(265 days)
Indications for Use
Focal seizure detection (with or without secondary generalization) in patients with epilepsy age 6 years and older.
160 MHz 802.11ax Wi-Fi and Bluetooth 5.0 (Dual Band)
The provided FDA 510(k) clearance letter and summary for the Philips Lumify Diagnostic Ultrasound System (K242519) primarily focus on demonstrating substantial equivalence to predicate and reference devices, rather than detailing a specific study to prove the device meets acceptance criteria in a comprehensive clinical performance sense for a new AI/software feature.
The submission is for the addition of a new transducer (C9-4ec) and a "Fertility Package" feature. The primary change is the addition of the Trans-vaginal clinical indication, enabled by the C9-4ec transducer.
Therefore, many of the requested points regarding acceptance criteria, specific studies, sample sizes, and ground truth establishment for a clinical performance study are not explicitly detailed in the provided documents, as the application relies more on non-clinical performance data and comparison to already cleared devices.
Here's a breakdown of the information that can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a table of specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for clinical performance of the Fertility Package or the C9-4ec transducer, nor does it report specific clinical performance metrics. Instead, "acceptance criteria were met" is a general statement from non-clinical testing.
The document indicates that non-clinical verification testing was conducted to address system-level requirements and design specifications, and that the device complies with referenced standards.
| Acceptance Criterion (General) | Reported Device Performance (General) |
|---|---|
| Compliance with Philips internal procedures | Met (non-clinical verification testing) |
| Assurance of continued safe and effective performance | Met (non-clinical verification testing) |
| Compliance with IEC 62304 (Medical device software) | Met |
| Compliance with IEC 62366-1 (Usability engineering) | Met |
| Compliance with ISO 14971 (Risk management) | Met |
| Compliance with IEC 60601-1 (Basic safety & essential performance) | Met |
| Compliance with IEC 60601-2-37 (Ultrasonic medical diagnostic equipment) | Met |
| Compliance with IEC 60601-1-2 (EMC) | Met |
| Compliance with IEC 62359 (Thermal/mechanical indices) | Met |
| Compliance with ISO 10993-1 (Biological evaluation) | Met |
| Meets intended use | Met (based on non-clinical testing) |
| Does not raise new questions of safety or effectiveness compared to predicate | Demonstrated (based on substantial equivalence argument) |
2. Sample size used for the test set and the data provenance
The document explicitly states: "The proposed Lumify Diagnostic Ultrasound System with C9-4ec transducer did not require clinical data for determination of substantial equivalence."
Therefore, there is no mention of a clinical "test set" sample size or data provenance (country of origin, retrospective/prospective) for a clinical performance study. The evaluation focused on non-clinical performance and substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set requiring expert-established ground truth for performance metrics is described.
4. Adjudication method for the test set
Not applicable, as no 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
Not applicable. The document does not describe an AI-assisted diagnostic feature that would warrant an MRMC study comparing human readers with and without AI assistance. The "Fertility Package" provides measurement tools and a summary page, which are productivity/workflow enhancements rather than AI-driven diagnostic interpretations.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The "Fertility Package" appears to be a set of measurement and reporting tools, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable for a clinical performance study since none was conducted or reported. For the non-clinical testing, the "ground truth" would be the engineering specifications and recognized industry standards against which the device's hardware and software performance were verified.
8. The sample size for the training set
Not applicable, as no clinical data-driven "training set" for a new algorithm is described or implied. The Fertility Package seems to be functionality built upon established ultrasound principles and measurement techniques found in reference devices.
9. How the ground truth for the training set was established
Not applicable, as no training set for a new algorithm is described or implied.
§ 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.