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The CrossLaps™ ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption and may be used as an aid in :
A. Monitoring bone resorption changes of

1. ) Anti-resorptive therapies in postmenopausal women:
   a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs
   b) Bisphosphonate therapies
2. ) Anti-resorptive therapies in individuals diagnosed with osteopenia;
   a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs
   b) Bisphosphonate therapies
3. } Anti-resorptive therapies in individuals diagnosed with Paget's disease of bone
   B. Predicting skeletal Response (Bone Mineral Density) in postmenopausal woman under going anti-resorptive therapies
   a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs
   b) Bisphosphonate therapies

The CrossLaps™ ELISA kit was developed for the quantitative measurement of Type I Collagen C-Telopeptide (CrossLaps™) in human urine. The EIA format is a competitive binding protein assay. CrossLaps™ in the urine competes with the antigen coated to the microtitration wells for the enzyme labeled antibody displacing it from binding to the antigen coated wells. Separation of free form the bound CrossLaps™ is achieved by washing the well. The resultant is analyzed in a spectrophotometer for absorbance The amount of enzyme labeled CrossLaps™ present in the sample.

The provided text describes the CrossLaps™ ELISA kit, an in vitro diagnostic device for measuring Type I Collagen C-Telopeptide in human urine, and its expanded indications for use. However, the document (K972788) is a 510(k) pre-market notification that demonstrates substantial equivalence to a previously cleared device (K960171), rather than a detailed study report proving the device meets specific acceptance criteria based on performance studies.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not explicitly present in the provided text. The document focuses on the unchanged nature of the device's technical and clinical performance despite a minor component change (one-component TMB instead of two-component TMB) from its predicate device. It also outlines the expanded indications for use that were supported by "clinical data" but does not detail that data.

Based on the information available:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document states:

"The technical and clinical performance of the device is not influenced by this substitution and no issues of safety and effectiveness are raised by this change."
This implies that the previous performance (of the predicate device K960171) was considered acceptable, and the minor change to the TMB substrate did not alter that performance. However, specific performance metrics or acceptance criteria are not quantified.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not provided. The document mentions "clinical data demonstrating that The CrossLaps™ ELISA assay is intended for in vitro diagnostic use..." but does not elaborate on the sample size, design, or provenance of this clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not provided. As the document is a 510(k) for substantial equivalence and expanded indications rather than a detailed performance study, it does not include specifics about expert adjudication or ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided.

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 information is not applicable/provided. The CrossLaps™ ELISA is an in vitro diagnostic assay, not an imaging device or AI-assisted diagnostic tool that would involve multi-reader studies or human-in-the-loop performance measurement.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable/provided. As an ELISA kit, this device performs a biochemical measurement and doesn't involve an "algorithm" in the sense of AI or image interpretation. Its performance is inherent to the assay's chemical and biological interactions.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not provided. For an in vitro diagnostic measuring a biomarker, the "ground truth" would typically involve correlation with clinical status, disease progression, or response to therapy, often established through clinical endpoints or reference methods. The document states the assay is "an indication of human bone resorption" and "an aid in monitoring bone resorption changes" and "Predicting skeletal Response (Bone Mineral Density)". This implies its performance is validated against these clinical outcomes or established markers. However, the specifics of how this ground truth was derived for any supporting clinical data are not detailed.

8. The sample size for the training set:

This information is not provided. ELISA kits do not typically have a "training set" in the same way machine learning models do. The development and validation of such assays involve different types of studies (e.g., analytical validation for sensitivity, specificity, accuracy, precision, linearity, and clinical validation for correlation with disease/outcomes). The document refers to "clinical data" but doesn't elaborate on its nature or sample size.

9. How the ground truth for the training set was established:

This information is not provided and is largely not applicable in the context of an ELISA assay's development.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence for an expanded indication for use, not a detailed scientific study report. It states that the device's performance is unchanged from its predicate despite a minor component alteration, but it does not detail the specific performance metrics, acceptance criteria, or the studies that would formally establish these for the current or predicate device.

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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

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.

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