(154 days)
EPIQ:
The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Cardiac), intra-luminal, intra-luminal, intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transveginal, Lung.
Modes of operation include: B Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging.
The clinical environments where EPIQ Series Diagnostic ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healtheare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
Affiniti:
The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculosketal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
Modes of operation include: B Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging.
The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healtheare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the Auto ElastQ software feature onto the EPIQ and Affiniti Series Diagnostic Ultrasound Systems. The proposed EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound Systems with new Auto ElastQ software feature, which is a workflow-enhancement software feature, is equivalent to predicate device, K240850.
The Auto ElastQ software feature is intended to assist users in making stiffness measurements using 2D-SWE in the liver by recommending specific frames and ROI positions to the user.
No hardware changes to the EPIQ or Affiniti Systems are reguired when using the Auto ElastQ software feature, and existing, commercialized Philips transducers are used for the Auto ElastQ software feature. The feature is supported by EPIQ and Affiniti models running software version 12.0.
Here's a summary of the acceptance criteria and the study conducted for the Philips Auto ElastQ software feature, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit for high agreement) | Reported Device Performance |
|---|---|---|
| Agreement with Manual Elastography Measurements | High agreement between algorithm-generated measurements and manual measurements. | Demonstrated high agreement of Auto ElastQ algorithm-generated measurements with manual elastography measurements based on statistical analysis. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "a retrospective data analysis study was conducted to evaluate the performance of the Auto ElastQ software compared to manual measurements."
- Data Provenance: Retrospective data analysis. Country of origin not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated. The ground truth was established by "manual measurements performed by expert readers."
- Qualifications of Experts: Not explicitly stated beyond "expert readers."
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The ground truth was established by "manual measurements performed by expert readers," implying an expert consensus or single expert reading for the manual measurements. No information suggestive of a 2+1 or 3+1 method is provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This document describes a study comparing the algorithm's performance to expert manual measurements, not a comparative effectiveness study of human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: Yes. The "retrospective data analysis study" directly evaluated the performance of the Auto ElastQ software (algorithm) "compared to manual measurements performed by expert readers." This indicates a standalone performance assessment of the algorithm.
7. Type of Ground Truth Used
- Ground Truth Type: Expert consensus/manual measurements. The summary states, "with the manual measurements used as ground truth for the study."
8. Sample Size for the Training Set
- Training Set Sample Size: Not explicitly stated. The document focuses on the performance study and does not detail the training set size for the AI algorithm.
9. How Ground Truth for the Training Set Was Established
- Training Set Ground Truth Establishment: Not explicitly stated. The document describes the "Auto ElastQ software feature is intended to assist users in making stiffness measurements using 2D-SWE in the liver by recommending specific frames and ROI positions to the user." While the testing involves expert manual measurements as ground truth, the method for establishing ground truth for the training data used to develop the algorithm is not detailed in this summary.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.