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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 TERATECH Model 8IOC4, 8IOL4, and 10LAP4 Probes are intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.

The TERATECH Model 810C4, 81OL4, and 10LAP4 Probes are intended for use with the Model TERATECH2000, a portable ultrasoundimaging system.

The provided text is a 510(k) summary for TERATECH Model 810C4, 810L4, and 10LAP4 Probes. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.

The document discusses:

• Device Name: TERATECH Model 8IOC4, 8IOL4, and 10LAP4 Probes
• Predicate Devices: Philips LI9-5, Philips CT8-4, Philips LAP L9-5, and TERATECH 10V5 (along with their associated 510(k) clearances).
• Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body. Specific indications are tabulated for each probe model across various clinical applications and modes of operation (e.g., B-mode, M-mode, PWD, CWD, Color Doppler, Combined Modes, Other).
• Device Description: Technical specifications (Frequency, # Elements, Array type, Pitch, Elevation width, Geometric focus, Azimuth radius, Azimuth length) for each probe model.
• Basis for Substantial Equivalence: The subject devices are claimed to be "identical in mechanical design and materials to the respective Philips," and intended for the same clinical applications. The FDA's letter confirms substantial equivalence.

Therefore, I cannot populate the table or answer the questions related to acceptance criteria and performance studies because this information is not present in the provided text. The document is a regulatory submission for substantial equivalence, which does not typically include detailed performance study results against pre-defined acceptance criteria in the way a clinical trial or a more rigorous performance study might.

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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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