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The NYU Langone Genome PACT assay is a qualitative in vitro diagnostic test that uses targeted next generation sequencing of formalin-fixed paraffin-embedded (FFPE) tumor tissue matched with normal specimens with solid malignant neoplasms to detect tumor gene alterations in a 607-gene panel. The test is intended to provide information on somatic mutations and small insertions and deletions) for use by qualified health care professionals in accordance with professional guidelines, and is not conclusive or prescriptive for labeled use of any specific therapeutic product. NYU Langone Genome PACT is a single-site assay performed at NYU Langone Health.

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This FDA 510(k) clearance letter acknowledges the substantial equivalence of the "NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)" device. However, it does not contain the detailed acceptance criteria and study results typically found in the predicate device’s 510(k) summary or the manufacturer’s submission. This document is a regulatory clearance letter, not a detailed technical report.

Therefore, I cannot provide the requested information based solely on the provided text.

To answer your request, I would need access to the actual 510(k) submission summary for K202304, which would describe the device's performance characteristics and the supporting studies.

What is available from the provided text:

• Device Name: NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)
• Intended Use: Qualitative in vitro diagnostic test using targeted next-generation sequencing of FFPE tumor tissue matched with normal specimens with solid malignant neoplasms to detect tumor gene alterations in a 607-gene panel. Intended to provide information on somatic mutations and small insertions/deletions for use by qualified healthcare professionals.
• Regulatory Class: Class II
• Product Code: PZM
• Regulation Number: 21 CFR 866.6080
• Regulation Name: Next generation sequencing based tumor profiling test
• Type of Use: Prescription Use

The following information remains unknown from the provided text:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, the effect size.
6. If a standalone performance (algorithm only) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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