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The Labat series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small organ (breast, thyroid, testes,etc.), neonatal cephalic, adult cephalic, trans-vaginal, trans-rectal, musculo-skeletal (conventional and superficial), cardiac (adult and pediatric), trans-esoph.(cardiac), peripheral vessel and urology exams.

The operator for Labat series Diagnostic Ultrasound System is intended for professional clinical staff or the qualified and trained personnel with experience in the use of ultrasound diagnostic equipment. The device is intended to be used in hospital or clinics.

Modes of operation include: B-Mode, Color Mode, Power (Dirpower)-Mode, PW Doppler Mode, CW Doppler Mode, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging, Anatomic M and combined mode.

The proposed Labat series Diagnostic Ultrasound System is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities.

The Labat series Diagnostic Ultrasound System is a touch screen controlled ultrasonic system. Nine models for the main units are included in this submission, that is Labat SE, Labat SP, Labat SG, Labat PE, Labat PG, Labat TE, Labat TG, Labat IE and Labat IG. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, Color-Mode, Power (Dirpower)-Mode, PW-Mode, CW-mode, Holo PW, Anatomic M (AMM), Tissue Doppler Imaging (TDI) and the combined modes. The system can also measure anatomical structures and offer software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis.

The Labat series Diagnostic Ultrasound System consists of the main unit, ultrasound probes, ECG cables, gel warmer, magnetic cup, foot switch, barcode reader, laser marker. TEE( transesophageal echocardiography) architecture arm, etc.

Ten different models of probes are available for the Labat series, that is C6-1B-H, C8-3-H, L15-4WB-H, L15-4NB-H, L22-10-H, L15-6-H, LH15-6-H, SP5-1-H, EV11-3-H, P7-3T-H.

The provided text describes the Labat series Diagnostic Ultrasound System (K210154). However, it does not contain information about acceptance criteria for device performance or a study that proves the device meets specific performance criteria related to diagnostic accuracy or clinical effectiveness.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Mindray TE7/TE5 Diagnostic Ultrasound System, K180912) and conformity to various safety and performance standards. It explicitly states: "The subject of this premarket submission, Labat series Diagnostic Ultrasound System, did not require clinical studies to support substantial equivalence."

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about a study proving specific performance metrics, as this information is not present in the provided text.

The closest information available that might relate to "acceptance criteria" and "performance" are the compliance with recognized standards for safety and acoustic output, but these are not diagnostic performance metrics.

I can, however, extract other requested information that is present in the document:

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

• Not applicable (N/A): The document does not specify acceptance criteria relating to diagnostic performance (e.g., sensitivity, specificity, accuracy) or report such performance for the Labat series Diagnostic Ultrasound System. It focuses on safety and technical compliance.

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 data is described, as the device "did not require clinical studies to support substantial equivalence." The performance data shared relates to engineering and biocompatibility testing.

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 clinical test set or ground truth determination by experts is mentioned, as no clinical studies were performed.

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

• N/A: No clinical test set and thus no 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:

• No: No MRMC study was done, nor is there any mention of AI assistance in this device's description.

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

• N/A: No standalone algorithm performance study was mentioned. The device is a diagnostic ultrasound system operated by professional clinical staff.

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

• N/A: No ground truth for clinical performance is mentioned, as no clinical studies were conducted to assess diagnostic accuracy.

8. The sample size for the training set:

• N/A: The document does not describe any machine learning or AI components that would require a "training set" in the context of diagnostic accuracy. The software verification and validation are for the operational software of the device, not for a diagnostic algorithm with a training set.

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

• N/A: As there is no mention of a training set for a diagnostic algorithm, this question is not applicable.

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The Diagnostic Ultrasound System is applicable for adults and pediatric patients. It is intended for use in pediatric, small organ (breast, thyroid, testicles, prostate), musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and dermatological exams.

The Paragon XHD Diagnostic Ultrasound System is a mobile software controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, Color Flow Doppler, Power/Dirpower mode or the combination of these modes. The system can also measure anatomical structures and offer software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis. The Paragon XHD Diagnostic Ultrasound System consists of the main unit, an ultrasound probe, power adapter, connecting cable.

The provided document is a 510(k) summary for the Shenzhen Wisonic Medical Technology Co., Ltd. Paragon XHD Diagnostic Ultrasound System. This document outlines the device's characteristics and its substantial equivalence to predicate devices, focusing on safety and performance.

However, the document does NOT contain information about acceptance criteria and the study that proves the device meets the acceptance criteria from an AI/algorithm performance perspective. Instead, it discusses the device's compliance with electrical safety, EMC, biocompatibility, and general performance standards for an ultrasound system.

Therefore, I cannot extract the requested information regarding AI/algorithm performance acceptance criteria, test set details, expert consensus, MRMC studies, or standalone algorithm performance, as these are not discussed in the provided text.

The information given pertains to the ultrasound system itself, not an AI component within it. The closest approximation to "performance testing" in the document describes evaluating "clinic measurement accuracy and system sensitivity," which are general ultrasound system performance metrics, not related to an AI algorithm that would have specific acceptance criteria like sensitivity, specificity, or AUC.

Without further information describing an AI component and its validation, I cannot fulfill your request in full detail. If there was an AI component, the provided document does not elaborate on its specific validation.

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