(209 days)
The Maverick Test Panel A0.B0 is an immunoassay for the quantitative determination of human thyroid stimulating hormone (thyrotropin, TSH) in human serum and K2EDTA plasma on the Maverick Diagnostic System TC1000. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The Maverick Diagnostic System TC1000 is an automated immunoassay analyzer intended for in vitro diagnostic use to determine analytes in a clinical laboratory. The system's assay applications utilize silicon photonics technology.
The Maverick Diagnostic System TC1000 is an automated immunoassay analyzer intended for in vitro diagnostic use to determine analytes in a clinical laboratory. The system's assay applications utilize silicon photonics technology. The Maverick Test Panel A0.B0 is an immunoassay for the quantitative determination of human thyroid stimulating hormone (thyrotropin, TSH) in human serum and K2EDTA plasma on the Maverick Diagnostic System TC1000.
The provided text is an FDA 510(k) clearance letter for an in vitro diagnostic (IVD) device, specifically the Maverick Diagnostic System TC1000 and Maverick Test Panel A0.B0, which is an immunoassay for quantitative determination of human thyroid stimulating hormone (TSH).
Therefore, the concepts of "AI models," "human readers," "radiologists," "MRMC studies," "effect size," and establishing "ground truth for test/training sets by expert consensus/pathology/outcomes data" are not applicable to this type of device and its clearance process.
The FDA clearance for this IVD device is based on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves performance studies (e.g., analytical performance, clinical performance) to show the new device performs as intended and is as safe and effective as the predicate. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for an IVD device like this would revolve around its analytical and clinical performance characteristics, not AI model metrics or reader studies.
Since the prompt's requested information format is tailored for an AI/CADe (Computer-Assisted Detection/Diagnosis) device, and the provided document describes an IVD device, directly answering the prompt's specific points (1-9) is not possible based on the text. The text does not contain information about AI model performance, human reader studies, or how a "ground truth" for an image-based AI would be established.
To address the spirit of the prompt, had this been an AI/CADe device, and assuming the information was present, here's how a response might look. However, it's crucial to reiterate that this specific document is not for such a device.
(Hypothetical response if the document were about an AI/CADe device, assuming the information was present within the document)
Disclaimer: The provided document is an FDA 510(k) clearance for an In Vitro Diagnostic (IVD) device (Maverick Diagnostic System TC1000 for TSH immunoassay), not an AI/CADe medical device. Therefore, the specific details requested in the prompt, such as AI model performance, expert interpretation of images, MRMC studies, or training/test set ground truth establishment for an AI, are not applicable to the content of this document. The following sections are provided as an example of how the prompt would be answered if the document were for an AI/CADe device and contained the relevant information, but the information below is NOT derived from the provided text.
(Hypothetical/Illustrative Answer - NOT based on the provided document)
(1) A table of acceptance criteria and the reported device performance
| Acceptance Criterion (e.g., Performance Metric Threshold) | Reported Device Performance (e.g., AI Model X) |
|---|---|
| Sensitivity ≥ 90% for detecting Condition A | Sensitivity: 92.5% |
| Specificity ≥ 85% for Condition A | Specificity: 88.0% |
| AUC (Area Under the ROC Curve) ≥ 0.90 | AUC: 0.915 |
| False Positive Rate ≤ 5 per image | False Positive Rate: 4.2 per image |
| Mean processing time ≤ 5 seconds per image | Mean processing time: 3.8 seconds |
(2) Sample size used for the test set and the data provenance
- Test Set Sample Size: 500 cases (e.g., 250 positive for Condition A, 250 negative).
- Data Provenance: Retrospectively collected data from multiple institutions across the United States, Germany, and Japan.
(3) Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: 3 independent expert readers.
- Qualifications of Experts: Each expert was a board-certified Radiologist with at least 10 years of experience specializing in the relevant imaging modality (e.g., thoracic imaging for lung nodules, breast imaging for mammography).
(4) Adjudication method for the test set
- Adjudication Method: 2+1 adjudication. If at least 2 of the 3 initial expert readers agreed on the ground truth, that was considered the consensus. If there was a disagreement (e.g., 1 agreed, 2 disagreed; or all 3 disagreed), a fourth, highly experienced senior expert (or an expert panel) performed a final review and 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
- MRMC Study Status: Yes, an MRMC comparative effectiveness study was conducted.
- Effect Size of Improvement: The study demonstrated a statistically significant improvement in reader performance (e.g., AUC). Human readers assisted by the AI model showed a mean increase of 0.05 in AUC (from 0.85 without AI to 0.90 with AI assistance) when interpreting cases for Condition A, compared to their performance without AI assistance. This corresponded to a reduction in diagnostic error rate of 15%.
(6) If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, standalone performance was evaluated. The algorithm's standalone AUC for Condition A was 0.915.
(7) The type of ground truth used
- Type of Ground Truth: Expert consensus with confirmation by pathology for positive cases of Condition A. Negative cases were confirmed through follow-up imaging and clinical outcomes over a specified period.
(8) The sample size for the training set
- Training Set Sample Size: 10,000 cases.
(9) How the ground truth for the training set was established
- Training Ground Truth Establishment: The ground truth for the training set was primarily established by a single expert radiologist's initial review, followed by confirmation from a second expert. Cases with disagreement were reviewed by a third, senior expert to reach consensus. A subset of cases (e.g., 20%) had pathology confirmation available. Automated labeling techniques, where feasible and validated, were also used to augment the manually reviewed data.
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July 22, 2024
Genalyte, Inc. Sasi Mudumba Senior Director of IVD & Clinical Regulatory 6620 Mesa Ridge Road San Diego, California 92121
Re: K234091
Trade/Device Name: Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid Stimulating Hormone Test System Regulatory Class: Class II Product Code: JLW, JJE Dated: June 21, 2024 Received: June 21, 2024
Dear Sasi Mudumba:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Thomas C. Miller Date: 2024.07.22 22:38:56 -04'00' -5 for Paula Caposion, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K234091
Device Name Maverick Diagnostic System TC1000 Maverick Test Panel A0.B0
Indications for Use (Describe)
The Maverick Test Panel A0.B0 is an immunoassay for the quantitative determination of human thyroid stimulating hormone (thyrotropin, TSH) in human serum and K2EDTA plasma on the Maverick Diagnostic System TC1000. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The Maverick Diagnostic System TC1000 is an automated immunoassay analyzer intended for in vitro diagnostic use to determine analytes in a clinical laboratory. The system's assay applications utilize silicon photonics technology.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.