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The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis, Vascular Imaging Applications and Analysis, Superficial Imaging Applications, Intraoperative Imaging Applications, Transcranial Imaging Applications.

The AcuNav 8F and 10F Ultrasound Catheter, ACUSON AcuNav™ V 10F Ultrasound Catheter, ACUSON AcuNav™ Volume 12F Ultrasound Catheter, SoundStar™ 8F Ultrasound Catheter, SoundStar™ 10F Ultrasound Catheter, SoundStar™ eco 8F Ultrasound Catheter, and SoundStar™ eco 10F Ultrasound Catheter are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. Catheters are intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The ACUSON SC2000 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode. M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging on a Display. The transducer and catheter based transducers will follow Track 3 acoustic labeling (AIUM 1004, IEC 2007, AIUM/NEMA 2004a).

Additional features for the ACUSON SC2000 v5.1 update includes the Joystick remote control accessory that is intended to be used for interventional procedures with the ACUSON AcuNav Volume ICE catheter where remote control of the cursor is desired. The joystick plugs into the system and allows selected control panel and cursor events to be triggered via joystick movement and button-press.

This is a premarket notification (510k) for the ACUSON SC2000 Diagnostic Ultrasound System. The information provided heavily references previous clearances for substantial equivalence rather than presenting new studies with acceptance criteria explicitly defined for the current submission.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding reported device performance metrics for this specific 510(k) submission (K181098). Instead, it relies on the substantial equivalence to previously cleared devices. The "Features on SC2000 System" table in Section 6.1 (pages 25-26) implicitly acts as a comparison to the predicate device, showing that the current device either has the same feature (√) or improved features (e.g., "Updated TEQ", "Added Manual Trace", "New" features). The "Frequencies Supported" are identical across the three compared devices for most applications.

The acceptance criteria here are implicit and based on the predicate device's established performance, meaning the new device must perform at least as well as, or be substantially equivalent to, the predicate in all relevant aspects.

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

The document explicitly states: "clinical studies were not required to support substantial equivalence" (Part 8, page 29). Therefore, there is no test set sample size mentioned, nor any data provenance (country of origin, retrospective/prospective). The submission relies on non-clinical tests (acoustic output, biocompatibility, safety standards compliance) and comparison to predicate devices.

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

Since no clinical studies were performed for this submission, there is no mention of experts or their qualifications for establishing ground truth. The substantial equivalence is based on technical specifications and adherence to recognized standards.

4. Adjudication Method for the Test Set:

As no clinical studies were conducted, no adjudication method is described.

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

No MrMC comparative effectiveness study was done or reported as clinical studies were deemed unnecessary due to substantial equivalence to predicate devices. Therefore, no effect size of human reader improvement with AI vs. without AI assistance is mentioned.

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

No standalone performance study of an algorithm is described or reported. The device is an ultrasound system with accessories, not an AI/algorithm-only product.

7. Type of Ground Truth Used:

For this 510(k) submission, the "ground truth" is established through adherence to recognized medical device safety standards (e.g., AAMI / ANSI ES60601-1, IEC series, ISO 10993-1) and comparison of technological characteristics to already cleared predicate devices. Clinical outcomes data or expert consensus for new evaluations were not used for this submission's substantial equivalence determination.

8. Sample Size for the Training Set:

The document does not mention any training set or its sample size, as it does not involve a de novo AI/ML model development requiring such data for this 510(k) submission.

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

Since no training set is discussed, the method for establishing its ground truth is not provided.

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The Compex Wireless USA is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.

The Compex Wireless USA is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the Compex Wireless USA stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the Compex Wireless USA programs is definitely not suitable for rehabilitation and physiotherapy. The Compex Wireless USA electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

The Compex Wireless USA may therefore be considered a technique of muscle training.

The Compex Wireless USA is a neuromuscular electrical stimulation (NMES) device, which stimulates nerve fibers by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Compex Wireless USA stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex Wireless USA may therefore be considered a technique of muscle training.

The device system is made up of a remote control, 4 stimulation modules, and electrodes, which are stored and shipped within the docking station which is used to recharge the remote and the modules. The docking station is powered by an AC-DC adapter.

The remote control is the interface between the stimulation modules and the user. It sends and receives information to and from the modules via a wireless network. The remote control allows the user to navigate through the user interface (UI), select stimulation program or objectives, set desired options and control the four (4) module intensities independently. The remote control is powered by a rechargeable battery.

The Compex Wireless USA stimulation module set is composed of 4 independent stimulation modules that are controlled via the remote control by a wireless connection. Each module is composed of two "pods" (1 battery "pod" and one stimulation "pod") linked by an electrical connection (cable). Two proprietary Compex standard snap gel electrodes are also needed to connect each "pod" to the body. The modules are powered by a Lithium Polymer (LiPo) rechargeable 3.7[V] /> 450 [mAh] battery.

The wireless protocol of the Compex Wireless USA Device is a proprietary design of a Radio-Frequency protocol operating the 2.4 GHz ISM band. It is used to 1) Send particular information from remote control to stimulation modules (stimulation settings) 2) Send particular information from stimulation modules to remote control, like current stimulation level and stimulation module subsystem status, 3) Transfer binary data to stimulation modules, and 4) Allow synchronization from stimulation modules to remote control clocks.

The provided text describes the Compex Wireless USA device, its indications for use, and a comparison to a predicate device (Compex Sport Elite) for 510(k) clearance. However, it does not contain the acceptance criteria or results of a study that proves the device meets specific performance criteria in terms of accuracy, sensitivity, specificity, or other clinical efficacy metrics as would be expected for an AI/ML or diagnostic device.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Identical Indications for Use.
• Similar technological characteristics in terms of basic device attributes and output specifications.
• Performance testing related to electrical safety, electromagnetic compatibility, FCC radio frequency, software verification, usability/human factors, and wireless coexistence, all against applicable standards.

Therefore, for the information requested in your prompt, I can only provide what is available in the text, which mainly pertains to regulatory compliance and safety/performance against engineering standards, not clinical performance or artificial intelligence specific metrics.

Here's an analysis of the provided text in response to your questions:

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

The document does not present clinical acceptance criteria (e.g., accuracy, sensitivity, specificity) for a specific diagnostic task or AI performance. Instead, the "acceptance criteria" are implied by compliance with various regulatory and engineering standards, and performance testing confirming functionality 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 describe a clinical test set or data provenance in the context of typical AI/ML or diagnostic device studies (i.e., patient data, images, etc.). The mention of "Performance Testing" refers to engineering and software validation, not clinical validation on a patient cohort.

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)

This is not applicable as the document does not describe a clinical study involving experts establishing ground truth for a test set.

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

This is not applicable as there is no described clinical test set or adjudication process.

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

A multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This device is a muscle stimulator, not a diagnostic imaging device with human readers.

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

This is not applicable in the sense of an AI algorithm making a diagnosis or prediction. The device itself is "standalone" in its operation of muscle stimulation, controlled by the user.

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

For the engineering and software validation tests performed, the "ground truth" would be the expected behavior and specifications defined by the design requirements and industry standards. For example, for "Software Verification," the ground truth is that the software performs its functions as designed. For "Electrical Safety," the ground truth is that the device passes specific tests outlined in the relevant IEC/AAMI standards. These are not clinical ground truths like pathology or outcomes data.

8. The sample size for the training set

This is not applicable. The device is not an AI/ML algorithm that requires a "training set" in the common sense of machine learning.

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

This is not applicable.

In summary: The provided FDA 510(k) clearance document for the Compex Wireless USA is for a traditional medical device (a powered muscle stimulator). It demonstrates substantial equivalence to a predicate device and compliance with safety and performance standards through engineering tests. It does not present clinical performance data, AI/ML algorithm validation, or studies involving human readers, test sets, or ground truth establishment in the context of diagnostic or AI-powered devices.

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

The device may include EchoPilot reporting software which provides guidance to support the quality of the echocardiography examination and report. It compares patient data, user entered clinical data and measurements to generally accepted guidelines and studies, and helps to identify mismatches, inconsistencies and unusual or missing data. It can generate a preliminary data analysis that can be used as basis for the examination report.

The Vivid i and Vivid q are mobile ultrasound consoles having a wide assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular and general ultrasound imaging. Its intuitive user interface, high level of auto-optimization along with significantly reduced size and weight make it readily maneuverable, efficient and easy to use.

The information provided pertains to the GE Healthcare Vivid i and Vivid q Diagnostic Ultrasound Systems (K121062). This submission is a 510(k) for a modified device, primarily claiming substantial equivalence to predicate devices (Vivid i and Vivid q Diagnostic Ultrasound Systems, K102388; Vivid E9 Diagnostic Ultrasound System, K101149).

Crucially, no new clinical studies were conducted or required to support the substantial equivalence of the modified device. The submission focuses on non-clinical tests to demonstrate safety and performance. Therefore, the device does not have explicit acceptance criteria based on performance metrics from clinical trials, nor a study proving it meets such criteria in the context of this 510(k) submission.

The "acceptance criteria" for this 510(k) are the various safety and performance standards the device conforms to, and the "study" demonstrating this is the summary of non-clinical tests.

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

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a modified device relying on substantial equivalence to predicates, the "acceptance criteria" are implied by conformity to standards and safety reviews. There are no specific quantitative performance metrics reported in this document from a clinical test.

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

• Sample Size for Test Set: Not applicable. No clinical tests were conducted for this 510(k) submission. Non-clinical tests typically refer to engineering, laboratory, and bench testing, not patient-based data.
• Data Provenance: Not applicable for patient data. The provenance of the non-clinical test data (e.g., conducted internally by GE Healthcare or by external labs) is not specified beyond "GE Healthcare considers..." and "The device has been evaluated for...".

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

• Number of Experts: Not applicable. No clinical test set with ground truth established by experts was used, as clinical studies were not required.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set with expert adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No. The document explicitly states: "The subject of this premarket submission, the modified Vivid i/q, did not require clinical studies to support substantial equivalence." Therefore, no MRMC study was performed.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no MRMC study or AI assistance feature is discussed in the context of clinical performance evaluation for this 510(k). The "EchoPilot reporting software" is mentioned as providing guidance for quality and generating preliminary data analysis, but its clinical effectiveness or impact on human reader performance through a comparative study is not assessed in this submission.

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

• Standalone Performance Study: No. This submission is for an ultrasound system and its transducers, not a standalone algorithm. Any software components (like EchoPilot) are part of the overall device functionality, but their isolated "standalone" performance in a clinical context is not evaluated as part of this 510(k).

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable for clinical performance. The ground truth for non-clinical tests would involve engineering specifications, recognized standards, and established testing methodologies (e.g., using phantoms for acoustic output, material standards for biocompatibility).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This 510(k) is not for an AI/ML algorithm that requires a training set of clinical data.

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

• Ground Truth for Training Set: Not applicable. This 510(k) is not for an AI/ML algorithm that requires a training set.

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