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

The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 87cm deep and 130 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color wide screen image display.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (a 510(k) summary) does not detail specific quantitative acceptance criteria or corresponding reported device performance metrics in the way one might expect for a clinical study comparing an AI algorithm's diagnostic accuracy to a threshold. Instead, the document focuses on demonstrating substantial equivalence to a predicate device.

The "acceptance criteria" here are implicitly related to meeting safety and performance standards, and having comparable intended use, imaging capabilities, and technological characteristics to the predicate device. The "reported device performance" is the conclusion that the device is "as safe, as effective, and performance is substantially equivalent."

Here's an interpretation based on the document's content:

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

The document states: "The subject of this premarket submission, LOGIQ E9, did not require clinical studies to support substantial equivalence." This indicates that no specific test set of patient data was used to evaluate the substantial equivalence of this device in a clinical context. The evaluation was based on non-clinical tests and comparison to a predicate device.

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

As no clinical studies were required, there was no test set for which expert ground truth would have been established.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done, as the document explicitly states that clinical studies were not required to support substantial equivalence. Therefore, there is no effect size of human readers improving with or without AI assistance to report.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The document describes an ultrasound system (hardware and integrated software features), not a standalone AI algorithm. The evaluation was for the entire system's substantial equivalence.

7. Type of Ground Truth Used

Not applicable, as no clinical studies were required and no ground truth from patient data was established for the purpose of demonstrating substantial equivalence. The "ground truth" in this context would be adherence to safety and performance standards and demonstrable equivalence to the predicate device through non-clinical testing.

8. Sample Size for the Training Set

Not applicable. This document describes a medical device (ultrasound system), not an AI algorithm that requires a training set in the conventional sense. The "training" for the device's functionality would be embedded in its design, engineering, and adherence to established physical principles of ultrasound imaging.

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

Not applicable. As noted above, this summary does not pertain to an AI algorithm that was "trained" on data to learn a task. Its "ground truth" is its compliance with a predefined design and manufacturing process that ensures safety and performance in line with a predicate device and industry standards.

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

The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 87cm deep and 130 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color wide screen image display.

The provided text is a 510(k) Premarket Notification Submission for the GE LOGIQ E9, LOGIQ E9 XDclear 2.0 Diagnostic Ultrasound System. This document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a new clinical study with acceptance criteria and device performance. Therefore, much of the requested information regarding acceptance criteria and performance studies in the traditional sense of a clinical trial for a novel device is not directly available in this document.

However, I can extract information related to the device's intended use, comparison to predicates, and the non-clinical tests performed.

Important Note: The acceptance criteria and performance data requested in the prompt typically refer to a clinical study demonstrating the efficacy and safety of a novel device. As this submission is for substantial equivalence to existing devices (K142160 GE LOGIQ E9, K131527 GE LOGIQ S8, K131514 GE Vivid E9), the "acceptance criteria" here are met by demonstrating that the new device shares the same intended use, imaging capabilities, technological characteristics, and safety and effectiveness as the predicate devices, and complies with applicable safety standards. There is no new clinical study presented that would define novel acceptance criteria and then report performance against them.

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a substantial equivalence submission, the "acceptance criteria" are implied by the features and performance of the predicate devices and compliance with relevant standards. The "reported device performance" is the demonstration that the LOGIQ E9, LOGIQ E9 XDclear 2.0 system performs equivalently to the predicates for its intended uses and complies with safety standards.

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

This document explicitly states: "The subject of this premarket submission, LOGIQ E9, did not require clinical studies to support substantial equivalence." Therefore, there is no test set, sample size, or data provenance from a new clinical study provided in this submission for device performance evaluation. The substantial equivalence relies on demonstrating that the new device operates similarly and safely as the predicate devices, which were previously cleared.

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, as no new clinical study (and thus no "test set" and "ground truth" to establish) was required for this substantial equivalence submission.

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

Not applicable, as no new clinical study was conducted.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of image interpretation. The "AutoEF and AFI" mentioned are software features but there's no MRMC study detailed here to show improved human reader performance.

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

Not applicable, as this is a diagnostic ultrasound imaging system, not a standalone algorithm.

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

Not applicable, as no new clinical study was required for this substantial equivalence submission. The "ground truth" for the predicate devices' clearance would have been established through methods appropriate for diagnostic ultrasound systems at the time of their original clearance (e.g., comparison to other imaging modalities, clinical correlation).

8. The sample size for the training set

Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for an algorithm described in this submission.

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

The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 86cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display.

The provided text describes the GE LOGIQ E9 Diagnostic Ultrasound System and its various transducers. It highlights the device's indications for use and a summary of non-clinical tests conducted to prove its safety and substantial equivalence to predicate devices. However, it explicitly states that no clinical studies were required or performed to support substantial equivalence.

Therefore, I cannot provide details on the acceptance criteria and a study that proves the device meets those criteria, as no such clinical study is reported in the provided document.

Here's a breakdown of the information that can be extracted or inferred based on your prompt and the document:

1. A table of acceptance criteria and the reported device performance:

Since no clinical studies were performed, there are no specific performance metrics derived from such studies to present in a table. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices through non-clinical testing and adherence to recognized standards.

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

• Sample Size for Test Set: Not applicable, as no clinical studies were conducted that would involve a "test set" of patients for performance evaluation. Non-clinical tests typically involve phantom, bench, or ex-vivo testing.
• Data Provenance: Not applicable for patient data, as no clinical studies were conducted. The document details adherence to international and national standards (AAMI/ANSI, IEC, NEMA, ISO), indicating these standards and tests were likely performed according to established protocols in manufacturing or testing facilities.

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, as no clinical studies were conducted requiring ground truth established by experts for a patient test set.

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

Not applicable, as no clinical studies were conducted requiring adjudication for a patient test set.

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. The GE LOGIQ E9 is a diagnostic ultrasound system and the document does not suggest or describe any AI components or MRMC studies for improved human reader performance.

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

Not applicable. The device is a diagnostic ultrasound system, not an algorithm, and the document does not describe standalone algorithm performance.

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

Not applicable for clinical ground truth, as no clinical studies were described. For non-clinical tests (acoustic output, safety, etc.), the "ground truth" would be defined by the specifications, standards, and established methodologies for each test (e.g., calibrated measurement devices for acoustic output).

8. The sample size for the training set:

Not applicable, as no clinical studies involving machine learning or AI models with a "training set" were described.

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

Not applicable, as no clinical studies involving machine learning or AI models with a "training set" were described.

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

The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 86cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display.

The provided document is a 510(k) Premarket Notification Submission for the GE LOGIQ E9 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through novel clinical studies against acceptance criteria.

Therefore, the document explicitly states: "The subject of this premarket submission, LOGIQ E9, did not require clinical studies to support substantial equivalence."

Because no clinical studies were performed, it is not possible to extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document instead focuses on:

• Summary of Non-Clinical Tests: Evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety.
• Compliance with Voluntary Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 3, ISO 10993-1, NEMA UD 2, ISO 14971, and NEMA DICOM Set.
• Quality Assurance Measures: Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), and Final Acceptance testing (Validation).
• Intended Use: A broad range of diagnostic ultrasound evaluations for various anatomical regions and clinical applications, with specific modes of operation (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, and other features like 3D/4D imaging and needle guidance) listed for each supported transducer.

In summary, the provided text does not contain the information required to populate the table or answer the questions as it pertains to clinical acceptance criteria and a study demonstrating performance against those criteria. The device's clearance was based on demonstrating equivalence, not on de novo clinical performance studies with acceptance criteria.

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

The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 86cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display.

The GE LOGIQ E9 Diagnostic Ultrasound System is a full-featured, general-purpose diagnostic ultrasound system. It consists of a mobile console and provides digital acquisition, processing, and display capabilities. The user interface includes a computer keyboard, specialized controls, a 10-inch LCD touch screen, and a 19-inch LCD image display.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or numerical performance metrics for the LOGIQ E9 system's image quality or diagnostic accuracy. Instead, the "acceptance criteria" are implied through the statement of substantial equivalence to its predicate device(s).

The reported device performance is that it is considered "as safe, as effective, and performance is substantially equivalent to the predicate device(s)."

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

The document explicitly states: "The subject of this premarket submission, LOGIQ E9, did not require clinical studies to support substantial equivalence."

Therefore, there is no test set of clinical data from human subjects mentioned in this 510(k) summary. The evaluation focused on non-clinical tests.

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

Since no clinical studies were performed on a test set, no experts were used to establish ground truth for a test set in the context of clinical performance evaluation. The evaluation was primarily engineering and performance testing against standards and the predicate device.

4. Adjudication Method for the Test Set

As no clinical test set was utilized, there was no adjudication method described for clinical data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission explicitly states no clinical studies were required.

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

Since the LOGIQ E9 is a diagnostic ultrasound system and not an AI-powered algorithm for image interpretation, the concept of "standalone (algorithm only without human-in-the-loop performance)" as typically applied to AI/ML devices is not directly applicable.

The "performance" evaluation for this device was based on engineering verification and validation, demonstrating that the system's technical specifications and imaging capabilities were comparable to its predicate devices, rather than a standalone AI performance study.

7. Type of Ground Truth Used

For the non-clinical tests, the "ground truth" would be established by:

• Engineering specifications and test standards: For acoustic output, thermal, electrical, electromagnetic, and mechanical safety.
• Biocompatibility testing results: Conformance to established biocompatibility protocols.
• Cleaning and disinfection effectiveness testing results: Verification against established protocols.
• Comparison to predicate device's established performance: The predicate device serves as a benchmark for "substantial equivalence."

No pathology, expert consensus on images, or outcomes data were used as ground truth for clinical performance, as clinical studies were not performed.

8. Sample Size for the Training Set

The LOGIQ E9 is a traditional diagnostic ultrasound system, not an AI/ML device that requires a "training set" of data in the same way. Therefore, there is no mention of a training set sample size.

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

As there is no mention of an AI/ML training set, this question is not applicable to this 510(k) submission.

Summary of Device Evaluation Approach:

The GE LOGIQ E9 Diagnostic Ultrasound System received 510(k) clearance based on its substantial equivalence to previously cleared predicate devices (K092271 GE LOGIQ E9 Diagnostic Ultrasound System and K052441 GE LOGIQ 7 Diagnostic Ultrasound System). This determination was made primarily through non-clinical tests and verification activities, rather than clinical studies. The non-clinical tests included evaluations for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and various safety aspects (thermal, electrical, electromagnetic, mechanical). The device also underwent a series of internal quality assurance measures such as risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, performance, safety, and final acceptance). The core argument for substantial equivalence rested on the device employing the "same fundamental scientific technology as its predicate device(s)" and conforming to applicable safety standards and voluntary standards.

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

The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 86 cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display. This modification will provide users with 8 additional transducers, an additional optional feature called Elastography Imaging and an enhanced version of the commercially available Volume Navigation (V Nav) optional feature. These modifications all lead to overall quality and image enhancement.

Here's a summary of the acceptance criteria and study information for the GE LOGIQ E9 BT2010 Diagnostic Ultrasound System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K092271) for the GE LOGIQ E9 BT2010 system does not specify quantitative acceptance criteria or specific device performance metrics in a readily extractable table format for individual features (like Elastography or Volume Navigation).

Instead, the documentation relies on a general statement of compliance and equivalence:

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

The document explicitly states: "The subject of this premarket submission, LOGIQ E9 BT2010, did not require clinical studies to support substantial equivalence."

This indicates that clinical test data (and thus a "test set" with a corresponding sample size and data provenance as would be customary for a clinical study) was not used to demonstrate the substantial equivalence of the modified device. The submission relies on non-clinical tests and comparison to predicate devices.

However, for the specific features:

• Elastography Imaging: The submission includes "DOC0605013 Verification Results Summary for Elastography Imaging". The document does not specify the sample size or provenance of data used in this verification, but it is implied to be non-clinical (e.g., phantom studies or controlled material tests) given the statement about not requiring clinical studies.
• Volume Navigation: The submission includes "DOC0631792 Verification Results Summary for Volume Navigation". Similar to Elastography, details on sample size and provenance are not provided, but it is implied to be non-clinical verification.

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

Since clinical studies were not required and new features were validated through non-clinical verification, there is no mention of human experts being used to establish ground truth for a clinical test set. The "ground truth" for the non-clinical verification studies (e.g., for Elastography and V Nav) would likely be physical measurements, known properties of test materials (phantoms), or engineering specifications, rather than expert consensus on clinical images.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was utilized for human expert review and thus no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance

Not applicable. The document describes a diagnostic ultrasound system and its features, not an AI-assisted diagnostic tool in the sense of image analysis that would typically involve MRMC studies to assess human reader improvement. The "Elastography imaging algorithm" is mentioned, but its performance is verified against the ability to differentiate stiffness, not as an AI assistant to human readers.

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

For the specific features mentioned:

• Elastography Imaging: A standalone algorithm verification was done, as evidenced by the "DOC0605013 Verification Results Summary for Elastography Imaging" which provides evidence that the algorithm can differentiate different structures with different stiffness. This verifies the algorithm's capability independent of human interpretation for basic feature function.
• Volume Navigation: A standalone verification was done for the V Nav feature, as evidenced by "DOC0631792 Verification Results Summary for Volume Navigation," which confirms it functions according to requirements and specifications.

7. The Type of Ground Truth Used

• Elastography Imaging: The ground truth for the Elastography imaging algorithm verification likely involved physical properties/measurements of materials with known varying stiffness (e.g., phantoms). The goal was to prove the algorithm could differentiate stiffness, implying a controlled environment with established ground truth for stiffness levels.
• Volume Navigation: The ground truth for Volume Navigation verification would be based on engineering requirements and specifications for tracking movement and needle tracking accuracy, verified against known positions or trajectories.
• Overall System: For the overall substantial equivalence claim, the "ground truth" implicitly refers to the performance and characteristics of the predicate devices (GE LOGIQ E9, GE Vivid E9, and SonixTouch Ultrasound Scanner's Elastography feature). The new device is determined to be equivalent based on having the same technological characteristics, safety, effectiveness, physical design, construction, materials, and intended uses.

8. The Sample Size for the Training Set

Not applicable. The document describes a medical device with updated features (additional transducers, enhanced Volume Navigation, and Elastography imaging functionality), not a machine learning or AI model trained on a dataset. Therefore, there is no "training set" in the context of machine learning. The verification studies for the new features (Elastography, V Nav) would involve test data specific to their function, but not "training data."

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

Not applicable, as there was no training set described.

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

The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 86 cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user includes a computer keyboard. specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display. This modification will provide users with additional probe options, additional software options (V Nav and Scan Assistant) leading to overall quality and image enhancement. The LOGIQ E9 Diagnostic Ultrasound System is initially released with the following 13 probes: S1-5, C1-5-D, 3CRF, 9L-D, 11L-D, IC5-9-D, M4S-D, M6C-D, ML6-15-D, RAB2-5-D, RIC5-9-D, RNA5-9-D, RSP6-16-D.

The GE LOGIQ E9 Diagnostic Ultrasound System is a general-purpose diagnostic ultrasound system. Its acceptance criteria and proof of meeting those criteria are established through a predicate device comparison rather than specific performance metrics like sensitivity or specificity.

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the GE LOGIQ E9 Diagnostic Ultrasound System is Substantial Equivalence to a legally marketed predicate device, specifically the GE LOGIQ BT08 Diagnostic Ultrasound System (K073408).

The reported device performance, which supports this acceptance criterion, is based on the claim that the GE LOGIQ E9:

• Has the same technological characteristics as the predicate device.
• Possesses key safety and effectiveness features similar to the predicate device.
• Is similar in physical design, construction, and materials to the predicate device.
• Has the same intended uses and basic operating modes as the predicate device.
• Conforms with applicable medical device safety standards (acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, and mechanical safety).
• Its design and development process conform to 21 CFR 820, ISO 9001, and ISO 13485 quality management systems.

The FDA's letter (Attachment {2}) confirms this determination of substantial equivalence.

Study Information

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

   • Not Applicable. The document explicitly states: "Clinical Tests: None required" (Attachment {1}). The device's substantial equivalence is based on non-clinical tests and comparison to a predicate device, not on clinical performance metrics derived from a test set of patient data.

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

   • Not Applicable. As no clinical tests were required or performed to establish novel performance claims, there was no test set requiring ground truth established by experts for performance evaluation.

3. Adjudication Method for the Test Set:

   • Not Applicable. No clinical test set was utilized.

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

   • Not Applicable. No MRMC study was conducted. The clearance is based on substantial equivalence to a predicate device, not on demonstrating improved human reader performance with or without AI assistance.

5. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

   • Not Applicable. This device is an ultrasound system, not an AI algorithm. Its performance is inherent in its hardware and software for image acquisition and display, which are deemed substantially equivalent to a predicate.

6. Type of Ground Truth Used:

   • Not Applicable. No clinical ground truth (e.g., pathology, outcomes data) was used to assess the device's performance, as no clinical performance study was conducted. The ground truth for substantial equivalence is the safety and effectiveness profile of the predicate device, K073408.

7. Sample Size for the Training Set:

   • Not Applicable. This submission is for a diagnostic ultrasound system (hardware and associated software features), not a machine learning or AI model that requires a "training set" of data in the typical sense. The 'training' for this type of device would involve engineering design, component testing, and adherence to quality standards.

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

   • Not Applicable. As there is no "training set" for an AI model, this question does not apply. The development is based on established engineering principles, regulatory standards, and the performance characteristics of the predicate device.

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