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510(k) Data Aggregation
(147 days)
The GSP Neonatal Thyroxine (T4) kit is intended for the quantitative determination of human thyroxine (T4) in blood specimens dried on filter paper as an aid in screening newborns for congenital (neonatal) hypothyroidism using the GSP instrument.
The GSP Neonatal T4 assay is a solid phase time-resolved fluoroimmunoassay based on the competitive reaction between europium-labeled T4 and sample T4 for a limited amount of binding sites on T4 specific monoclonal antibodies (derived from mice). The use of 8-anilino-1-naphthalenesulfonic acid (ANS) and salicylate in the T4 Assay Buffer facilitates the release of T4 from the binding proteins. Thus the assay measures the total amount of T4 in the test specimen. A second antibody, directed against mouse IgG, is coated to the solid phase, and binds the IgG-thyroxine complex, giving convenient separation of the antibody-bound and free antigen. DELFIA Inducer dissociates europium ions from the labeled antibody into solution where they form highly fluorescent chelates with components of DELFIA Inducer. The fluorescence in each well is then measured. The fluorescence of each sample is inversely proportional to the concentration of T4 in the sample.
The provided text describes a 510(k) premarket notification for an in vitro diagnostic device, the GSP Neonatal Thyroxine (T4) kit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study with specific acceptance criteria and ground truth for disease diagnosis in the same way an AI/ML powered device might.
Therefore, the requested information regarding "acceptance criteria" for an AI device, "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," and "ground truth for training/testing" in the context of an AI/ML study does not directly apply to this submission.
However, I can extract the closest analogous information available within this document, focusing on the performance characteristics presented to demonstrate equivalence.
Here's an attempt to answer the questions based on the provided document, interpreting "acceptance criteria" as performance metrics for this diagnostic kit.
1. Table of Acceptance Criteria and Reported Device Performance
For an in-vitro diagnostic kit like this, "acceptance criteria" are typically defined by demonstrating that the new device performs comparably to or within acceptable ranges relative to a predicate device and established analytical performance specifications. The document provides a comparison of various features and performance characteristics between the new GSP Neonatal T4 kit and its predicate device, AutoDELFIA Neonatal T4 Kit.
| Performance Characteristic | Predicate Device (AutoDELFIA T4) Performance (Analogous to "Acceptance Criteria" for comparison) | GSP Neonatal T4 Kit Reported Performance (Analogous to "Device Performance") |
|---|---|---|
| Precision (CVs) | Control 1; 3.95 µg/dL serum - Intra-assay variation 14.9 % - Inter-assay variation 10.0 % - Total variation 18.0 % Control 2; 8.08 µg/dL serum - Intra-assay variation 10.6 % - Inter-assay variation 7.1 % - Total variation 12.7 % Control 3; 18.2 µg/dL serum - Intra-assay variation 8.2% - Inter-assay variation 4.3% - Total variation 9.3 % | Sample 1; 2.0 µg/dL - Within run 1.0% - Within lot 15.5% - Total variation 15.8% Sample 2; 4.8 µg/dL - Within run 7.3% - Within lot 10.7% - Total variation 11.4% Sample 3; 7.5 µg/dL - Within run 6.5% - Within lot 8.4% - Total variation 8.6% Sample 4; 16.6 µg/dL - Within run 4.5% - Within lot 7.8% - Total variation 8.5% Sample 5; 19.8 µg/dL - Within run 7.2% - Within lot 9.9% - Total variation 10.3% Sample 6; 21.4 µg/dL - Within run 7.1% - Within lot 9.8% - Total variation 10.1% |
| Measuring Range | 1.5 µg/dL to the highest level calibrator | 1.6 to 30 µg/dL serum |
| Limit of Blank (LoB) | < 1.5 µg/dL | 0.457 µg/dL |
| Limit of Detection (LoD) | Not available | 0.99 µg/dL |
| Limit of Quantitation (LoQ) | Not available | 1.61 µg/dL |
| Interference | Bilirubin at 20 mg/dL has no significant effect. | Icteric (unconjugated bilirubin ≤ 342 µmol/L, equivalent to 20 mg/dL in serum, and conjugated bilirubin ≤ 237 µmol/L, equivalent to 20 mg/dL in serum), Lipemic (Intralipid¹ ≤ 15 mg/mL in serum), and Hemoglobin up to 15 g/L samples do not interfere. [¹Intralipid is a registered trademark of Fresenius Kabi AB.] |
| Cross-reactivity | LT3: 0.89% 3,3',5-Triiodoacetic acid: 0.45% 3,5-Diiodo-L-thyronine: < 0.1% 3,5-Diiodotyrosine (DIT): < 0.1% 5,5 Diphenylhydantoin: < 0.1% 3-iodo-L-tyrosine (MIT): < 0.1% Phenylbutazone: < 0.1% 6-n-Propyl-2-thiouracil: < 0.1% Methimazole: < 0.1% L-Tyrosine: < 0.1% Acetylsalicylic acid: < 0.1% | LT3: 1.67% 3,3',5-Triiodothyroacetic acid: 0.14% 3,5-Diiodo-L-thyronine: < 0.1% 3,5-Diiodotyrosine (DIT) dihydrate: < 0.1% 5,5-Diphenylhydantoin: < 0.1% 3-iodo-L-tyrosine (MIT): < 0.1% Phenylbutazone: < 0.1% 6-n-Propyl-2-thiouracil: < 0.1% Methimazole: < 0.1% L-Tyrosine: < 0.1% Acetylsalicylic acid: < 0.01% |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" sample size in the context of an AI/ML algorithm validation. Instead, it describes analytical performance studies.
- Precision study: The precision data (Within run, Within lot, Total variation) is presented for six different samples at various concentration levels (2.0, 4.8, 7.5, 16.6, 19.8, 21.4 µg/dL). The number of replicates or runs for each sample is not explicitly stated.
- Interference study: Not explicitly stated, but the document mentions testing with specific concentrations of bilirubin, Intralipid, and hemoglobin.
- Cross-reactivity study: Not explicitly stated, but specific substances and their cross-reactivity percentages are listed.
- Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. Given the nature of a premarket submission for an IVD kit, these studies are typically conducted by the manufacturer as part of the validation process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. For an immunoassay kit like this, the "ground truth" is established by the direct measurement of T4 concentration using the device itself, calibrated against known standards. There are no human "experts" establishing ground truth through image review or clinical assessment in the way an AI/ML device for diagnosis would require. The "qualification" of personnel pertains to "adequately trained laboratory personnel" running the assay.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods are relevant for studies where multiple independent human readers or algorithms are assessing the same data, and their results need to be reconciled (e.g., in medical image interpretation). This is an analytical performance study of an immunoassay.
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
This question is not applicable. This is an immunoassay kit, not an AI/ML-powered device intended for human-in-the-loop assistance in clinical decision-making or image interpretation. Therefore, no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device itself is a standalone diagnostic kit (reagents and instrument) that produces quantitative T4 measurements. It is not an AI/ML algorithm.
7. The type of ground truth used
For an immunoassay, the "ground truth" for evaluating the device's performance is typically established through:
- Known Calibrator Concentrations: The device's measurements are compared against a standard curve generated from calibrators with precisely known T4 concentrations.
- Reference Methods: If available, comparison to a gold standard reference method for T4 measurement would be part of validation (though not explicitly detailed as "ground truth" in this summary).
- Control Materials: Use of quality control materials with target T4 concentrations.
The document discusses "calibrators" and "controls" which are used to establish and verify the accuracy of the measurements.
8. The sample size for the training set
This question is not applicable. This is not an AI/ML device that requires a "training set" for model development. The performance data presented relates to the validation of the manufactured kit through analytical studies.
9. How the ground truth for the training set was established
This question is not applicable as there is no "training set" in the context of an AI/ML model for this type of medical device submission.
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