(512 days)
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
- ) Anti-resorptive therapies in postmenopausal women:
a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs
b) Bisphosphonate therapies - ) Anti-resorptive therapies in individuals diagnosed with osteopenia;
a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs
b) Bisphosphonate therapies - } 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.
§ 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.