(26 days)
The H60 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
The H60 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The H60 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The H60 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The acceptance criteria and study proving device performance are not explicitly detailed in the provided document. The document is a 510(k) premarket notification for the H60 Diagnostic Ultrasound System, which focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed performance metrics from a specific study against acceptance criteria.
However, based on the information provided, we can infer some aspects related to acceptance criteria and the nature of the "study" conducted.
Here's an attempt to structure the information based on your request, with significant caveats that specific numerical acceptance criteria and study results are not present in this type of FDA document (510(k) summary):
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria or numerical performance metrics for the H60 V2.00 Diagnostic Ultrasound System. Instead, it asserts substantial equivalence to predicate devices based on intended use, technological characteristics, and compliance with recognized safety and performance standards.
The "performance" is implicitly demonstrated through:
- Compliance with Safety Standards: IEC 60601-1, UL 60601-1, CSA C22.2 No.601.1, IEC 60601-2-37, IEC 60601-1-2.
- Acoustic Output Standards: NEMA UD-2, NEMA UD-3.
- Biocompatibility Standard: ISO10993-1.
- Risk Management Standard: ISO14971.
- Functionality Equivalence: The system performs diagnostic ultrasound imaging and fluid flow analysis with various modes (B-mode, M-mode, PW Doppler, CW Doppler, Color Doppler, Power Amplitude Doppler, Tissue Harmonic Imaging, 3D/4D imaging, Combined modes) and features (Panoramic, Elastoscan, XI STIC, Auto IMT+, Needle Mate, MultiVision, ClearVision, 3D MagiCut, Volume Calc, Volume NT/IT, e-Motion Marker), consistent with its predicates.
| Aspect of Performance/Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Intended Use | Intended for diagnostic ultrasound imaging and fluid analysis of the human body for specified clinical applications (Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal, Urology, Cardiac Adult, Cardiac Pediatric, Peripheral vessel). |
| Technological Characteristics | Functions to acquire and display ultrasound data in various modes (B, M, PW, CW, Color, Power Amplitude, Harmonic, Tissue Doppler, 3D/4D, Elastoscan), perform measurements and analysis. Substantially equivalent to predicate devices (UGEO H60 K132861, RS80A K141620, UGEO WS80A K133329, UGEO PT60A K142466). |
| Safety (Electrical, Thermal, Mechanical) | Evaluated and found to conform to applicable medical device safety standards including UL 60601-1, CSA C22.2 No. 601.1, EN/IEC60601-1, IEC60601-2-37. |
| Electromagnetic Compatibility (EMC) | Conforms to EN/IEC60601-1-2. |
| Acoustic Output | Evaluated and conforms to NEMA UD-2 and NEMA UD-3 standards, with real-time display of mechanical and thermal indices. |
| Biocompatibility | Patient contact materials tested to ISO 10993-1. |
| Risk Management | Conforms to ISO14971. |
| Software Features | Addition of features like Panoramic, Elastoscan, XI STIC, Auto IMT+, Needle Mate, and name changes (SCI to MultiVision, SDMR to ClearVision). Described functionalities match those of cleared features. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail a "test set" in the context of clinical images or patient data used for evaluating the algorithm's performance. The "tests" mentioned are primarily non-clinical bench tests for safety, EMC, acoustic output, and biocompatibility.
- Sample Size for Test Set: Not applicable or not specified in terms of clinical data. The evaluation is against established standards for general device functionality, safety, and equivalence to predicates, not a clinical image dataset.
- Data Provenance: Not applicable or not specified for clinical data benchmarking. The evaluation appears to be based on engineering and performance criteria against regulatory standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since clinical image test sets and AI algorithms with explicit ground truth establishment by experts are not mentioned in this 510(k) summary, this information is not applicable or not provided. The device is an ultrasound system itself, not an AI-based diagnostic aid that requires ground truth labeling of images from a test set by human experts.
4. Adjudication Method for the Test Set
As there is no mention of a clinical image test set or human expert review for establishing ground truth, an adjudication method is not applicable or not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improvement with AI vs. Without AI Assistance
This information is not applicable and not provided. The H60 Diagnostic Ultrasound System is a foundational imaging device. The document describes the system's capabilities and compliance, but not a comparative effectiveness study involving human readers with and without AI assistance, as the primary device itself is the imaging system, not an AI add-on for image interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable and not provided. The submission is for a diagnostic ultrasound system, not a standalone AI algorithm. While software features are listed (e.g., Auto IMT+, Elastoscan), their performance as standalone algorithms is not described in this document; rather, they are presented as integrated functionalities of the ultrasound system.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the safety and performance evaluations mentioned (acoustic output, biocompatibility, EMC), the "ground truth" is defined by the requirements and test methods specified in the cited international and national standards (e.g., IEC 60601 series, NEMA UD series, ISO 10993-1, ISO 14971). There is no "ground truth" from expert consensus, pathology, or outcomes data relevant to assessing the performance of a diagnostic device (rather than an interpretation algorithm) in this context.
8. The Sample Size for the Training Set
This information is not applicable and not provided. As this submission is for a general diagnostic ultrasound imaging system, not an AI algorithm that requires a training set of images, this concept does not apply to the documentation provided.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons as point 8.
§ 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.