(48 days)
DPC's IMMULITE® Pyrilinks"-D is a solid-phase, chemikaninescent enzyme immuneassay for use with the IMMULITE® Automated Analyzer and is designed for the quantitative measurement of deoxyppyridinoline (DPD) in urine. It is intended strictly for in vitro diagnostic use as an indicator of bone resorption.
IMMULITE® Pyrilinks -D is a clinical device for use with the IMMULITE® Automated Immunoassay Analyzer. The IMMULITE® Pyrilinks -D assay is designed for the quantitative measurement of deoxypyridinoline in urine It is intended strictly for in vitro diagnostic use as an indicator of bone resorption. IMMULITE Pyrilinks -D is a solid-phase, chemiluminescent immunoassay for use with the IMMULITE Automated Inimunoassay 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 centrifugal 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 yead an unstable intermediate. The continuous production of this intermediate results in the sustained 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 luminometeris inversely proportional to the concentration of DPD in the sample.
The provided document describes the safety and effectiveness summary for the IMMULITE® Pyrilinks -D device, focusing on its substantial equivalence to a predicate device, Metra Biosystems "Pyrilinks"-D.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state pre-defined acceptance criteria (e.g., a specific r-value or a range of acceptable mean differences). Instead, it presents a method comparison study to demonstrate "Performance Equivalence" and "substantially equivalent results" to the predicate device. The performance is assessed through linear regression analysis.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (IMMULITE® Pyrilinks®-D vs. Metra Biosystems® Pyrilinks®-D) |
|---|---|
| Statistical Correlation (r-value) | r = 0.966 |
| Linear Regression Equation | (IMMULITE® Pyrilinks®-D) = 1.00 (Metra Biosystems® Pyrilinks®-D) + 0.57 nM |
| Mean DPD Concentrations | IMMULITE® Pyrilinks®-D: 70 nM |
| Metra Biosystems® Pyrilinks®-D: 70 nM |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Seventy-five (75) patient urine samples.
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, but the phrasing "was compared to" for patient samples suggests a retrospective or cross-sectional comparison of existing or freshly collected samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The "ground truth" for this type of immunoassay comparison is typically the result from the predicate device itself, which is assumed to be accurate. There's no mention of a separate expert panel establishing ground truth for the DPD concentrations.
4. Adjudication method for the test set
This information is not applicable and not provided. Imunoassay results are quantitative measurements, not subjective interpretations requiring adjudication.
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 an MRMC comparative effectiveness study involving human readers or AI. It is a direct comparison between two diagnostic devices. Therefore, this information is not applicable and not provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This statement refers to the performance of a diagnostic device (an immunoassay analyzer), which operates as a standalone system to quantify DPD in urine. There is no "human-in-the-loop" component in the sense of interpretative assistance; the device directly measures and reports DPD concentrations. The performance data presented (linear regression, r-value, mean concentrations) are reflective of this standalone device's output.
7. The type of ground truth used
The "ground truth" in this study is the measurement of deoxypyridinoline (DPD) in urine samples obtained from the predicate device, Metra Biosystems® Pyrilinks®-D. The study aims to demonstrate that the new IMMULITE® Pyrilinks®-D device provides results that are substantially equivalent to those of the established predicate device.
8. The sample size for the training set
The document does not mention a separate "training set" for the IMMULITE® Pyrilinks®-D in the context of this 510(k) summary. Immunoassays are developed and validated using a different process than machine learning algorithms, which typically involve distinct training and test sets. For this type of device, the "training" (development and optimization) would have been part of the product's R&D phase, not a specific "training set" as understood in AI studies.
9. How the ground truth for the training set was established
As there is no separate "training set" described in the provided summary, information on how its ground truth was established is not applicable and not provided. The focus of the 510(k) summary is on demonstrating equivalence to an existing device using a test set of patient samples.
§ 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.