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The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/M9 Premium Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates.

It is intended for use in fetal, abdominal, Intra-operative, Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-raginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph.(Cardiac), peripheral vessel and urology exams.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healtheare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended tc be used in a hospital or medical clinic.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).

The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).

This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array probe.

This document is a 510(k) Premarket Notification from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. for their M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System.

Based on the provided text, the device in question is a general diagnostic ultrasound system, and the submission is for the addition of a new transducer, P8-2s, to an already cleared system (K210416).

Therefore, the performance data provided is not for a new AI/ML-driven medical device requiring extensive clinical or standalone performance studies against set acceptance criteria, but rather for a modification to an existing device.

The document explicitly states:
"8. Clinical Studies Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence."

This indicates that a formal study proving the device meets specific acceptance criteria in the way a novel AI/ML device would is not present in this submission. Substantial equivalence for this modification is based on non-clinical tests and comparison to a predicate device.

Given this, I cannot provide the detailed information requested regarding acceptance criteria, test set sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these types of studies were not deemed necessary for this particular 510(k) submission.

The "acceptance criteria" for this submission are fundamentally satisfied by demonstrating:

1. Technological Characteristics Similarity: The new P8-2s transducer has comparable design principles and parameters to existing transducers.
2. Safety Compliance: The device and the new transducer comply with recognized electrical, physical, and acoustic safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 14971, ISO 10993-1, IEC 62366-1, IEC 60601-1-6).
3. Biocompatibility: Materials used are biocompatible (specifically Valox 3706, MLG-34-G/MLG-34-N, RTV162, RTV167 for the P8-2s probe shell, acoustic lens, and mucilage glue).
4. Cleaning, Disinfection, and Sterilization Effectiveness: The design allows for effective reprocessing.
5. Acoustic Output: The acoustic output is below the FDA limits (Ispta.3 < 720mW/cm2 and either MI=1.9 or Isppa.3 < 190W/cm2).

To summarize from the provided document:

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

• Acceptance Criteria (Implicit for a modification based on substantial equivalence):
  • Maintain performance characteristics and safety profile of the predicate device.
  • Compliance with recognized industry standards for medical ultrasound devices.
  • Biocompatibility of new components.
  • Acceptable acoustic output.
• Reported Device Performance:
  • New P8-2s transducer (5MHz, Phased, 96 elements) is designed to acquire and display ultrasound data in various modes (B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined Modes, Tissue Harmonic Imaging, iScape, Color M, Smart 3D, TDI) for specific indications (Abdominal, Pediatric, Neonatal Cephalic, Adult Cephalic, Musculo-skeletal (Conventional), Cardiac Adult, Cardiac Pediatric).
  • Acoustic output is "below Ispta.3 = 720mW/cm2 and either MI=1.9 or Isppa.3 = 190W/cm2".
  • Compliance with various medical device safety and performance standards (listed in section 7).

2. Sample size(s) used for the test set and the data provenance

• Not applicable for this type of submission. No clinical test set data from patients is described. The testing performed was non-clinical (e.g., electrical safety, acoustic output measurements) on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No clinical ground truth establishment or expert review of images is mentioned.

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

• Not applicable. No clinical image review or adjudication was performed for this submission.

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 submission is for a diagnostic ultrasound system and a new transducer, not an AI/ML-assisted image interpretation device.

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

• Not applicable. This submission is for a diagnostic ultrasound system and a new transducer, not an AI/ML algorithm.

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

• Not applicable. Ground truth in the context of clinical performance evaluation is not relevant here as no such evaluation was conducted. The "ground truth" for this submission relates to engineering verification and validation against known standards and specifications.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable. As above.

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