(107 days)
The intended use of Philips EPIQ 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 (Adult), Cephalic (Neonatal). Fetal/Obstetric. Gynecological. Intra-cardiac Echo. Intra-luminal, Intraoperative (Vascular). Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Transesophageal (Cardiac), Transrectal, Transvaginal, Lung,
The clinical environments where Philips EPIQ 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 healthcare 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 intended use of the 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 (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
The clinical environments where the Affiniti Diagnostic Ultrasound Systems can be used include Clinics, 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 judgment and best clinical procedure.
Philips EPIQ and Affiniti Series Diagnostic Ultrasound Systems are durable, reusable capital equipment medical devices intended for high-resolution general imaging; interventional radiology, cardiology, vascular, obstetrics, and gynecology applications; and fluid flow analysis. They are intended to be used by trained professionals at various settings of patient care such as clinical admission, periodic evaluations, prior to hospitalization discharge, and/or academic research, via maneuverable caster wheels or mobile handheld components.
The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the Auto Measure software-only feature for use on the Philips EPIQ and Affiniti Series Diagnostic Ultrasound Systems. The Philips Auto Measure feature provides the end user with semiautomated functionality for a subset of 2D and Doppler measurements currently available on the Philips EPIQ and Affiniti systems when performing or reviewing an adult transthoracic echocardiography (TTE) with simultaneously acquired electrocardiogram (ECG). The AI/MLenabled algorithm is designed to produce semi-automated and editable measures.
The provided text is a 510(k) summary for the Philips EPIQ and Affiniti Ultrasound Systems with the new "Auto Measure" feature. It focuses on demonstrating substantial equivalence to predicate devices. However, the document does not contain the detailed performance data, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment methods typically found in a clinical study report or a more comprehensive validation study.
The "Performance Data" section in the K211597 summary only broadly states that non-clinical testing included a "Performance Validation Study" and that "Software Verification and Validation testing were used to support substantial equivalence." It also mentions "adherence to the aforementioned Philips internal processes."
Therefore, I cannot extract the specific information requested in your prompt based on the provided text. The document clearly omits the granular details of the validation study.
Here's what the document does tell us about the study, albeit at a high level:
- Study Type: A "Performance Validation Study" was conducted for the Auto Measure software, alongside Software Verification and Validation testing.
- Purpose: To demonstrate that the Auto Measure feature meets defined requirements and performance claims, and to support substantial equivalence to the currently marketed manual measuring options.
- What was tested: The "Auto Measure" software-only feature, which provides semi-automated functionality for a subset of 2D and Doppler measurements during adult transthoracic echocardiography (TTE) with simultaneously acquired ECG. The end user can edit, accept, or reject the measurements.
Without the actual performance validation study report or more detailed information, I cannot fill in the table or answer most of your specific questions.
If this information were available, here's how I would attempt to reconstruct it:
Hypothetical Acceptance Criteria and Device Performance (Based on common FDA expectations for such devices, NOT from the provided text)
| Acceptance Criteria Category | Specific Acceptance Criteria (Example) | Reported Device Performance (Example) |
|---|---|---|
| Accuracy (2D Measurements) | Mean Absolute Difference (MAD) vs. Manual Gold Standard 0.95 for LVIDd (AI-assist) | |
| System Robustness | Successful processing rate > 95% across varied image quality. | 98% successful processing rate |
| Clinical Equivalence (if MRMC) | AI-assisted readers demonstrate non-inferiority or superiority to manual readers for specific diagnostic tasks (e.g., LVEF assessment accuracy). | Not Applicable (information not provided) |
| Safety (False Positives/Negatives impact) | No increase in clinically significant false positives or false negatives compared to manual measurement. | Clinically acceptable false positive/negative rates (details not provided) |
| Usability/Workflow | Acceptance by users (e.g., via survey on ease of use, time savings). | Not Applicable (information not provided) |
Missing Information from the Provided Document:
- A table of acceptance criteria and the reported device performance: NOT PROVIDED. The document only states that testing demonstrated the feature "meets the defined requirements and performance claims" but does not enumerate these.
- Sample sizes used for the test set and the data provenance: NOT PROVIDED.
- Test Set Sample Size: Unknown
- Data Provenance: Unknown (country of origin, retrospective or prospective)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: NOT PROVIDED. The document refers to "manual measuring options" as a comparison, implying human expert measurements, but doesn't detail the ground truth process.
- Number of Experts: Unknown
- Qualifications: Unknown
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: NOT PROVIDED.
- 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 PROVIDED. The document discusses "semi-automated and editable measures" which implies human-in-the-loop, but doesn't describe an MRMC study or effect size. It only states the AI offers "semi-automated functionality" compared to "manual" on predicate devices.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "Auto Measure" feature is described as providing "semi-automated and editable measures," suggesting human oversight is intended. A purely standalone performance might have been part of the internal validation, but it's not explicitly detailed as a primary regulatory performance endpoint in this summary.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Based on the comparison to "manual measuring options," the ground truth likely involved expert human measurements (manual measurements by sonographers/cardiologists). Whether this was a single expert, consensus, or other method is NOT SPECIFIED.
- The sample size for the training set: NOT PROVIDED.
- How the ground truth for the training set was established: NOT PROVIDED.
In conclusion, while the document confirms that performance validation was conducted and software V&V was performed in accordance with FDA guidance, it lacks all the granular details about the study design and results that your prompt requested. This level of detail is typically found in the full 510(k) submission and supporting technical reports, not usually in the summary made publicly available.
§ 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.