(54 days)
The TBD One-Step Ovulation Predictor Test is an at-home in vitro diagnostic use test to be marketed over-the-counter (OTC) to lay consumers. The test device product is intended for the detection of human luteinizing hormone (hLH) in urine as an aid in the prediction of ovulation.
The TBD One-Step Ovulation Predictor Test is a simple to use, plastic stick, in vitro device. The top of the stick is clear to allow the user to visualize the migration of the test reagents. The stick contains a chromatographic test strip which has all the necessary reagents to perform the test. An absorbent tip collects and delivers the urine sample to the reagents on the chromatographic strip. The test is performed by placing the absorbent tip into the urine stream for 5 seconds. Alternatively, the test may be performed by immersing the absorbent tip into a container of urine for 5 seconds. The urine sample from the absorbent tip migrates by capillary action along the chromatographic strip, reconstituting the reagents placed strategically along the strip. Visualization of the test results occurs when the appropriate reagents react producing one or two pink-purple lines which appear in a window in the hull of the test stick. The luteinizing hormone (LH) surge is indicated if the test line is similar to or darker than the reference line. If there is no test line or the test line is lighter than the reference line, then there has been no LH surge.
The provided text describes the TBD One-Step Ovulation Predictor Test and its similarity to a predicate device. However, it does not include detailed acceptance criteria or the specific study that would directly prove the device meets these criteria in the format requested.
Here's an analysis based on the information available in the text, highlighting what is missing for a complete answer to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the TBD One-Step Ovulation Predictor Test was found to have "equivalent performance to that of the predicate device" in a direct laboratory comparison, and in consumer use studies, it was "at least as accurate as the predicate device with regard to consumers' accuracy in performing the test."
Missing Information:
- Specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds).
- Detailed quantitative performance metrics for the TBD One-Step Ovulation Predictor Test.
- Quantitative performance metrics for the predicate device to compare against.
2. Sample Size for the Test Set and Data Provenance:
The document mentions "direct laboratory comparison" and "consumer use studies."
Missing Information:
- Sample Size: The number of participants or samples used in these studies is not specified.
- Data Provenance: The country of origin of the data is not mentioned. It is implied that the studies were conducted by Carter-Wallace, Inc., an American company. The description refers to "consumer use studies," which suggests prospective data collection, but this is not explicitly stated. It's unclear if any retrospective data was used.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not mention the involvement of experts in establishing ground truth for the performance studies. Since it's an at-home ovulation predictor test intended for lay consumers, the "accuracy in performing the test" likely refers to the consumers' ability to correctly interpret the results based on the package inserts, rather than expert interpretation of complex clinical data.
Missing Information:
- Details on expert involvement in establishing ground truth are entirely absent.
4. Adjudication Method:
Given the nature of an at-home ovulation test, the concept of an adjudication method as typically applied to expert review of medical images or complex diagnoses is not directly applicable or described.
Missing Information:
- No adjudication method is mentioned or implied.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study is not relevant to this type of device (an at-home diagnostic test for a single user).
Missing Information:
- An MRMC study was not conducted or described.
6. Standalone Performance:
The "direct laboratory comparison" and "consumer use studies" would likely represent the standalone performance of the device as it would be used by consumers, without human-in-the-loop assistance beyond the consumer following instructions.
Missing Information:
- While implied, the term "standalone performance" isn't explicitly used, and specific metrics for this are absent (as noted in point 1).
7. Type of Ground Truth Used:
The ground truth for an ovulation predictor test would typically involve confirming actual ovulation, likely through other clinical methods (e.g., daily blood hormone levels, ultrasound). However, the document focuses on the prediction of the LH surge and refers to "consumers' accuracy in performing the test." This suggests the ground truth for consumer studies might be tied to how well users followed instructions and achieved a correct reading. For the "direct laboratory comparison," the ground truth for LH levels would be laboratory-measured LH concentrations.
Missing Information:
- The exact method for establishing ground truth (e.g., comparison against a gold standard lab assay, confirmation of actual ovulation through other means) for the performance studies is not explicitly detailed.
8. Sample Size for the Training Set:
The concept of a "training set" applies to machine learning algorithms. This device is a biochemical in-vitro diagnostic test, not an AI or machine learning product. Therefore, there wouldn't be a training set in that context.
Missing Information:
- Not applicable as this is not an AI/ML device.
9. How Ground Truth for the Training Set Was Established:
As above, this is not an AI/ML device, so a training set and its associated ground truth establishment are not applicable.
Missing Information:
- Not applicable as this is not an AI/ML device.
In summary, the provided text serves as a 510(k) summary demonstrating substantial equivalence to a predicate device, focusing on technological characteristics and overall performance claims ("equivalent performance," "at least as accurate"). It lacks the granular detail about specific study designs, acceptance criteria, and quantitative results that would be expected in a comprehensive study report to fulfill all aspects of your requested information.
§ 862.1485 Luteinizing hormone test system.
(a)
Identification. A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.