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The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, vascular and neuro).

The subject device consists of a mobile console with keyboard. specialized controls, a color video LCD display with electronicarray transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 generalpurpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.

The provided 510(k) summary for the GE Healthcare LOGIQ P5 BT11 Ultrasound System (K101878) does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

This document is a premarket notification for a new device, asserting substantial equivalence to previously cleared predicate devices. The focus of this type of submission is to demonstrate that the new device is as safe and effective as existing legally marketed devices, rather than proving performance against specific acceptance criteria through a clinical validation study.

Here's a breakdown of why the requested information is not present and what the document does provide:

Key Takeaways from the Document:

• Substantial Equivalence: The primary assertion is that the LOGIQ P5 BT11 employs the "same fundamental scientific technology as its predicate devices" (K060993 LOGIQ P5/A5 Ultrasound System and K092271 LOGIQ E9 Ultrasound System). This is the basis for its clearance, not individual performance metrics against acceptance criteria.
• No Clinical Studies Required: The document explicitly states: "The subject of this premarket submission, LOGIQ P5, did not require clinical studies to support substantial equivalence." This means there would be no data from a clinical trial to report for acceptance criteria.
• Non-Clinical Tests: The device underwent non-clinical tests for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety, and conformity with applicable medical device safety standards. These are safety and performance standards, but not typically reported as specific acceptance criteria with performance data in this type of summary.
• Quality Assurance Measures: The document lists general quality assurance measures applied during development (Risk Analysis, Requirements Reviews, Design Reviews, various levels of testing, safety testing). These are internal processes to ensure quality, not external validation studies with specific performance metrics.
• Indications for Use: The document clearly outlines the intended uses and clinical applications for the system and its various transducers (e.g., Fetal, Abdominal, Cardiac, Peripheral Vascular). This defines the scope of the device but doesn't quantify its performance within those applications.

Addressing the Specific Questions (based on the provided document):

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

   • N/A. This document does not specify quantitative acceptance criteria or report device performance against such criteria. The "performance" is implicitly deemed equivalent to the predicate devices.

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

   • N/A. No clinical test set or data provenance is mentioned as no clinical studies were required.

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):

   • N/A. No ground truth establishment for a test set is discussed as no clinical studies were performed.

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

   • N/A. No test set or adjudication method 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:

   • N/A. This document predates widespread AI in medical devices and is for an ultrasound system, not an AI-powered diagnostic tool. No MRMC study is mentioned.

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

   • N/A. This is a hardware-based ultrasound system, not an algorithm. Standalone performance as typically understood for AI algorithms is not applicable here.

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

   • N/A. No ground truth is discussed as no clinical studies were performed.

8. The sample size for the training set:

   • N/A. This is not an AI/machine learning device, so there is no concept of a "training set" in the context it's usually used for such applications.

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

   • N/A. Not applicable, as it's not an AI/machine learning device.

In summary, this 510(k) submission primarily focuses on demonstrating that the LOGIQ P5 BT11 Ultrasound System is substantially equivalent to existing, legally marketed predicate devices, thereby not requiring new clinical performance studies or the establishment of new acceptance criteria for efficacy.

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