Search Results

The Sonix Ultrasound Scanner is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial,

The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculo-skeletal} 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 Sonix Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed(PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console.

The system has an electrocardiography (ECG) display feature and support for a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage.

The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes.

The biopsy kits are accessories to the Sonix Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle quides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle guides will support various sized needle guides are sold in sterile kits that contain multiple needle quides, sterile sheaths, ultrasound transmission gel, and bands.

The provided text is a 510(k) summary for the Sonix Ultrasound Scanner, specifically detailing the addition of two new transducers. It outlines general information about the device, its intended use, and a comparison to predicate devices, focusing on technological characteristics and safety considerations. Crucially, this document does not contain any information about a study proving the device meets acceptance criteria for clinical performance metrics (e.g., accuracy, sensitivity, specificity) of an AI algorithm.

The information provided is primarily for regulatory clearance based on substantial equivalence to existing devices, meaning it demonstrates that the new transducers on the Sonix Ultrasound Scanner perform as safely and effectively as other legally marketed devices with the same intended use. This typically involves performance bench testing, electrical safety, and biocompatibility, but not clinical performance studies for an AI component in the way you've described.

However, I can extract information related to safety and technical specifications, which are a form of acceptance criteria for regulatory bodies.

Here's a breakdown of what can be extracted or inferred based on the prompt's requirements, and what cannot be found in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are related to acoustic output limits and compliance with safety standards, rather than clinical performance metrics like accuracy, sensitivity, or specificity, as there is no AI algorithm being evaluated in a clinical context in this document.

Note: The document specifies that these limits are the same as predicate Track 3 devices, implying that the device performs within these established safe ranges.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Cannot be determined from the provided text. The document describes a regulatory submission for device clearance, not a clinical performance study involving a test set of data or patient images for an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Cannot be determined from the provided text. This information would be relevant for a clinical study evaluating an AI algorithm, which is not present in this document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Cannot be determined from the provided text. This information is pertinent to clinical studies with expert reviewers, not for a device's regulatory clearance based on substantial equivalence and safety standards.

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. A MRMC study was not done. The document does not describe the evaluation of an AI algorithm or human reader performance.

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

No. The document describes an ultrasound scanner and its transducers, not a standalone AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Cannot be determined from the provided text. Ground truth is relevant for evaluating the performance of an AI model against a known correct answer, which is not the subject of this document. The "ground truth" in this context would be the physical measurements of acoustic output and compliance with electrical safety standards.

8. The sample size for the training set

Cannot be determined from the provided text. This information is relevant for AI model development, which is not discussed.

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

Cannot be determined from the provided text. This information is relevant for AI model development, which is not discussed.

In summary: The provided 510(k) summary focuses on demonstrating that the Sonix Ultrasound Scanner, with its new transducers, is substantially equivalent to previously cleared devices in terms of technology, intended use, and safety. It details compliance with acoustic output limits and international safety standards, which serve as "acceptance criteria" for the device's safe operation. However, it does not include any studies or data related to the clinical performance of an AI algorithm, a test set, expert adjudication, or training data for an AI model.

Ask a specific question about this device

The Sonix Ultrasound Imaging System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial.

The system also provides the ability to measure anatomical structures (fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peribheral vessel, musculo-skeletal} 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 Sonix Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed(PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Morde, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console.

The system has an electrocardiography (ECG) display feature and support for a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording, capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage.

The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes.

The biopsy kits are accessories to the Sonix Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle guides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle guides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands.

I am sorry, but the provided text does not contain specific acceptance criteria, study details, or performance metrics for the Sonix Ultrasound Scanner as you requested. The document is primarily a 510(k) summary for premarket notification, focusing on:

• Device Description: General features and function of the ultrasound system and its accessories.
• Intended Uses: A broad list of clinical applications for the system and various transducers.
• Comparison to Predicate Devices: Establishing substantial equivalence based on intended use, principles of operation, and technological characteristics.
• Safety Considerations: Compliance with general safety standards and acoustic output limits.
• Transducer Specifications: Detailed tables outlining the modes of operation and new/previously cleared indications for each transducer.

There is no mention of:

• Specific acceptance criteria (numerical thresholds for performance).
• Any particular study (e.g., clinical trial, bench study with performance data) to prove device meets acceptance criteria.
• Sample sizes used for test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications to establish ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• How ground truth was established for the training set.

The document highlights the device's compliance with general safety and acoustic output standards, but these are not presented as performance acceptance criteria in the context of clinical efficacy or diagnostic accuracy.

Therefore, I cannot populate the table or answer the specific questions you've posed based on the provided text.

Ask a specific question about this device

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (abdominal organs and vascular), Intraoperative Neurological, Pediatric, Small Organ (breast, thyroid, testicle), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, MSK Conventional, MSK Superficial, Transcranial Doppler.

The Sonix Ultrasound Scanner is a highly mobile, software-controlled, diagnostic ultrasound system capable of the following operating modes: 2D B-mode, M, Pulsed and CW Doppler, Color Flow (including amplitude Doppler). The system can generate real-time compound images and harmonic images. The system has an electrocardiography (ECG) display feature and support a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PA and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage. The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes. The biopsy kits are accessories to the Sonix Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle guides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle guides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands. The needle guides are single use (disposable).

Here's an analysis of the provided text regarding the acceptance criteria and study for the SONIX Ultrasound Scanner:

Acceptance Criteria and Device Performance for SONIX Ultrasound Scanner

The provided 510(k) summary for the SONIX Ultrasound Scanner (K061827) does not present explicit "acceptance criteria" in terms of specific performance metrics with target values that the device met. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety and performance standards.

The primary "acceptance criteria" appear to be implicit in the device's compliance with established industry and regulatory standards, and its substantial similarity to predicate devices. The "reported device performance" is primarily articulated through these compliance statements and the operational capabilities described.

Table of Acceptance Criteria and Reported Device Performance

• Complies with UL 2601-1 (Underwriters Laboratories Standards, Medical Electrical Equipment)
• Complies with C22-2 No 601-1 (Canadian Standards Association, Medical Electrical Equipment)
• Complies with EM 60601-1-1-2 (European Norm, Collateral Standard, Electromagnetic Compatibility)
• Complies with IEC 60601-2-37 (Particular requirements for the safety of ultrasonic medical diagnostic equipment)
• Complies with IEC 601-1 (1988) Medical Electrical Equipment, Part 1: General Requirements for Safety. |
  | Acoustic Output Standards Compliance | - Complies with "Standard For Real Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment (1992)" published by NEMA as UD-3.
• Complies with guideline limits set in the September 30, 1997 revision of 510(k) Diagnostic Ultrasound Guidance. |
  | Acoustic Output Limits (Specific Values) | - ISPTA(d): 720mW/cm²
• TIS/TIB/TIC: 0.1 - 4.0 (Range)
• Mechanical Index (MI): 1.9 (Maximum)
• ISPPA(d): 0 - 700W/cm² (Range)
• The stated limits are the same as predicate Track 3 devices. |
  | Functional Equivalence to Predicate Devices | - Substantially equivalent to predicate devices (Ultrasonix Ergosonix 500, ATL HDI 5000 System, Acuson Sequoia) with respect to intended use/indications for use, principles of operation, and technological characteristics.
• Operates identically to predicate devices (piezoelectric material, sound wave transmission/reflection, electrical signal conversion, 2D/M-mode imaging, Doppler shift display).
• Modes of operation (2D, PW Doppler, Color Flow Mapping Doppler, Power Doppler) are the same as predicate devices.
• Transducer patient contact materials are biocompatible.
• Beam forming architecture is very similar to predicate devices.
• Receiving and processing hardware is similar but innovative (programmable system with 2 building blocks, reconfigurable for different imaging modes).
• Image quality adjustment parameters (TGC gain sliders, depth control, angling) are the same as predicate devices. |
  | Intended Use / Clinical Applications (for each transducer) | - Each transducer is indicated for various clinical applications (Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, MSK Conventional, MSK Superficial, Intraoperative, Intraoperative Neurological, Transcranial Doppler) and modes of operation (B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined modes, Freehand 3D imaging, Live 3D imaging, Directional Power Doppler) as indicated in the "Diagnostic Ultrasound Indications for Use Form" for each specific transducer. "P" against an application/mode indicates "previously cleared by FDA," implying equivalence to predicate devices for these uses. |
  | Biopsy Capability | - The intended use of biopsy is supported by biopsy kits (polymeric brackets, needle guides) which are accessories to the scanner. The brackets prevent incorrect orientation and are designed to accept and retain needle guides. Needle guides are sterile, single-use, and support various needle sizes. |
  | Other Features | - UPS, Wireless, Barcode reader, Data Management for ultrasound QA, ECG display, PA and CW audio output, cine review, image zoom, labeling, measurements and calculations, image storage and review, printing, recording capabilities, DICOM module. These are presented as features of the device, implying they meet appropriate functional standards for such features. |

Study Details:

The provided document describes a 510(k) Premarket Notification for a medical device. This type of submission relies on demonstrating substantial equivalence to a predicate device already legally marketed, rather than conducting new clinical trials to prove efficacy or establishing new acceptance criteria through extensive studies.

Therefore, the study details you'd typically expect for a software-based AI device are largely not applicable in this context. Here's a breakdown based on the information provided:

1. Sample Size Used for the Test Set and Data Provenance:

   • Not explicitly provided. This is not a study that involves a test set of patient data in the way an AI algorithm validation would. The "test" for this device involved demonstrating compliance with standards and comparing technical specifications and intended uses to predicate devices.
   • Data Provenance: Not applicable in the context of clinical performance evaluation with a test set of data. The "data" here would be technical specifications, engineering test results (for acoustic output, electrical safety), and comparative analysis with predicate devices.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

   • Not applicable. There was no "test set" of clinical cases requiring expert ground truth for this 510(k) submission.

3. Adjudication Method for the Test Set:

   • Not applicable. No clinical test set requiring adjudication was used.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No such study was done. This is a traditional ultrasound scanner, not an AI-assisted diagnostic tool in the sense of the query. The submission focuses on hardware and software functionality and safety, not on improving human reader performance with AI.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Not applicable. The device is a diagnostic ultrasound system intended for use by a qualified physician. There is no standalone "algorithm" performance being evaluated independently of human operation.

6. Type of Ground Truth Used:

   • Not applicable in the context of clinical "ground truth" for diagnostic accuracy. The "ground truth" for this submission revolves around:
     • Regulatory Standards: Compliance with electrical safety, EMC, and acoustic output standards (e.g., EN 60601-1, IEC 60601-2-37, NEMA UD-3).
     • Predicate Device Specifications: The technical and performance characteristics of legally marketed predicate ultrasound devices (Ultrasonix Ergosonix 500, ATL HDI 5000, Acuson Sequoia) served as the benchmark for "substantial equivalence."

7. Sample Size for the Training Set:

   • Not applicable. This device does not use a "training set" in the machine learning sense. Its design and development would have involved engineering and calibration, not algorithm training on a dataset of cases.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable. As there is no training set for an AI algorithm, no ground truth was established for it.

Ask a specific question about this device