(58 days)
IMMULITE® Pyrilinks-D is a solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULITE Automated Analyzer and is designed for the quartitative measurement of deoxypyridinoline (DPD) in urine. It is intended strictly for in vitro diagnostic use in monitoring type 1 collagen resorption changes, especially in bone in post menopausal women diagnosed with osteoporosis and receiving antiresorptive therapy (amino-bisphosphonate).
IMMULITE® Pyrilinks* - D is a clinical device for use with the IMMULITE® Automated Immunoassay Analyzer. IMMULITE® Pvrilinks"-D is a solid-phase, chemiluminescent immunoassay for use with the IMMULITE Automated Immunoassay Analyzer. The solid-phase, a polystyrene bead enclosed within an IMMULITE Test Unit, is coated with a monoclonal antibody specific for DPD, The patient sample and alkaline phosphatase-conjugated DPD are simultaneously introduced into the Test Unit, and incubated for approximately 30 minutes at 37°C with intermittent agitation. During this time, DPD in the sample competes with enzyme-labeled DPD for a limited number of antibody-binding sites on the bead. Unbound material is then removed by a centrifygal wash, after which substrate is added and the Test Unit is incubated for a further 10 minutes. The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex-and thus also the photon output, as measured by the luminometer- is inversely proportional to the concentration of DPD in the sample.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:
It's important to note that this document describes a 510(k) premarket notification for an in vitro diagnostic (IVD) device (IMMULITE® Pyrilinks®-D). For IVDs, the "acceptance criteria" and "study" typically revolve around demonstrating substantial equivalence to a predicate device, focusing on analytical performance rather than clinical effectiveness in the same way a therapeutic device might. The "performance equivalence" section addresses this.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Method Comparison with Predicate Device: | |
| Consistency in DPD concentration range | DPD concentrations ranging from approximately 7.6 to 280 nM. |
| Equivalent mean values | IMMULITE® Pyrilinks®-D Mean: 70 nM |
| Metra Biosystems® Pyrilinks®-D Mean: 70 nM | |
| Strong linear correlation (slope, intercept, R-squared) | Linear Regression: |
| (IMMULITE® Pyrilinks®-D) = 1.00 (Metra Biosystems® Pyrilinks®-D) + 0.57 nM | |
| R-squared (r) = 0.966 |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Seventy-five (75) patient urine samples.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, it's typically understood to be retrospective for method comparison studies like this, using archived samples or freshly collected samples specifically for the comparison. The fact that it's "patient urine samples" suggests it's human biological samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is generally not applicable for an IVD method comparison study. The "ground truth" here is the measurement obtained by the predicate device (Metra Biosystems® Pyrilinks®-D), not an expert panel's interpretation. The goal is to show the new device performs similarly to an already cleared device, not to independently establish a diagnosis based on expert consensus.
4. Adjudication method for the test set
This is not applicable for this type of IVD method comparison study. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple human readers or experts who are establishing a ground truth for diagnostic imaging or clinical assessment. Here, the "truth" is the quantitative value from the predicate device.
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 is not applicable. This document describes an in vitro diagnostic device, not an AI-assisted diagnostic system where human readers interact with AI. The device directly measures a biomarker in urine.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is implicitly a standalone study, in the sense that the IMMULITE® Pyrilinks®-D assay (the algorithm/methodology) was directly compared to the predicate device, without a specific human-in-the-loop component being evaluated for performance improvement in this section. The "human" element comes in the form of a lab technician operating the analyzer, but their interpretive skill is not being assessed here.
7. The type of ground truth used
The "ground truth" (or reference standard) for this method comparison was the results obtained from the legally marketed predicate device: Metra Biosystems® Pyrilinks®-D. The study aimed to demonstrate that the new device's measurements correlated well with those from the predicate.
8. The sample size for the training set
The document does not explicitly describe a separate "training set" for the method comparison study itself. For an IVD, the "training" of the assay involves developing the reagents, optimizing the assay parameters, and establishing calibration curves during the device's development phase. This information is typically proprietary and not detailed in a 510(k) summary focused on demonstrating substantial equivalence to a predicate. The 75 samples mentioned are for the comparison study.
9. How the ground truth for the training set was established
As there's no explicitly described "training set" in the context of the method comparison in this document, the method for establishing its ground truth is not provided. If we interpret "training set" loosely as the data used to develop the IMMULITE® Pyrilinks®-D assay itself, the ground truth would have been established through internal validation studies using reference methods or characterized samples during assay development by Diagnostic Products Corporation. This information is usually not part of the 510(k) summary review.
§ 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.