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510(k) Data Aggregation
(64 days)
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen;Pediatric;Small Orqan(breast.tests.thyroid);heart soft tissue; Peripheral Vascular; Musculo-skeletal(conventional); Ob/Gyn and Urology.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: General (TRACK 1 ONLY), Specific (TRACKS 1 & 3)
Mode of Operation: B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Other* Combined, Tissue Harmonic Imaging
Specific Applications: Ophthalmic, Fetal, Abdominal, Intra-operative Specify, Intra-operative Neuro, Laparoscopic, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph.(non-Card), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Intravascular, Other (Ob/GYN), Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Other (specify), Peripheral vessel, Other (specify)
Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD
The CGMC OPUS 5000 diagnostic doppler ultrasound system is a compact and portable diagnostic ultrasound device,have integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The user interface includes a specialized control keyboard and color 15-inch LCD display. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows costeffective system integration to a variety of upgrade-able options and features.
The major features of the CGMC OPUS 5000:
- · 64 Channel all digital beam former
- · Progressive dynamic receive focusing
- · Wide band all digital demodulation
- Native frequency digital scan converter
- . OPUS 5000 can be hand carried for portable use
- Remote access image management through LAN port
- USB2.0 flash drive for image transport and software upgrade
- Supports 2D B-mode, M-mode, Harmonic Image, Color, Power Doppler, . Pulse wave Doppler, and CW.
This K102989 510(k) submission for the CGMC OPUS 5000 Diagnostic Doppler Ultrasound System and its associated transducers focuses on substantial equivalence to a predicate device, the SonoScape Ultrasound System SSI-1000 (K042369). The submission primarily justifies equivalence through technological characteristics and intended uses, rather than presenting a performance study with explicit acceptance criteria for a new clinical claim. Therefore, the information provided below reflects that context.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for an ultrasound system, the acceptance criteria are typically related to the device meeting established performance standards for diagnostic ultrasound, ensuring image quality, acoustic output safety, and electrical safety comparable to a predicate device. The submission does not present specific quantitative acceptance criteria for clinical performance metrics (e.g., sensitivity, specificity for a particular disease) nor does it provide a formal performance table against such criteria. Instead, it asserts equivalence based on fulfilling recognized industry standards and having similar technological characteristics and intended uses as the predicate device.
| Acceptance Criteria (Inferred from 510(k) process for ultrasound systems) | Reported Device Performance (as stated or implied in the submission) |
|---|---|
| Compliance with IEC 60601-1 (Safety of Medical Electric Equipment) | OPUS 5000 has been designed to meet IEC 60601-1 |
| Compliance with AIUM/NEMA UD2 (Acoustic Output Measurement Standard) | OPUS 5000 has been designed to meet AIUM/NEMA UD2 |
| Compliance with AIUM NEMA UD3 (Real-time Display of Acoustic Output) | OPUS 5000 has been designed to meet AIUM NEMA UD3 |
| Compliance with AIUM 1998 (Acoustic Output Measurement and Labeling) | OPUS 5000 has been designed to meet AIUM 1998 |
| Compliance with EN 60601-1, EN 60601-1-1, EN 60601-1-2, EN 60601-2-37 | OPUS 5000 has been designed to meet these EN standards |
| Compliance with ISO 10993 (Biocompatibility) | OPUS 5000 has been designed to meet ISO 10993 |
| Ability to produce high detail resolution imaging | Device is "capable of producing high detail resolution" |
| Functionality across stated display modes, measurements, and controls | General Device Description and Technological Characteristics sections describe full functionality for these modes, measurements, and controls. |
| Acoustic Output within safe limits | Acoustic output parameters (Derated Ispta: 720mW/cm2 max, MI: 1.9 max, etc.) are specified. |
| Substantial Equivalence to predicate device (SonoScape SSI-1000) | Stated as "of a comparable and substantially equivalent type" with "same technological characteristics, key safety and effectiveness features, physical design, and has the same intended uses and basic operating modes." |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not describe a clinical performance study with a test set of patient data to evaluate the device's diagnostic accuracy or clinical effectiveness. The assessment of the device's performance against the acceptance criteria is based on engineering verification and validation, adherence to recognized standards, and comparison of technical specifications to a predicate device. Therefore, no sample size for a test set of patient data or data provenance (country of origin, retrospective/prospective) is explicitly mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical performance study with a specific test set is described, there is no mention of experts being used to establish a ground truth for such a set.
4. Adjudication Method for the Test Set
As there is no described test set requiring ground truth establishment, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not conducted and is not discussed in this submission. The submission primarily focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and safety standards, not on proving improved clinical effectiveness with human-AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study, as typically understood for an AI algorithm (without human-in-the-loop performance), was not conducted or described. This submission is for a general-purpose diagnostic ultrasound system, not an AI-powered diagnostic algorithm.
7. Type of Ground Truth Used
Given the nature of the submission (510(k) for a general-purpose ultrasound, relying on substantial equivalence to a predicate and compliance with technical standards), the "ground truth" used is the adherence to established engineering and medical device safety and performance standards (e.g., IEC, AIUM/NEMA standards) and the technical specifications of the predicate device. There is no mention of clinical ground truth (e.g., pathology, outcomes data, or expert consensus on patient cases) being used in a formal study within this document.
8. Sample Size for the Training Set
This submission does not discuss a training set. The device is a traditional ultrasound imaging system, not an AI/ML-based device that would require a training set of data for algorithm development.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned, the method for establishing its ground truth is not applicable.
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