(15 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
The LOGIQ BT08 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display. This modification will provide users with additional probe options, improved user interface and overall quality and image enhancement.
The provided document is a 510(k) premarket notification for a diagnostic ultrasound system (GE LOGIQ BT08). It aims to demonstrate substantial equivalence to a predicate device. For devices like this, the acceptance criteria and study proving they meet such criteria are typically not presented as performance metrics of an AI model in the way you might expect for an AI/ML-driven diagnostic tool.
Instead, the "acceptance criteria" and "study" in this context refer to:
- Acceptance Criteria: Conformance to recognized safety and performance standards for diagnostic ultrasound systems and transducers, as well as maintaining substantial equivalence to a predicate device in terms of intended use and technological characteristics.
- Study: Non-clinical tests to verify compliance with these standards (e.g., acoustic output, biocompatibility, electrical/mechanical safety) and a comparison to a legally marketed predicate device. Clinical tests are often not required for these types of 510(k) submissions if substantial equivalence can be demonstrated through other means.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance / Evaluation Outcome |
|---|---|---|
| Intended Use | The device should be intended for diagnostic ultrasound evaluation in specific clinical applications (e.g., Fetal, Abdominal, Cardiac, Small Organ, etc.) and modes of operation (B-mode, M-mode, Doppler modes, Harmonic Imaging, Coded Pulse, 3D/4D imaging). | Main Device (GE LOGIQ BT08 System): Intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical). Supported various operational modes (B, M, PW, CW, Color, Color M, Power Doppler, Combined, Harmonic, Coded Pulse, 3D/4D). |
Individual Transducers (e.g., 3CRF, 9L-D, IC5-9-D, M4S-D, M6C-D, ML6-15-D, RAB2-5-D, RIC5-9-D, RNA5-9-D, RSP6-16-D, SP10-16-D): Each transducer provides specific sets of indications/clinical applications and modes of operation, generally aligning with the overall system's intended uses but tailored to the probe's capabilities. All are marked as "P" (previously cleared by FDA) for their respective indications. |
| Technological Characteristics | The device should have comparable technological characteristics to the predicate device. Expected to be a full-featured, general-purpose diagnostic ultrasound system with digital acquisition, processing, display capabilities, user interface (keyboard, specialized controls, LCD touch screen, LCD image display). | The LOGIQ BT08 is described as a "full featured, general purpose diagnostic ultrasound system which consists of a mobile console... that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display." The modification provides "additional probe options, improved user interface and overall quality and image enhancement." It is stated to have the "same technological characteristics" as the predicate. |
| Safety and Effectiveness | The device should meet applicable medical device safety standards for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, and mechanical safety. Should be safe and effective for its intended uses. | "The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards." The design and development process conforms to 21 CFR 820, ISO 9001 and ISO 13485 quality management systems. Compliance verified through independent evaluation. |
| Substantial Equivalence | The device should be substantially equivalent to a legally marketed predicate device (GE LOGIQ 7 Diagnostic Ultrasound System – K010329, K032182, K041813, K052441). | The GE LOGIQ BT08 is stated to be "of a comparable type and substantially equivalent to the current GE LOGIQ 7. It has the same technological characteristics, key safety and effectiveness features, and is similar in physical design, construction and materials and has the same intended uses and basic operating modes as the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of this 510(k). This submission relies heavily on non-clinical testing and comparison to a predicate device, rather than a clinical performance study with a "test set" of patient data.
- Data Provenance: Not applicable. The "data" here refers to engineering and manufacturing specifications, test results against standards, and the specifications of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There was no "test set" requiring ground truth established by experts in the typical sense of a clinical performance study for an AI algorithm. The device itself is the diagnostic tool. Clinical equivalence is established by comparing the device's technological and functional characteristics to a predicate, and by demonstrating compliance with recognized performance and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no "test set" or clinical study requiring adjudication.
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
- No. This device is a diagnostic ultrasound system, not an AI-driven interpretive aid for human readers. Therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI vs without AI assistance" was not performed and is not relevant to this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a hardware diagnostic imaging system; it is not an algorithm being submitted for standalone performance evaluation in the context of AI. The performance is the overall system's ability to acquire and display ultrasound images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. In this 510(k), "ground truth" for proving safety and effectiveness primarily relates to:
- Engineering specifications and measurements: Verifying acoustic output, electrical safety, mechanical integrity against established industry standards.
- Regulatory standards: Demonstrating compliance with norms like 21 CFR 820, ISO 9001, ISO 13485.
- Predicate device characteristics: The "truth" of what is considered safe and effective for diagnostic ultrasound is established by legally marketed predicate devices, and the new device's equivalence to these characteristics forms the basis of clearance.
8. The sample size for the training set
- Not applicable. This is a hardware device; there is no "training set" in the context of machine learning model development.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI model, there is no ground truth established for it.
§ 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.