(300 days)
The Quest Diagnostics Hair Check-DT (PCP) is a test system that utilizes the IDS The Quest Diaghoutes Kit for the qualitative detection of Phencyclidine at or above 300 pg/mg in head hair samples. This test system has not been evaluated for use in specific user populations or with hair specimens other than the head. It is an in vitro spoorne asor populations exclusively for in-house professional use only and is not intended for sale to anyone.
The Quest Diagnostics Hair Check-DT (PCP) screening test provides only a I ne Quest Diaghesate ist result. A more specific alternate chemical method must be prominal J analynour a confirmed result. Gas Chromatograph - Mass Spectrometry used in order to obtain a ion monitoring (SIM) mode is the preferred method with operating in the serected inter chemical confirmation methods are available. deateration interiation and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
Not Found
Here's an analysis of the provided text regarding the Quest Diagnostics HairCheck-DT (PCP) device, addressing your specific points.
It's important to note that the provided documents are a 510(k) summary (or a letter related to it). These documents typically focus on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with all the specifics of acceptance criteria, study methodologies, and granular performance data that would be found in a full clinical trial report or validation study. Therefore, some of the information you requested may not be explicitly present or might require inference.
Acceptance Criteria and Device Performance
The provided document (a 510(k) clearance letter and Indications for Use) does not explicitly state specific acceptance criteria (e.g., sensitivity, specificity thresholds) or provide a table of reported device performance in those terms. The clearance states that "the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."
The key performance characteristic mentioned is the qualitative detection of Phencyclidine (PCP) at or above 300 pg/mg in head hair samples.
However, based on the nature of a 510(k) for a qualitative diagnostic test, acceptance criteria would typically relate to:
- Sensitivity: Ability to correctly identify positive samples (PCP present at or above 300 pg/mg).
- Specificity: Ability to correctly identify negative samples (PCP absent or below 300 pg/mg).
- Accuracy: Overall correct classification rate.
- Precision/Reproducibility: Consistency of results.
- Correlation with a confirmatory method: How well the screening test's preliminary positive results are confirmed by the gold standard (GC-MS).
While actual numerical performance figures or a formal acceptance criteria table are not in the provided text, the core "performance" stated is its ability to qualitatively detect PCP at or above 300 pg/mg.
Study Details from the Provided Text
Given the limited nature of a 510(k) clearance letter, many of the detailed study specifics you requested are not present in the provided document. A 510(k) typically summarizes data submitted, but the full study reports are usually much more extensive.
Here's what can be inferred or explicitly stated:
-
A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as numerical thresholds (e.g., sensitivity > X%, specificity > Y%). The primary "acceptance" is substantial equivalence to a predicate and the ability to detect PCP at/above 300 pg/mg.
- Reported Device Performance: The primary stated performance characteristic is the "qualitative detection of Phencyclidine at or above 300 pg/mg in head hair samples." No specific sensitivity, specificity, or accuracy figures are provided in this document.
Performance Metric Acceptance Criteria (Implied/Typical for 510(k)) Reported Device Performance (from this document) Qualitative Detection Must reliably detect PCP at or above 300 pg/mg threshold and yield valid negative results below threshold; substantially equivalent to predicate. Qualitatively detects PCP at or above 300 pg/mg in head hair samples. Specific metrics not given. Confirmatory Method Preliminary positive results require confirmation by a more specific alternate chemical method. Mentions Gas Chromatograph - Mass Spectrometry (GC-MS) in selected ion monitoring (SIM) mode is preferred. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided documents.
- Data Provenance: Not specified. It's likely US-based given the FDA clearance, but this isn't explicitly stated.
- Retrospective or Prospective: Not specified.
-
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):
- Number of Experts: Not specified.
- Qualifications: For drug testing, the "ground truth" is typically established by confirmatory analytical chemistry methods (e.g., GC-MS) performed by qualified laboratory personnel, not by medical "experts" in the clinical sense (like radiologists). The document explicitly states: "A more specific alternate chemical method must be performed to obtain a confirmed result. Gas Chromatograph - Mass Spectrometry (GC-MS) operating in the selected ion monitoring (SIM) mode is the preferred method..."
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable in the context of analytical drug testing where GC-MS is the gold standard. The GC-MS result forms the objective ground truth. There's no "adjudication" among multiple readers of the primary test as it's an automated or semi-automated qualitative assay.
-
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 to the Quest Diagnostics HairCheck-DT (PCP). This device is an in vitro diagnostic for drug detection, not an AI-assisted imaging device or a decision support system for human readers. There are no "human readers" to improve in this context. It's a laboratory test.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance of the "Quest Diagnostics HairCheck-DT (PCP) is a test system..." is inherently a standalone performance evaluated against a confirmed analytical method (GC-MS). It performs the "screening test" qualitatively. Human interaction is for specimen collection, preparation, running the assay, and interpreting the preliminary result, but the "performance" of the device itself is its ability to yield a result.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for this device is based on confirmatory analytical chemistry methods, specifically Gas Chromatograph - Mass Spectrometry (GC-MS) operating in the selected ion monitoring (SIM) mode, for the presence and concentration of PCP in the hair samples. This is the gold standard for drug testing.
-
The sample size for the training set:
- Training Set Sample Size: Not specified. For in vitro diagnostic assays, the "training set" concept (as used in machine learning) isn't directly applicable in the same way. Development often involves method development, optimization, and internal validation using various panels of known positive and negative samples, and spiked samples. These details are not in the 510(k) letter.
-
How the ground truth for the training set was established:
- Similar to the test set, the ground truth for any development or internal validation ("training") would be established through confirmatory analytical chemistry methods (GC-MS), typically against certified reference materials, spiked samples, and clinical samples confirmed by GC-MS.
N/A