(127 days)
The Polymedco SpotChem EX and ALT test system is an in vitro diagnostic instrument and procedure intended to measure the activity of the enzyme alanine amino transferase or ALT (also know as a serum glutamic pyruvic transaminase or SGPT) in serum, plasma and whole blood. ALT measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
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This document is a 510(k) clearance letter from the FDA for the SpotChem EZ Analyzer and ALT Test. It acknowledges that the device is substantially equivalent to a legally marketed predicate device. However, it does not contain the detailed study information required to answer the prompt thoroughly.
The letter primarily focuses on the regulatory classification and marketing authorization, not on the specific performance studies. Therefore, much of the requested information is absent from this document.
Here's what can be extracted, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in this document.
- Reported Device Performance: Not detailed in this document. The letter only states that the device is "substantially equivalent" to a predicate device, implying its performance should be comparable, but no specific metrics are provided.
2. 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 available in this document.
- Data Provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not available in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not available in this document.
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 device is an in-vitro diagnostic analyzer for enzyme activity (ALT/SGPT), not an AI-assisted diagnostic imaging or interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is a standalone instrument for measuring enzyme activity. Its performance would inherently be "standalone" in the sense that it doesn't involve a human interpreting its output in the context of an algorithm's assistance. However, the exact study details are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For an ALT test, the "ground truth" would typically be established by a reference method of ALT measurement, often a well-established enzymatic kinetic assay, which is considered the gold standard for accurately determining enzyme activity in a sample. This document does not specify the method.
8. The sample size for the training set:
- Not applicable as this is not an AI/ML device that requires a training set in that context. If we interpret "training set" broadly as the data used to validate the initial assay, that information is not present.
9. How the ground truth for the training set was established:
- Not applicable for the same reasons as point 8.
Summary of what can be inferred or is explicitly stated:
- Device Name: SpotChem EZ Analyzer and ALT Test
- Intended Use: To measure the activity of the enzyme alanine amino transferase (ALT or SGPT) in serum, plasma, and whole blood for the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
- Regulatory Status: Substantially Equivalent (510(k) clearance) to legally marketed predicate devices.
- Regulatory Class: Class I
- Product Codes: CKA (Alanine amino transferase (ALT/SGPT) test system) and JJF.
- Manufacturer: ARKRAY, Inc.
To fully answer your prompt, you would need to consult the actual 510(k) submission document (K040332) which would contain the detailed pre-market performance data submitted by the manufacturer to the FDA. This letter only provides the outcome of the FDA's review.
§ 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.