evaluation of the Elecsys PTH CalCheck 5, which included "value assignment and stability." The core of this proof lies in the detailed comparison with the predicate device.

Table 1: Acceptance Criteria and Reported Device Performance

As explicit numerical acceptance criteria are not stated for all aspects, the table below reflects the characteristics compared between the candidate and predicate devices, implying these characteristics form the basis of "acceptance" for substantial equivalence. "Reported Device Performance" here refers to the characteristics of the Elecsys PTH CalCheck 5.

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Elecsys PTH CalCheck 5)
Intended Use	Periodic verification of calibration of the Elecsys Parathyroid Hormone test.	An assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys PTH quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only. (Broader scope than predicate)
Analyte	PTH	PTH
Levels	Three	Five (Increased levels compared to predicate)
Assay Measuring Range	1.20 - 5000 pg/mL	1.20 - 5000 pg/mL
Check Target Values	Check 1: < 5 pg/mL, Check 2: 60 pg/mL, Check 3: 3000 pg/mL	Check 1: ≤ 1 pg/mL, Check 2: 60 pg/mL, Check 3: 2500 pg/mL, Check 4: 4000 pg/mL, Check 5: 5000 pg/mL (More targets and different specific values for some checks)
Format	Lyophilized	Lyophilized
Handling	Reconstitute with 1.0 mL distilled/deionized water, stand 15 min, mix gently.	Reconstitute with exactly 1.0 mL distilled/deionized water, stand 15 min, then mix gently by inversion. (Similar with minor wording differences)
Unopened Stability	Store at 2-8°C until expiration date.	Store at 2-8°C until expiration date.
Reconstituted Stability	20-25°C: 4 hours	20-25°C: 5 hours (Improved stability compared to predicate)
Matrix	Human serum matrix	Human serum matrix

Since this is a control material and not an AI/ML medical device, the following points are not applicable or the information is not provided in the document:

Sample sizes used for the test set and the data provenance: Not applicable in the context of an AI/ML test set. The performance evaluation mentioned generally involves laboratory testing of the control material, but specific sample sizes (e.g., number of batches, number of replicates) are not detailed in this summary for "value assignment and stability." The data provenance would be internal laboratory testing, likely based in the US (Indianapolis, IN, where Roche Diagnostics is located). It would be prospective testing of the manufactured control lots.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a control material is established through precise analytical methods during manufacturing and assay validation, not typically by expert human interpretation in the way AI/ML diagnostics are evaluated.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a control material, the "ground truth" (or reference value) for the PTH concentration in each check level is established during the manufacturing process through quantitative analytical methods and confirmed through a process of value assignment. This is an objective, quantitative measurement, not based on expert consensus, pathology, or outcomes data.
The sample size for the training set: Not applicable. There is no AI/ML model to train.
How the ground truth for the training set was established: Not applicable.

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