(26 days)
The HS70A 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, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-raginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
The HS70A 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(S-Harmonic), Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS70A 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 HS70A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance, based on the requirements you outlined.
It's important to note that the provided document is a 510(k) Premarket Notification from the FDA, specifically concerning the SAMSUNG MEDISON HS70A Diagnostic Ultrasound System. This type of submission focuses on demonstrating "substantial equivalence" to existing, legally marketed predicate devices, rather than proving novel clinical efficacy or undertaking broad clinical trials typical for new therapeutic devices or high-risk diagnostics. Therefore, much of the requested information regarding detailed clinical study performance, ground truth establishment for a test set, and multi-reader multi-case studies will likely not be present as it falls outside the scope of a 510(k) for an ultrasound system of this class.
Acceptance Criteria and Device Performance Study for SAMSUNG MEDISON HS70A Diagnostic Ultrasound System (K152962)
The provided document describes the substantial equivalence determination for the HS70A Diagnostic Ultrasound System. For this type of device and submission, the "acceptance criteria" are primarily based on demonstrating equivalence to predicate devices across various technological characteristics and meeting established medical device safety standards, rather than specific performance metrics from a clinical study for a new intended use.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the comparison to predicate devices and adherence to relevant standards. The performance is then demonstrated by showing that the HS70A meets or exceeds the capabilities of these predicate devices and complies with safety standards.
| Acceptance Criterion (Implicit) | Reported Device Performance (HS70A) |
|---|---|
| Intended Use Equivalence: Capable of diagnostic ultrasound imaging and fluid analysis for human body, across specified clinical applications. | Meets/Exceeds Predicates: Intended for diagnostic ultrasound imaging and fluid analysis of the human body. Clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel. (Identical or expanded list compared to predicates). |
| Technological Characteristics Equivalence: Comparable operational modes, scanhead types, frequency ranges, and features. | Meets/Exceeds Predicates: Operates in B mode, Color Doppler, Power Doppler (including S-Flow), PW Spectral Doppler, CW Spectral Doppler, Harmonic imaging (S-Harmonic), Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging (real time 4D imaging), Elastoscan Mode, or combinations. Supports Linear Array, Curved Linear Array, Endocavity, and Phased Array scanheads. Frequency range 1.0 ~ 20.0 MHz. Includes various advanced functionalities like MultiVision, Panoramic, Elastoscan, etc., some of which are new or enhanced compared to specific predicates. |
| Safety and EMC Compliance: Adheres to recognized medical device safety and electromagnetic compatibility standards. | Meets/Exceeds Predicates: Conforms to UL 60601-1, CSA C22.2 No. 601.1, IEC60601-2-37 (Diagnostic Ultrasound Safety), EN/IEC60601-1, EN/IEC60601-1-2 (EMC), NEMA UD-2 (Acoustic Output Measurement), NEMA UD-3 (Real Time Display of AI/TI). Biocompatibility tested to ISO10993-1. Application of risk management to ISO14971. Acoustic output display (Track 3) is present and compliant. |
| Patient Contact Materials: Biocompatibility shown. | Meets Criteria: Patient contact materials tested to ISO 10993-1. |
| Quality System Compliance: Manufactured under a quality management system. | Meets Criteria: Design, development, and quality process conforms with 21 CFR 820 and ISO 13485. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Summary of Clinical Tests: Not applicable. The subject of this submission. HS70A, did not require clinical studies to support substantial equivalence."
Therefore, there is no test set in the traditional sense of a clinical or retrospective imaging dataset used to evaluate diagnostic performance against a ground truth. The "proof" of performance relies on engineering verification and validation (bench testing, safety compliance) and comparison of technical specifications to legally marketed predicate devices, as detailed in the "Technological Characteristics Comparison Table" (pages 23-24).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no clinical test set was required or performed for diagnostic performance evaluation, this information is not applicable. The "ground truth" for a 510(k) submission of this nature refers to the established safety and effectiveness of the predicate devices.
4. Adjudication Method for the Test Set
As no clinical test set was used for diagnostic performance evaluation against an established ground truth, adjudication methods are not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states that clinical studies were not required to support substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The HS70A is a diagnostic ultrasound system. While it incorporates advanced features/algorithms (like Tissue Harmonic Imaging, 3D imaging, MultiVision, Elastoscan), these are integrated functionalities of the device rather than standalone AI algorithms being submitted for independent performance claims. The performance is assessed as part of the overall system's technical specifications and safety profile, in comparison to predicates. Therefore, a "standalone algorithm performance" study as typically understood for AI/ML devices is not applicable in this context.
7. The Type of Ground Truth Used
The "ground truth" in this 510(k) pertains to the established safety, effectiveness, and performance of the predicate devices (WS80A, RS80A, A35, ACCUVIX XG). The HS70A demonstrates substantial equivalence by showing that its technological characteristics and performance meet or exceed those of these already cleared devices, and that it complies with all relevant safety standards. No new disease diagnosis performance metrics against an independent ground truth (e.g., pathology, outcomes data) were required or presented for this specific submission given its regulatory pathway.
8. The Sample Size for the Training Set
Since this is a diagnostic ultrasound system submission under the 510(k) pathway, and not a de novo AI/ML algorithm submission, there is no mention or requirement for a "training set" in the context of machine learning model development. The development of the device itself would involve internal engineering and design verification/validation, but not typically a "training set" for an explicit algorithm performance evaluation against clinical ground truth.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of an AI/ML algorithm, this information is not applicable. The "ground truth" for the predicate devices' safety and effectiveness was established through their own prior clearances and clinical use.
§ 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.