(10 days)
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. Modes of Operation: B, M, PW D, CW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD).
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), 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 Kontron Medical Sigma 5000 series, Imagic ultrasound system is a medical diagnostic ultrasound imaging system.
Here's an analysis of the provided text regarding its acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria or quantifiable performance metrics for the device. Instead, the acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device (Kontron Medical Sigma 110/330, K002239) and compliance with relevant safety and quality standards.
The reported device performance is broadly stated as conformant with applicable medical device safety standards and consistent with traditional clinical practice and FDA guidelines.
| Acceptance Criteria Category | Description of Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety and Effectiveness | Substantial equivalence to predicate device (Kontron Medical Sigma 110/330, K002239). | The technological characteristics of the new device are the same as those of the predicate device. |
| Acoustic Output | Conformity with applicable medical device safety standards. | Device has been evaluated and found conformant. A post-clearance special report with acoustic output measurements from production line devices is required. |
| Biocompatibility | Conformity with applicable medical device safety standards. | Device has been evaluated and found conformant. |
| Thermal Safety | Conformity with applicable medical device safety standards. | Device has been evaluated and found conformant. |
| Electrical Safety | Conformity with applicable medical device safety standards. | Device has been evaluated and found conformant. |
| Mechanical Safety | Conformity with applicable medical device safety standards. | Device has been evaluated and found conformant. |
| Quality System | Conformity with 21 CFR 820 Quality System Regulation and ISO13485 quality system standards. | Manufacturer's design and development process conforms to these standards. |
| Intended Use | Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines. | Confirmed. |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or data provenance (country of origin, retrospective/prospective) is described for the clinical performance of the device. The submission explicitly states: "Clinical tests: Since the Sigma 5000 series Imagic uses the same technology and principles as existing devices, clinical tests are not required."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since clinical tests were not required, there is no mention of a test set, experts, or ground truth establishment in this context.
4. Adjudication Method for the Test Set
Not applicable, as no external test set with expert adjudication was used for clinical performance.
5. 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
There is no mention of an MRMC comparative effectiveness study, nor is there any AI component described in this device. This is a conventional diagnostic ultrasound imaging system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a diagnostic ultrasound system, not an AI algorithm. Its performance is intrinsically linked to human operation and interpretation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the purpose of demonstrating substantial equivalence, the "ground truth" implicitly relies on the established safety and effectiveness of the predicate device (Kontron Medical Sigma 110/330, K002239) and general clinical consensus regarding the safe and effective performance of ultrasound technology. No new ground truth specific to this device's clinical performance was established via studies mentioned in this document.
8. The Sample Size for the Training Set
Not applicable. The device is a hardware and software system, not a machine learning model that requires a training set in this context. Its "training" or development likely involved engineering design, testing against specifications, and conformity to standards, rather than data-driven model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set (in the context of machine learning) is mentioned or implied for this 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.