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510(k) Data Aggregation
(718 days)
ACTOnco, ACTOnco IVD
The ACTOnco IVD assay is an in vitro diagnostic test that uses targeted next generation sequencing of formalin-fixed. paraffin-embedded tumor tissue from patients with solid malignant neoplasms to detect genetic alterations in a broad multi gene panel. The test is intended to provide informations, small insertions and deletions, ERBB2 gene amplification, and tumor mutational burden 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. ACTOnco IVD is a single-site assay performed at ACT Genomics.
The ACTOnco IVD assay is an in-vitro diagnostic assay intended to provide information 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.
The assay is a custom targeted sequencing platform, utilizing amplicon-based sequencing, to detect point mutations (single nucleotide variants, or SNVs), small insertions and deletions (Indels), ERBB2 gene amplification, and tumor mutational burden (TMB) in tumor specimens. The assay uses custom DNA primers corresponding to all exons and selected introns of oncogenes, tumor suppressor genes, drug metabolism genes, and immune-related genes. Primers are synthesized by a secondary manufacturer (Thermo Fisher Scientific). An overlapping amplicon approach is utilized in which tiled primers are designed to generate multiple overlapping amplicons of the same region to avoid allele dropout. In total, the primers target approximately 1.8Mb of the human genome. Genomic DNA is extracted from FFPE tissue samples.
Sequence libraries are prepared through a multiplex polymerase chain reaction (PCR) amplification step to enrich target sequences. Target sequences are tagged with index oligonucleotide to identify individual sample and adaptor oligonucleotide to anchor the amplicon to complimentary oligonucleotides embedded on the surface of the sequencing bead. Target sequences on the sequencing beads are amplified using emulsion PCR before sequencing. Multiple barcoded sequence libraries (from different patients) are pooled and then sequenced on a Thermo Fisher Ion GeneStudio™ S5 Prime System. Sequence reads are then aligned to the reference human genome. By comparing the identity of bases from the tumor DNA and the reference human genome, variant alterations are identified in the tumor.
The assay system includes a sequencing instrument, reagents (DNA extraction, library preparation and sequencing), software (operation of the sequencing instrument and variant calling), and standard operating procedures (SOPs) for the use of the system. ACT Genomics takes the responsibilities in monitoring the instrument; reagents and consumable materials which will be used in the assay process.
Multiple software components will be used in the assay. The NGS raw read analysis will be done using Thermo Fisher software. Variant calling for SNVs, insertions and deletions will be done using Thermo Fisher software. Mutation and variant annotation will be done using software from ACT Genomics, the Cunningham Lab and Golden Helix software. ERBB2 gene amplification will be done using software from Boeva Lab. Tumor Purity and Zygosity will be done using software from Halgamuge Lab (Kaushalya Amarasinghe). Calculations for tumor mutational burden will be done using ACT Genomics software.
I will analyze the provided text to extract information about the acceptance criteria and the study proving the device meets these criteria. I will then structure this information according to your requested format.
However, based on the provided text, it appears to be a 510(k) summary for a medical device (ACTOnco IVD, a next-generation sequencing-based tumor profiling test). The document describes performance testing (precision/reproducibility, analytical sensitivity/limit of detection, analytical specificity/interference, cross-contamination, DNA input, DNA extraction) and method comparison data.
Crucially, this document
does not contain a direct table of acceptance criteria nor explicit statements about "acceptance criteria" met by the device.
It also does not describe a "Multi Reader Multi Case (MRMC) comparative effectiveness study" or information about "human readers improve with AI vs without AI assistance" as it is a diagnostic test and not an AI-assisted diagnostic imaging device/software for human readers.
Therefore, I will provide the acceptance criteria based on the performance observed in the various analytical validation studies, as these implicitly define the performance considered acceptable for the device. I will also make clear when certain information is not present in the provided text.
Here is the information structured according to your request, extracted from the provided 510(k) summary:
Device: ACTOnco IVD - Next generation sequencing based tumor profiling test
1. Table of Acceptance Criteria (Inferred from Performance Studies) and Reported Device Performance:
Since explicit acceptance criteria are not called out as a separate table, I will infer them from the "Performance Testing" sections, assuming that the reported performance metrics were considered acceptable for the device's clearance.
| Performance Metric Category & Specificity | Inferred Acceptance Criterion (Target) | Reported Device Performance (observed outcomes from studies) |
|---|---|---|
| Precision / Reproducibility (SNVs, Indels) | ||
| Overall Call Rate (Positive) | ≥ 95% | 98.33% (35,308/35,906) |
| SNV Call Rate | ≥ 95% | 98.33% (31,837/32,377) |
| MNV Call Rate | ≥ 95% | 97.18% (963/991) |
| Insertion (INS) Call Rate | ≥ 95% | 96.97% (512/528) |
| Deletion (DEL) Call Rate | ≥ 95% | 99.30% (1,996/2,010) |
| Overall Call Rate (Negative/WT) | ≥ 99% | 99.997% (723,628/723,648) |
| Precision / Reproducibility (ERBB2 Amplification) | ||
| Positive Call Rate | 100% | 100% (based on 144 observations from 3 amplified samples) |
| Negative Call Rate | 100% | 100% (based on 816 observations from 17 non-amplified samples) |
| Precision / Reproducibility (TMB) | CV% ≤ 16% for TMB scores when Tumor Purity ≥ 20% | Ranges from 4.151% to 59.144% (for tumor purity 32.5% to 72.7%). Explicitly stated acceptable across tumor purities at or above 20% with percent CV 30%. |
| Analytical Sensitivity / Limit of Detection (LoD) | ||
| SNVs (Hotspot, 2% cutoff) | LoD/C95 for individual variants evaluated. Target to be near or below the cutoff. | Established MAF Range: 1.5%-6.6% |
| SNVs (Non-hotspot, 5% cutoff) | LoD/C95 for individual variants evaluated. Target to be near or below the cutoff. | Established MAF Range: 2.4%-15.1% |
| Insertions | LoD/C95 for individual variants evaluated. Target to be near or below the cutoff. | Established MAF Range: 1.1%-45.4% |
| Deletions | LoD/C95 for individual variants evaluated. Target to be near or below the cutoff. | Established MAF Range: 1.9%-22.0% |
| TMB (DNA Input) | Acceptable CV across relevant tumor purity and DNA input ranges | Acceptable TMB performance across tumor purities at or above 20% with percent CV 30%. |
| ERBB2 Amplification (LoD) | 100% call rate for samples > 10% tumor purity | 100% call rate for samples with tumor purity over 10%. (Data supported consistent repeatability at tumor purity 30%). |
| Analytical Specificity / Interference (SNVs and Indels) | ||
| Correct Positive Calls (Spike-in) | 100% (consistent with control) | 100% (3288/3288) with lower 95% CI of 99.88% |
| Correct Negative Calls (Spike-in) | 99.99% (consistent with control) | 99.99% (122,656/122,664) with lower 95% CI of 99.99% |
| Necrotic Tissue Tolerance | Acceptable processing and agreement up to 50% necrotic tissue | Control Group ( |
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