(38 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 Supertional and Supertional and Superticial, Urology (including prostate); Transvaginal; and Intractir Onlinemional; and and neurosurgical).
The GE LOGIQ 9 is a full-featured general-purpose diagnostic ultrasound system. It consists of a mobile console approximately 64 cm wide, 90 cm deep and 140-160 cm (adjustable) high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a color video CRT or LOD display and LCD touch panel. This modification will provide users with an intima media thickness measurement tool and enhanced 3D image manipulation.
The provided text is a 510(k) premarket notification for the GE LOGIQ 9 Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria based on clinical performance metrics. Therefore, many of the requested elements for a study showing acceptance criteria are not directly present in this submission.
Specifically, this submission states:
- "Clinical Tests: None required." This indicates that for this particular submission, no new clinical performance study was conducted to establish acceptance criteria or demonstrate the device meets them, as the device is considered substantially equivalent to a previously cleared device.
- The primary method for demonstrating safety and effectiveness is through comparison to a predicate device, specifically the "current GE LOGIQ 7."
Therefore, I cannot provide detailed information about acceptance criteria, a study proving the device meets them, sample sizes, expert qualifications, or adjudication methods for clinical performance, as these were not required or performed for this 510(k) submission.
However, I can extract information related to the device's technical specifications and intended uses, which serve as criteria for this type of submission:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Predicate Device Equivalence) | Reported Device Performance (GE LOGIQ 9 BT07) |
|---|---|
| Technological Characteristics: Comparable to predicate device. | "Same technological characteristics." |
| Key Safety and Effectiveness Features: Same as predicate device. | "Same key safety and effectiveness features." |
| Physical Design, Construction, and Materials: Same as predicate device. | "Same physical design, construction, and materials." |
| Intended Uses: Same as predicate device. | "Same intended uses." |
| Basic Operating Modes: Same as predicate device. | "Same basic operating modes." |
| Diagnostic Ultrasound Evaluation: For Fetal; Abdominal; Pediatric; Small Organ; Neonatal/Adult Cephalic; Cardiac; Peripheral Vascular; Musculo-skeletal (Conventional and Superficial); Urology; Transvaginal; Intraoperative; Intraoperative Neurological. | The device is intended for use in these applications across various modes (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse). |
| Acoustic Output: Conforms with applicable medical device safety standards. | "Has been evaluated for acoustic output... and has been found to conform with applicable medical device safety standards." |
| Biocompatibility: Conforms with applicable medical device safety standards. | "Has been evaluated for... biocompatibility... and has been found to conform with applicable medical device safety standards." |
| Cleaning and Disinfection Effectiveness: Conforms with applicable medical device safety standards. | "Has been evaluated for... cleaning and disinfection effectiveness... and has been found to conform with applicable medical device safety standards." |
| Thermal, Electrical, and Mechanical Safety: Conforms with applicable medical device safety standards. | "Has been evaluated for... thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards." |
| Quality Systems: Conforms to 21 CFR 820, ISO 9001:2000, and ISO 13485. | "The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems." |
Here's the breakdown of the other requested information, based on the provided text:
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1. A table of acceptance criteria and the reported device performance: See table above. The "acceptance criteria" in this context are primarily the characteristics of the predicate device and relevant safety standards, which the GE LOGIQ 9 BT07 is deemed to meet by being substantially equivalent.
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2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is presented as "Clinical Tests: None required." The assessment is based on demonstrating substantial equivalence to a predicate device and adherence to safety standards, not a new clinical performance study with a test set.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert-established ground truth was performed or presented.
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4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication was performed or presented.
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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: Not applicable. This submission is for an ultrasound system, not an AI-assisted diagnostic tool leveraging human readers. No MRMC study was reported.
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6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI algorithm submission. The device is a diagnostic ultrasound system.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of a new clinical performance study. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device (GE LOGIQ 7) and adherence to recognized medical device safety standards.
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8. The sample size for the training set: Not applicable. This submission does not involve a "training set" in the context of machine learning or AI.
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9. How the ground truth for the training set was established: Not applicable. This submission does not involve a "training set" or its ground truth establishment.
§ 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.