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HS AMICA is intended for coagulation (thermoablation) of soft tissues. Not for use in cardiac procedures.

HS AMICA (Apparatus for MICrowave Ablation) is an integrated system for interstitial thermoablation of soft tissues through controlled emission of microwaves. The system is composed by three interactive devices, namely: AMICA-GEN: a digitally controlled microwave power source, operating at 2450 MHz and delivering up to 100 W CW (continuous wave); it features a single output channel. AMICA-PROBE: an interstitial single-use coaxial microwave applicator, fed by AMICA--GEN. AMICA-PUMP: a peristaltic pump for convective applicator cooling through continuous circulation of liguid coolant, fully controlled by AMICA-GEN.

The provided text is a 510(k) summary for the HS AMICA Microwave Tissue Coagulation System. It describes the device's technical characteristics, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, specific device performance data (like sensitivity, specificity, accuracy), sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case (MRMC) studies.

The "Performance testing" mentioned on page 3 is a general statement: "Performance testing was executed to ensure that HS AMICA functions as intended and meets design specifications. Sufficient data were obtained to show that the device meets safety and effectiveness criteria and is substantially equivalent to the predicate device." This statement, while confirming testing was done, does not provide any of the quantitative details requested.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and qualifications
4. Adjudication method
5. MRMC comparative effectiveness study details
6. Standalone performance details
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

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This biopsy instrument is used for drawing of osteomedulary substance and or for explantation of bone marrow.

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This document is a 510(k) Premarket Notification for a bone marrow biopsy needle, the "TrapMatic System® Set." It is a regulatory submission to the FDA, not a study report detailing acceptance criteria and device performance. Therefore, I cannot extract the requested information from the provided text.

The text primarily focuses on:

• Regulatory Information: Applicant details, contact person, submission date, trade name, common name, classification, and product code.
• Indication for Use: "This biopsy instrument is used for drawing of osteomedullary substance and or for expllantation of bone marrow."
• FDA Communication: A letter from the FDA determining substantial equivalence to predicate devices, outlining regulatory requirements, and permitting marketing.

There is no information on:

• A table of acceptance criteria or reported device performance.
• Sample sizes for test sets or training sets.
• Data provenance.
• Number/qualifications of experts.
• Adjudication methods.
• MRMC studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used or how it was established.

This document is a formal notification for market clearance based on substantial equivalence, not a clinical or performance study report.

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