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Osteomark NTx Point of Care (POC) is a urinary assay for the quantitative measure of the excretion of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine (nM Bone Collagen Equivalents/mM creatinine). The test is used to monitor bone resorption changes following initiation of antiresorptive therapy (e.g., hormone replacement therapy).

Osteomark NTx Point of Care (POC) is a urinary assay for the quantitative measure of the excretion of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine (nM Bone Collagen Equivalents/mM creatinine).

This document is a 510(k) clearance letter from the FDA for a device called "OSTEOMARK® NTx Point of Care (POC)". It is not a study report, and therefore, it does not contain the detailed information necessary to answer the questions about acceptance criteria and study design.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or details on training sets.
• Information on ground truth establishment (number of experts, qualifications, adjudication method, type of ground truth).
• Details on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone performance.

The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It refers to the "Indications For Use" which describes what the device does (measures N-telopeptides of type I collagen to monitor bone resorption changes following antiresorptive therapy).

To answer these questions, you would need to refer to the actual 510(k) submission document (K992997) or other study reports related to the OSTEOMARK® NTx Point of Care (POC) device, which are not included in this provided text.

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Osteomark NTx Point of Care (POC) is a urinary assay for the quantitative measure of the excretion of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine (nM Bone Collagen Equivalents/mM creatinine). The test is used to monitor bone resorption changes following initiation of antiresorptive therapy (e.g., hormone replacement therapy).

The Osteomark® NTx POC device is a single-use, disposable four-channel reflectance photometer integrated with dry reagent chemistry strips and contained within a sealed plastic case. Each unit consists of:

• an optics subassembly that also supports the reagent strips .
• electronics, batteries, photodetectors, and light emitting diodes (LEDs). ●
• . plastic parts
• two reagent strips ●
• a desiccant ●
• a liquid crystal display (LCD) ●
  The reagent strips capillary transport with various chemical reactions. The first strip is an immunoassay for measuring the NTx, and the second strip is a general chemistry assay for measuring the creatinine. In both strips, a blue color is measured in discrete test zones. The test zones are the areas where the specific reaction occurs and concentrations are measured.
  The NTx reaction proceeds as follows: anti-NTx antibody, conjugated to blue microparticles, migrate across the strip upon the addition of urine sample. The amount of blue microparticles captured on the test zones is proportional to the amount of NTx in the sample.
  The creatinine reaction proceeds as follows: the addition of the urine sample solubilizes enzymes immobilized in the strip test zones. A cascade of enzymatic reactions mediates the production of hydrogen peroxide from the oxidation of creatinine. In the presence of horseradish peroxidase and a color indicator, a blue color is generated from the hydrogen peroxide with an intensity proportional to the concentration of creatinine in the sample.
  The LEDs and silicon photodetectors compare the reflectances of the color intensities before and after the sample addition. Based on the calibration parameters stored in memory, the numerical concentrations of NTx and creatinine are calculated. Assay results are expressed in nM Bone Collagen Equivalents (BCE) divided by mM creatinine (nM BCE/mM creatinine).

Here's a breakdown of the acceptance criteria and study information for the Metrika DRx® NTx (Osteomark® NTx Point of Care) device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Note regarding Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for many metrics. The "Implied Acceptance Criteria" column infers what might be considered acceptable based on typical clinical assay performance or the statement that studies "demonstrated substantial equivalence." The FDA's successful clearance implies that the reported performance was deemed acceptable.

Study Details

1. Sample size used for the test set and the data provenance:

   • Accuracy Study: 235 urine samples.
     • Provenance: This dataset was used for comparative testing between Osteomark® NTx POC and the two predicate methods. The samples were assayed by Osteomark® NTx POC across three "POLtype" clinical sites (Physician Office Laboratories) and by the predicate methods at a reference laboratory. It is implied these were prospective samples collected for the purpose of the study, given they were tested at clinical sites. The country of origin is not specified but is implicitly the USA given the FDA submission.
   • Clinical Performance (HRT Monitoring): 200 samples from 50 HRT-treated women.
     • Provenance: Retained samples from a published study. This indicates a retrospective analysis of previously collected samples. Country of origin not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Accuracy Study: The ground truth for the accuracy study was established by predicate methods (Osteomark® NTx EIA and Creatinine Plus) performed at a reference laboratory. These are established analytical methods, not subjective expert assessment. Therefore, no human "experts" in the traditional sense (e.g., radiologists) were used to establish ground truth for this aspect. The expertise lies in the validated predicate assays themselves.
   • Clinical Performance (HRT Monitoring): The ground truth for comparing NTx changes and correlation with BMD comes from the reference method (Osteomark NTx EIA) and Bone Mineral Density (BMD) measurements. Again, these are objective measurements, not subjective expert interpretation.

3. Adjudication method for the test set:

   • Not applicable. The ground truth was established by laboratory measurements using predicate devices and BMD measurements, not through expert consensus requiring adjudication.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) assay that provides quantitative measurements, not an AI-assisted diagnostic imaging device requiring human reader interpretation. Therefore, the concept of human readers improving with/without AI assistance does not apply.

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

   • Yes, the device itself provides a standalone result (NTx/creatinine ratio). The accuracy and precision studies evaluate the performance of this device in isolation, comparing its output to predicate methods. While a professional user operates the device, the device's measurement and calculation of the final result (NTx/creatinine) are entirely automated ("algorithm only"). The intended use states "professional use," indicating human operation, but the core analytical performance is standalone.

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

   • Analytical Ground Truth: For accuracy and linearity, the ground truth was established by measurements obtained from legally marketed predicate devices (Osteomark® NTx EIA and Creatinine Plus) in a reference laboratory setting.
   • Clinical Ground Truth: For the HRT monitoring study, the ground truth included measurements from the predicate Osteomark NTx EIA and Bone Mineral Density (BMD) measurements, which are established clinical outcome measures for bone health.

7. The sample size for the training set:

   • The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is a quantitative assay based on dry reagent chemistry and reflectance photometry, not a machine learning algorithm that requires a distinct training phase. Therefore, the concept of a training set for an AI model is not applicable here. The assay's internal calibration parameters are "stored in memory," suggesting a pre-determined calibration process rather than an adaptive training set.

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

   • As there is no "training set" in the context of an AI/ML algorithm, this question is not applicable. The device relies on established scientific principles of immunoassay and enzymatic reactions with internal calibration.

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The Osteomark NTx Point of Care (POC) Controls are assayed for the verification of device performance when using the Osteomark NTx POC for the quantitative measure of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine (nM Bone Collagen Equivalents/mM creatinine). The controls are used as consistent test samples of known nM BCE/mM creatinine concentration that may be measured over time as a means of evaluating analytical precision, as well as device performance.

The Osteomark® NTx Point of Care Control Set is a human urine-based, liquid, 2-level control set to be used in quality control procedures with the Osteomark® NTx Point of Care test. The assayed control set is used for evaluating precision and systematic analytical deviations that may arise from reagent or device variations.

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and the study that proves the device meets those criteria:

Device: Osteomark® NTx Point of Care (POC) Control Set

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state numerical acceptance criteria in terms of precision or accuracy targets. Instead, it describes the purpose of the controls and the method used to demonstrate their functionality. The acceptance criteria can be inferred from the study's objective: to demonstrate the control set's ability to evaluate the quality of day-to-day performance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The study used three manufactured lots of the Osteomark® NTx POC Control Set. For each control lot, each of the two control levels was tested six times a day for five days.
  • This equates to: 3 lots * 2 control levels/lot * 6 tests/day * 5 days = 180 data points (measurements).
• Data Provenance: Not explicitly stated, but it is a premarket submission for a medical device in the US, so the study was likely conducted by the manufacturer (Metrika, Inc.) or a contracted lab under their supervision. It appears to be prospective data collection as it describes an evaluation study performed for regulatory submission. Country of origin is not specified for the data itself, but the applicant and reviewer are US-based.

3. Number of Experts Used to Establish Ground Truth for the Test Set and their Qualifications

• This device is a quality control material, not a diagnostic device that requires expert interpretation of results. Therefore, the concept of "ground truth" established by experts in a diagnostic context (like radiologists) does not directly apply here.
• The "ground truth" for a control material is its assigned value (concentration). How these assigned values were originally established for the control lots is not detailed in this 510(k) summary, but it would typically involve rigorous analytical methods and calibration traceable to reference materials.

4. Adjudication Method for the Test Set

• Adjudication methods (e.g., 2+1) are typically used in studies where multiple human readers interpret results and discrepancies need to be resolved.
• Since this study involves the analytical performance of an in vitro diagnostic control, there is no human adjudication method described or typically applicable. The results are quantitative measurements from an instrument.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, 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 done.
• This device is an in vitro diagnostic quality control material. It does not involve human readers interpreting images or data for diagnostic purposes, nor does it incorporate AI. Therefore, concepts like human reader improvement with or without AI assistance are not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• This device is a physical control material, not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not applicable.
• The study does evaluate the device (control set) in a standalone analytical context, meaning its performance characteristics are assessed independently to verify its utility in controlling the main diagnostic assay.

7. The Type of Ground Truth Used

• For the Osteomark® NTx POC Control Set, the "ground truth" for the controls themselves are their known or assigned quantitative concentrations of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine. These values are pre-assigned to the control lots.
• The study then assessed how well the Osteomark® NTx POC device measured these known values from the control set to demonstrate the control set's utility for evaluating the device's performance.

8. The Sample Size for the Training Set

• The 510(k) summary does not mention a "training set" in the context of device development. This is because the Osteomark® NTx POC Control Set is a control material, not an algorithm that requires machine learning training data. There is no algorithm being trained here.
• The study mentioned (testing three lots, etc.) served as the validation/verification study for the control product itself.

9. How the Ground Truth for the Training Set was Established

• As there is no training set for an algorithm, this question is not applicable.
• The ground truth (assigned values/concentrations) for the control materials themselves would be established through a characterization process, including:
  • Analytical testing using established reference methods.
  • Calibration against traceable standards.
  • Statistical analysis to assign a target value and acceptable range.
  • This process is not detailed in the provided summary.

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Osteomark® NTx Serum EIA provides a quantitative measure of cross-linked Ntelopeptides of type I collagen (NTx) in serum as an indicator of human bone resorption. Serum NTx level is used to aid in predicting skeletal response (bone mineral density) to antiresorptive therapy and in monitoring bone resorption changes following initiation of antiresorptive therapy. Prior to initiating antiresorptive therapy, serum NTx level is used to determine the probability for a decrease in bone mineral density after one year in postmenopausal women treated with hormonal antiresorptive therapy relative to those treated with calcium supplement.

The Osteomark NTx Serum EIA is a competitive-inhibition enzyme-linked immunosorbent assay (ELISA/EIA) for quantitative determination of NTx present in human serum. NTx is adsorbed to a 96-well microplate: Diluted samples are added to the microplate wells, followed by a horseradish peroxidase labeled monoclonal antibody. NTx in the specimen competes with the NTx epitope on the microtiter plate for antibody binding sites. Following a wash step, the amount of labeled antibody bound is measured by colorimetric generation of a peroxide substrate. NTx concentration is determined spectrophotometrically and calculated using a standard calibration curve. Assay values are reported in nanomoles Bone Collagen Equivalents per liter (nM BCE).

The Osteomark NTx Serum EIA is a competitive-inhibition enzyme-linked immunosorbent assay (ELISA/EIA) designed for the quantitative determination of NTx in human serum. This assay is used to predict skeletal response to antiresorptive therapy and to monitor changes in bone resorption after therapy initiation. It also helps determine the probability of bone mineral density decrease in postmenopausal women on hormonal antiresorptive therapy versus those on calcium supplements.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document describes several studies:

• Reference Range Studies:
  • Premenopausal Women: N = 257 (multi-center, cross-sectional study at five regional sites). The country of origin is not specified but implied to be the US given the FDA submission. This was a prospective study to determine reference ranges.
  • Men: N = 176 (multi-center, cross-sectional study at three regional sites). The country of origin is not specified but implied to be the US. This was a prospective study to determine reference ranges.
• Intra-subject Variability Studies:
  • Postmenopausal Women: n=271 (short-term), n=261 (long-term). Provenance not specified. Retrospective/Prospective not specified for this specific study, but the overall context suggests prospective data collection in clinical settings.
  • Men: n=32 (short-term), n=27 (long-term). Provenance not specified. Retrospective/Prospective not specified for this specific study.
• Assay Reproducibility and Precision Studies:
  • Intra-assay variability: Four human serum specimens. Provenance not specified. Not directly tied to a clinical population, but rather assay samples.
  • Inter-assay variability: Eight human serum specimens. Provenance not specified. Not directly tied to a clinical population, but rather assay samples.
  • Total assay precision: Level I Serum Control and Level II Serum Control tested at four clinical laboratories. Provenance not specified. These are control materials, not patient samples.
• Antigen Recovery: Nine serum specimens. Provenance not specified. These are assay samples.
• Dilutional Linearity: Five serum specimens. Provenance not specified. These are assay samples.
• Clinical Studies (HRT):
  • Postmenopausal Women treated with HRT: The study enrolled a cohort of postmenopausal women. The baseline NTx mean was 15.9 nM BCE. Post-treatment mean was 12.2 nM BCE. While a specific N for the HRT group is not provided in this summary, the context suggests a clinical trial. The study results (Reference 4) indicate the source is likely from U.S. clinical trials. This was a prospective clinical trial.
• Clinical Studies (Bisphosphonate):
  • Postmenopausal Women treated with Bisphosphonate: The study was conducted at a regional specialty hospital in the northeast United States. The study was randomized and double-blind. N is not explicitly stated in the summary, but it involved women randomized to either placebo or alendronate. This was a prospective clinical trial.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The document does not describe the use of human "experts" to establish ground truth for the device performance studies in the traditional sense of a diagnostic interpretation.

For the clinical efficacy studies (HRT and Bisphosphonate), the "ground truth" was clinical outcomes:

• Bone Mineral Density (BMD) changes: Measured by objective methods (e.g., DEXA scans) over time. This is an objective clinical measurement, not expert consensus on an image or test result.
• Response to therapy: Defined by changes in NTx levels and subsequent changes in BMD.

4. Adjudication Method for the Test Set

Not applicable. The reported studies evaluate the analytical performance of the assay and its correlation with clinical outcomes (BMD changes), not the interpretation of results by human readers requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The Osteomark NTx Serum EIA is an in-vitro diagnostic assay for quantitative measurement. It does not involve human readers interpreting images or data where AI assistance would be relevant for a MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, implicitly. The performance characteristics (variability, recovery, linearity) and the clinical utility of the assay itself (e.g., "Osteomark NTx Serum EIA mean baseline values... fell significantly after 3 months of therapy") are reported as standalone performance of the diagnostic kit. There is no human-in-the-loop component for the assay's execution or the interpretation of the numerical NTx values for these studies. The physician uses the derived NTx value in clinical management.

7. Type of Ground Truth Used

• Analytical Performance: The ground truth for analytical performance (variability, recovery, linearity) is based on established laboratory analytical methods and expected theoretical values for spiked samples or diluted controls.
• Clinical Studies: The ground truth for the clinical studies (HRT and Bisphosphonate) is outcomes data and objective clinical measurements:
  • Bone Mineral Density (BMD) assessed after one year.
  • Changes in NTx levels post-therapy. This is an outcome of the intervention, not an externally established ground truth for the device itself.

8. Sample Size for the Training Set

The document describes the device performance validation and clinical studies. There is no description of a "training set" in the context of machine learning (AI) for this diagnostic assay. The terms "training set" and "test set" are not applicable in the typical AI sense to this type of in-vitro diagnostic device. Instead, the studies cited relate to establishing reference ranges and validating analytical and clinical performance.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no "training set" in the AI sense is described. The analytical and clinical performance data were established through direct laboratory measurements and clinical trial outcomes, respectively, as outlined above.

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Osteomark is a urinary assay that provides a quantitative measure of the excretion of cross-linked N-telopeptides of type I collagen (NTx) as an indicator of human bone resorption. Elevated levels of urinary NTx indicate elevated human bone resorption. Measurement of NTx is intended for use in:

A. Predicting skeletal response (bone mineral density) to hormonal antiresorptive therapy in postmenopausal women.

B. Therapeutic monitoring of:

• 1. antiresorptive therapies in postmenopausal women
• 2. antiresorptive therapies in individuals diagnosed with osteoporosis
• 3. antiresorptive therapies in individuals diagnosed with Paget's disease of bone

4. estrogen-suppressing therapies

C. Assessing the relative risk for loss of spinal bone mass after one year if not treated with hormonal antiresorptive therapy

Osteomark is a competitive enzyme-linked immunosorbent assay (ELISA) which utilizes a horseradish peroxidase labeled monoclonal antibody directed against the cross-linked N-telopeptides (NTx) present in urine specimens. An Osteomark® kit is comprised of the following reagents:

Antigen Coated 96-Well Plate Calibrators: 1 nM BCE 30 nM BCE 100 nM BCE 300 nM BCE 1000 nM BCE 3000 nM BCE Antibody Conjugate Concentrate Antibody Conjugate Diluent Level I and Level II Urine Controls 30X Wash Concentrate Buffered Substrate Chromogen Reagent Stopping Reagent

The solid phase utilizes microwells onto which NTx has been adsorbed. NTx in the specimen or Calibrator competes with the solid phase NTx for antibody binding sites. The resulting amount of Antibody Conjugate bound to the solid phase is indirectly proportional to the amount of NTx in the specimen or Calibrator. The quantity of NTx in the specimen is determined from a standard calibration curve using reagents supplied in the kit. Assay values are standardized to an equivalent amount of bone collagen, and are expressed in nanomole bone collagen equivalents per liter (nM BCE). BCE reflects the amount of immunoreactive NTx, as measured by Osteomark, liberated from human bone collagen following digestion with bacterial collagenase, as measured by hydroxyproline by high performance liquid chromatography (HPLC).

Here's an analysis of the provided text, outlining the acceptance criteria and the studies performed for the Osteomark® device:

Acceptance Criteria and Device Performance Study for Osteomark®

The Osteomark® device is a urinary assay designed to quantitatively measure N-telopeptides of type I collagen (NTx) as an indicator of human bone resorption. The provided documentation details several performance characteristics and studies that likely served as the basis for acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria with defined pass/fail thresholds for a regulatory submission. Instead, it presents performance characteristics and reference ranges derived from studies. Based on the "Performance Characteristics" section, we can infer the following:

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Osteomark® is a urinary assay that provides a quantitative measure of the excretion of crosslinked N-telopeptides of type I collagen (NTx) as an indicator of human bone resorption. Elevated levels of urinary NTx indicate elevated human bone resorption. Measurement of NTx is intended for use in:

A. Predicting skeletal response (bone mineral density) to hormonal antiresorptive therapy in postmenopausal women

B. Therapeutic monitoring of:

• 1. anti-resorptive therapies in postmenopausal women
• 2. anti-resorptive therapies in individuals diagnosed with osteoporosis
• 3. anti-resorptive therapies in individuals diagnosed with Paget's disease of bone
• 4. estrogen-suppressing therapies

The measurement range of Osteomark is 20 to 3000 nM Bone Collagen Equivalents (BCE) of NTx.

Osteomark is a competitive enzyme-linked immunosorbent assay (ELISA) which utilizes a horseradish peroxidase labeled monoclonal antibody directed against the cross-linked Ntelopeptides (NTx) present in urine specimens. An Osteomark® kit is comprised of the following reagents:

Antigen Coated 96-Well Plate Calibrators: 1 nM BCE 30 nM BCE 100 nM BCE 300 nM BCE 1000 nM BCE 3000 nM BCE Antibody Conjugate Concentrate Antibody Conjugate Diluent Level I and Level II Urine Controls 30X Wash Concentrate Buffered Substrate Chromogen Reagent Stopping Reagent

The solid phase utilizes microwells onto which NTx has been adsorbed. NTx in the specimen or Calibrator competes with the solid phase NTx for antibody binding sites. The resulting amount of Antibody Conjugate bound to the solid phase is indirectly proportional to the amount of NTx in the specimen or Calibrator. The quantity of NTx in the specimen is determined from a standard calibration curve using reagents supplied in the kit. Assay values are standardized to an equivalent amount of bone collagen, and are expressed in nanomole bone collagen equivalents per liter (nM BCE). BCE reflects the amount of immunoreactive NTx, as measured by Ostcomark, liberated from human bone collagen following digestion with bacterial collagenase, as measured by hydroxyproline by high performance liquid chromatography (HPLC).

Acceptance Criteria and Device Performance for Osteomark®

This response synthesizes information from the provided text to describe the acceptance criteria and the studies that prove the Osteomark® device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Given that Osteomark is a diagnostic assay, acceptance criteria typically revolve around its analytical and clinical performance in fulfilling its intended use. Here's a table based on the provided data:

2. Sample Sizes and Data Provenance

The document provides details for several studies:

• Reference Range Determination (Premenopausal Women):
  • Sample Size: 258 women
  • Data Provenance: Multi-center, cross-sectional study; likely prospective for urine collection after study definition.
• Reference Range Determination (Men):
  • Sample Size: 81 men
  • Data Provenance: Study conducted at a large reference laboratory. Implied prospective since it's for reference range establishment.
• Within-Subject Variability:
  • Sample Size: 8 healthy subjects
  • Data Provenance: Urine specimens collected every 2-3 days over 2 months. Prospective.
• Intra-assay Variability:
  • Sample Size: 8 urine specimens, each tested in replicates of 10.
  • Data Provenance: Not specified, likely internal lab testing.
• Inter-assay Variability:
  • Sample Size: 3 urine specimens, each tested in duplicate over 20 separate assay runs.
  • Data Provenance: Not specified, likely internal lab testing.
• Antigen Recovery:
  • Sample Size: 3 normal urine specimens.
  • Data Provenance: Not specified, likely internal lab testing.
• Dilutional Linearity:
  • Sample Size: 4 urine specimens.
  • Data Provenance: Not specified, likely internal lab testing.
• Clinical Study: Predicting Skeletal Response & Monitoring HRT in Postmenopausal Women:
  • Sample Size (completed study): 227 women (109 HRT group, 118 calcium group)
  • Data Provenance: Multi-center, randomized, prospective clinical trial. (Campodarve et. al., 1995)
• Clinical Study: Monitoring Estrogen Suppressing Therapy:
  • Sample Size: Not explicitly stated for all analyses, but for percent change analysis: 88 subjects (55/88 had ≥30% change, 33/88 had

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