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The Acclarix LX9 Series/ Acclarix AX8 Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluation in hospitals and clinics. Clinical applications include Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Musculoskeletal, Peripheral vascular, Intra-operative, Pediatric, Neonatal and Adult Cephalic.

The Modes of Operation for Acclarix LX9 series include B mode, Doppler mode, Harmonic Imaging, Elastography Imaging, Contrast imaging and their combination modes.

The Modes of Operation for Acclarix AX8 include B mode, M mode, Harmonic Imaging, Elastography Imaging and their combination modes.

Acclarix AX8/ Acclarix LX9 Series is a software controlled Diagnostic Ultrasound System, which consists of a main unit along with associated transducers. It is intended for use by a qualified physician or allied health professional for ultrasound evaluations. This system is a Track 3 device to acquire and display ultrasound data in various imaging modes.

The provided FDA 510(k) summary for the Acclarix AX8/LX9 Series Diagnostic Ultrasound System does not contain information about studies proving the device meets acceptance criteria related to AI or machine learning algorithms, specific performance metrics for image interpretation (e.g., sensitivity, specificity), or comparative effectiveness studies with human readers.

The document states: "Clinical testing is not required." and emphasizes non-clinical testing for electrical safety, EMC, and compliance with general ultrasound standards. The submission primarily focuses on demonstrating substantial equivalence to predicate devices based on design features, intended use, and general performance (e.g., transducer additions, new imaging modes).

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them in the context of AI/ML performance, as such information is not present in the provided text.

Specifically, the following requested information is not available in the provided document:

1. A table of acceptance criteria and the reported device performance: No such table is present for AI/ML performance.
2. Sample sized used for the test set and the data provenance: Not applicable as no AI/ML performance testing is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not done or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not done or reported for AI/ML algorithms.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The "Performance Data" section solely details non-clinical testing for electrical safety, electromagnetic compatibility (EMC), general ultrasound equipment standards, and biocompatibility. The "Conclusion" explicitly states that "Verification and validation testing has been conducted... This premarket notification submission demonstrates that Acclarix LX9 Series Diagnostic Ultrasound Systems are substantially equivalent to the predicate devices." This substantial equivalence is based on the technical characteristics and intended use, not on specific AI/ML diagnostic performance metrics.

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The Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include:

• Abdominal
• Gynecology (including endovaginal)
• Obstetric
• Cardiac
• Small parts (Breast, Testes, Thyroid, etc.)
• Urology
• Musculoskeletal
• Peripheral vascular
• Intra-operative
• Pediatric
• Neonatal (including abdominal and cephalic)
• Adult Cephalic

The Acclarix series contains the Acclarix AX8 and Acclarix LX8 Diagnostic Ultrasound Systems sharing a software platform (Edan Ultrasound Software Platform, also abbreviated as EUP) and the most parts of hardware platform from Edan Instruments. The Acclarix AX8 is a portable laptop diagnostic ultrasound system. A simple way to summarize the difference is that the Acclarix LX8 is a cart based version of the Acclarix AX8.

This FDA 510(k) K180862 document describes the Acclarix LX8 and Acclarix AX8 Diagnostic Ultrasound Systems, focusing on their intended use, clinical applications, and comparison to predicate devices to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a "table of acceptance criteria" in the format of specific thresholds for quantitative performance metrics (e.g., sensitivity, specificity, accuracy) and then report actual device performance against those thresholds. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices.

The "acceptance criteria" can be inferred as meeting the safety and performance requirements of standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993 for biocompatibility, as well as adherence to FDA guidelines for acoustic output (NEMA UD 2, UD3). The reported device performance is that it complies with these standards and has similar performance effectiveness and safety to the predicate devices.

We can synthesize the comparison tables (Table 2-1, 2-2, 2-3) to show how the device's characteristics meet or are similar to the predicate devices, which implies meeting the established performance and safety profiles.

Inferred "Acceptance Criteria" and Reported Performance:

• IEC 60601-1 Electrical Safety
• IEC 60601-1-2 Electromagnetic Compatibility
• IEC 60601-2-37 Requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
• NEMA UD 3 Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment. |
  | Acoustic Output Compliance | Acoustic output testing performed as per FDA guidelines ("Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008).
• Track 3: MI, TIS, TIC, TIB (TI Range 0-6.0)
• Derated ISPTA: 720 W/cm² maximum
• Mechanic Index ≤1.9 maximum or Derated ISPPA 190 W/cm² max
• Ophthalmic use: TI = Max (TIS_as, TIC) ≤1; ISPTA.3 ≤ 50m/W/cm2; and MI ≤ 0.23 |
  | Biocompatibility of Patient Contact Materials | Complies with ISO 10993-1, ISO 10993-5, and ISO 10993-10. |
  | Intended Use (Comparison to Predicate) | Same as predicate devices (Diagnostic ultrasound imaging or fluid flow analysis of the human body). |
  | Indications for Use (Comparison to Predicate) | Same as predicate devices (extensive list including Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Musculoskeletal, Peripheral vascular, Intra-operative, Pediatric, Neonatal cephalic, Adult cephalic). |
  | General Product Design & Features (Comparison to Predicate) | Similar in product design, principle of operation, and transducer types/frequency range to predicate devices. Differences in modes of operation, measurements, display, and transducer ports are noted but do not raise questions of effectiveness and safety. |
  | Performance Effectiveness (Comparison to Predicate) | Similar performance effectiveness to the predicate device. Differences are noted but deemed not to affect basic design principle, usage, effectiveness, and safety. |
  | Performance Safety (Comparison to Predicate) | Similar performance safety to the predicate device. Differences are noted but deemed not to affect basic design principle, usage, effectiveness, and safety. |

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

The document does not specify any sample size for a test set in the context of clinical performance evaluation (e.g., number of patients/scans). This is because the submission primarily relies on non-clinical testing and comparison to predicate devices to establish substantial equivalence.

Similarly, there is no information provided regarding data provenance (country of origin, retrospective or prospective) for clinical data, as formal clinical testing with patient data was not a required component of this 510(k) submission.

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):

As no "test set" in the sense of clinical cases evaluated for ground truth is described in the document, there is no information regarding the number or qualifications of experts used to establish ground truth.

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

Since there is no described test set or expert evaluation of clinical cases, there is no adjudication method mentioned in the document.

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:

The document does not mention any MRMC comparative effectiveness study, nor does it discuss AI assistance or its effect size on human reader performance. The device described is a diagnostic ultrasound system, not an AI-powered diagnostic tool.

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

The device is a diagnostic ultrasound system, not an algorithm, so a "standalone" algorithm performance study is not applicable and not mentioned.

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

As there were no clinical studies described, there is no mention of the type of ground truth used for performance evaluation. The "ground truth" for the non-clinical testing would be the engineering specifications and compliance with recognized standards.

8. The sample size for the training set:

The document describes a diagnostic ultrasound system, not an AI or machine learning algorithm that requires a training set. Therefore, there is no information regarding the sample size for a training set.

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

Since no training set for an algorithm is discussed, there is no information on how ground truth for a training set was established.

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The Acclarix AX8 Diagnostic Ultrasound system Acclarix LX8 Diagnostic Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include:

• Abdominal
• Gynecology (including endovaginal)
• Obstetric
• Cardiac
• Small parts (Breast, Testes, Thyroid, etc.)
• Urology
• Musculoskeletal
• Peripheral vascular
• Intra-operative
• Pediatric
• Neonatal (including abdominal and cephalic)
• Adult Cephalic

The Acclarix series contains the Acclarix AX8 and Acclarix LX8 Diagnostic Ultrasound Systems sharing a software platform (Edan Ultrasound Software Platform, also abbreviated as EUP) and the most parts of hardware platform from Edan Instruments. The Acclarix AX8 is a portable laptop diagnostic ultrasound system. A simple way to summarize the difference is that the Acclarix LX8 is a cart based version of the Acclarix AX8.

The provided text describes the Acclarix AX8 and Acclarix LX8 Diagnostic Ultrasound Systems. However, it does not explicitly state acceptance criteria in the typical sense of quantitative thresholds for performance metrics. Instead, it outlines the scope of the device's intended use and compares its features and compliance with standards to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, explicit quantitative acceptance criteria are not presented. The document focuses on demonstrating substantial equivalence to predicate devices by comparing intended use, design features, safety standards compliance, and modes of operation.

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

The document states: "Clinical testing is not required." This implies that the device's performance was not evaluated through a clinical study with a "test set" of patient data in the typical sense that would involve a sample size and data provenance (country of origin, retrospective/prospective). The assessment is based on non-clinical tests (e.g., engineering benchmarks, compliance with standards) and comparison to legally marketed predicate devices.

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

Not applicable, as "Clinical testing is not required." Therefore, there was no "ground truth" for a test set established by experts in this context.

4. Adjudication Method:

Not applicable, as "Clinical testing is not required."

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

Not applicable. The document does not describe any MRMC studies or the use of AI. The devices are diagnostic ultrasound systems, not AI-powered diagnostic aids, and the submission is for an updated version of existing devices, primarily focusing on hardware and software updates and expanded indications.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device is an ultrasound system, not an AI algorithm intended for standalone performance evaluation without human-in-the-loop.

7. Type of Ground Truth Used:

Not directly applicable in the context of clinical performance evaluation (e.g., pathology, outcomes data). For the purpose of regulatory submission, the "ground truth" for demonstrating substantial equivalence is compliance with established safety and performance standards for diagnostic ultrasound equipment (e.g., acoustic output, electrical safety, biocompatibility) and functional equivalence to predicate devices.

8. Sample Size for the Training Set:

Not applicable. This document is for a medical device regulatory submission for an ultrasound system, not for an AI/machine learning algorithm that would require a "training set."

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

Not applicable, as there is no "training set" for this device in the context of an AI algorithm.

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The Edan Acclarix AX8 Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include: Abdominal Gynecology (including endovaginal) Obstetric Cardiac Small parts (Breast, Testes, Thyroid, etc.) Urology Musculoskeletal Peripheral vascular Intra-operative

The Acclarix AX8 is a portable laptop diagnostic ultrasound system, intended for use by a qualified physician or sonographer for ultrasound evaluation in Point of Care environments such as Emergency Departments, Interventional procedures and mobile imaging centers, which applies advanced technologies such as HPRF, Dual screen display, Panorama, Spatial Compounding Imaging, Frequency Compounding Imaging, Multi-Beam-Forming, Speckle Resistance Imaging (eSRI), One-Key Optimization, B-Steer, Digital Zoom, Needle Visualization, etc. Various image parameter adjustments, 15 inch LCD display with 10 inch touch screen and 5 inch track pad and diverse probes are configured to acquire and display clear and stable ultrasound images.

The provided document is a 510(k) premarket notification for the Edan Instruments Acclarix AX8 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving effectiveness through clinical studies against specific acceptance criteria for diagnostic performance.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning advanced diagnostic performance (e.g., sensitivity, specificity, accuracy) for a given clinical task.

Instead, the document highlights:

• Substantial equivalence: The device is claimed to be substantially equivalent to predicate devices (Acclarix AX8 r.10 Diagnostic Ultrasound System/K150999 and U50 Diagnostic Ultrasound System/K142511).
• Compliance with safety and technical standards: The device complies with standards like IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility), and acoustic output testing guidelines, as well as biocompatibility standards (ISO 10993 series).
• Intended Use and Clinical Applications: The document lists the intended use as "Diagnostic ultrasound imaging or fluid flow analysis of the human body" and specifies various clinical applications (e.g., Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Musculoskeletal, Peripheral vascular, Intra-operative).

Missing Information:

The document explicitly states: "Clinical testing is not required." This means there is no study presented in this document that would provide acceptance criteria for diagnostic accuracy, sensitivity, specificity, etc., nor a study proving the device meets such criteria for a specific clinical task.

Therefore, I cannot provide the following information based on the given text:

1. A table of acceptance criteria and the reported device performance: No such criteria or performance metrics for diagnostic effectiveness are detailed.
2. Sample size used for the test set and the data provenance: No clinical test set or data provenance is mentioned as clinical testing was not required.
3. 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 set is described.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not conducted. The focus is on substantial equivalence to existing devices.
6. Standalone performance (algorithm only without human-in-the-loop performance): This is not an AI-driven diagnostic algorithm but a general-purpose ultrasound imaging system, so this concept does not apply in the context of this document.
7. Type of ground truth used: Not applicable as diagnostic performance metrics (which require ground truth) are not provided.
8. Sample size for the training set: Not applicable as this is not an AI algorithm requiring a training set in the sense of machine learning for diagnostic tasks.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information:

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

• Acceptance Criteria for Substantial Equivalence: Demonstrated "same intended use, similar product design, same performance effectiveness, performance safety as the predicate device" (K150999 and K142511).
• Reported Device Performance:
  • Safety Standards Compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, -5, -10, -12, AIUM, NEMA UD 2, UD 3.
  • Acoustic Output: Track 3: MI, TIS, TIC, TIB (TI Range 0-6.0), Derated ISPTA: 720W/cm2 maximum, Mechanic Index ≤ 1.9 maximum or Derated ISPPA 190 W/cm2 max. Ophthalmic use: TI = Max (TIS_as, TIC) ≤1; ISPTA.3 ≤ 50m/W/cm2; and MI

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