(72 days)
The DSL ACTIVE CrossLaps™ ELISA assay is intended for the quantitative determination of CrossLaps™ in human urine. The measurement of CrossLaps™ is used as an indicator of human bone resorption.
The DSL 10-1700 ACTIVE CrossLaps™ ELISA kit was developed for the quantitative measurement of Type I Collagen Telopeptide (CrossLaps™) in human urine. The ELISA format is a competitive binding protein assay. CrossLaps™ in the urine sample competes with antigen coated to the microtitration wells for the enzyme labelled CrossLaps™ antibody. CrossLaps™ in the sample binds to the enzvme labelled antibody displacing it from binding to the antigen coated wells. Separation of free from bound CrossLaps™ is achieved by aspirating and washing the wells. The resultant is analyzed in a spectrophotometer for bound absorbance. The amount of enzyme-labeled CrossLaps™ bound to the microtiter well is inversely proportional to the concentration of the CrossLaps™ present in the sample.
The provided text describes the "DSL 10-1700 ACTIVE CrossLaps™ ELISA Kit" and a study demonstrating its substantial equivalence to another assay, the "OSTEX OSTEOMARK assay." However, the document does not contain all the requested information, especially regarding specific acceptance criteria, detailed device performance metrics, and information typically associated with AI/ML device studies. This is likely because the document describes a traditional ELISA kit developed in 1996, predating widespread use of AI in diagnostics as we understand it today in regulatory submissions.
Here's a breakdown of the available information and areas where data is missing based on your request:
Acceptance Criteria and Study Details for DSL 10-1700 ACTIVE CrossLaps™ ELISA Kit
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to the OSTEX OSTEOMARK assay, as measured by linear regression analysis of results for CrossLaps™ in human urine. | Correlation Coefficient (r): 0.95 (This value, being close to 1, indicates a strong positive linear relationship between the two assays, supporting substantial equivalence. While not explicitly stated as an "acceptance criterion," a strong correlation is the basis for demonstrating equivalence in such studies and implicitly serves as one.) |
| Regression Equation: Y = 3.18(X) + 16.69 (This equation relates the results of the DSL assay (Y) to the OSTEX OSTEOMARK assay (X), further characterizing their relationship.) |
Missing Information:
- Specific numerical thresholds for correlation (e.g., "r > 0.90") that would constitute formal acceptance criteria are not explicitly stated.
- Other performance metrics typical for device studies (e.g., sensitivity, specificity, accuracy, precision, limit of detection, linearity) are not reported. The study focused solely on substantial equivalence via correlation.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Sixty individuals' urine samples.
- Data Provenance: The document states "urine samples from sixty individuals were collected." It does not specify the country of origin.
- Retrospective or Prospective: Not explicitly stated, but the phrase "samples were collected" could imply a prospective collection for the study, or it could refer to collecting previously stored samples (retrospective). Without further context, it's unclear.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable / Not specified: This type of information is usually relevant for studies involving subjective interpretation of medical images or data by human experts (e.g., radiologists, pathologists). For an ELISA kit that measures an analyte (Type I Collagen Telopeptide) objectively, the "ground truth" is typically defined by the reference method (in this case, the OSTEX OSTEOMARK assay) or by a gold standard laboratory method, not by expert consensus on the sample itself. The document does not mention any experts for establishing ground truth.
4. Adjudication Method for the Test Set
- Not applicable / Not specified: As mentioned above, this typically applies to subjective assessments by multiple experts. For this quantitative biological assay, the comparison is direct measurement against a predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No: An MRMC study involves multiple human readers evaluating multiple cases, often with and without AI assistance, to compare diagnostic performance. The described study compares two assays for quantitative measurement, not human diagnostic performance. Therefore, this type of study was not performed.
- Effect Size of Human Readers with/without AI: Not applicable, as no AI component or human reader study was conducted.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
- Not applicable (in the context of AI/ML): The device is an ELISA kit, a laboratory diagnostic tool that processes samples. Its performance is inherent to the kit's chemical reactions and detection system. It's not an "algorithm" in the AI/ML sense that would have a "standalone performance" besides its intended use in a lab. The study did evaluate the performance of the DSL kit "standalone" in the sense that it was run independently and its results were compared to the OSTEX OSTEOMARK assay.
7. The Type of Ground Truth Used
- "Ground Truth" for this study: The results obtained from the OSTEX OSTEOMARK assay served as the comparator or reference for establishing substantial equivalence. The document doesn't detail how the ground truth for that assay was established, but implicitly assumes its validity as a predicate device.
- Not based on: Expert consensus, pathology, or outcomes data in the direct sense of establishing the analyte level itself. The "ground truth" here is a comparative measurement against an existing, equivalent method.
8. The Sample Size for the Training Set
- Not applicable / Not specified: ELISA kits typically do not have "training sets" in the AI/ML sense. Their development involves R&D and validation steps, but not machine learning training on data sets. The "sixty individuals" samples were used for the comparison study, which can be seen as a validation/test set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable: As there's no training set in the AI/ML context, this question is not relevant.
In summary: The provided document is a 510(k) summary for a traditional in vitro diagnostic (ELISA kit) from 1996. It details a comparative study to establish substantial equivalence to a predicate device, focusing on correlation. Many questions in your prompt are tailored towards AI/ML-based medical devices and are therefore not addressed, or are not applicable, in this document.
§ 862.1400 Hydroxyproline test system.
(a)
Identification. A hydroxyproline test system is a device intended to measure the amino acid hydroxyproline in urine. Hydroxyproline measurements are used in the diagnosis and treatment of various collagen (connective tissue) diseases, bone disease such as Paget's disease, and endocrine disorders such as hyperparathyroidism and hyperthyroidism.(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.