(29 days)
The TBD Pregnancy Test is a simple-to-use, at-home pregnancy test marketed over-the-counter (OTC) to lay consumers. The test device product is intended for the detection of human chorionic gonadotropin (hCG) in urine as an aid in the detection of early pregnancy.
The TBD Pregnancy Test is a Class II in vitro diagnostic medical device product that functions by way of an immunochemical chromatographicchromogenic method in detecting the presence of hCG in the urine as an aid in the early diagnosis of pregnancy. It consists of a plastic stick, housing an absorbent material that collects and delivers urine to reagents on a chromatographic strip contained within the device. The test is performed by dipping the device into a container of urine for 20 seconds. The absorbent section of the strip allows the urine sample to move chromatographically along the reagent strip reconstituting the diffusible reagents placed strategically along the strip and delivering them to the appropriate capture zones for visualization of the test results. The detection of hCG in the urine sample (pregnant) is indicated by the appearance of two pink lines in the result window. If there is no hCG (not-pregnant) in the urine, one pink line will appear.
The provided text describes a 510(k) summary for the "TBD Pregnancy Test," an at-home pregnancy test. However, it does not contain detailed acceptance criteria, a comprehensive study report that proves the device meets those criteria, or the specific information requested in your prompt (e.g., sample sizes for test/training sets, number/qualifications of experts, adjudication methods, details on MRMC studies, or specific ground truth methodologies beyond general statements).
The document mentions several studies but only describes their general purpose. It lacks the quantitative results and methodologies needed to populate the requested tables and answer the questions thoroughly.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's an attempt to answer the questions based only on the provided text, highlighting what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Laboratory Accuracy | Conducted studies to determine performance in comparison to predicate device. (Specific results/metrics not provided) |
| Sensitivity | Evaluated and confirmed in a third laboratory study. (Specific sensitivity values not provided) |
| Lay Consumer Performance | Evaluated in two separate studies. (Specific metrics for ease of use/interpretation not provided) |
| Lay Consumer Interpretation | Evaluated in two separate studies. (Specific metrics for accuracy of interpretation by lay users not provided) |
| Substantial Equivalence to Predicate Device | Declared substantially equivalent to CLEARBLUE™ Easy One-Step Pregnancy Test. (Specific data supporting this claim not provided) |
| Detection of hCG in urine | Functions by immunochemical chromatographic-chromogenic method. (Specific detection limits/assay range not provided) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "laboratory studies" and "separate studies" for consumer evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified in the provided text. The term "experts" or "qualified personnel" is not used in the context of ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified in the provided text.
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
- No, an MRMC comparative effectiveness study was not explicitly mentioned or implied. The device is an at-home pregnancy test, not an AI-assisted diagnostic tool for human readers. The studies focused on laboratory performance and lay consumer performance/interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in essence. The "TBD Pregnancy Test" is an in-vitro diagnostic device designed to operate "stand-alone" in terms of its chemical reaction and visual readout. The "standalone performance" is covered by the "laboratory accuracy" and "sensitivity" studies mentioned. However, the term "algorithm" is not applicable as this is a chemical-based test, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Implied Ground Truth: For the "laboratory accuracy" studies, the ground truth would typically be established by a reference method for hCG detection, or by using known positive and negative hCG samples. For the "sensitivity" study, it would involve known concentrations of hCG. For "lay consumer performance/interpretation," the ground truth for pregnancy status would likely be established by a laboratory reference test. However, the specific methodology (e.g., reference lab results, clinical diagnosis) is not detailed.
8. The sample size for the training set
- Not specified in the provided text. The concept of a "training set" typically applies to machine learning algorithms, which is not directly applicable to this chemical-based diagnostic device. The studies described are performance evaluations, not algorithm training.
9. How the ground truth for the training set was established
- N/A, as an AI/algorithm training set is not applicable to this device.
Summary of Missing Information:
The provided text from the 510(k) summary is a high-level overview. It describes the device, its intended use, technological characteristics, and that performance studies were conducted. However, it lacks the detailed quantitative data, specific methodologies, and statistical information typically found in a full study report that would allow for a complete answer to your prompt. Specifically, all requested sample sizes, exact performance metrics for acceptance criteria, details on expert involvement, and adjudication methods are absent.
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.