(46 days)
The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, transesophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
The Acuson Acunav Ultrasound Catheter is intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
The ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. The function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude, Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display.
This document is a 510(k) Pre-market Notification from the FDA regarding the Siemens Medical Solutions Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems. It primarily states that the device is substantially equivalent to previously cleared devices (K142876 for the systems, and various K#s for specific transducers).
Therefore, the information regarding acceptance criteria and study details for demonstrating performance against those criteria is limited because the device is cleared based on demonstrating substantial equivalence to a predicate device rather than novel performance claims.
Here's a breakdown of the information that can be extracted, and where limitations exist based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy for a specific diagnostic task). Instead, acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device (K142876).
The table provided in the document (pages 33-34) compares the features and indications for use of the current submission device versus the predicate device, showing that they are essentially identical.
| Feature / Characteristic | Acuson S1000/S2000/S3000 (This Submission) | Acuson S1000/S2000/S3000 (Predicate K# 142876) | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|---|---|
| Indications for Use: | Identical to predicate device | Matches predicate device | ||
| Fetal, Abdominal, Intraoperative, etc. | √ | √ | Cleared applications are identical | All listed applications are supported |
| Center Frequencies Supported: | Identical to predicate device | All listed frequencies are supported | ||
| 2.0 MHz, 3.0 MHz, etc. | √ | √ | Supported frequencies are identical | All listed frequencies are supported |
| Modes: B, M, PWD, CWD, Color Doppler, Amplitude Doppler | √ | √ | Supported modes are identical | All listed modes are supported |
| Features: Native tissue harmonic imaging, SieScape panoramic imaging, etc. | √ | √ | Supported features are identical | All listed features are supported |
| Monitor: 21" FPD | √ | √ | Same monitor as predicate | 21" FPD |
| Patient Contact Materials | Tested to ISO 10993-1 | Tested to ISO 10993-1 | Conformance to ISO 10993-1 | Conforms to ISO 10993-1 |
| UL 60601-1 Certified | √ | √ | Conformance to UL 60601-1 | Certified to UL 60601-1 |
Study Information (Based on Substantial Equivalence Logic):
The document explicitly states that clinical data is not required because the device uses the "same technology and principles as existing devices" (referring to the predicate device K142876). This means there was no specific study conducted to prove the device meets specific performance criteria as if it were a de novo device or had new clinical claims.
- Sample size used for the test set and the data provenance: Not applicable for performance claims, as clinical data was not required for substantial equivalence. The "test set" for this submission would have been comparison to the predicate device's specifications and functionality.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as clinical validation with ground truth establishment was not performed or required for this specific submission because it demonstrated substantial equivalence.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for performance claims.
- 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 device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a diagnostic ultrasound system, not an AI algorithm evaluated in standalone mode.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for performance claims. The "ground truth" for this submission was the established safety and effectiveness of the predicate device.
- The sample size for the training set: Not applicable. This document describes an ultrasound system, not an AI/machine learning model that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of Non-Clinical Tests (from document):
The device was evaluated for:
- Acoustic output
- Biocompatibility
- Cleaning and disinfection effectiveness
- Thermal, electrical, electromagnetic, and mechanical safety
It was found to conform with applicable medical device safety standards, including:
- UL 60601-1
- IEC 60601-2-37
- CSA C22.2 No. 601-1
- AIUM/NEMA UD-3 and UD-2
- 93/42/EEC Medical Devices Directive
- EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2
- ISO 10993-1 Biocompatibility
Conclusion:
The Siemens Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems were granted 510(k) clearance based on demonstrating substantial equivalence to existing, legally marketed predicate devices (K142876). This means that its safety and effectiveness are considered equivalent to the predicate, and therefore, extensive new clinical efficacy studies with specific performance criteria were not required by the FDA for this submission. The validation was primarily based on non-clinical testing to ensure safety, electrical, mechanical, and biocompatibility standards were met, and that its functionalities and technical characteristics matched those of the predicate device.
§ 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.