(124 days)
Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
General (Track I only)
Specific (Tracks I & III)
Ophthalmic
Fetal
Abdominal
Intra-operative (Spec.)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (Spec.)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel
Other (spec.)
The Hitachi EUB-6000 Ultrasound Diagnostic Scanner is a Track 3 diagnostic ultrasound pulsed Doppler and pulsed echo imaging system capable of the following operating modes: B (including harmonic imaging), M, Pulsed and Continuous Doppler, and Color Flow (including Amplitude Doppler). It is intended for general ultrasound imaging of the human body, with specific uses under the general applications of cardiac, peripheral vessel, and fetal imaging and other.
The provided documentation for the Hitachi EUB-6000 Ultrasound Diagnostic Scanner is a 510(k) premarket notification summary. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed performance studies with acceptance criteria in the same way a de novo or PMA submission might.
Therefore, the document does not contain the explicit acceptance criteria, specific study designs, sample sizes, expert qualifications, adjudication methods, or detailed ground truth information as requested. Instead, it describes compliance with existing standards and refers to the device's intended uses.
However, I can extract and infer some information based on the typical requirements for a 510(k) submission for an ultrasound device.
Here's an attempt to address your points, with the caveat that detailed information is not present in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document does not present a table of quantitative acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) or clinical outcomes. Instead, performance is established by demonstrating compliance with recognized safety standards and substantial equivalence to predicate devices for specific clinical applications and operational modes.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from 510(k) Process) | Reported Device Performance (Inferred/Stated in Doc) |
|---|---|---|
| Acoustic Output Safety | Compliance with "Standard for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (1992)" (NEMA UD-3). | Hitachi EUB-6000 Ultrasound Diagnostic Scanner complies with NEMA UD-3. |
| Compliance with guideline limits set in the April 14, 1994, Revision of 510(k) Diagnostic Ultrasound Guidance. | Hitachi EUB-6000 Ultrasound Diagnostic Scanner complies with the guideline limits. | |
| General Electrical Safety | Compliance with IEC 601-1 (1988) Medical Electrical Equipment, Part 1, General Requirements for Safety. | Hitachi EUB-6000 Ultrasound Diagnostic Scanner is designed to comply with IEC 601-1 (1988). |
| Intended Use Equivalence | The device performs the intended diagnostic ultrasound imaging and fluid flow analysis for specified clinical applications and modes of operation to a level substantially equivalent to predicate devices. | The device is determined to be substantially equivalent to legally marketed predicate devices for the specified indications for use, across various clinical applications (Fetal Imaging, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal/Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal, Cardiac, Peripheral Vessel) and modes (B, M, PWD, CWD, Color Doppler, Combined, Amplitude Doppler, Harmonic Imaging) with various transducers. The specific applications are marked 'N' (new indication) on the provided tables. |
| Post-Clearance Acoustic Output | Submission of a post-clearance special report containing complete acoustic output measurements based on production line devices, meeting approved levels. | This is a condition of clearance; the report is required to be submitted and must contain acceptable values to maintain 510(k) clearance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify any sample size for a clinical test set. 510(k) submissions for diagnostic ultrasound equipment primarily rely on engineering performance data, compliance with standards, and comparison to predicate devices, rather than de novo clinical trial data.
- Data Provenance: Not applicable, as detailed patient data or clinical study data is not presented. The "study" here refers to the demonstration of compliance with standards and the technical specifications that show equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. A 510(k) for a diagnostic ultrasound does not typically require a human-read diagnostic performance study with expert-established ground truth in the same way an AI/CADe device might. The focus is on the technical capability of the imaging system.
4. Adjudication Method for the Test Set
- Not applicable, as a clinical test set with adjudicated ground truth is not described.
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, an MRMC comparative effectiveness study was not done. This device is a diagnostic ultrasound scanner, not an AI or CADe (Computer-Aided Detection/Diagnosis) system designed to assist human readers. Thus, there is no AI component for human readers to improve with or without.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This is a hardware imaging device, not a standalone algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For the purpose of this 510(k), the "ground truth" for the device's performance relies on compliance with established engineering standards (e.g., NEMA UD-3, IEC 601-1) for acoustic output and electrical safety, and the technical specifications demonstrating that the device can acquire images suitable for the listed clinical applications in various modes, similar to its predicate devices. There is no mention of pathology, expert consensus on clinical cases, or outcomes data in this summary.
8. The Sample Size for the Training Set
- Not applicable. This device is a diagnostic ultrasound scanner; it is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for such a device would relate to engineering design and testing, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for an AI/ML algorithm.
In summary, the provided document demonstrates the Hitachi EUB-6000 Ultrasound Diagnostic Scanner meets acceptance criteria primarily through compliance with recognized safety and performance standards and by establishing substantial equivalence to existing legally marketed predicate ultrasound devices for its specified intended uses. It is crucial to understand that a 510(k) submission for a primary imaging device like this differs significantly from submissions for AI/CADe software, which would typically contain the detailed performance study information you requested.
§ 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.