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The ZS3 and z.one PRO Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal/obstetric, gynecological; Abdominal (renal, GYN/Pelvic; Intra-operative (abdominal, thoracic, and vascular), Intra-operative neurological; Pediatric: small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic; Trans-recinal, Trans-cranial, Trans-sophageal (non-cardiac and cardiac); Musculosketal (conventional & superficial); 3D/4D; Cardiac - Adultí Pediativ Fetal; Echo, Intra-Cardiac; Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity.

The ZS3 and z.onewo Ultrasound Systems (hereafter referred to as "ZS3 Ultrasound Platform" or "ZS3" for simplicity) are full-featured, general purpose, software controlled, diagnostic ultrasound systems used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. The platform utilizes ZONARE's patented zone technology which allows the system to collect more data at one time, thereby optimizing image quality.

This document describes the ZONARE Medical Systems, Inc. ZS3 and z.onepro Ultrasound Systems, which were submitted for 510(k) premarket notification (K151175). The submission primarily concerns adding new patient contacting materials to the E9-4 transducer and expanding the indications for use for one transducer (C9-3sp), stating that the core system and other transducers remain unchanged from a previous clearance (K150249).

Here's an analysis of the provided information concerning acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

For this submission, the acceptance criteria are based on compliance with various safety and performance standards for ultrasound systems and the equivalence to a previously cleared predicate device. The reported device performance is presented as "PASS" for all tested categories.

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The ZS3 and z.onepro Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal/obsteric, gynccological; Abdominal (renal, GYN/Pelvic; Intracter and vascular), Intra-operative neurological; Pediatric: small organ (thyroid, breast, testes, etc.), Adult & Neonatal Cephalic; Trans-rectal, Trans-vaginal, Trans-esophageal (non-cardiac and cardiac); Musculoskeletal (conventional & superficial); 3D/4D; Cardiac - Adult/ Pediatric/ Fetal; Echo, Intra-Cardiac; Peripheral vascular; hamonic tissue and contrast imaging and Tissue elasticity.

The ZS3 and z.one, Ultrasound Systems (hereafter referred to as "ZS3 Ultrasound Platform" or "ZS3" for simplicity) are full-featured, general purpose, software controlled, diagnostic ultrasound systems used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. The platform utilizes ZONARE's patented zone technology which allows the system to collect more data at one time, thereby optimizing image quality.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ZS3 and z.onepro Ultrasound Systems.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with performance metrics in the typical sense of a diagnostic algorithm. Therefore, many of the requested items related to AI/algorithm performance (like effect size, training set details, ground truth for training) are not applicable or not provided in this type of submission.

Acceptance Criteria and Device Performance

The acceptance criteria for the ZS3 and z.onepro Ultrasound Systems are based on compliance with various safety and performance standards for diagnostic ultrasound systems, as well as demonstrating substantial equivalence to predicate devices (ZONARE's ZS3 Ultrasound System K120703 and ZONARE's z.one ultra Ultrasound System K101091).

The "reported device performance" in this context refers to the outcomes of the non-clinical testing performed to show compliance with these standards and specifications.

Study Details (Non-Clinical Testing for Substantial Equivalence)

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

   • The document describes non-clinical testing which typically does not involve a "test set" of patient data in the same way an AI algorithm study would. Instead, it involves testing the hardware and software against engineering specifications and regulatory standards.
   • No specific sample sizes for image data or patient cases are mentioned, as this is not a clinical performance study. The "test set" consists of the physical device components and software.
   • Data provenance: N/A for this type of non-clinical testing. The "testing" is conducted on the manufactured device itself or its components.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable (N/A). The "ground truth" for non-clinical engineering and regulatory compliance testing is established by the specifications and standards themselves, not by expert interpretation of medical images. For example, the ground truth for "Electrical Safety" is whether the device meets the specified limits in IEC 60601-1, which is measured by test equipment, not human experts.

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

   • N/A. Adjudication methods are relevant for studies involving human interpretation where consensus is needed to establish ground truth for medical conditions. This document details engineering compliance testing.

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 done. This submission is for a diagnostic ultrasound system, not an AI-assisted diagnostic tool. There is no mention of AI assistance for human readers.

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

   • No standalone algorithm performance was done in the context of diagnostic interpretation. This is a medical imaging device, not a standalone AI diagnostic algorithm.

6. The type of ground truth used:

   • For the non-clinical testing, the "ground truth" is defined by established engineering standards (e.g., IEC 60601-1, IEC 60601-2-37, ISO 10993) and the device's internal performance specifications. For instance, the ground truth for "Acoustic Output" is the maximum derated ISPTA and Mechanical Index values allowed by the standard, and the device is tested to ensure it operates within these limits.

7. The sample size for the training set:

   • N/A. This is a hardware and software system, not an AI/machine learning model that requires a "training set" of data in the common sense. The software validation refers to standard software development lifecycle testing, not AI model training.

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

   • N/A, as there is no "training set" in the context of AI.

Summary of the Study:

The "study" described in the provided document is a comprehensive set of non-clinical, engineering, and regulatory compliance tests. The purpose of these tests is to demonstrate that the ZS3 and z.onepro Ultrasound Systems meet all applicable safety, electrical, mechanical, and performance standards for diagnostic ultrasound devices. This type of submission (510(k)) relies heavily on showing that the new device is "substantially equivalent" to predicate devices already cleared for market, meaning it operates in a similar way, has similar intended uses and indications for use, and meets the same safety and effectiveness standards, without raising new questions of safety or effectiveness. No clinical efficacy studies or AI-related performance metrics are presented or required for this type of device clearance.

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The CardioOptics Augmentative Cardiac Optical Imaging System is intended to image and onical structures within the chambers of the heart and great vessels. The system is to be used in conjunction with fluoroscopic imaging.

The system is also indicated for accessing the coronary sinus for pacemaker lead implantation. The system includes visualization means to image anatomical structures to augment navigation into the coronary sinus.

The CardioOptics Augmentative Cardiac Optical Imaging System is composed of a single-use catheter, accessories, and an Image Acquisition System. The system incorporates infrared light (IR) technology to provide visualization through flowing blood. This submission modifies the indications for use originally cleared in 510(k) No. K050808 to include visualization of the cardiac chambers and great vessels.

I'm sorry, but based on the provided text, I cannot find the information needed to describe the acceptance criteria, the study that proves the device meets those criteria, or any of the detailed aspects like sample sizes, ground truth establishment, or MRMC studies.

The document is a 510(k) summary for the CardioOptics Augmentative Cardiac Optical Imaging System, primarily focused on its regulatory clearance. It identifies the device, its indications for use, and confirms that it was found substantially equivalent to predicate devices. However, it does not include performance data, detailed study designs, or acceptance criteria usually found in a clinical study report.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Intracrdiac, Intraoperative, Musculo-skeletal, Peripheral Vascular, Small Organ, Cardiac (Adult, Pediatric, Trans-esoph), Endo-cavity (Trans-rectal, Trans-vaginal), Adult and Neonatal Cephalic, Gynecological.

The HD11 is a diagnostic ultrasound device. It consists of a system console containing the power supply and electronic circuitry required to generate the image, a display screen and a connection to the separate transducers.

The provided text is a 510(k) summary for the Philips HD11 Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices for the purpose of FDA clearance, rather than presenting a standalone study with defined acceptance criteria and performance metrics for a novel AI device.

Therefore, the specific information requested in your prompt (acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is largely not present in the provided text.

The document highlights the following:

1. Acceptance Criteria and Reported Device Performance:

The document states that the HD11 is substantially equivalent to predicate devices based on:

• Indications for Use: Both the predicate and HD11 are indicated for diagnostic ultrasonic imaging and fluid flow analysis.
• Capabilities: Both have the same gray-scale and Doppler capabilities.
• Technology: Both use essentially the same technologies for imaging, Doppler functions, and signal processing.
• Acoustic Output: Both have acoustic output levels below Track 3 FDA limits.
• Quality Systems & Biosafety: Both are manufactured under equivalent quality systems and with materials of equivalent biosafety.
• Safety Standards: Both are designed and manufactured to the same electrical and physical safety standards.

No specific quantitative acceptance criteria or reported performance metrics (e.g., sensitivity, specificity, AUC) are provided for image quality or diagnostic accuracy in the way they would be for a new AI-powered diagnostic device. The "performance" demonstrated is adherence to existing regulatory frameworks and equivalence to already cleared devices.

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not applicable/not provided. This document is not describing a performance study based on a test set of patient data in the context of AI.
• Data Provenance: Not applicable/not provided. The comparison is based on device features and regulatory compliance rather than clinical data from a specific country or retrospective/prospective collection.

3. Number of Experts and Qualifications:

• Not applicable/not provided. This type of information would be relevant for establishing ground truth in a clinical performance study, which is not described here.

4. Adjudication Method:

• Not applicable/not provided.

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

• No MRMC study is mentioned. This document predates the widespread regulatory push for MRMC studies for AI devices. The comparison is against predicate devices, implying similar fundamental imaging capabilities, not an improvement over human readers.

6. Standalone Performance:

• No standalone performance (algorithm only) is discussed. The device is a diagnostic ultrasound system designed for human operation and interpretation.

7. Type of Ground Truth Used:

• Not applicable in the context of the substantial equivalence claim. The "ground truth" here is the regulatory clearance and established safety/effectiveness of the predicate devices. For the technical aspects, the "ground truth" would be engineering specifications and compliance with standards.

8. Sample Size for Training Set:

• Not applicable/not provided. This is not an AI/ML device that requires a training set.

9. How Ground Truth for Training Set was Established:

• Not applicable/not provided for the same reason as above.

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a diagnostic ultrasound system, not a study evaluating the performance of an AI-powered device with specific acceptance criteria and detailed study methodology. The "acceptance criteria" are effectively the regulatory requirements for substantial equivalence, and the "study" is the submission itself, asserting that the new device meets those equivalence criteria by having similar technical characteristics, indications for use, and safety profiles to existing cleared devices.

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