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510(k) Data Aggregation
(200 days)
The Oxalate Normal and Elevated Controls are for use in the quality control of the Thermo Oxalate method for the quantitative determination of urine oxalate. The control is used for monitoring accuracy and precision on automated clinical chemistry analysers and for manual operations. It is for in vitro diagnostic use only.
The Oxalate Standard is intended for the calibration of Oxalate assays using the Thermo Oxalate Reagent. It is for in vitro diagnostic use only.
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This FDA 510(k) summary document describes Oxalate Urine Controls (Normal & Elevated) and Oxalate Standard, which are calibrators and controls for an existing oxalate assay. This type of device does not typically involve the kind of "AI model performance" described in your request (e.g., test sets, ground truth, experts, MRMC studies, standalone performance).
Instead, "acceptance criteria" and "device performance" for these types of in vitro diagnostic (IVD) devices relate to their analytical performance (e.g., accuracy, precision, linearity, stability) in conjunction with the assay they are designed to control or calibrate. The "study that proves the device meets acceptance criteria" would typically be validation studies demonstrating these analytical characteristics.
Therefore, many of the requested fields are not applicable to the information provided in this document. I will fill in what can be inferred or is directly stated, and mark as "N/A" (Not Applicable) where the information is not relevant to this type of device or not present in the provided text.
Acceptance Criteria and Study for Oxalate Urine Controls and Oxalate Standard
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Typically established by manufacturer) | Reported Device Performance (Summary from validation study) |
|---|---|---|
| Accuracy (Controls) | Not explicitly stated in this document. Typically assessed against target values. | Not explicitly stated in this document. Implied by substantial equivalence to predicate. |
| Precision (Controls) | Not explicitly stated in this document. Typically expressed as %CV. | Not explicitly stated in this document. Implied by substantial equivalence to predicate. |
| Calibration Performance (Standard) | Not explicitly stated in this document. Typically assessed by recovery, linearity. | Not explicitly stated in this document. Implied by substantial equivalence to predicate. |
| Stability | Not explicitly stated in this document. Typically shelf-life and in-use stability. | Not explicitly stated in this document. Implied by substantial equivalence to predicate. |
| Substantial Equivalence | Device is substantially equivalent to a legally marketed predicate device. | Device is found substantially equivalent to a predicate device for the stated indications for use (K062521). |
2. Sample size used for the test set and the data provenance
- Sample Size: N/A (Analytical performance studies for calibrators/controls don't typically refer to "test sets" in the same way an AI model does. Instead, they involve multiple runs, replicates, and lots of control/calibrator material.)
- Data Provenance: N/A (Not specified in this document. Typically, validation studies are performed internally by the manufacturer.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A (Ground truth for calibrators/controls is established through gravimetric/volumetric preparation, analytical assays, and certified reference materials, not expert consensus on images or similar data.)
4. Adjudication method for the test set
- N/A (Not relevant for this type of 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
- N/A (This is not an AI-assisted diagnostic device. It is a control/calibrator for a laboratory assay.)
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A (Not an AI algorithm. Its performance is evaluated analytically, not in a diagnostic "standalone" manner.)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For calibrators and controls, the "ground truth" (or target value) is established through precise manufacturing, gravimetric/volumetric preparation, and often verification against higher-order reference materials or methods. The document does not specify the exact methods used to assign target values to the controls or to determine the concentration of the standard.
8. The sample size for the training set
- N/A (Not an AI model; no training set in this context.)
9. How the ground truth for the training set was established
- N/A (Not an AI model; no training set in this context.)
Summary based on the provided document:
The provided document is an FDA 510(k) clearance letter for Oxalate Urine Controls (Normal & Elevated) and Oxalate Standard. The primary "acceptance criteria" discussed in this letter is substantial equivalence to an existing legally marketed predicate device. The "study that proves the device meets the acceptance criteria" is the premarket notification (510(k)) submission, which contained data (e.g., analytical performance studies) demonstrating that the device is as safe and effective as the predicate. The letter confirms that the FDA reviewed these submissions and determined substantial equivalence. Detailed analytical performance data (accuracy, precision, stability, etc.) would have been part of the 510(k) submission, but is not detailed within this specific public document.
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