Search Results
Found 1 results
510(k) Data Aggregation
(126 days)
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System
The DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. It is intended for use in fetal, abdominal. intra-operative (abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, cardiac(adult, pediatric), trans-soph. (Cardiac), peripheral vessel, and urology exams.
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/ DC-TQ is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CCW-Mode, Color-Mode , Power/Dirpower Mode, THI, Smart3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Strsin Elastography, Contrast imaging (Contrast agent for Liver and LVO), STE, STQ, Ultrasound Fusion Imaging, GYN/Pelvic and the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include Linear array, Convex array, Phased array, Volume and Pencil probe.
Here's a breakdown of the acceptance criteria and the study information for the DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1 | Evaluated and conducted in accordance with ISO 10993-1. |
| Electrical Safety | IEC 60601-1 | Complies with IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | Complies with IEC 60601-1-2. |
| Ultrasound Specific Safety | IEC 60601-2-37 | Complies with IEC 60601-2-37. |
| Acoustic Power Output | FDA Guidance for Industry and FDA Staff "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" | Below the limits recommended by FDA guidance. |
| Software General Safety | IEC 62304 and FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | Software verification and validation testing were conducted and documentation was provided. |
| Usability | IEC 62366 and IEC 60601-1-6 | Designed in compliance with these standards. |
| Risk Management | ISO 14971 | Application of risk management as per ISO 14971. |
| Quality Systems | 21 CFR 820, ISO 9001, ISO 13485 | Conforms with these quality systems. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not explicitly state specific sample sizes for test sets for the performance data. The sections on performance data refer to compliance with standards and guidelines rather than specific study parameters involving patient data.
Regarding data provenance, the document mentions non-clinical tests (biocompatibility, electrical safety, EMC, acoustic power, software verification/validation) and compliance with international standards. There is no mention of patient data (retrospective or prospective) or countries of origin for test data in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The non-clinical tests described involve compliance with established standards, which don't typically involve human expert ground truth for comparative performance in the same way clinical studies do.
4. Adjudication Method for the Test Set:
This information is not provided in the document. The tests performed are primarily technical and regulatory compliance checks.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improving with AI vs. without AI assistance:
This information is not provided in the document. The document explicitly states: "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." An MRMC study would be a type of clinical study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The document describes the device as a "software controlled, ultrasonic diagnostic system" with various "Main Added Features" (e.g., Ultrasound Fusion Imaging, Smart Pelvic Floor, STE/STQ, Strain Elastography, Smart Face, Smart Planes FH, Glazing Flow, Fusion RESP). While these features are algorithm-based, the document does not explicitly detail standalone performance studies for these specific algorithms, nor does it refer to them as "AI" in the context of standalone performance evaluation. The evaluation focuses on overall system compliance with safety and effectiveness standards, and the capabilities of these features as part of the system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests detailed, the "ground truth" is implied by the international and regulatory standards themselves (e.g., IEC, ISO, FDA guidance limits). For instance, acoustic power output is compared against specified limits, and electrical safety against defined safety requirements. There is no mention of clinical ground truth (like pathology or outcomes data) because clinical studies were not conducted.
8. The Sample Size for the Training Set:
This information is not provided in the document. The document describes specific software features but does not delve into the development or training of any potential machine learning components within these features.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the document, as details about training sets and their ground truth establishment are absent.
Ask a specific question about this device
Page 1 of 1