Search Results

Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates.

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

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

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

Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in 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, Smart 3D, 4D(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, STE, STQ, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver). Subject device can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria or reported device performance metrics for the Consona N9/N8/N7 series Diagnostic Ultrasound System. The submission is a 510(k) premarket notification for substantial equivalence, not a performance study against specific acceptance criteria.

The document primarily focuses on demonstrating that the subject device is substantially equivalent to legally marketed predicate devices (primarily the Mindray MX7, K212900) in terms of intended use, imaging modes, features, functions, and technological characteristics.

Instead of a table of specific performance metrics, the document highlights:

• Indications for Use: The subject device's indications are comparable to the predicate.
• Patient Contact Materials: Same as predicate or tested under ISO 10993-1.
• Acoustic Power Levels: Below FDA limits and same as the predicate (MX7).
• Electrical and Physical Safety Standards: Complies with FDA recognized standards, same as the predicate (MX7).
• Features and Functions: Same as predicate devices, with new options being either improvements or enhancements of cleared functions, with no new intended uses or clinical risks introduced.

2. Sample Size Used for the Test Set and Data Provenance

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

Therefore, there is no test set, no sample size, and no data provenance (e.g., country of origin, retrospective/prospective) related to clinical performance for this submission. The evaluation is based on non-clinical tests and comparison to predicate devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

As there were no clinical studies conducted and no test set, this information is not applicable. Ground truth for clinical performance was not established by experts for this particular submission.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used for performance evaluation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done, as the document states that clinical studies were not required and were not performed. Therefore, there's no reported effect size of human readers improving with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone performance study of an algorithm was conducted or reported, as this is a general-purpose diagnostic ultrasound system, not an AI-driven diagnostic algorithm. The new features like "Smart Calc" are described as semi-automatic tools that assist the user, implying a human-in-the-loop design, but no performance study specific to this feature is detailed.

7. Type of Ground Truth Used

Given the absence of clinical studies, there is no mention of ground truth established through expert consensus, pathology, or outcomes data. The basis for substantial equivalence relies on technical specifications, compliance with safety standards, and functional comparison to predicate devices, rather than clinical performance data against a defined ground truth.

8. Sample Size for the Training Set

Not applicable. This submission concerns a diagnostic ultrasound system and does not involve an AI model with a distinct "training set" in the conventional sense of machine learning algorithms requiring large datasets for training. The "new options" like Smart Calc are described as improvements or enhancements but not as standalone AI algorithms whose performance requires training and validation datasets.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set for an AI model.

Ask a specific question about this device

Consona N6, Consona N6 Pro, Consona N6 Super, Consona N6S, Consona AE, Consona AT, Consona N6 Exp, Consona No Elite, Consona N6T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates.

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

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

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 to be used in a hospital or medical clinic.

Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include : B. M. PWD. CWD. Color Doppler. Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, Amplitude PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart 3D, 4D(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

Subject device can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.

This document is a 510(k) summary for a diagnostic ultrasound system (Consona N6 series). It appears the device does not rely on AI features requiring specific performance metrics or a human-in-the-loop study for its predicate equivalence. The summary explicitly states "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence."

Therefore, the requested information about acceptance criteria, specific study designs (MRMC, standalone), ground truth establishment for a test set and training set, and expert qualifications for AI/ML performance evaluation cannot be extracted from this document because such studies were not deemed necessary for this device's regulatory review.

The document describes a general diagnostic ultrasound system and focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use: Similar applications (fetal, abdominal, cardiac, etc.)
• Technological Characteristics: Similar imaging modes (B, M, Doppler), transducers, and features.
• Non-clinical Tests: Compliance with acoustic output, biocompatibility, electrical safety, and software standards.

The only "new option" mentioned that might be interpreted as having an "intelligent" component is "Smart Calc," described as: "Semi-automatically recognizes the contour of the target area and measures the diameter, area and circumference of the target area. The user needs to identify the target area first. When the measures results are not satisfactory, the user can use the trackball to manually edit the contour." However, this is presented as an enhancement based on cleared functions, not a new intended use or a feature requiring a specific AI/ML performance study as typically understood in the context of FDA submissions for AI-enabled devices.

Summary of what cannot be provided given the document:

• Table of acceptance criteria and reported device performance for AI features: Not provided as specific AI performance studies were not cited.
• Sample size and data provenance for a test set: Not applicable; no such test set was described for AI performance.
• Number of experts and qualifications for ground truth: Not applicable.
• Adjudication method for the test set: Not applicable.
• MRMC comparative effectiveness study, effect size: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable for AI performance studies.
• Sample size for the training set: Not applicable.
• How ground truth for the training set was established: Not applicable.

Information that can be extracted related to the device as a whole (not AI-specific):

• Non-clinical Tests: The device underwent testing for acoustic output (NEMA UD 2-2004), electrical safety (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37), usability (IEC 60601-1-6, IEC 62366-1), risk management (ISO 14971), biocompatibility (ISO 10993-1), and software lifecycle processes (IEC 62304). This demonstrates the device meets general safety and performance criteria through adherence to recognized standards.
• Clinical Studies: Explicitly stated as "Not applicable."
• Device Performance: The conclusion states that the device "was found to have a safety and effectiveness profile that is similar to the predicate device" based on "performance data as documented in the study" (referring to the non-clinical tests described).

In conclusion, this document does not contain the information requested about AI acceptance criteria and study designs because the device, as described for this 510(k) submission, does not appear to be an AI-enabled device requiring such specific performance evaluations for its regulatory clearance, or at least, those details are not provided in this public summary.

Ask a specific question about this device

TE7/TE5/TE7 Max/TE9 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, Laparoscopic, abdominal,Intra-operative(abdominal, thoracic, and vascular), Pediatric ,small organ(breast, thyroid, testes), neonatal and adult cephalic,trans-esoph. (Cardiac), transrectal, trans-vaginal, musculo-skeletal(conventional, superficial), urology, Peripheral vessel, Adult and Pediatric cardiac, ophthalmic, Thoracic/Pleural exams.

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

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

TE7/TE5/TE7 Max/ TE5 Max/TE9 is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-mode, Color-Mode , Amplitude Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Contrast imaging (Contrast agent for LVO),TDI, Color M, Smart 3D,Contrast imaging (Contrast agent for Liver) and iScape View. This system is a Track 3 device that employs an array of probes that include Linear array, Convex array, Phased array and Volume probe.

This document is a 510(k) summary for the Shenzhen Mindray Bio-medical Electronics Co., LTD. TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System. It largely focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance rather than detailed performance studies against specific acceptance criteria for novel AI features.

Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs, sample sizes for test and training sets, and expert involvement for ground truth is not explicitly provided in this type of regulatory submission. The submission primarily relies on showing that the new features or modifications are "similar to" or "have been cleared with" existing features in predicate devices. There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or a standalone algorithm-only study.

However, based on the information provided, here's what can be extracted and inferred:

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

The document does not provide specific quantitative acceptance criteria or detailed performance metrics for the added features like Smart IVC, Smart VTI, Smart B-Line, EPSS, Smart Trace, Auto GA, Smart Bladder, or Smart FHR OB1. Instead, it states that these features are "similar to" or "have been cleared on" predicate devices, implying that their performance is considered equivalent and therefore acceptable.

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

This information is not provided in the document. The submission relies on "similarity" to predicate devices, implying that testing data from those predicate devices supports the current submission, or that specific testing for these features was performed internally without detailing the datasets.

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)

This information is not provided. The document makes no mention of expert involvement for ground truth establishment related to the new features. Given the approach of "similarity to cleared features," it's likely that established methods of performance evaluation for ultrasound systems were followed, but the specifics are not disclosed.

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

This information is not provided.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the document. The submission does not claim to include AI assistance to human readers that would necessitate such a study; rather, it describes automated measurement and image processing features that are presumably integrated into the device's functionality.

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

While the new features (e.g., Smart IVC, Smart VTI, Smart B-Line, Smart Bladder, Smart FHR OB1) imply automated algorithms perform measurements or detections, the document does not explicitly describe a standalone algorithm-only performance study. The context is the overall ultrasound system, and these features are presented as integrated capabilities of the device.

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

This information is not explicitly stated. Given the nature of ultrasound imaging and a 510(k) submission primarily focused on substantial equivalence for a diagnostic ultrasound system:

• For quantitative measurements (e.g., Smart IVC, Smart VTI, Auto GA, Smart Bladder, Smart FHR OB1), the ground truth would likely be established through manual measurements by trained Sonographers/Physicians using validated techniques, or comparison against other gold standard measurement methods if available.
• For image processing and detection features (e.g., Smart 3D, iScape View, Smart B-Line, Smart Trace), the ground truth would likely involve expert visual assessment and consensus by radiologists/cardiologists/specialists interpreting the images and verifying the function's output.
  However, this is inferred, not stated.

8. The sample size for the training set

This information is not provided. The document is a 510(k) summary for an ultrasound system, not a detailed technical report for an AI algorithm. In submissions of this type for devices primarily relying on substantial equivalence, detailed training set information is often not required or included unless the AI component is a truly novel aspect requiring extensive de novo review. The features described are framed as similar to those already cleared.

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

This information is not provided.

Ask a specific question about this device

DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vessel, and urology exams.

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

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

DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, CW mode, Color-mode, Power/Dirpower mode, THI mode, 3D/4D mode, iScape mode, Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver) or the combined mode (i.e. B/M-Mode).

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

This document is a 510(k) summary for the Mindray DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System, dated November 2, 2020. As such, it primarily focuses on establishing substantial equivalence to predicate devices rather than proving specific performance criteria through detailed studies as would be seen in a de novo submission or a PMA.

Therefore, the information regarding acceptance criteria and the study that proves the device meets them mainly revolves around regulatory compliance and comparison to already cleared devices.

Here's the breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in the typical sense for a new AI/software feature. Instead, the acceptance criteria are implicit in the comparison to predicate devices and adherence to recognized standards. The "performance" is stated as being "similar" or "same" as 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)

The document states: "8. Clinical Tests: Not Applicable." (Page 9) This indicates that no clinical "test set" in the context of human data was used to demonstrate the performance of the new features or the overall device for substantial equivalence. The evaluation relies on non-clinical tests and comparisons to predicate devices.

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)

Since no clinical tests were performed, there are no details provided on experts or ground truth establishment from clinical data. The "ground truth" for compliance testing is against the established specifications and performance of the predicate device and recognized standards.

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

Not applicable, as no clinical test set was used.

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. The document specifically states "Clinical Tests: Not Applicable," and this ultrasound system is being cleared based on substantial equivalence to existing devices, not as an AI-assisted diagnostic tool requiring MRMC studies to demonstrate human reader improvement. The "Smart" features mentioned (i.e., Smart Face, Smart NT, Smart OB) are likely automated measurement or optimization tools rather than advanced AI diagnostic algorithms requiring such studies for substantial equivalence.

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

Not applicable, as no clinical studies are mentioned. The "standalone" performance testing for this type of device would typically involve technical and safety checks against industry standards, not a diagnostic accuracy assessment divorced from clinical use.

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

For the non-clinical tests and comparisons to predicate devices, the "ground truth" is established by:

• Compliance with recognized industry standards: e.g., AAMI/ANSI 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971, NEMA UD 2, ISO 10993-1, IEC 62366-1, IEC 60601-1-6.
• Established performance and specifications of the predicate devices: The functionality, acoustic output, and safety profile of the cleared predicate devices (Mindray DC-30, DC-40, Z60) serve as the benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. The document does not describe any machine learning/AI models that would require a dedicated "training set" to establish substantial equivalence for this device. The "Smart" features are presented as extensions or improvements consistent with existing device capabilities, not as entirely new, data-trained diagnostic algorithms.

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

Not applicable, as no training set is mentioned for AI/machine learning model development.

Ask a specific question about this device

The Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative (abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculoskeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel, and urology exam.

The Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode , Power/Dirpower Mode, 4D, Smart3D,TDI, Color M, Elastography, Biopsy Guidance, Contrast imaging (Contrast agent for Liver) or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include Linear array, Convex array probe.

The provided text is a 510(k) Pre-market Notification from the FDA, and it does not contain information about a study that proves the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML-driven device would. This document pertains to traditional diagnostic ultrasound systems.

Specifically, it states multiple times:

• "Not applicable. The subject of this submission, Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." (Page 26, Section 8. Clinical Studies)
• "The Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System has the same technological characteristics, is comparable in key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate devices." (Page 25, Section 6. Comparison with Predicate Devices)

Therefore, based on the provided document, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets those criteria, as an AI/ML performance study was not conducted or required for this conventional diagnostic ultrasound system.

The document focuses on demonstrating substantial equivalence to already legally marketed predicate devices, primarily the Mindray Z6 (K182603) and DC-40 (K183377), by showing:

• Same intended uses: The document lists "fetal, abdominal, intra-operative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams." (Page 24)
• Similar technological characteristics and operating modes: B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, 4D, Smart3D, TDI, Color M, Elastography, Biopsy Guidance, Contrast imaging (for liver). (Page 23)
• Compliance with recognized safety standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62366, IEC 60601-1-6, ISO 14971, ISO 10993-1. (Page 25-26)
• Acoustic power levels below FDA limits. (Page 25)

The concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" as it relates to AI/ML performance (e.g., specific sensitivity, specificity, or AUC targets, or human-in-the-loop improvement metrics) is not relevant to this type of traditional device submission. The "acceptance criteria" here are implicitly meeting the performance characteristics and safety standards of the predicate devices.

Ask a specific question about this device

The Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Fetal, Abdominal, Pediatric, Musculo-skeletal (conventional, superficial) , Peripheral Vascular, Trans-rectal, Trans-vaginal, Small organ (breast, thyroid and testes) , Cephalic (neonatal and adult) , Cardiac (adult and pediatric) and Urology exams.

The Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, Color-Mode, Power/Dirpower Mode, THI, Smart3D, 4D, iScape, Biopsy Guidance or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include Linear array, Convex array probe.

The provided document is a 510(k) premarket notification for the Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through novel clinical studies.

Therefore, many of the requested details about specific acceptance criteria and a study proving those criteria are not present in this document because it's not a de novo or PMA submission that would typically require such detailed performance data from a new study. The document primarily focuses on demonstrating that the new device is as safe and effective as a previously cleared device.

However, I can extract the information available from the document that is relevant to your request:

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

The document does not specify quantitative acceptance criteria or report specific device performance metrics in the way a clinical study would for a novel device. Instead, it relies on demonstrating that the new device has "the same intended uses, technological characteristics, is comparable in key safety and effectiveness features, and has the same basic operating modes as the predicate devices."

The key performance aspect mentioned is that "The acoustic power levels of Z5/Z50/Z50T/Z50S/Z50 Pro are below the limits of FDA, which is the same as the predicated device Z5 (K130695)". This implicitly means the acoustic output meets FDA limits as specified by relevant standards.

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

The document explicitly states: "Not applicable. The subject of this submission, Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." This means there was no specific "test set" of patient data or images used in a clinical study to evaluate the device's performance as would be done for a new device. The evaluation is based on technical comparisons to predicate devices and adherence to recognized standards.

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, as no clinical studies with a test set requiring ground truth establishment were conducted or reported in this submission.

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

Not applicable, as no clinical studies with a test set requiring adjudication were conducted or reported in 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. The document is for a diagnostic ultrasound system and does not mention any AI components or MRMC studies.

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

Not applicable. The device is a diagnostic ultrasound system, not an algorithm, and the submission does not describe standalone algorithm performance.

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

Not applicable, as no clinical studies requiring ground truth were conducted or reported in this submission.

8. The sample size for the training set

Not applicable, as the document is not about an AI/ML algorithm that would require a training set. The evaluation is based on compliance with standards and comparison to predicate devices.

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

Not applicable, as the document is not about an AI/ML algorithm that would require a training set or its associated ground truth.Conclusion from the Document:

The Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System received 510(k) clearance based on demonstrating substantial equivalence to existing predicate devices (Mindray Z5 (K130695), Z6 (K182603), and DC-40 (K183377)). This equivalence was supported by:

• Having the same intended uses and basic operating modes.
• Comparable technological characteristics.
• Acoustic power levels remaining below FDA limits, similar to the predicate device.
• Compliance with recognized electrical, physical, and software safety standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62366, IEC 60601-1-6, ISO14971, ISO 10993-1).
• No clinical studies were deemed necessary to support this substantial equivalence claim.

Ask a specific question about this device