(126 days)
PTS PANELS CHOL+HDL Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure cholesterol and high density lipoprotein cholesterol in whole blood. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various liver and renal diseases.
Dry chemistry test strip for use with PTS reflectance photometer. One test strip containing two tests.
This document is a 510(k) summary for the PTS Panels CHOL+HDL Panel Test Strips. It focuses on the device modification and its substantial equivalence to previously cleared predicate devices. The provided text is a regulatory submission, not a detailed scientific study report. Therefore, much of the requested information regarding a "study that proves the device meets the acceptance criteria" in terms of rigorous clinical trial design (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance) is not present in the provided text.
Here's an analysis of the information that can be extracted, and where limitations exist:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the format of specific thresholds for accuracy, precision, or other performance metrics. Instead, it aims to demonstrate substantial equivalence to predicate devices. The "reported device performance" is essentially the claim that the new device performs "the same" as the predicate device regarding its intended use and chemical methods.
The key acceptance criterion implied by a 510(k) submission is that the modified device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and as effective. This is achieved by demonstrating that the modified device has the same intended use, technology, storage, specimen type, chemistry methods, and calibration curve as the predicate, with minor differences that do not raise new questions of safety or effectiveness.
The document highlights the following similarities and differences:
| Item | Predicate | Modified Device |
|---|---|---|
| Intended Use | Intended to measure cholesterol and HDL cholesterol | Same |
| Technology | Dry chemistry test strip for use with PTS reflectance photometer. | Same |
| Product Storage | Store with vial tightly capped in a cool dry place at room temperature of 68-86°F. | Same |
| Specimen | Whole blood from fingerstick or venous blood collected in an EDTA or heparin tube. | Same |
| Chemistry Methods | Cholesterol: Colorimetric enzymatic (cholesterol esterase/oxidase) trinder method for cholesterol. | |
| HDL: Colorimetric enzymatic (cholesterol esterase/oxidase) trinder method for cholesterol. Dextran Sulfate fractionation. | Same | |
| Calibration Curve | Resides on a read-only memory (EEPROM) chip packaged with the test strips. | Same |
| Number of test strips to obtain results | Two | One test strip containing two tests. |
| Time to obtain results | About one minute for each test result. | About two minutes. |
Conclusion regarding performance: The document implicitly argues that because the core technology, chemistry, and intended use are the same, the performance is also "the same" or substantially equivalent. The only reported performance difference is the time to obtain results (2 minutes for the new device vs. 1 minute per test for the old, but the new device combines both tests into one strip).
Study Information (Not Present in Detail)
The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence, not typically a detailed report of a new clinical study with specific acceptance criteria and performance data. Therefore, the following information is not available in the provided document:
- Sample size used for the test set and the data provenance: Not mentioned. The 510(k) summary typically references studies conducted, but the details of those studies (like sample size or data origin) are usually found in the full 510(k) submission, not the summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
- 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: Not applicable. This device is a test strip for chemical analysis, not an AI-assisted diagnostic imaging device that involves human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an algorithm. This is a chemical test strip. Its "standalone" performance would be its analytical accuracy and precision, which are typically evaluated against a reference method. While such studies would have been performed for the original predicate devices and likely for the modified device to show equivalence, the details are not in this summary.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned explicitly. For chemical assays like this, the "ground truth" (or reference method) is typically a highly accurate laboratory method (e.g., a standardized enzymatic reference method run on a clinical chemistry analyzer).
- The sample size for the training set: Not applicable for this type of device. There isn't an "algorithm" being trained in the conventional sense of machine learning. The "calibration curve" resides on an EEPROM chip, which is pre-programmed based on manufacturing data and chemical principles, not a "training set" of patient data.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
In summary, the provided text is a regulatory submission demonstrating substantial equivalence for a modified medical device (test strips for cholesterol and HDL). It does not contain the detailed study results and specific acceptance criteria that would typically be found in a clinical performance study report for an AI-enabled device or a novel diagnostic. The "acceptance criteria" here are met by demonstrating that the new device is fundamentally the same as its cleared predecessors.
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(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.