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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 LX8 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).

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

The Edan Acclarix LX8 Diagnostic Ultrasound system consists of a main system along with associated transducers. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The waves are then reflected within the body and detected by the transducer, which then converts back to an electrical signal. The Acclarix LX8 Diagnostic Ultrasound system then analyzes the returned signal to generate an image or conduct Doppler processing. The Acclarix LX8 Diagnostic Ultrasound system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis. The system provides both touch screen and hard buttons for the User Interface.

This document is a 510(k) Premarket Notification for the Acclarix LX8 Diagnostic Ultrasound System. It aims to demonstrate that the device is substantially equivalent to legally marketed predicate devices. The document does not describe acceptance criteria or a study that proves the device meets specific performance acceptance criteria beyond regulatory safety and performance standards. It primarily focuses on comparing the new device's features and safety compliance with predicate devices to establish substantial equivalence.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy for a diagnostic task) or clinical performance metrics. Instead, it outlines regulatory compliance and feature equivalence as the basis for substantial equivalence.

The "reported device performance" is essentially that the device complies with various safety and performance standards and offers similar or expanded features compared to its predicates.

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

The document explicitly states: "Clinical test: Clinical testing is not required."
Therefore, there is no test set of patient data, nor is there information on data provenance (country of origin, retrospective/prospective). The assessment for substantial equivalence relies on non-clinical tests and comparisons to predicate devices.

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

Since no clinical testing was performed, there was no test set requiring ground truth established by experts.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used.

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

No, an MRMC comparative effectiveness study was not done. The document states "Clinical test: Clinical testing is not required."

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 AI algorithm for standalone performance evaluation in the context of this submission. The "algorithm" here refers to the internal signal processing of the ultrasound system itself, which is evaluated through technical performance standards rather than clinical algorithm performance studies.

7. The Type of Ground Truth Used:

For the demonstration of substantial equivalence, the "ground truth" primarily refers to:

• Compliance with recognized consensus standards (e.g., IEC 60601 series for electrical safety and electromagnetic compatibility, ISO 10993 series for biocompatibility, NEMA UD for acoustic output). These standards define technical performance requirements.
• Equivalence to predicate devices based on their previously cleared performance and safety profiles.

8. The Sample Size for the Training Set:

Not applicable. This document describes a traditional medical device (ultrasound system) submission, not an AI/Machine Learning device that undergoes a training phase with a specific dataset.

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

Not applicable, as there is no training set mentioned.

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The Acclarix LX8 Diagnostic Ultrasound System is intended for use by a qualified physician or sonographer for ultrasound evaluation. Clinical applications include: Abdominal, Gynecology (including endovaginal), Obstetic, Cardiac, Small parts (Breast, Testes, Thyroid, etc.), Urology, Musculoskeletal, and Peripheral vascular, and Intra-operative.

The Edan Acclarix LX8 Ultrasound system consists of a main system along with associated transducers. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The waves are then reflected within the body and detected by the transducer, which then converts back to an electrical signal. The Acclarix LX8 system then analyzes the returned signal to generate an image or conduct Doppler processing. The Acclarix LX8 system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis. The system provides both touch screen and hard buttons for the User Interface.

The provided document is a 510(k) summary for the EDAN INSTRUMENTS, INC. Acclarix LX8 Diagnostic Ultrasound System. It outlines the device's indications for use and compares it to predicate devices to establish substantial equivalence. However, the document explicitly states that clinical testing was not required for this submission (Page 15, "Clinical test: Clinical testing is not required."). Therefore, the detailed information requested regarding acceptance criteria and studies proving the device meets those criteria for clinical performance is not available within this document.

The document focuses on non-clinical testing and benchmarking against predicate devices to demonstrate safety and effectiveness.

Here's a breakdown of the available information based on your request:

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

Since no clinical studies were performed, there are no specific clinical performance acceptance criteria or reported clinical performance metrics in this document. The "acceptance criteria" appear to be compliance with relevant safety and performance standards for ultrasound devices, which are met through non-clinical testing.

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

• Test set sample size: Not applicable, as no clinical test set was used.
• Data provenance: Not applicable, as no clinical data was generated for the purpose of this submission. The testing was non-clinical (electrical safety, electromagnetic compatibility, acoustic output, biocompatibility) and based on engineering validation.

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 with human-established ground truth was used.

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

Not applicable, as no clinical test set requiring adjudication was used.

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

Not applicable. The device is a diagnostic ultrasound system, not an AI-powered image interpretation device, and no MRMC study was performed or required for this 510(k) submission.

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

Not applicable. The device is a diagnostic imaging system, not a standalone algorithm.

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

Not applicable. For the non-clinical tests conducted, the "ground truth" would be established by reference standards or engineering specifications.

8. The sample size for the training set:

Not applicable, as 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, as this is not an AI/Machine Learning device requiring a training set.

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