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The Teratech Corporation Terason t3000™ is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal, Abdominal, Intra-operative (abdominal, thoracic and PV); Pediatrics, Small Organ (Breast, testes, thyroid); Neonatal and Adult Cephalic; Trans-rectal and Trans-vaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.

The subject-modified device is a general purpose Ultrasound System intended for use by a qualified physician for the evaluation by ultrasound imaging or fluid-flow analysis of the human body. Specific clinical applications and exam types include: Fetal, Abdominal, Intra-Operative (spec. and Neuro), Laparoscopic, Pediatric, Small Organ (breast, testes, thyroid), Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-sketetal (Conventional and Superficial), Cardiac (adult and pediatric), and Peripheral Vascular.

The Terason t3000 is a modified version of the Echo/t3000 Ultrasound System. The modifications include the addition of 6 new transducers (12L5A, 4V2A, 12HL7, 8EC4A, 8EC4V, and 10V5S) and improved needle guidance technology components developed by SOMA Access Systems LLC and integrated into the Terason 10V5S transducer.

The design and construction of the Terason t3000 is similar to the Terason™ Echo/t3000 Ultrasound system. These systems utilize a laptop computer running Windows to run the ultrasound application and a custom designed engine for control of the acoustic array and processing of the return echoes. The engine is housed in a compartment that is attached to the bottom of the laptop.

The differences between the Terason t3000 and the Terason Echo/t3000 Ultrasound System (the predicate device) include the following:

• Six new transducers have been added to the system. The software has been modified to control these transducers and ensure compliance to the standards controlling acoustic and thermal power.
• An improved needle guidance technology is provided with the 10V5S transducer. An array of Hall Effect sensors with a data capture board is integrated into the body of the 10V5S transducer. The sensors track the position of the needle by sensing and determining the position of a magnet located on the needle. This information is transferred through the Terason engine to the application software that generates a graphic overlay upon the ultrasound image showing the position of the tip of the needle to the ultrasound acquired target. The needle tip is a virtual highlight, providing the user with a real time position update, making it easier to insert the needle in the intended target in the first attempt. This improvement is intended to result in significant reductions of multiple insertions, adjustments of needle position during insertions and resultant trauma. infections and ancillary complications from less adequate methods of needle guidance. The needle guidance software component that produces the graphic overlay of needle position is developed by Soma Access Systems LLC of Greenville, S.C. and integrated into the Terason t3000 ultrasound software application.

The provided 510(k) summary for the Terason t3000™ Ultrasound System primarily focuses on demonstrating substantial equivalence to a predicate device (Terason™ Echo/t3000 Ultrasound System, K080234), particularly regarding the addition of new transducers and improved needle guidance technology. It does not describe specific acceptance criteria and a study proving the device meets those criteria in the context of a diagnostic accuracy or clinical performance study for image interpretation by an algorithm.

The studies mentioned are primarily non-clinical electrical, acoustic emission, and biocompatibility tests intended to ensure safety and compliance with recognized standards.

Here's an analysis based on the information provided, highlighting what is missing or not applicable within the context of a diagnostic AI device:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided for diagnostic performance (e.g., sensitivity, specificity, accuracy) related to an AI algorithm for image interpretation. The document lists compliance with various IEC and NEMA standards for safety and acoustic output, which are technical acceptance criteria for the hardware itself.

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

Not applicable in the context of a diagnostic accuracy study for an AI algorithm interpreting ultrasound images. The document mentions non-clinical technical tests, which do not typically involve patient-derived test sets in this manner. The "needle guidance technology" is an assistive tool, not a diagnostic algorithm interpreting images.

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

Not applicable. The studies described are non-clinical safety and performance tests of the ultrasound system and its components (transducers, needle guidance system), not diagnostic accuracy studies requiring expert-adjudicated ground truth for image interpretation.

4. Adjudication Method for the Test Set

Not applicable. There is no diagnostic accuracy test set or associated adjudication 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 MRMC study is mentioned. The improved needle guidance technology is described as an assistive tool, but no formal comparative effectiveness study quantifying human improvement with this assistance is detailed in this summary.

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

No standalone algorithm performance study is mentioned for image interpretation. The "needle guidance technology components" integrated into the 10V5S transducer provide a graphic overlay, which is an assistive feature, not a standalone diagnostic algorithm.

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

Not applicable in this document for the reasons stated above. Ground truth for safety and acoustic output tests would typically involve physical measurements and comparisons to engineering specifications or regulatory limits.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set as this device is an ultrasound system with enhanced needle guidance, not a machine learning-based diagnostic algorithm.

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

Not applicable. As above, there is no mention of a training set.

Conclusion:

This 510(k) summary is for a traditional diagnostic ultrasound system with added transducers and a novel needle guidance feature. The "acceptance criteria" and "studies" detailed are primarily for demonstrating the safety and technical performance of the hardware (ultrasound system and transducers) and its compliance with established regulatory standards (e.g., IEC, ISO, NEMA). It does not contain the type of AI-specific or diagnostic accuracy information (such as sensitivity, specificity, reader studies, or training/test set details) that would be relevant for a device utilizing artificial intelligence to interpret medical images or make diagnostic assessments. The needle guidance system is presented as an aid to physical procedures, not as an AI-powered diagnostic tool.

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The Aloka ProSound C3 is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal, Abdominal, Intra-operative (abdominal, thoracic and PV); Pediatrics, Small Organ (Breast, testes, thyroid); Neonatal and Adult Cephalic; Trans-rectal and Trans-vaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.

The Aloka ProSound C3cv is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal, Abdominal, Intra-operative (abdominal, thoracic and PV); Pediatrics, Small Organ (Breast, testes, thyroid); Neonatal and Adult Cephalic; Trans-rectal and Trans-vaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.

The subject-modified device is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid-flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Intra-operative (abdominal, thoracic and PV); Laparoscopic; Pediatric; Small Organ (breast, testes, thyroid), Neonatal and Adult Cephalic; Transrectal and Transvaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (adult & pediatric); Peripheral Vascular.

The subject-modified device is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid-flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Andominal (GYN & Urology); Intra-operative (abdominal, thoracic and PV); Laparoscopic; Pedintria; Small Organ (breast, testes, thyroid), Neonatal and Adult Cephalic; Transrects | and Transvaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (adult & pediatric); Peripheral Vascular.

The ProSound C3 is a modified version of the Echo/t3000 Ultrasound System. The modifications include a change in the Product Label (of both the systems and the transducers), addition of Foreign language support (French, German, Italian, and Spanish), a slight modification of Transmit circuitry, providing a slightly different acoustic profile and the introduction of a spatial compounding feature called OMNIBeam.

The design and construction of the ProSound C3 is similar to the Terason™ Echo/t3000 Ultrasound system. These systems utilize a laptop computer running Windows to run the ultrasound application and a custom designed engine for control of the acoustic array and processing of the return echoes. The engine is housed in a compartment that is attached to the bottom of the laptop.

The ProSound C3cv is a modified version of the Echo/t3000 Ultrasound System. The modifications include a change in the Product Label (of both the systems and the transducers), addition of Foreign language support (French, German, Italian, and Spanish) and the introduction of a spatial compounding feature called OmniBeam.

The design and construction of the ProSound C3cv is similar to the Terason™ Echo/t3000 Ultrasound system. These systems utilize a laptop computer running Windows to run the ultrasound application and a custom designed engine for control of the acoustic array and processing of the return echoes. The engine is housed in a compartment that is attached to the bottom of the laptop.

The provided text describes modifications to an ultrasound system (Aloka ProSound C3 and C3cv) and its transducers, and references various non-clinical tests to demonstrate compliance with general safety and performance standards. However, it does not contain information about acceptance criteria for specific imaging performance metrics, nor does it describe studies with sample sizes, expert ground truth, or comparative effectiveness with human readers using AI.

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device by showing that the new device is as safe and effective. This is often achieved through non-clinical testing against recognized standards rather than extensive clinical performance studies as would be required for novel devices or AI systems making diagnostic claims.

Therefore, most of the requested information cannot be extracted from this document because such studies were not conducted or described in this regulatory filing.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria for image quality or diagnostic performance, nor does it report specific device performance metrics in comparison to such criteria. Instead, compliance is demonstrated through adherence to recognized international and national standards for medical electrical equipment and ultrasonic devices.

Missing Information (Not found in the provided document):

• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No information on test sets (beyond compliance testing) for clinical performance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test sets with ground truth are described.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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. AI assistance is not mentioned as a feature of this ultrasound system. The "OMNIBeam" feature is spatial compounding, which is an image processing technique, not an AI diagnostic aid.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a diagnostic ultrasound system (hardware and associated software), not a standalone diagnostic algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" demonstrated is compliance with engineering and safety standards.
• The sample size for the training set: Not applicable. The document does not describe an AI/machine learning component that would require a training set. The software modifications are for foreign language support and spatial compounding (OMNIBeam).
• How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence through compliance with established medical device safety and performance standards for an ultrasound system and its transducers. This type of regulatory submission does not typically include detailed clinical performance studies, ground truth establishment, or AI-specific assessment criteria as would be expected for novel diagnostic algorithms. The modifications primarily concern product labeling, foreign language support, a minor transmit circuitry change, and the addition of a spatial compounding feature (OMNIBeam), all of which are assessed for safety and basic functionality rather than intricate diagnostic performance studies with expert ground truth.

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MDxNet is intended for use under physician's orders and/or oversight and management.

MDxNet is indicated for acquisition of related sets of 2D ultrasound images and 3D reconstruction of ultrasound images in the adult and pediatric patient utilizing existing ultrasound systems. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 2D and 3D image processing. MDxNet is indicated to acquire, digitize, archive and retrieve single or sequences of 2D ultrasound images.

MDxNet is intended as a general purpose digital image processing and archiving tool for use in abdominal, pelvic, fetal, cardiac, peripheral vascular and neurovascular imaging.

MDxNet add-on indications are for the assessment of pulmonary function to acquire, analyze, store and retrieve this assessment in male/female adult and pediatric patients utilizing FDA approved Spirometry. MDxNet additional add-on will provide 12-lead resting electrocardiogram (ECG) which permits the detection of abnormalities in the transmission of the cardiac impulse through the heart muscle and serves as an important aid in the diagnosis of heart ailments through utilizing 12-lead ECG.

MDxNet consists of MDxPAC, MDxStation (PC or Notebook, laptop computer), MDxServer, and the proprietary software component called MDxView. MDxPAC consists of limited hardware, that bundle and power FDA approved Commercial Off-The-Shelf devices (COTS). MDxNet features an integrated 2D/3D streaming engine which permits PC's or notebooks to control the server and to review 2D and 3D reconstructions. MDxNet is capable of image review, archiving, data collection, database maintenance, reporting and basic 3D capabilities including color rendering. Upon receipt of FDA approval to market MDxNet, finished devices will be distributed only under direction and/or orders of physicians.

MDxNct inherits and integrates concepts first pioneered in the National Aeronautics and Space Administration (NASA) sponsored Telemedicine Instrument Pack (TIP) project and the Defense Advanced Research Projects Agency (DARPA) sponsored Medical Ultrasound Three-dimensional, Portable with Advanced Communication (MUSTPAC) project, and its predecessors. It expands capability to include a server component, augments data acquisition to include wireless options, redesigns the Graphical User Interface (GUI) for more intuitive interaction and provides improved packaging for better usability.

MDxNet has the capability to record ultrasound transducer spatial position in six degrees of freedom during use. Coordinate tracking is achieved with a miniature magnetic field sensor within a transmitted pulsed magnetic field. This is done by attaching a plastic holding plate to the FDA approved probe of the host Ultrasound system, to which the receiver of an electromagnetic sensor device is attached.

2D ultrasound images are acquired sequentially in a series of steps as the ultrasound transducer is moved across the patient scan site. The resulting set of digitized 2D images is then converted into a 3D data volume.

IQmark Digital ECG and Spirometer both FDA approved devices have been integrated into MDxNet as requested by the end user of the validation study. The Midmark software for each of these devices and indications of use have not been altered, though permit the end user as demonstrated in both clinical studies to capture additional potentially key clinical results within MDxNet for data collection, review, comparison, reporting and archiving.

Here's a breakdown of the acceptance criteria and study information for the CyberMDx MDxNet device, based on the provided FDA 510(k) Premarket Notification:

The provided document K060035 for CyberMDx, Inc. MDxNet is a 510(k) Premarket Notification. It explicitly states that MDxNet is an "Image Processing Server" and a "System, Image Processing, Radiological." This type of device primarily functions as a tool for displaying, processing, archiving, and retrieving medical images. It's important to note that this document does not describe a device that performs AI-driven interpretation or diagnosis, nor does it present "acceptance criteria" in the sense of performance metrics (like sensitivity, specificity, or AUC) that an AI algorithm would need to meet.

Instead, the submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices by comparing features and intended uses. The "studies" mentioned are primarily about verifying the device's functionality and safety as an image processing system rather than validating the diagnostic accuracy of an AI component.

Therefore, the requested information, particularly regarding AI-specific performance metrics, ground truth, expert adjudication, sample sizes for AI training/test sets, and MRMC studies, is largely not applicable (N/A) in the context of this 2006 510(k) for an image processing server. The device predates the widespread adoption and regulatory requirements for AI in medical imaging.

However, I will extract and organize the relevant information that is present in the document.

Acceptance Criteria and Reported Device Performance

Given that this is an image processing server, the "acceptance criteria" discussed are primarily related to its functional capabilities and conformity to design intent and quality standards, rather than diagnostic accuracy metrics. The document emphasizes functional equivalence to predicate devices.

Table 5-1 explicitly shows "Yes" for MDxNet across all listed common features (2D Image Review, Multiplanar Reformatting, 3D Volume Rendering, Maximum Intensity Projection, Image Archiving, Image Filming, Image Transfer/Network Connectivity, Examination of 2D image as 3D volume, Comparison of Multiple Scans, General medical imaging indications, Computer Platform, Image Display, Operating System). |
| Accuracy and Performance to Specification (general system performance) | "bench testing was conducted to establish MDxNet's accuracy, performance to specification, as well as testing to accepted industry standards..." (Section 5.3)

"Test results to date included elsewhere support the conclusion that the actual device, software and hardware satisfies the design intent. Actual device performance as tested internally and by third parties (including controlled clinical trials) conforms to the system performance standards and has met expectations." (Section 5.6) |
| Adherence to Quality System Regulations (e.g., FDA 21 CFR 820) | "Continual nonclinical testing is being conducted through internal company procedures according the FDA 21CFR820 Quality System and Current Good Manufacturing Practices." (Section 5.6) |
| Hardware Testing | "All hardware testing will be conducted and meet the specified acceptance criteria before the device is marketed." (Section 4, Hardware & Software Information) |
| Software Level of Concern | "The level of concern relative to the software has been determined as minor using the decision tree provided in the revised FDA Software Guidance, May 11, 2005." (Section 4, Hardware & Software Information) |

Study Details (Focusing on Functional & Safety Verification)

As noted, this is not an AI performance study. The "clinical studies" mentioned are for system validation, not diagnostic accuracy of an AI algorithm.

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

   • Test Set Sample Size: The document states that "Two MDxNet Systems were developed to acquire potential end user input and to allow validation of the software, hardware, server and integration under Investigational Review Board (IRB) approval in a medical clinic setting." It also mentions "controlled clinical trials." However, no specific sample size (number of patients or images) for any particular "test set" is provided.
   • Data Provenance: "Medical clinic setting" and "third parties (including controlled clinical trials)." No specific countries are mentioned, but the company is US-based (Providence, RI). The studies appear to be prospective as they were conducted for validation.

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

   • N/A. The document does not describe a clinical diagnostic "ground truth" establishment process for imaging analysis that would require experts. The device is a tool, not an AI for diagnosis. The validation focuses on whether the system functions as intended and safely integrates other FDA-approved devices (Spirometry, ECG).

3. Adjudication method for the test set:

   • N/A. No expert adjudication is described as the device is not performing diagnostic interpretations that would require it.

4. 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 not an AI-assisted device. Therefore, no MRMC study comparing human readers with and without AI assistance was conducted or is applicable.

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

   • N/A. The MDxNet is a system that allows users to process and view images. It is not a standalone diagnostic algorithm.

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

   • N/A. For the image processing and display features, "ground truth" would relate to the accuracy of image reconstruction, archiving, and retrieval, which are engineering and system performance validations rather than clinical diagnostic ground truth. For the integrated ECG and Spirometry, the "ground truth" would be the direct output of those separate FDA-approved devices. The main focus of the study was about the integration and display of these clinical results, not their diagnostic determination by MDxNet.

7. The sample size for the training set:

   • N/A. The document does not mention any "training set" in the context of machine learning or AI.

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

   • N/A. No training set for AI is mentioned.

Summary of Device Context:

The CyberMDx MDxNet, as described in this 2006 510(k) submission, is a general-purpose image processing server. Its primary function is to:

• Acquire, digitize, archive, and retrieve 2D ultrasound images.
• Perform 3D reconstruction of ultrasound images.
• Provide tools for image review, multiplanar reformatting, volume rendering, and maximum intensity projection.
• Integrate data from external FDA-approved devices (like spirometers and 12-lead ECGs) for capture, review, comparison, reporting, and archiving.

The submission demonstrates substantial equivalence to predicate devices by virtue of its functional features as an imaging workstation/server, not by demonstrating AI-driven diagnostic performance. The "studies" mentioned are for systematic validation of the device's ability to perform these functions safely and effectively, and to integrate data from other medical devices, within a clinical setting under IRB approval.

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The TERASON™ Ultrasound System with Continuous Wave (CW) Doppler is 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 TERASON™ Ultrasound System with Continuous Wave (CW) Doppler introduces two new versions of the TERATECH Model 2000 Imaging System.

The provided document is a 510(k) summary for the TERASON™ Ultrasound System with Continuous Wave (CW) Doppler. It outlines the device's intended use and substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on specific performance studies with acceptance criteria, sample sizes, ground truth establishment, or expert evaluations.

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The TERATECH Model 10V5 Smart Probe is 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 TERATECHModel 10V5 Smart Probe is intended for use with the Model TERATECH 2000 , a portable ultrasound imaging system.

Here's a breakdown of the acceptance criteria and study information for the TERATECH Model 10V5 Smart Probe, based on the provided document:

This 510(k) summary does not contain acceptance criteria in the traditional sense of performance metrics (e.g., sensitivity, specificity, accuracy) from a clinical study. Instead, the device's acceptance is based on its substantial equivalence to existing predicate devices.

The "study" that proves the device meets the acceptance criteria is the comparison to predicate devices to demonstrate substantial equivalence.

Here's the information extracted and organized:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not describe a test set or data provenance in terms of clinical study participants or imaging datasets. The "test" for substantial equivalence primarily relies on a comparative analysis of device specifications, intended uses, and modes of operation against legally marketed predicate devices.

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

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication method 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

Not applicable. This is a 510(k) for a diagnostic ultrasound transducer, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm-only device. It's a hardware component (transducer) for an ultrasound system, inherently requiring a human operator.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" here is the established safety and effectiveness of the predicate devices (Acuson 10V4 Sequoia™ Ultrasound System and Harmonic Imaging, Acuson Aspen™ Ultrasound System, and other previously cleared devices referenced by K-numbers for specific clinical applications). The new device is deemed acceptable because it performs equivalently or is a subset of these already approved devices.

8. The Sample Size for the Training Set

Not applicable. This device does not use a training set for machine learning or AI.

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

Not applicable. No training set is involved.

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The TERATECH Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes is intended for diagnostic ultrasoundimaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.

Technical specifications for the Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes are as follows: System Transducer frequencies: 2-4 MHz (4C2 and 4V2), 4-8 MHz (8EC4, 8L4) Frame rate: 15 - 58 fps (Imaging only) Ultrasound lines/frame: 128 Fields of View: 2.5 - 24 cm External Video Output: Composite Video, VGA Monitor Display: 15.7" SXGA TFT Liquid-Crystal Size: 13.125" Width: 11.25" Height: 1.62" Depth: 8.6 lb. Weight: Laptop Computer 10 oz Smart Probe Electrical Input: 115-250 VAC, Output: 19 VDC @ 4A External Power: Li-Ion battery pack (70 Whr) Battery: Leakage Current: 50 µA maximum Primary Breakdown Voltage: greater than 1500 V AC Safety Standards: IEC 601-1, UL 2601, Can/CSA C22.2 601.1 Protection Class: Class I: per IEC 601-1 Degree of Protection: Type BF: per IEC 601-1 Environmental Mechanical Shock (Smart Probe): IEC 68-2-27 compliant (Smart Probe only) Mechanical Vibration: Sinusoidal: IEC 68-2-6 (Smart Probe only) Drop Test (to concrete): 3 feet Operating Temperature: 0 to 50 C (Smart Probe only) Humidity: 20 to 80% RH, non-condensing Water Resistance: Transducer array watertight to the strain relief Altitude: 0 -- 12,500 feet (operating) Refer to computer manufacturer's documentation for relevant environmental specifications. Storage Temperature: -25 to 60 C Humidity: 15 to 98% RH, non-condensing

The provided document does not contain acceptance criteria or details of a study that proves the device meets specific acceptance criteria in the way described by the prompt. This document is a 510(k) summary for a medical device (TERATECH Model 2000 Handheld Ultrasound System), which focuses on demonstrating substantial equivalence to predicate devices, not on proving performance against a set of quantitative or qualitative acceptance criteria through a dedicated study.

Specifically:

• There is no table of acceptance criteria and reported device performance.
• There are no details of sample sizes used for test sets, data provenance, number of experts for ground truth, or adjudication methods.
• There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes of human readers with/without AI.
• There is no mention of a standalone algorithm performance study.
• The type of ground truth used for any performance evaluation is not specified, nor are training set details.

Instead, the document states:

"The TERATECH Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes is substantially equivalent to Deppter and Sequoia™ and Aspen™, which are currently in commercial distribution in the United States, since the subject device has intended uses and modes of operation which are a subset of those of the predicates."

This indicates that the primary method for clearance was demonstrating substantial equivalence based on similar intended uses and operational modes to existing, legally marketed predicate devices (Acuson Sequoia™ Ultrasound System and Harmonic Imaging (K97367), Acuson Aspen™ Ultrasound System (K991805)). This approach relies on the predicate devices having already met the necessary performance and safety standards, and the new device being sufficiently similar that it does not raise new questions of safety or effectiveness.

The tables presented in the later sections outline the intended uses and modes of operation for different transducers with the system, indicating which applications are "new indications" (N) or "previously cleared by FDA" (P) under other 510(k)s. This is about defining the scope of the device's permissible use, not about performance metrics against specific criteria.

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