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The SonixGPS Nerve Block Needle Kit is intended for use in regional anesthesia and pain therapy by a trained physician, to target peripheral nerves by visualization at the needle tip using an ultrasound imaging device. The needle is used to inject local anesthesia or analgesic to the targeted nerve bundle to induce regional anesthesia for surgical procedures.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the "SonixGPS Nerve Block Needle Kit." This document DOES NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in a study report.

The letter primarily confirms that the device has been found substantially equivalent to predicate devices and outlines regulatory compliance requirements. It details the device's name, regulation class, product code, and indications for use.

Therefore, I cannot extract the requested information as it is not present in the provided document.

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The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The device is available in two models 0.55mm and 0.9mm in diameter.

The SonixGPS™ Needle Sensor is an electromagnetic sensor that is placed inside a tracked instrument and used within an electromagnetic field. The position and orientation can be detected and combined with the acquired imaging to assist with navigation of the tracked instrument. The needle sensor allows physicians the precise placement of instruments during each procedure by monitoring the real-time trajectory of the instrument as it advances through delicate anatomy to the center of a target. The needle sensor consists of a sensor head, cable and a connector.

Here's an analysis of the acceptance criteria and study information for the SonixGPS™ Needle Sensor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Implied Acceptance Criteria for System Accuracy:

The document states, "The subject devices met the same defined accuracy criteria as the predicate device," and "[The SonixGPS™] demonstrated equivalent performance which met the defined criteria." While the specific numerical accuracy criteria for the predicate are not detailed in this 510(k) summary, the core acceptance criterion for the SonixGPS™ Needle Sensor was to achieve performance equivalent to the predicate device (K092619) under its established accuracy protocol.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not explicitly state the numerical sample size (e.g., number of tests, number of measurements, number of devices tested) for the performance "System Accuracy" testing. It only mentions that the "performance test used the same ultrasound system and setup to perform the accuracy test for SonixGPS™ 0.9mm Needle Sensor, SonixGPS™ 0.55mm Needle Sensor and the predicate device."
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The "System Accuracy" test appears to be a technical or engineering performance test against a defined protocol, rather than a clinical study requiring expert interpretation or ground truth establishment in a diagnostic sense.

4. Adjudication Method for the Test Set

This information is not applicable as the "System Accuracy" test described is a technical performance assessment, not a study involving human readers or interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The study described is a technical performance test comparing the new device against a predicate device's existing performance standards.

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

This document describes a standalone performance test of the device itself (the needle sensor), not an algorithm. The accuracy test described is for the device's ability to track position, which is an inherent function of the device, not an "algorithm only" performance separate from its intended use. While it's a "device only" test, the term "standalone" as typically used in AI/software refers to algorithmic performance without human intervention, which isn't directly applicable here as it's a physical device.

7. The Type of Ground Truth Used

For the "System Accuracy" test, the ground truth would be established by the needle sensor accuracy performance protocol and the Sonix 3D Motion Tracking (SonixGPS™) Verification Protocol and Report. This implies a defined, objective standard or known positions against which the device's tracking accuracy was measured. It's a technical ground truth rather than a clinical ground truth like pathology or expert consensus.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The SonixGPS™ Needle Sensor is an electromagnetic tracking hardware device, not an AI or machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided as there is no training set for this type of device.

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The SonixTABLET Ultrasound Imaging System is intended for the following applications: Abdominal, Cardiac, Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, 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 SonixTABLET 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 optional electrocardiography (ECG) display feature and support for a 3lead 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 SonixTABLET 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.

Here's a breakdown of the acceptance criteria and study information for the SonixTABLET Ultrasound Scanner, based on the provided document:

The document is a 510(k) Summary for the SonixTABLET Ultrasound Scanner, focusing on the addition of two new transducers (m4DC7-3/40 and L40-8/12) to a previously cleared device. As such, the "acceptance criteria" discussed are largely related to substantial equivalence to predicate devices and compliance with relevant safety and performance standards for ultrasound systems, rather than specific performance metrics for a novel AI device feature. The document does not describe a study involving human readers or AI assistance in the context of diagnostic performance. Instead, it focuses on the device's adherence to regulatory standards and its intended use.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) cannot be fully answered as they pertain to a type of study not detailed in this 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for an ultrasound system, the acceptance criteria are generally based on compliance with recognized standards and substantial equivalence to predicate devices, particularly regarding safety and fundamental performance. Specific performance metrics like sensitivity/specificity for a diagnostic task are not detailed for the overall ultrasound system in this type of submission unless a new diagnostic claim is being made.

• ISPTA(d): 720mW/cm2
• TIS/TIB/TIC: 0.1 - 6.0 (Range)
• Mechanical Index (MI): 1.9 (Maximum)
• ISPPA(d): 0 - 700W/cm2 (Range)
  These limits are stated to be "the same as predicate Track 3 devices." |
  | Safety - Electrical | Compliance with IEC 60601-1 (1988) Medical Electrical Equipment, Part 1: General Requirements for Safety, and IEC 60601-2-37: Particular Requirements For The Safety Of Ultrasonic Medical Diagnostic And Monitoring Equipment. | The system is designed to comply with these standards. |
  | Biocompatibility | Transducer patient contact materials must be biocompatible. | "Transducer patient contact materials are biocompatible." |
  | Intended Use | The intended uses for the added transducers (m4DC7-3/40 and L40-8/12) must align with general diagnostic ultrasound applications and modes of operation as previously cleared or as new, appropriate indications. | The document lists specific clinical applications and modes for the new transducers (marked with "N" for New indication and "P" for Previously cleared under K102997), covering various anatomical regions and imaging modalities (B-mode, M-mode, PW Doppler, Color Doppler, Power Doppler, Combined modes, and notes for features like Elastography, 3D imaging, biopsy guidance). |

Detailed breakdown of specific questions:

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

• Not applicable / Not provided. This document is a 510(k) summary for an ultrasound system seeking clearance for new transducers. It does not contain information about a test set or data provenance for a diagnostic performance study in the way a submission for an AI/CADe device would. The "study" here is primarily a demonstration of compliance with engineering standards and substantial equivalence to predicate devices, which typically doesn't involve clinical "test sets" in this context.

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)

• Not applicable / Not provided. As above, no diagnostic performance study with a distinct "test set" and "ground truth" established by experts is described for the purpose of demonstrating the device's diagnostic accuracy. The safety and performance are assessed against technical standards and comparison to predicate devices, not through a clinical accuracy study with expert ground truth.

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

• Not applicable / Not provided. No clinical diagnostic performance study requiring an "adjudication method" for a test set is detailed in this 510(k) summary.

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 comparative effectiveness study was not done. The document describes a traditional ultrasound imaging system with added transducers, not an AI or AI-assisted diagnostic device. Therefore, there's no mention of human readers improving with or without AI assistance.

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

• No, this is not applicable. The SonixTABLET Ultrasound Scanner is a hardware and software system for real-time ultrasound imaging used by a human operator, not a standalone algorithm.

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

• Not applicable / Not provided. No diagnostic performance study with an explicit "ground truth" for evaluating diagnostic accuracy is presented in this 510(k) summary. The "ground truth" in this context would be the underlying physical principles of ultrasound imaging and engineering specifications, and comparison to images produced by predicate devices, rather than clinical outcomes or pathology for specific diagnoses.

8. The sample size for the training set

• Not applicable / Not provided. This is an ultrasound imaging system, not an AI model that requires a training set.

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

• Not applicable / Not provided. As in 8, this is not an AI model.

In summary, the provided document is a regulatory submission demonstrating the safety and substantial equivalence of an ultrasound device and its transducers to existing devices and standards. It does not contain the kind of clinical study details (test sets, expert ground truth, AI performance metrics, etc.) that would be found in a submission for a novel AI/CADe diagnostic device.

Ask a specific question about this device

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 SonixTABLET Ultrasound Imaging System is intended for the following applications: Abdominal, Cardiac, 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 SonixTABLET 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. 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 optional electrocardiography (ECG) display feature and support for a 3lead 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 arrav scanning modes, and supports linear, convex, microconvex and phased array probes.

The biopsy kits are accessories to the SonixTABLET 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 provided text is a 510(k) Summary for the SonixTABLET Ultrasound Scanner. It details the device's characteristics, intended uses, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, device performance metrics, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case (MRMC) comparative effectiveness studies, standalone performance studies, or the ground truth establishment for training sets.

Therefore, many parts of your request cannot be answered from the provided document.

The document focuses on demonstrating that the SonixTABLET Ultrasound Scanner is substantially equivalent to previously cleared predicate devices (Sonix Ultrasound Scanner (K093462), Sonix TOUCH Ultrasound Scanner (K083095), SONIX MDP Ultrasound Scanner (K080935)) in terms of intended use, principles of operation, and technological characteristics. This type of submission generally relies on demonstrating equivalence rather than conducting new performance studies with detailed acceptance criteria as would be expected for a novel device.

The "Safety considerations" section mentions compliance with standards related to acoustic output limits, but these are general safety standards, not performance acceptance criteria for diagnostic accuracy.

What can be extracted directly (or inferred) from the provided text:

• Device Name: SonixTABLET Ultrasound Scanner
• Predicate Devices: Sonix Ultrasound Scanner (K093462), Sonix TOUCH Ultrasound Scanner (K083095), SONIX MDP Ultrasound Scanner (K080935)
• Reason for Submission: New product clearance for SonixTABLET Ultrasound Scanner and supporting transducers, due to a name change request and new product clearance.
• Technological Characteristics: Substantially similar to predicate devices, using piezoelectric material, yielding real-time ultrasound images, and having similar modes (2D, PW Doppler, Color Flow Mapping Doppler, Power Doppler, Continuous Wave Doppler).
• Key Safety Standards: IEC 60601-1, IEC 60601-1-2, AIUM AOL, AIUM RTD1-2004, UD-3 of NEMA, and FDA's 510(k) Diagnostic Ultrasound Guidance regarding acoustic output.
• Acoustic Output Limits (reported performance in relation to safety standards):
  • ISPTA (d): 720mW/cm²
  • TIS/TIB/TIC: 0.1 - 4.0 (Range)
  • Mechanical Index (MI): 1.9 (Maximum)
  • ISPPA (d): 0-700W/cm² (Range)
  • These limits are stated to be the same as predicate Track 3 devices.

Summary of Information NOT found in the provided text:

1. A table of acceptance criteria and the reported device performance (in terms of diagnostic accuracy/efficacy). The document focuses on performance relative to safety standards and equivalence to predicates, not specific diagnostic accuracy metrics.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance. (This device is an ultrasound scanner, not an AI or CADe/CADx device mentioned in this context.)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done. (Again, not an AI device.)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
8. The sample size for the training set. (Not an AI device with a training set in the typical sense).
9. How the ground truth for the training set was established. (Not an AI device with a training set in the typical sense).

Essentially, the provided document is a regulatory submission for substantial equivalence of an ultrasound device, which doesn't typically require the detailed performance study information you've requested for AI/CADx/CADe devices.

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

The SonixTouch 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, Intravascular, Laparoscopic.

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 SonixTouch 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 SonixTouch 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 quides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands.

The provided document is a 510(k) Summary for the SonixTouch Ultrasound Scanner, which primarily focuses on establishing substantial equivalence to predicate devices and detailing general safety considerations for an ultrasound system. It is not a study proving device performance against specific acceptance criteria in the manner typically seen for AI/ML-enabled diagnostic devices that generate quantifiable results (e.g., sensitivity, specificity for disease detection).

The document details the device's technical specifications and clinical applications for various transducers. It mentions "Elastography verification data" which points to a verification protocol, but this is described as verifying the algorithm's ability to differentiate different structures with different rigidity, rather than a clinical performance study with acceptance criteria.

Therefore, much of the requested information (like quantitative acceptance criteria, sample size for test sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, and training set details) is not present in the provided text, as this type of information is usually associated with studies validating a diagnostic claim or quantitative performance, which is not the primary focus of this 510(k) submission for a general ultrasound imaging system.

However, I can extract information related to the device's safety acceptance criteria and the methods used to demonstrate compliance.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes compliance with specific acoustic output limits as a safety consideration.

Ask a specific question about this device

The SONIX MDP Ultrasound 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.

The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal} and provides 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 MDP Ultrasound System indication(s) for use are the same as the predicate devices.

The ultrasound plateform is similar to the predicate devices in terms of operation. A transducer is applied to the patient and the system generates ultrasound waves then transmit the wave into human body. The system then receives echoes back from human body, processes them to yield an image on a display.

The provided document is a 510(k) summary for the "Sonix MDP Ultrasound Scanner". This type of document is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.

**Key sections that are usually part of a study proving acceptance criteria and device performance (like clinical trials or performance studies) are explicitly stated as "N/A" or simply not present in this 510(k) summary because: **

• This submission is for a "New product clearance" for an ultrasound system and its transducers, where the primary pathway to clearance is demonstrating substantial equivalence to predicate devices, not by conducting independent clinical efficacy studies in the same way a novel therapeutic or diagnostic device would.
• The approval is based on comparison to existing, legally marketed ultrasound systems and transducers.
• For diagnostic ultrasound systems, the "device performance" in a 510(k) is usually about technical specifications (e.g., acoustic output, image quality parameters, safety standards compliance) rather than diagnostic accuracy against a ground truth.
• A "Name change request" is also part of this submission, further indicating a focus on equivalence rather than new performance claims. The clearance is granted conditional on submission of a post-clearance special report with acoustic output measurements, which are technical performance criteria, not clinical.

Therefore, the typical metrics for an AI/ML device (sensitivity, specificity, accuracy, etc., against a ground truth) and the experimental setup to test them (sample size, expert ground truth, adjudication, MRMC studies) are not applicable or detailed in this 510(k) summary. The "acceptance criteria" here refer to the criteria for substantial equivalence to predicate devices and adherence to relevant standards.

Based on the provided text, here's a breakdown of what can be extracted, acknowledging the limitations for an ultrasound scanner 510(k):

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable (N/A) / Not provided. This 510(k) summary for an ultrasound system does not describe a "test set" in the context of clinical images or data being analyzed by the device for diagnostic accuracy. The substantial equivalence determination is based on the device's technical specifications, design, and intended uses being comparable to previously cleared devices. Device performance tests would involve engineering and safety verification rather than clinical data sets.

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

• N/A / Not provided. There is no mention of experts establishing a ground truth for a test set, as this is not a study focused on diagnostic accuracy of an AI/ML algorithm against a ground truth. The 'ground truth' here is essentially the technical and clinical performance established for the predicate devices.

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

• N/A / Not provided. No test set requiring adjudication of findings is described.

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 is a clearance for a diagnostic ultrasound imaging system itself, not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI assistance effect size is mentioned or applicable.

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

• No. This device is an ultrasound scanner, which is inherently a human-operated imaging tool. It does not perform "standalone" algorithmic diagnosis.

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

• N/A / Not provided. As no diagnostic accuracy study is described, no specific "ground truth" for diagnostic evaluation exists in this document. The "ground truth" for substantial equivalence is the existing, legally marketed predicate devices and their established safety and effectiveness.

8. The sample size for the training set:

• N/A / Not provided. This is not a submission for an AI/ML device that requires a training set.

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

• N/A / Not provided. As no AI/ML device or training set is discussed, this information is not applicable.

In summary, the provided 510(k) is for a new general-purpose ultrasound imaging system. The "study" proving it meets acceptance criteria is the 510(k) process itself, which involves demonstrating substantial equivalence to predicate devices through technical comparisons, adherence to performance standards (like acoustic output), and verifying that its indications for use are consistent with those of already cleared devices. It is not an AI/ML device, and therefore, typical AI/ML clinical study metrics are not relevant here.

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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.

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The Ergosonix and Modulo Ultrasound Scanners are intended for use in obstetrics/gynecology, general radiology, cardiac examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies. The specific intended uses of this system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), cephalic, small organ (breast, thyroid, testicle), trans-vaginal, trans-rectal, pediatric and fetal imaging, cardiac (adult) and cardiac (pediatric), transcranial, transesophageal.

The Ergosonix 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 Modulo Ultrasound Scanner is identical to the Ergosonix Ultrasound Scanner, except that it has a different, smaller, enclosure. The Modulo Ultrasound Scanner has the same software and hardware as the Ergosonix Ultrasound Scanner, except for logo displays. These systems have 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 provided document is a 510(k) summary for the Ultrasonix Ergosonix 500 Ultrasound, updated with new transducers, applications, and imaging modes. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to safety standards. This document does NOT contain information about performance acceptance criteria or a study proving the device meets such criteria.

The 510(k) process for ultrasound systems often relies on demonstrating substantial equivalence to already cleared devices and compliance with recognized safety standards (like acoustic output limits) rather than conducting specific clinical performance studies that define and then meet acceptance criteria as one might see for novel diagnostic AI devices.

Therefore, I cannot fulfill all parts of your request based on the provided text.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as performance criteria in the sense of a clinical outcome metric. The document focuses on compliance with general safety standards and equivalence to predicate devices.
• Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported for clinical use or diagnostic effectiveness. The performance is implied to be equivalent to the predicate devices.

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

• Not provided. This type of information is not typically part of a 510(k) summary for an ultrasound system focused on hardware and mode updates through substantial equivalence. There is no "test set" in the context of clinical performance evaluation against specific criteria here.

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

• Not applicable. There is no "test set" or ground truth establishment described for diagnostic performance evaluation.

4. Adjudication method for the test set:

• Not applicable.

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:

• Not applicable. This device is an ultrasound imaging system, not an AI-powered diagnostic tool. No AI component is mentioned, and therefore no MRMC study or effect size related to AI assistance is present.

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

• Not applicable. This is a hardware/software imaging system, not an algorithm being evaluated for standalone performance.

7. The type of ground truth used:

• Not applicable. No ground truth for diagnostic performance is mentioned. The submission focuses on technical specifications, safety (acoustic output), and substantial equivalence to legally marketed predicate devices. The "ground truth" in this context is the established safety and performance of the predicate devices and adherence to regulatory standards.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device requiring a training set.

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

• Not applicable.

Summary of available information:

The document primarily serves as a 510(k) premarket notification to demonstrate that the Ergosonix and Modulo Ultrasound Scanners, including new transducers and applications, are substantially equivalent to legally marketed predicate devices (Ultrasonix Ergosonix 500 Ultrasound Scanner (K020630), ATL HDI 5000 System (K002003), Acuson Sequoia (K973767)).

Acceptance Criteria (Implied - focused on safety and equivalence):

The acceptance criteria are implicitly tied to:

• Compliance with recognized safety standards for medical electrical equipment and a coustic output.
• Demonstration of technological characteristics and intended uses being substantially similar to predicate devices.

Reported Device Performance (Implied - focused on safety and technical specifications):

• Acoustic Output Limits: The devices comply with the guideline limits set in the September 30, 1997 revision of 510(k) Diagnostic Ultrasound Guidance.
  • 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 limits are stated to be the same as predicate Track 3 devices.
• The device operates in modes (2D, PW Doppler, Color Flow Mapping Doppler, Power Doppler) identical to predicate devices.
• The beam forming architecture and image quality adjustment parameters are "very similar" or "the same" as predicates.

The study that "proves the device meets the acceptance criteria" in this context is the 510(k) premarket notification process itself, which establishes substantial equivalence through a comparison of technical features, intended use, and adherence to safety standards. No specific clinical performance trial against predefined acceptance criteria is detailed in the provided document.

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