(14 days)
Diagnostic ultrasound investigations: Imaging (B-mode), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continous wave Doppler (CW Doppler), Color Flow Mapping (CFM) adn Color Time motion (CM mode).
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small organs (Thyroid, Breast, Testicle), Cardiac, Transesophageal, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
The Sigma 5000 series, Imagic is an ultrasound instrument intended to perform the following diagnostic ultrasound investigations: Imaging (B-mode), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Color Flow Mapping (CFM) and Color Time motion (CM mode). The submission also includes the transducers necessary for these procedures. The system is a mobile console approximately 60 cm wide, 95 cm deep and 130 cm high equipped with a keyboard control panal, a large TFT screen, assorted transducers and image storage or hard-copy devices.
The provided document is a 510(k) Premarket Notification from Kontron Medical for their Sigma 5000 series, Imagic ultrasound system. It is a declaration of substantial equivalence to a predicate device (Kontron Medical Sigma 110/330, K002239), and not a study proving the device meets specific performance criteria through clinical trials. The document explicitly states:
"Clinical tests: Since the Sigma 5000 series Imagic uses the same technology and principles as existing devices, clinical tests are not required."
Therefore, the device's acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device rather than meeting pre-defined acceptance criteria through a specific study with a test set of data.
Given this, I cannot extract the requested information regarding acceptance criteria and performance from a study because such a study was not conducted or reported in this document.
However, I can summarize the non-clinical tests that were performed and the basis for the substantial equivalence claim.
Summary based on the provided document:
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Table of Acceptance Criteria and Reported Device Performance: Not applicable. The submission asserts substantial equivalence based on technological characteristics being the same as the predicate device, not on meeting specific quantitative performance metrics from a clinical study.
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Sample size used for the test set and the data provenance: Not applicable. No test set of data from clinical studies was used.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established from a clinical test set.
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Adjudication method for the test set: Not applicable. No test set or expert adjudication was performed.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document predates widespread AI in medical imaging and focuses on ultrasound system equivalence, not AI effectiveness.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm-only performance study was conducted.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The equivalence is based on the technological characteristics of the device being the same as the predicate device.
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The sample size for the training set: Not applicable. No machine learning algorithm training was mentioned or evaluated.
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How the ground truth for the training set was established: Not applicable. No machine learning algorithm training was mentioned or evaluated.
Information that can be extracted regarding device acceptance:
The device's acceptance is based on its substantial equivalence to Kontron Medical Sigma 110/330 (K002239). The reasoning provided is that:
- The technological characteristics of the new device (Sigma 5000 series, Imagic) are the same as those of the predicate device.
- The device has been evaluated for non-clinical tests: acoustic output, biocompatibility, and thermal, electrical, and mechanical safety, and has been found to conform to applicable medical device safety standards.
- The design and development process conforms with 21 CFR 820 Quality System Regulation and ISO13485 quality system standards.
- Compliance is verified through independent evaluation with ongoing factory surveillance.
- Diagnostic ultrasound has a long history of safe and effective performance.
Therefore, the acceptance criteria implicitly rely on the predicate device's established safety and effectiveness through conformity to standards and regulations, rather than new clinical performance data for this specific device.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.