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The S2000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal. Intraoperative. Pediatric. Small Parts. Transcranial. OB/GYN. Cardiac, Pelvic, Neonatal/Adult Cephalic, Vasculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures (fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information 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 S2000™ has been designed to meet the following product safety standards:

• l UL 60601-1, Safety Requirements for Medical Equipment
• l IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
• t CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
• li AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• I AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
• t 93/42/EEC Medical Devices Directive
• Safety and EMC Requirements for Medical Equipment 트
  • . EN/IEC 60601-1
  • . EN/IEC 60601-1-1
  • I EN/IEC 60601-1-2
• IEC 1157 Declaration of Acoustic Power 트
• ISO 10993-1 Biocompatibility l

This 510(k) submission (K093812) for the Siemens Acuson S2000 Ultrasound System describes the device's technical specifications and intended uses, and asserts substantial equivalence to a predicate device. However, it does not contain information regarding a specific clinical study with acceptance criteria and device performance metrics, as would be expected for a novel AI-powered diagnostic device.

The document primarily focuses on:

• Device Description: Listing safety standards the system meets (e.g., UL 60601-1, IEC 60601-2-37).
• Intended Use: Broad applications for ultrasound imaging across various anatomical regions and patient populations.
• Transducer Information: Detailed tables indicating the modes of operation (A, B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging) and additional features (e.g., tissue harmonic imaging, spatial compounding) cleared for each specific transducer.
• Predicate Device: Stating the Acuson S2000 is substantially equivalent to the Acuson Antares Ultrasound System.

The "Arterial Health Package (AHP) software," which provides "capability to measure Intima Media Thickness and the option to reference normative tables," mentions that these tables "have been validated and published in peer-reviewed studies." However, it does not provide details of an internal study conducted by Siemens to prove that their device's AHP functionality meets specific acceptance criteria based on these peer-reviewed studies.

Therefore, I cannot populate the requested tables and information as a study proving device performance against acceptance criteria is not present in the provided text. The document is a regulatory submission for device clearance based on substantial equivalence, rather than a detailed report of a performance study.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transvaginal; Intraoperative (obdominal, thoracic, and vascular), Intra-cardiac and Inra-luminal.

The GE Vivid-i and Vivid-q is compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transancess. It has an overall size approximately 36 cm wide, 31.5 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

Here's an analysis of the provided text regarding the GE Vivid-i and Vivid-q Diagnostic Ultrasound System.

Acceptance Criteria and Study for GE Vivid-i and Vivid-q Diagnostic Ultrasound System (K082374)

Based on the provided document, the GE Vivid-i and Vivid-q Diagnostic Ultrasound System's acceptance criteria and proof of their being met are primarily based on substantial equivalence to a predicate device and compliance with recognized safety and quality standards, rather than a clinical performance study with specific quantitative acceptance criteria or statistical measures of device performance.

The document states: "The modified GE Vivid-i is of a comparable type and substantially equivalent to the currently marketed GE Vivid-i. It is a compact and readily portable unit having the same design, construction, and materials; is comparable in key safety and effectiveness features. It has the same intended uses as the predicate device and additional software features are identical to that of other cleared GE Ultrasound systems."

And under "Conclusion": "Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and ISO13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Medical Systems that the GE Vivid-i and Vivid -d Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market."

Furthermore, it explicitly states under "Clinical Tests: None required."

Therefore, the "acceptance criteria" here are framed around demonstrating equivalence to existing, legally marketed devices and adherence to established regulatory and engineering standards.

1. Table of Acceptance Criteria and Reported Device Performance

Given that no specific quantitative performance metrics from a clinical study are reported, the table reflects the qualitative acceptance criteria related to substantial equivalence and safety/quality standards.

2. Sample size used for the test set and the data provenance

• Sample Size for the Test Set: Not applicable. No clinical test set or study validating specific performance metrics (like sensitivity/specificity) was conducted. The clearance is based on substantial equivalence to a predicate device and adherence to manufacturing and safety standards.
• Data Provenance: Not applicable for a performance test set. The predicate device (GE Vivid-i Ultrasound System, K061525) and other cleared GE Ultrasound systems provide the basis for equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No new clinical trials or studies requiring ground truth establishment by experts for specific diagnostic performance were conducted for this 510(k) submission. The safety and effectiveness are inferred from the predicate device and the known history of diagnostic ultrasound.

4. Adjudication method for the test set

• Not applicable. No performance test set requiring adjudication was conducted.

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. This submission does not involve AI. The device is a diagnostic ultrasound system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This submission does not involve an algorithm. The device is a diagnostic ultrasound system.

7. The type of ground truth used

• Not applicable. No new clinical performance data requiring ground truth was generated. The approval relies on the established safety and effectiveness of the predicate device and the general class of diagnostic ultrasound systems.

8. The sample size for the training set

• Not applicable. This submission does not involve a machine learning algorithm or AI that would require a training set.

9. How the ground truth for the training set was established

• Not applicable. This submission does not involve a machine learning algorithm or AI that would require a training set.

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Diagnostic imaging or fluid flow analysis of the human body as follows:
General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (cardiac), Pediatrics, Neonatal Cephalic, Cardiac (adult, pediatric), Trans-esophageal, Peripheral Vessel, Intra-luminal and Intra-cardiac applications, and intended uses as defined in the FDA guidance document.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The Cypress system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product that is already cleared for USA distribution under the following 510(k) Premarket Notification number(s):
K042055 (August 16, 2004) cleared as Cypress™ Ultrasound System .
K021497 (July 9, 2002) cleared as Cypress™ Ultrasound System .
K010950 (June 27, 2001) cleared as Cypress™ Ultrasound System .
K991872 (June 16, 1999) cleared as Lynx Ultrasound System .
K982800 (September 22, 1998) cleared as Ecton Lynx Ultrasound System .
The Cypress Ultrasound System has been designed to conform to the following product safety standards:
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment ●
AIUM/NEMA UD-2, 1998, Acoustic Output Measurement Standard for . Diagnostic Ultrasound
AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
93/42/EEC Medical Device Directive .
Safety and EMC Requirements for Medical Equipment ●
EN 60601-1 .
EN 60601-1-1, Safety Requirements for Medical Equipment .
EN 60601-1-2 .
EN 60601-1-2-37 ●
ISO 10993 Biocompatibility .
The system's acoustic output is in accordance with ALARA principle (as low as reasonably achievable)

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, results of any study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC comparative effectiveness studies, standalone performance, ground truth types, or training set details. This document is a 510(k) summary for an ultrasound system, primarily focusing on its regulatory classification, predicate devices, device description, and intended uses, along with various transducer-specific indications. It states that the device is "substantially equivalent" to previously cleared predicate devices but does not provide details of any new study conducted to demonstrate this.

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The Sequoia platform is intended for use in the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA guidance document. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The Sequoia system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product that is already cleared for USA distribution under the following 510(k) PreMarket Notification number: K051139 (May 13, 2005) cleared as ACUSON Sequoia™ Diagnostic Ultrasound . System. The Sequoia Diagnostic Ultrasound System has been designed to conform to the following product safety standards: UL 2601-1, Safety Requirements for Medical Equipment . CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment . AIUM/NEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic . Ultrasound AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment 93/42/EEC Medical Device Directive . Safety and EMC Requirements for Medical Equipment . . EN 60601-1 · EN 60601-1-1 EN 60601-1-2 . ISO 10993 Biocompatibility . The system's acoustic output is in accordance with ALARA principle (as low as . reasonably achievable)

The provided document is a 510(k) Pre-Market Notification for the ACUSON Sequoia™ Ultrasound System. It primarily outlines the substantial equivalence to a previously cleared device (K051139) and lists the intended uses for various transducers. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document details the intended uses for a wide range of transducers and clinical applications, stating that these uses were "P=previously cleared by the FDA" under various earlier 510(k) notifications. This indicates that the current submission relies on the prior clearances for its claimed performance.

Therefore, since no new performance study is described in this document, the requested information cannot be provided based on the input text.

Here's a breakdown of why each section cannot be addressed based on the provided text:

1. Table of acceptance criteria and reported device performance: Not available. The document is a 510(k) submission primarily establishing substantial equivalence to a predicate device and listing intended uses for transducers already cleared. It does not present new performance data or acceptance criteria in the context of a new study.
2. Sample size used for the test set and data provenance: No new test set is described. The document refers to "previously cleared" applications, implying that any testing was conducted for earlier submissions.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no new test set with ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size: Not applicable. The document does not describe any MRMC study or AI assistance.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable. This document pertains to an ultrasound system, not an AI algorithm.
7. Type of ground truth used: Not applicable, as no new ground truth establishment is described.
8. Sample size for the training set: Not applicable, as no AI algorithm or training set is mentioned.
9. How the ground truth for the training set was established: Not applicable.

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Ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal, Abdominal, Intraoperative Abdominal, Intraoperative Neurological, Pediatric, Small Organ (breast, testes, thyroid, penis), Neonatal Cephalic, Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral Vessel, Laparoscopic, Musculo-skeletal (Conventional and Superficial) applications, and intended uses as defined in the FDA guidance document. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The Sequoia system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product that is already cleared for USA distribution under the following 510(k) PreMarket Notification number: K032114 (July 21, 2003) cleared as ACUSON® Sequoia 8.0 Diagnostic Ultrasound System. The Sequoia Diagnostic Ultrasound System has been designed to conform to the following product safety standards: UL 2601-1, Safety Requirements for Medical Equipment; CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment; AIUMNEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic Ultrasound; AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment; 93/42/EEC Medical Device Directive; Safety and EMC Requirements for Medical Equipment; EN 60601-1, EN 60601-1-1, EN 60601-1-2; ISO 10993 Biocompatibility. The system's acoustic output is in accordance with ALARA principle (as low as reasonably achievable).

The provided document is a 510(k) summary for the ACUSON® Sequoia Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to a predicate device and discussing the intended uses and safety standards. It does not contain information about acceptance criteria for device performance, or details of a study (test set, training set, ground truth, expert qualifications, etc.) that proves the device meets specific performance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document is a regulatory submission, not a performance study report.

The tables in the document (pages 5-31) are "Indications for Use" tables for various transducers, listing the clinical applications for which each transducer is cleared, and the imaging modes (A, B, M, PWD, CWD, Color Doppler, Power Doppler, Color Velocity Imaging, Combined, Harmonic Imaging) that can be used for those applications. The 'P' indicates that these indications and modes were "previously cleared by the FDA under premarket notifications #K033650 and #K033196." This shows that the current submission is for modifications to an existing and cleared device, and not a de novo submission requiring extensive new performance validation data to establish acceptance criteria.

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