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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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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), Fetabl/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transvaginal.

The clinical environments where the EPIQ 5, EPIQ 7, Affiniti 50 Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

The proposed EPIO and Affiniti Diagnostic Ultrasound Systems, which includes EPIO 5. EPIQ 7, Affiniti 50 and Affiniti 70 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). In addition to the physical knobs and buttons of the main control panel, the user interface consists of a touch screen with soft key controls. EPIO also has a QWERTY keyboard.

The removable transducers are connected to the system using a standard technology, multipin connectors. The proposed EPIQ and Affiniti systems use standard transducer technology, and supports phased, linear, curved linear array, TEE, motorized 3D curved linear arrays as well as non-imaging (pencil) probes.

Clinical data storage consists of a local repository as well as off-line image storage via the network, DVR, DVD, and USB storage devices. The images are stored in industry-standard formats (e.g. JPEG. AVI, DICOM) and are intended to be readable using industry-standard hardware and software. On-line review of the images is available. Secure access tools are provided to restrict and log access to the clinical data repository according to HIPAA.

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 Doppler functions of the system process the Doppler shift frequencies from the echoes of moving targets such as blood to detect and graphically display the Doppler shifts of these tissues as flow.

The proposed EPIQ and Affiniti systems give the operator the ability to measure anatomical structures and offer analysis packages that provide information used by competent healthcare professionals to make a diagnosis. The proposed EPIQ and Affiniti systems enable image guided navigation and image fusion via the optional PercuNav feature (K121498).

The document describes the Philips EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems, and Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems. It primarily details their indications for use and compares their technological characteristics to a previously cleared predicate device (Philips EPIQ Diagnostic Ultrasound System K132304).

Based on the provided text, a "study that proves the device meets the acceptance criteria" in terms of clinical performance or specific statistical metrics is not explicitly described. The document explicitly states: "Clinical data was not required to demonstrate safety and effectiveness of the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems since the proposed EPIQ or Affiniti system introduces no new indications for use, modes or features that have not been previously cleared with the predicate device EPIQ system (K132304). The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices."

Therefore, the acceptance criteria are demonstrated through substantial equivalence to a predicate device, and compliance with recognized safety and performance standards, rather than a de novo clinical study for this specific submission.

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

1. Table of Acceptance Criteria (from Standards) and Reported Device Performance (Compliance Statement)

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The CX50 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical --mode), Pulse Wave Doppler, continuous Wave Doppler, color Doppler, tissue Doppler Imaging and Harmonics (Tissue and contrast) modes. The device is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic, Fetal, Abdominal, Pediatric, Small Organ, Adult Cephalic, Neonatal Cephalic, Trans-vaginal, Musculo-skeletal, Gynecological, Cardiac Adult, Cardiac pediatric, Trans-Esoph. (Cardiac), Peripheral Vessel, Other (Carotid)

The CX50 Diagnostic Ultrasound System is a compact, AC or battery powered, 128 channel, cardiac ultrasound imaging. It uses custom digital electronic and fabrication technologies to provide diagnostic ultrasound information and is housed in a portable, laptop-style chassis. The only changes made in this CX50 510(k) are the additional indications of Cardiac Pediatric and Neonatal Cephalic. There are no new or unique features/technical characteristics introduced with the addition of the new indications.

The Philips CX50 Diagnostic Ultrasound System received clearance for additional indications for Cardiac Pediatric and Neonatal Cephalic applications. This was a 510(k) Premarket Notification based on substantial equivalence to predicate devices (Philips HD11 Diagnostic Ultrasound System, K043535 and earlier CX50 submissions K091804 and K081802). The submission states that no new features or technical characteristics were introduced.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define quantitative "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, resolution) for the new indications. Instead, the "acceptance criteria" for this 510(k) largely revolve around demonstrating substantial equivalence to previously cleared devices for these specific indications and confirming that no new safety or effectiveness concerns arise.

The "device performance" reported is that the CX50 system, with the additional indications, is substantially equivalent in safety and effectiveness to its predicate devices.

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

No specific test set or clinical study data is provided for the new indications with the CX50. The submission explicitly states: "No new testing was required to determine safety and efficacy of the CX50 with the new indications."

Safety and effectiveness were demonstrated through substantial equivalence to existing predicate devices already cleared for these applications, and through previous submissions for the CX50 system itself. Therefore, there is no explicit "sample size used for the test set" or direct "data provenance" for this 510(k) submission regarding the new indications. The reliance is on prior clearances.

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

Since no new clinical testing was performed for this specific 510(k) for the new indications, there is no mention of "experts used to establish ground truth for the test set." The substantial equivalence argument relies on the established safety and efficacy of the predicate devices.

4. Adjudication Method for the Test Set

As no specific test set or clinical study was conducted for the new indications in this submission, no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs Without AI Assistance

No MRMC comparative effectiveness study was conducted or referenced in this submission. The device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of image interpretation software.

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

This submission is for a diagnostic ultrasound system, which inherently requires a human operator and interpreter. It is not an "algorithm only" device, and therefore, no standalone algorithmic performance study was conducted.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Given that no new clinical study was performed for the new indications, no specific "type of ground truth" was established or used for this submission pertaining to the new indications. The ground truth for the clinical safety and effectiveness of the predicate ultrasound systems would have been established through methodologies typical for medical device approvals at their time, likely involving assessments by qualified medical professionals (e.g., radiologists, cardiologists) correlating ultrasound findings with patient presentation, other diagnostic tests, or clinical outcomes.

8. The Sample Size for the Training Set

No training set is mentioned as part of this 510(k) submission, as it relates to the addition of new indications to an existing ultrasound system. The device itself is not a machine learning or AI-driven algorithm that would typically require a training set for its core functionality.

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

Since no training set is mentioned in this submission, there is no information on how its ground truth would have been established.

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Diagnostic ultrasound imaging and fluid flow analysis of the human body as follows: Ophthalmic, Fetal/Obstetric, Abdominal, Intra-operative (vascular/epicardial), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (thyroid, scrotum, prostate, breast), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Intra-luminal, Other (Gynecological), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Other (Fetal), Peripheral vessel, Musculo-skel (conventional), Musculo-skel (superficial).

The HD7 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 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 differing acoustic properties of the tissues in the body reflect some of the transmitted energy back to the transducer, where it is converted back to electrical signals and sent back to the system. In the system, advanced signal processing technologies convert the returned signals into images of the tissues. The Doppler functions of this system process the Doppler shift frequencies from the echoes of moving targets (such as blood), to detect and graphically display the Doppler shifts of these tissues as flow.

The provided document is a 510(k) premarket notification for the Philips HD7 Diagnostic Ultrasound System and its associated transducers. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for reporting performance metrics against specific acceptance criteria from a new clinical study. Therefore, much of the requested information regarding detailed study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness (MRMC) studies is not present in this document.

The document focuses on establishing equivalence based on:

• Intended Use: Both the predicate and the HD7 are indicated for diagnostic ultrasonic imaging and fluid flow analysis.
• Technological Characteristics: They have the same gray-scale and Doppler capabilities, use similar technologies for imaging, Doppler functions, and signal processing.
• Acoustic Output: Both have acoustic output levels below Track 3 FDA limits.
• Manufacturing and Biosafety: Both are manufactured under equivalent quality systems, of materials with equivalent biosafety, and designed/manufactured to the same electrical and physical safety standards.

The tables provided in sections {5}-{17} are "Indications for Use Forms" which describe the clinical applications and modes of operation for which the device and each transducer are indicated. They categorize indications as:

• N: New indication
• P: Previously cleared by FDA (referring to previous 510(k) clearances for the predicate device).
• E: Added under Appendix E (also referring to indications previously cleared, but specifically in an appendix related to extensions/modifications).

These tables are not performance reports, but rather statements of intended use within the scope of existing clearances.

Based on the provided text, here's what can be extracted:

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

The document does not specify quantitative acceptance criteria or detailed performance metrics. The "performance" assessment is qualitative, stating that the HD7 system and transducers function in a manner identical to other Philips ultrasound systems and transducers and are substantially equivalent to the predicate device (M2540/EnVisor ultrasound systems, cleared in K014191) in terms of safety and effectiveness.

• Identical intended use.
• Same gray-scale and Doppler capabilities.
• Essentially same technologies.
• Acoustic output below Track 3 FDA limits.
• Equivalent quality systems and biosafety materials.
• Designed and manufactured to same electrical and physical safety standards. |
  | Acoustic output levels below Track 3 FDA limits. | Acoustic output levels are below the Track 3 FDA limits. |

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

Not applicable. This 510(k) submission establishes substantial equivalence through comparison to a predicate device and engineering analysis, rather than new clinical performance data from a specific test set. No separate "test set" or data provenance information is mentioned.

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)

Not applicable. The document does not describe a clinical study requiring expert-established ground truth for a test set.

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

Not applicable. No test set or expert 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 is not an AI-enabled device. No MRMC study or AI assistance is mentioned.

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

Not applicable. This is a diagnostic ultrasound system, not an algorithm, and its performance is inherently linked to human operation.

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

Not applicable. No new clinical performance study requiring a specific "ground truth" is reported in this summary. The basis for clearance is substantial equivalence to a predicate, which implies the predicate's established performance serves as the benchmark.

8. The sample size for the training set

Not applicable. No machine learning or AI component requiring a "training set" is described for this device.

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

Not applicable. See point 8.

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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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