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PTS PANELS LDL Cholesterol Test Strips are intended to measure low density lipoprotein. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This system is intended for professional use.

Dry (Test Strip)

The provided text does not contain detailed acceptance criteria or a study description with the specific information requested in the prompt. The document is primarily a 510(k) summary for a medical device (PTS PANELS LDL Cholesterol Test Strips), focusing on its substantial equivalence to a predicate device.

It includes:

• Contact information for the submitter.
• Trade/common names, product code, and device classification.
• A comparison of the new device with a predicate device (Roche LDL-C Plus) regarding their intended use, test principle, sample requirements, and differences in sample type, form, and instrumentation.
• An FDA letter confirming the substantial equivalence determination and allowing marketing of the device.
• Indications for Use for the PTS PANELS LDL Cholesterol Test Strips.

However, the document does not provide:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts and their qualifications for establishing ground truth.
4. Adjudication method.
5. Information on any Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI.
6. Details about a standalone (algorithm only) performance study.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document states that the new device shares the "Intended Use" with the predicate device: "Direct quantitative determination of LDL Cholesterol," and mentions that lipoprotein measurements are used in the "diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases." This describes the clinical utility but not specific performance metrics or acceptance criteria for the device itself.

To provide the requested information, a different type of document, such as a detailed study report, clinical trial results, or a specific section of the 510(k) submission detailing analytical and clinical performance data, would be needed.

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