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Ultrasound scanner and transducers for B, M and combined mode imaging. Guidance of biopsy needles, geometrical measurements and calculation of parameters. Non monitoring ECG for superimposing the ultrasound information. Clinical applications: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small Parts (organs), Transvaginal.

2101 supports the following scanning modes and mode combinations: B-mode and B+M-mode (M=motion). An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations. The system operates with 3 types of transducers: mechanical sector, linear array and convex array (curved linear array). The system can perform simple geometric measurements, and perform calculations in the arcas of Urology, Cardiology and OB/GYN applications.

The provided text describes a 510(k) summary for the Ultrasound Scanner Type 2101. However, it does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test or training sets, expert qualifications, or ground truth establishment relevant to clinical efficacy or diagnostic accuracy.

The document primarily focuses on:

• Device Description: Scanning modes (B-mode, M-mode, B+M-mode), optional ECG, transducer types (mechanical sector, linear array, convex array).
• Intended Use: Listing clinical applications (Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small Parts, Transvaginal) and modes, comparing it to a predicate device (Type 2002, K943315).
• Safety and Standards Compliance: Discussion of controls affecting radiated fields (global maximum M/I and Ispta values within allowable limits for Track 3 non-ophthalmic devices), patient contact materials complying with ISO10993-1, maximum Thermal Index (TI ≤ 6.0), electrical/thermal/mechanical safety tested to IEC 60601-1, and acoustic output reporting according to FDA and NEMA standards.
• 510(k) Clearance Letter: A letter from the FDA confirming substantial equivalence to the predicate device (K943315) for the stated indications for use, and an "ADD-TO-FILE" request for a special report on acoustic output.

Therefore, I cannot provide the requested information, which pertains to clinical performance and validation studies, as it is not present in the given text. The text suggests that the device's accuracy for clinical measurements is described in the User Guide, but it does not report those accuracies or the studies conducted to verify them.

Summary of missing information from the provided text:

1. Acceptance criteria and reported device performance related to diagnostic accuracy: Not provided. The document focuses on technical and safety compliance.
2. Sample size for test set and data provenance: Not mentioned.
3. Number and qualifications of experts for ground truth: Not mentioned.
4. Adjudication method for test set: Not mentioned.
5. MRMC comparative effectiveness study results (AI vs. human): Not applicable, as this is a traditional ultrasound scanner, not an AI diagnostic device.
6. Standalone (algorithm-only) performance: Not applicable.
7. Type of ground truth used: Not mentioned.
8. Sample size for training set: Not applicable (no AI training data discussed).
9. How ground truth for training set was established: Not applicable.

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