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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.

The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems are general purpose, software controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and to display the data in various modes of operation. The devices consist of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers). The removable transducers are connected to the system using a standard technology, multi-pin connectors.

Here's an analysis of the acceptance criteria and supporting studies for the Philips EPIQ and Affiniti Diagnostic Ultrasound Systems based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics for the device itself (e.g., accuracy, sensitivity, specificity for diagnostic tasks). Instead, it focuses on demonstrating compliance with recognized safety and performance standards for ultrasound devices, and equivalence to predicate devices. The "performance" described relates more to meeting these technical and regulatory standards.

However, based on the Safety Considerations and Nonclinical Performance Data sections, we can infer the following:

• Ispta.3 ≤ 720 MW/cm2
• MI

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The ClearVue850 Diagnostic Ultrasound system is a general purpose, portable, cart based ultrasound system, intended for use by customers in various clinical settings (private offices, clinics, small hospitals, primary and community healthcare centers) by different users (General Practitioners, Paraprofessionals, physician specialists including OBG's, Ultrasound Lab physicians, and nurse practitioners, etc.,

The System is intended for diagnostic ultrasound imaging in the following modes: B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Tissue Harmonics, iSCAN, X-Res, Angio, 3D (freehand), 4D and SonoCT, Combined modes includes FloVue, Elastography (strain).

The system is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications, as listed in FDA 's Diagnostic Ultrasound Indications for Use Form section 1.3 which includes Fetal / OB, Abdominal, Pediatric, Small Organ (breast, thyroid, testicle), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Other: GYN, Other: Urology, Cardiac Pediatric, Transesophageal (Cardiac), Other (Fetal Echo), Peripheral vessel and Cerebral Vascular.

The ClearVue850 Diagnostic Ultrasound System is a general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation.

The ClearVue 850 System is substantially equivalent to the currently marketed and predicate ClearVue350/550 system(K120321) in terms of design and fundamental scientific technology. The ClearVue850 Model is provided with additional transducers D2CWC and L12-5 and software features and additional modes. The software feathres of the ClearVue 850 System include -Live Panoramic Imaging, FloVue, Strain Elastography Imaging, Curved ROI Tool, QLAB plug-ins IMT and GI3DQ, Stress Echo protocol.

The ClearVue 850 System supports CW Doppler transducer with external CW adapter module which gets attached to the SAM transducer connector, an Up/down mechanism for control panel. The system is designed to be highly reliable and easily serviceable.

This document is a 510(k) premarket notification for the Philips ClearVue 850 Diagnostic Ultrasound System. It aims to demonstrate substantial equivalence to previously cleared devices.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in a pass/fail manner. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly demonstrated by stating that the ClearVue 850 shares the same fundamental scientific technology, has similar intended uses and technological characteristics, and has undergone non-clinical testing for compliance with relevant safety and EMC standards.

The closest to "acceptance criteria" are the Indications for Use outlined in the tables (pages 4-11), which detail the clinical applications and modes of operation for the system and its various transducers. The device "meets" these by being listed for these applications. The "reported device performance" is a general statement of equivalency rather than specific metrics.

Table of Acceptance Criteria and Reported Device Performance:

Since explicit quantitative acceptance criteria are not presented, this table lists the stated "Indications for Use" as the de facto "acceptance criteria" that the device is intended to meet, and the "Reported Device Performance" as the claim of substantial equivalence for these indications.

The ClearVue 850 is demonstrated to meet these indications for use through substantial equivalence to predicate devices (K120321, K132304, K141261). The document repeatedly states that the device introduces "no new indications for use, features, or technologies as compared to the currently marketed and predicate devices (EPIQ/ClearVue) that require clinical testing."

Specific additions/equivalences mentioned:

• L12-5 and D2CWC transducers: Added with equivalent additional indication for use to K132304.
• FloVue: New indication, substantially equivalent to the coded pulse mode of GE K141261 (both help in simultaneous imaging of tissue and blood flow).
• Elastography: Already cleared with EPIQ K132304.
• Other software features: Live Panoramic Imaging, Strain Elastography Imaging, Curved ROI Tool, QLAB plug-ins IMT and GI3DQ, Stress Echo protocol, CW Doppler transducer with external CW adapter module. |
  | Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-37 standards (Non-clinical performance data). | Non-clinical tests were performed to demonstrate compliance with these standards. |

Study Information:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document explicitly states: "Summary of Clinical Tests: The ClearVue850 System introduces no new indications for use, features, or technologies as compared to the currently marketed and predicate devices (EPIQ/ClearVue) that require clinical testing." This indicates that no new primary clinical testing (test set) was performed specifically for this 510(k) submission. The substantial equivalence relies on the performance of the predicate devices. Therefore, there is no information about a test set sample size or its provenance in this document.

2. 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 new clinical testing was performed for this submission, this information is not provided. The ground truth for the predicate devices' clearances would have involved relevant medical experts, but details are not in this document.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as no new clinical test set was used for this submission.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   No MRMC study was performed or is mentioned. The device is a diagnostic ultrasound system and not an AI-assisted diagnostic tool in the sense of providing automated interpretations to readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is a diagnostic ultrasound system, which inherently involves a human operator and interpreter. It is not an algorithm that provides standalone diagnostic outputs without human interaction.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the purposes of this 510(k) submission, the "ground truth" relies on the established safety and effectiveness of the predicate devices. The document implies that the clinical safety and effectiveness of ultrasound systems with these characteristics are "well accepted." For the predicate devices, their ground truth would likely have been established through a combination of expert clinical interpretation, correlation with other imaging modalities, and potentially pathology or surgical outcomes, depending on the specific application. However, these details are not provided for the ClearVue 850 in this submission.

7. The sample size for the training set:
   Not applicable. This document describes a traditional 510(k) for an ultrasound system, not an AI/Machine Learning device that requires a distinct "training set" in the computational sense. The "training" for the device's development would be through extensive engineering, design, and internal validation processes based on established ultrasound principles and medical knowledge.

8. How the ground truth for the training set was established:
   Not applicable for the same reasons as above.

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The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications: Fetal: Abdominal (renal & GYN/pelvic); Pediatric, Small Organ (breast, testes, thyroid); Adult Cephalic; Trans-rectal, Trans-vaginal, Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV): and Urology (including prostate).

E-CUBE 15 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 18.5" (or 19.5") wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
Modes of operation:

1. Signal Mode:
   B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode, Pulsed Wave Doppler(PWD) mode, Tissue Harmonic Imaging (THI)
2. Combination Mode:
   B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/PD/PWD, B/CF/M
   Acoustic output track: Track 3

The provided text describes the "E-CUBE 15 Diagnostic Ultrasound System" and its various transducers but does not contain information about specific acceptance criteria, studies proving performance, sample sizes, data provenance, expert ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies related to any AI components. The document is a 510(k) premarket notification to the FDA, focusing on establishing substantial equivalence to previously cleared predicate devices for various clinical applications and operating modes.

The document lists the intended uses and technical specifications of the E-CUBE 15 system and its transducers, comparing it to predicate devices (E-CUBE 9 and iU22). The "Summary of Non-Clinical Tests" mentions evaluation for biocompatibility, acoustic output, and thermal, electrical, electromagnetic, and mechanical safety, conforming to applicable medical device safety standards. It also lists quality management system measures applied during development.

Crucially, the "Summary of Clinical Tests" section explicitly states:
"The subject of this premarket submission, E-CUBE 15, did not require clinical studies to support substantial equivalence."

This means that for the purposes of this 510(k) submission, the device's substantial equivalence was established through non-clinical testing and comparison to predicate devices, rather than through clinical trials with defined acceptance criteria for AI performance, independent test sets, expert ground truth, or MRMC studies.

Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes, data provenance, expert adjudication, MRMC studies, or standalone algorithm performance for AI components cannot be extracted from this document, as it appears the submission did not rely on such data for device clearance. The document focuses on hardware aspects and basic functional modes, not advanced AI features requiring such rigorous evaluation.

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The Teratech Corporation Terason™ uSmart3200T is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intra-operative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-Card.) Musculo-skel. (Convent.), Musculo-skel. (Superfic); Cardiac (Adult & Pediatric); Trans-esophageal (Cardiac) Peripheral Vascular.

The Terason uSmart3200T ultrasound system is a portable tablet-style, fullfeature, general purpose diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. The Terason uSmart3200T Ultrasound System is equivalent to the previously cleared versions of the uSmart3200T Ultrasound Systems. The modification includes the addition of 5 transducers (9MC3, 8TE3, PDOF, 8L2, 8V3A), the Trans-esophageal (non-Cardiac and Cardiac) IFUs and the Ophthalmic IFU associated with the 12L5A and 15L4 transducers with no change to the tablet-style computer form factor.

The document provided is a 510(k) premarket notification for the Terason uSmart3200T Ultrasound System, detailing its substantial equivalence to predicate devices. It focuses on the safety and performance aspects of the device and its transducers.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a consolidated manner for the entire device. Instead, it describes various tests and standards met. However, it does provide specific acoustic output limits and the measured values for different transducers.

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

The document does not explicitly state a "sample size" for a specific test set of patient data. The studies performed are primarily non-clinical bench tests on the ultrasound system and its transducers.

• Data Provenance: Not applicable as the documented tests are primarily for physical and technical performance and safety, not diagnostic accuracy on patient data. The document mentions acoustic tank evaluations for transducers.

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

Not applicable. The reported tests are not clinical studies that require expert-established ground truth on patient cases. They are technical performance evaluations against engineering standards and specifications.

4. Adjudication Method for the Test Set

Not applicable. As no clinical test set with patient data requiring expert consensus or adjudication is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a diagnostic ultrasound system, not an AI-powered image analysis tool. The document describes the system's technical and safety characteristics, not its comparative effectiveness in a clinical reading environment with AI assistance.

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

Not applicable. This is a medical imaging device, not a standalone algorithm. The "performance" discussed relates to the physical and technical capabilities of the ultrasound system and its transducers.

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

The type of "ground truth" for the tests performed is primarily based on technical standards and specifications (e.g., NEMA UD 2, NEMA UD 3, IEC 60601-2-37 for acoustic output; AIUM guidelines for B-Mode and Doppler accuracy/sensitivity; ISO 10993 for biocompatibility). For a diagnostic device, the "ground truth" is that it performs according to these established and recognized technical and safety benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is a hardware-based diagnostic imaging system, not an AI model that requires a training set of data.

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

Not applicable, as there is no AI model or training set described in this document.

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