(59 days)
This product is intended for use with Exigent Diagnostics Cartridges when used by laboratory professionals for the in vitro measurement of various clinical chemistry analytes in human blood.
This product is indicated for in vitro measurement of various clinical chemistry analytes in human blood.
The Exigent Diagnostics CareSide™ System utilizes individual (analyte specific) test cartridges to perform a variety of clinical blood tests. The user introduces the whole blood, serum, or plasma specimen into the cartridge sample deposition well, closes the lid and inserts the cartridge into the Exigent Diagnostics CareSide™ Analyzer. The Exigent Diagnostics CareSide™ Analyzer automatically performs up to 6 quantitative test results in approximately ten minutes using approximately 85 microliters of human blood per test. Results are provided on-screen, and may be transferred to a floppy disk for subsequent uploading to a laboratory information system. The Exigent Diagnostics CareSide™ System components include: CareSide™ Analyzer and Analyte-specific Cartridge(s).
The CareSide™ Analyzer is a compact tabletop chemistry analyzer that performs multiple discrete analyses on human whole blood, plasma, or serum specimens. The CareSide™ analyzer is semi-automated: the only operator intervention is the addition of the specimen to the test cartridge and the insertion of the dosed cartridge into the analyzer. The CareSide™ Analyzer automatically warms, separates, meters, dispenses, and incubates the specimen before reading the signal and calculating results. The CareSide™ Analyzer is intended only for use with Exigent Diagnostics CareSide™ test cartridges.
The provided text describes a 510(k) summary for the Exigent Diagnostics CareSide™ Analyzer, submitted on February 23, 1998. It details the device's characteristics and compares its performance to a predicate device, the Vitros DT 60 II System, to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the comparison to the predicate device, Vitros DT 60 II System, aiming for "as safe, effective, and performs as well as or better than" the predicate. The performance characteristics evaluated are Precision, Relative Accuracy, Linearity, Interference, and Detection Limit.
| Performance Metric | Acceptance Criteria (Implied by Predicate) | Reported CareSide™ Performance |
|---|---|---|
| Precision | Typical total CV 1.5% to 5.2% (for 4 tests evaluated by predicate) | Typical total CV 3.1% to 8.5% (for 4 tests evaluated) |
| Relative Accuracy | Not explicitly stated for predicate; implied to be acceptable for predicate | Mean difference [Vitros - CareSide™] from method comparison means is test specific (3% for 4 tests evaluated) |
| Linearity | Not provided for predicate; implied to be acceptable for predicate | Correlation coefficient >= 0.95 |
| Interference | Not provided for predicate; implied to be acceptable for predicate | Susceptibility to interference is test specific. |
| Detection Limit | Not provided for predicate; implied to be acceptable for predicate | Test specific. |
Note: The phrasing "as safe, effective, and performs as well as or better than the legally marketed predicate device" suggests that matching or improving upon the predicate's performance is the acceptance criterion. However, for "Precision," the CareSide™'s reported CV range (3.1% to 8.5%) is wider than the predicate's (1.5% to 5.2%), which might indicate worse precision. The submission, nonetheless, concludes that the data "demonstrate that the CareSide™ Analyzer is as safe, effective, and performs as well as or better than" the predicate, implying the FDA accepted these differences as not impacting substantial equivalence for the intended use.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in the comparative performance studies (Precision, Relative Accuracy, Linearity, Interference, Detection Limit). It mentions "4 tests evaluated" for Precision and Relative Accuracy, but this refers to the number of different types of chemical analytes for which performance was assessed, not the number of samples used for each evaluative test.
The data provenance (e.g., country of origin, retrospective or prospective) is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set. Given that this is a clinical chemistry analyzer, the "ground truth" would typically come from a reference method run by a certified clinical laboratory, rather than expert interpretation of images or clinical findings.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. This type of device (a micro chemistry analyzer) does not typically involve expert adjudication in the way, for example, a diagnostic imaging device might. Its performance is measured against reference methods, not subjective expert opinion.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not performed. MRMC studies are typically relevant for diagnostic devices where human interpretation is a key component, such as radiology or pathology imaging, to assess how AI assistance impacts human reader performance. This device is an automated analyzer, so such a study would not be applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the data presented ("Comparative Performance Characteristics") are for the standalone performance of the CareSide™ Analyzer. The device is described as "semi-automated" requiring only operator intervention for specimen addition and cartridge insertion, with the analyzer then automatically performing all steps and calculating results. The performance metrics (Precision, Accuracy, Linearity) reflect the algorithm's direct output compared to standard methods.
7. The Type of Ground Truth Used
The ground truth for assessing the CareSide™ Analyzer's performance implicitly comes from comparison to a legally marketed predicate device (Vitros DT 60 II System) and established laboratory reference methods.
- For Relative Accuracy, the comparison is directly stated: "Mean difference [Vitros - CareSide™]". This implies the Vitros results are considered a form of "ground truth" or a highly correlated reference.
- For Precision, this is measured inherently by repeated tests on the same sample, with the expectation that results should be tightly clustered.
- For Linearity and Detection Limit, these would be established by testing samples with known, varied concentrations or concentrations near the expected limit, using reference methods to determine the true values.
Therefore, the ground truth is based on established reference laboratory methods and comparison to a predicate device's performance.
8. The Sample Size for the Training Set
The document does not provide any information about a "training set" or its sample size. This submission is for a device based on established chemical principles and reflectance photometry, not a machine learning or AI algorithm that would typically require a distinct training set in the modern sense. The "master dose-response curve" used for calculation is likely derived from validation studies during the device's development, but specific details on the dataset used for this are not given.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a separate "training set" in the context of modern AI/ML development isn't explicitly described for this device. The "master dose-response curve" and "lot-specific coefficients" are central to the analyzer's calculations. These would have been established during the development and manufacturing process using samples with known analyte concentrations, validated through standard laboratory reference methods, to ensure accurate quantification of reflectance to concentration. However, the exact methodology and ground truth establishment for these internal calibration curves are not detailed in this 510(k) summary.
§ 862.2170 Micro chemistry analyzer for clinical use.
(a)
Identification. A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.(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.