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The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thvroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, and Ob/Gyn.

The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/QB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.

This device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen; Pediatric; Small Organ (breast, testes, thyroid); heart soft tissue; Peripheral Vascular; Musculo-skeletal; Ob/Gyn and Urology.

The device is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Abdomen, Cardlac, Small Organ (breast, thyroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, Ob/Gyn, Trans-rectal, Trans-vaginal, Urology.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (Breast, Thyroid, Testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Ob/GYN, Cardiac Adult, Cardiac Pediatric, Peripheral vessel.

The UP600 diagnostic doppler ultrasound system is a compact and portable diagnostic ultrasound device, have integrated preprogrammed color ultrasound imaging system, capable of producing a resolution intended for clinical diagnostic imaging applications. The user interface includes a specialized control kevboard and color 15-inch LCD display. The digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows system integration to a variety of upgrade-able options and features.

The provided text is a 510(k) Premarket Notification Summary for the BenQ Medical Technology UP600 Diagnostic Doppler Ultrasound System. This document does not describe specific acceptance criteria and a study proving the device meets those criteria in the typical format expected for AI/ML device evaluations. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.

Therefore, many of the requested elements (sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or extractable from this specific document, as it predates the widespread regulatory expectations for AI/ML device evaluations.

Here's a breakdown of what can be extracted, along with explanations for what cannot:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria (e.g., specific sensitivity, specificity, or image quality metrics) or report performance against such criteria. Instead, it relies on demonstrating comparable technological characteristics and intended uses to legally marketed predicate devices. The "performance" aspect is implicitly shown by comparison to these predicate devices rather than through specific quantitative metrics presented for the UP600 itself.

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

This information is not provided in the document. As a premarket notification for a general ultrasound system based on substantial equivalence, the submission primarily focuses on technical specifications, safety standards, and comparison to existing devices rather than clinical study data with specific test sets.

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 information is not provided in the document. No specific clinical test set requiring expert ground truth is described.

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

This information is not provided in the document. No specific clinical test set requiring 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

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable for this type of device submission. The UP600 is a diagnostic ultrasound system, a hardware device, and does not incorporate AI/ML functionality that would assist human readers in image interpretation. Therefore, there is no "AI vs without AI assistance" comparison.

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

A standalone performance evaluation of an algorithm was not performed, nor is it applicable. The UP600 is a diagnostic ultrasound system, not an algorithm, and is intended for use by a qualified physician (human-in-the-loop).

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

This information is not provided in the document. No specific ground truth for performance evaluation is mentioned, as the focus is on substantial equivalence.

8. The sample size for the training set

This information is not provided in the document. This device is a hardware system, not an AI/ML algorithm that would typically have a training set.

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

This information is not provided in the document. Not applicable for this hardware device.

Summary of the Study (or lack thereof, in the context of AI/ML evaluation):

The BenQ Medical Technology UP600 Diagnostic Doppler Ultrasound System's acceptance was based on a demonstration of substantial equivalence to legally marketed predicate devices (BenQ Medical Technology UP600 K121983, GE Healthcare Voluson i K053435, and CGMC OPUS 5000 K102989). This is the primary "study" or justification presented in the 510(k) summary.

The document highlights the following to support substantial equivalence:

• Comparable Indications for Use: The UP600 and its transducers are intended for the same clinical applications as the predicate devices.
• Similar Technological Characteristics: The UP600 shares core operational principles (applying high voltage burst to piezoelectric material, detecting reflected echoes, constructing 2D B-mode, Doppler color, and Doppler spectrum images) and many features (display modes, measurements, transducer types) with the predicate devices. Some features, like the 128-channel digital beam former, are even identical to one predicate (GE Voluson I) and an improvement over another (CGMC OPUS 5000).
• Compliance with Safety Standards: The device meets recognized national and international safety standards (NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1).
• Equivalent Acoustic Output: The acoustic output levels are identical to the predicate devices and stated to be below applicable FDA limits ("Track 3; MI, TIS, TIC, TIB. Derated Ispta: 720mW/cm2 maximum," etc.).
• Biocompatible Patient Contact Materials: Materials used for patient contact are compliant with ISO10993-5 (a standard for biological evaluation of medical devices).

The 510(k) summary concludes that "The UP600 is substantially equivalent in safety and effectiveness to the predicate systems." This implies that by meeting the technical and safety specifications and having comparable intended uses to already cleared devices, it is deemed safe and effective without the need for extensive clinical performance studies that would typically involve test sets, expert ground truth, or AI-specific evaluations.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/OB; Abdominal; Intra-operative (abdominal, thoracic, and vascular); Intra-operative Neuro; Pediatric; Small Organ (Thyroid, Breast, Testes, etc.); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-cranial, trans-esoph (cardiac/noncardiac), musculo-skel conventional & superficial 3D/4D. cardiac adult & pediatric and other applications as shown in section 4.3.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative, Pediatric, Small organ/parts (breasttestes, thyroid, etc), Transrectal, Transcranial, Trans-esoph, Trans-urethral, OB/GYM, Cardiac, Pelvic, Neonatio. Vascular, 3D/4D, Tissue elasticity, Musculoskeletal (cardias, Superficial Musculoskeletal, and Peripheral Vascular applications.

The z.one Ultra is a general purpose diagnostic ultrasound system. It consists of a portable scanner approximately 8 inches wide and 3 inches high that can be held by the user in one hand and includes buttons for controlling the system and a screen that display ultrasound mages and user interface. The portable scanner can be held by the user in one hand accommodates a removable transducer module. Signals received from the transducer module are digitized and preprocessed. The transducer module comes into contact with the patient and receive ultrasound energy.

The docking station (aka carts) provides holders for the portable scanner, and transducer modules, as well as battery chargers and other accessories. The modification for this submission include new features and functionality that will enhance user convenience and work flow as well as provide clinicians with new indications of use.

The provided document is a 510(k) premarket notification for the ZONARE z.one Ultra Ultrasound System. This type of submission is for demonstrating substantial equivalence to legally marketed predicate devices, not for proving the device meets acceptance criteria through clinical studies in the same way a new, high-risk device might.

The document explicitly states: "Clinical Tests: Non Required" and then elaborates: "ZONARE designs and develops their products according to 21 CFR 820, ISO 13485:2003 quality systems. The device conforms to applicable medical device safety standards and compliance for safety and effectiveness is verified through defined evaluation and market surveillance. Conforming to the required worldwide ultrasound standards, enables ZONARE to state that the ZONARE z.one Ultra Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices current cleared for market."

Therefore, many of the requested categories related to clinical study design and performance metrics cannot be directly extracted from this document, as such studies were not required for this type of submission. The "acceptance criteria" here largely refer to the device's ability to perform its intended functions similarly to predicate devices and adherence to safety standards.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since formal clinical studies with specific performance metrics are not required and therefore not reported in this 510(k), I can only infer the "acceptance criteria" as meeting the general capabilities and safety standards demonstrated by predicate devices.

Each table indicates whether an application is a "P" (previously cleared by FDA 510k # 022858, implying equivalence to the existing ZONARE z.one) or "N" (new indication). For "P" indications, the device is considered to perform equivalently to the predicate. For "N" indications, the device is being introduced for those uses, likely based on similarity to other cleared devices or demonstrating safety and basic functionality in non-clinical tests.

Examples of supported modes for various transducers include:

• B¹ (B-Mode and Harmonic Imaging): P (Previously cleared) or E (Added under Appendix E) or N (New indication) across most applications.
• M (M-Mode): P or E or N across most applications.
• PWD² (Pulsed Wave Doppler and HPRF): P or E or N across most applications.
• CWD (Continuous Wave Doppler): P or N for specific applications (e.g., Fetal, Abdominal, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac Adult & Pediatric, Peripheral Vascular for the main system, and specific entries for some transducers).
• Color Doppler³ (Color Doppler, Directional Power Doppler, Power Doppler): P or E or N across most applications.
• Combined Modes⁴: P or E or N across most applications.
• Other⁵,⁸ (e.g., Color M-Mode, Freehand tissue elasticity): P or E or N for relevant applications.

The presence of "P" or "E" in these tables fundamentally means that for those indications and modes, the ZONARE z.one Ultra performs equivalently to the already cleared ZONARE z.one (K022858) or other cleared predicate devices. The "N" indications represent new proposed uses for the system or specific transducers, which are deemed safe and effective through substantial equivalence to other devices or non-clinical testing. |
| Safety and Effectiveness Standard Adherence: The device must conform to applicable medical device safety standards. | "The device has been evaluated according to the applicable medical device safety standards for acoustic output, biocompatibility, cleaning, and disinfection effectiveness as well as thermal, electrical, and mechanical safety."
"The device conforms to applicable medical device safety standards and compliance for safety and effectiveness is verified through defined evaluation and market surveillance."
"ZONARE designs and develops their products according to 21 CFR 820, ISO 13485:2003 quality systems." |
| Predicate Device Features Equivalence: The device must have the same important safety and effectiveness features, design, materials, and construction as predicate devices. | "Additionally, they [ZONARE z.one Ultra and predicate devices] have the same important safety and effectiveness features, as well as design, materials, and construction." |

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

• Sample Size for Test Set: Not applicable. No clinical test set (in the sense of patient data for performance evaluation) was specified as "Clinical Tests: Non Required."
• Data Provenance: Not applicable. No clinical data was used for a test set. The validation relies on substantial equivalence and adherence to safety standards.

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

• Not applicable, as no clinical test set requiring expert ground truth was performed for this 510(k) submission.

4. Adjudication Method for the Test Set

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

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• Not applicable. This document is for a diagnostic ultrasound system, not an AI-assisted device, and no MRMC study was conducted or required.

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

• Not applicable. This is not an algorithmic/AI device; it's a hardware system.

7. The Type of Ground Truth Used

• Ground Truth: In the context of this 510(k), the "ground truth" for the device's safety and effectiveness is established by its substantial equivalence to legally marketed predicate devices and its compliance with recognized medical device safety standards. This is not a "ground truth" in the clinical data sense (e.g., pathology, outcomes data). The existing ZONARE z.one (K022858), GE Voluson i (K053435), Philips iU22 (K042540), and Siemens Acuson S2000 (K072786) served as predicates.

8. The Sample Size for the Training Set

• Not applicable. The device is a diagnostic ultrasound system, not an AI/machine learning model that typically undergoes a "training" phase with a dataset.

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

• Not applicable for the same reason as above.

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