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The GE LOGIQ 200 MD is a general purpose imaging system intended for use in obstetrics, gynecology, urology and general radiology examinations by a qualified physician to aid in the diagnosis and evaluation of soft tissues by generating two dimensional images, time-motion images and biometric data. Specific Clinical applications included in the indications for use are: Fetal. Abdominal. Intraoperative (abdominal), Pediatric, Small organs (breast, male and female reproductive organs, limbs & extremities), Adult cephalic, Cardiac (adult & pediatric), Transvaginal, Transrectal and Urological.

The GE LOGIQ 200 MD consists of a mobile console approximately 40 cm wide, 60 cm deep and 125 cm high, weighing approximately 75 kg. The user interface consists of a keyboard and monochrome video monitor. The system is designed for use in B, M and B/M scanning modes and supports linear, convex, micro convex and phased array probes.

The information provided describes a 510(k) premarket notification for the GE LOGIQ 200 MD Diagnostic Ultrasound System. This submission is for substantial equivalence to a legally marketed predicate device (GE LOGIQ a200, K960700).

Key takeaway on acceptance criteria and study: This 510(k) states that no clinical tests were required for demonstrating substantial equivalence. Instead, the device's safety and effectiveness were established through non-clinical tests and comparison to the predicate device. Therefore, a study proving device performance against acceptance criteria as might be seen for novel AI/ML devices is not present in this documentation. The acceptance criteria essentially revolve around meeting general safety standards and having comparable technological characteristics to the predicate.

Here's the breakdown based on your request, as much as can be extracted from the provided text:

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

Since no specific performance metrics or acceptance criteria for clinical outcomes are presented as part of a new device study, this table will reflect the general safety and equivalence claims.

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

• Sample Size for Test Set: Not applicable. No clinical test set data is described.
• Data Provenance: Not applicable. No clinical studies were conducted for this 510(k) submission.

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. No clinical tests or expert-established ground truth for a test set are mentioned. The equivalence is based on engineering and design comparisons to a predicate device.

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

• Not applicable. No clinical test set.

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 device is a diagnostic ultrasound system, not an AI/ML device, and no MRMC study was conducted.

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

• Not applicable. This is a medical device (ultrasound system), not an algorithm.

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

• Not applicable. No clinical studies were performed requiring ground truth establishment. The "ground truth" for substantial equivalence in this context is the safety and effectiveness profile of the predicate device and compliance with regulatory standards.

8. The sample size for the training set

• Not applicable. This is a traditional medical device, not an AI/ML product that would typically involve a training set.

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

• Not applicable.

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