Search Results
Found 6 results
510(k) Data Aggregation
(249 days)
Shenzhen Wisonic Medical Technology Co., Ltd.
The Carnation series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It intended for use in Fetal/Obstetrics, abdominal/GYN, pediatrics, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculoskeletal(conventional and superficial), cardiac (adult and pediatric), peripheral vessel, urology, Thoracic/Pleural, Vascular Access exams.
The Camation series Diagnostic Ultrasound System is a general purpose diagnostic ultrasound system for use by qualified healthcare professionals. The clinical environments where the Carnation series can be used include critical care and emergency room environments, as well as point-of care areas in offices, clinical and hospital settings for diagnosis of patients.
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(TDI), Anatomic M-mode(AMM), Color M Mode(CM), Panoramic Imaging(PANO), and combined mode.
The proposed Carnation 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 Carnation series Diagnostic Ultrasound System is a touch screen controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, Color-Mode, Power(Dirpower)-Mode, PW Doppler Mode, CW Doppler mode, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging(TDI), Anatomic M-mode(AMM), Color M Mode(CM), Panoramic Imaging(PANO), and combined mode. 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.
Holo PW is based on the echo planar imaging, and forms the planar data by emitting and receiving multiple beams to synchronously display the blood flow at multiple sampling gates.
The Carnation series Diagnostic Ultrasound System consists of the main unit, ultrasound probes, ECG lead wire, Magnetic cup, Foot switch, Scanner, USB headset, Camera and Black/white video printer.
The Carnation series Diagnostic Ultrasound System utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Some biopsy kits are available for needle-guidance procedures. The system also includes several automated measurement function: wiCalc_Diaph, wiCalc_Vas, wiCalc_Vol.Flow, Automatic trace, wiCalc_VTI, wiCalc_IVC, wiCalc_IMT, those measurement function can assist users to carry out relevant measurement automatically. The output results of those automatic measurement function are for reference only by users, and the final results need to be confirmed and modified by users based on professional knowledge.
The Carnation series Diagnostic Ultrasound System also include the function of wiScan, wiShow, wiGuide and wiNerve. wiScan is an easy-to-use quality assurance and workflow tool that automatically guides the user through an exam to ensure required steps are performed while reducing key strokes. wiShow is a teaching video recording software, which is an independent functional module integrated in the ultrasound diagnostic system. The function enables doctors to record and edit teaching videos, and export the video to a U disk or network storage. wiGuide uses the characteristics of the magnetic field to enhance the visualization effect of the needle by detecting the magnetized needle, and can better detect the position of the needle when it is in the human body. wiNerve is an education purpose tool, which aims to automatic recognition of different anatomical structures and display the recognized anatomical structures in different colors, to help doctors to improve the skills. The results of wiNerve are not used as diagnostic evidence.
Eight models for the main units are included in this submission, that is Carnation, Carnation Fast, Carnation T, Carnation Exp, Carnation Neo, Carnation+, Carnation Pro, Carnation Ultra. There are thirteen different models of probes: C6-1B-H. C6-2-H, C8-3-H, C9-3-H, EV11-3-H, L15-4WB-H, L15-4NB-H, L15-6-H, L22-10-H, L8-3-H, SP5-1-H, P8-3-H and P12-4-H are available for the Carnation series.
The provided text is a 510(k) Summary for the Carnation series Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive details on a specific study designed to meet pre-defined acceptance criteria for a novel device.
Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance studies is not present in this document. The document explicitly states that clinical studies were not required to support substantial equivalence.
However, I can extract the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific "acceptance criteria" for device performance (e.g., sensitivity, specificity, accuracy) are reported in this document. The substantial equivalence argument is based on similarities in intended use, technological characteristics, and compliance with recognized standards.
| Feature/Metric | Acceptance Criteria (Not explicitly defined in the document for performance) | Reported Device Performance (as implied by equivalence) |
|---|---|---|
| Intended Use | Covered by predicate device's intended use | Similar to predicate device (K180599), with all proposed indications covered by the predicate. |
| Operation Modes | Similar to predicate, with known differences covered by reference devices. | Similar to predicate (K180599), Holo PW covered by K211886, PANO by K173471. |
| Functions | Similar to predicate, with known differences covered by reference devices. | Similar to predicate, wiGuide and wiNerve similar to K211886. |
| Acoustic Power Levels | Below FDA limits. | Complies with FDA limits; same as predicate (K180599). |
| Biocompatibility | Complies with ISO 10993. | Cytotoxicity, Sensitization, Skin Irritation tests successful (in accordance with ISO 10993). |
| Electrical Safety & EMC | Complies with IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2. | Complies with IEC 60601-1, IEC 60601-2-37 (safety), and IEC 60601-1-2 (EMC). |
| Software V&V | Complies with FDA guidance for "Moderate" level of concern. | Verification and validation testing conducted; documentation provided as recommended by FDA guidance. |
| Acoustic Testing | Complies with NEMA UD 2-2004 (R2009). | Conducted in accordance with NEMA UD 2-2004 (R2009). |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The document states, "The subject of this premarket submission, Carnation series Diagnostic Ultrasound System, did not require clinical studies to support substantial equivalence." Therefore, there was no separate test set of data from clinical studies for performance evaluation.
- Data Provenance: Not applicable for performance data. Non-clinical testing data (biocompatibility, electrical safety, EMC, software V&V, acoustic testing) was generated by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical test set was required or used for performance evaluation for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set was required or used for performance evaluation for substantial equivalence.
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 MRMC comparative effectiveness study was done. The device is a "Diagnostic Ultrasound System" and the listed "wiCalc" and "wiNerve" functions are described as "measurement functions for reference only" or "education purpose tool" and "not used as diagnostic evidence." There is no indication of AI assistance for human readers in diagnostic interpretation being evaluated.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No standalone algorithm performance study was reported. The device is a diagnostic ultrasound system, not an AI-driven interpretation algorithm meant to function independently for diagnosis. Its automated features are for reference/education.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for clinical performance evaluation. For non-clinical tests, "ground truth" would be the established standards and specifications (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety, NEMA UD 2 for acoustics).
8. The sample size for the training set:
- Not applicable. The document does not describe the development or training of any AI model that would require a 'training set.' The automated functions ("wiCalc", "wiNerve") are not presented as AI models for diagnostic decision-making that would require extensive clinical training data.
9. How the ground truth for the training set was established:
- Not applicable, as no training set for an AI model for diagnostic purposes is described.
Ask a specific question about this device
(190 days)
Shenzhen Wisonic Medical Technology Co.,Ltd.
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.
Ask a specific question about this device
(263 days)
Shenzhen Wisonic Medical Technology Co., Ltd.
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.
Ask a specific question about this device
(54 days)
Shenzhen Wisonic Medical Technology Co., Ltd.
The Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.
The Piloter Exp/ Piloter P Diagnostic Ultrasound System is a touch screen controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, Color Flow Doppler, Pulsed Wave Doppler, Continued Wave 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 Piloter Exp/ Piloter P Diagnostic Ultrasound System consists of the main unit named Piloter series, ultrasound probes, probe extender, power adapter, connecting cable and mobile trolley.
Three models for the main units are included in this submission, that is Piloter Exp. Piloter and Piloter P. there are three different models of probes are available for the Piloter series.
The provided text is a 510(k) summary for the Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new device meets specific, novel acceptance criteria through a clinical study or performance study with a defined test set, ground truth, and expert adjudication.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically understood for AI/ML devices or novel diagnostic tools. Instead, it relies on non-clinical data and comparison to a legally marketed predicate device.
Specifically, the document states:
- "The subject of this premarket submission, Piloter/ Piloter/ Piloter P Diagnostic Ultrasound System, did not require clinical studies to support substantial equivalence." (Page 27, Section 8)
- "Performance testing was conducted on the Piloter Exp/ Piloter P Diagnostic Ultrasound System, to evaluate the clinic measurement accuracy and system sensitivity, and all of the tested parameters met the predefined acceptance criteria." (Page 26, Section 7, Performance testing)
While it mentions "predefined acceptance criteria" for performance testing, it does not provide the specifics of these criteria or the reported device performance in the format requested, nor does it detail a study that would involve a test set, ground truth established by experts, or MRMC studies. The "performance testing" described is likely technical verification against engineering specifications and industry standards for ultrasound devices, not a clinical validation as would be performed for a deep learning model.
Therefore, I cannot populate the requested table and answer the questions based on the provided text. The document's purpose is to demonstrate substantial equivalence of a conventional ultrasound system, not to validate an AI/ML component with a test set, ground truth, and expert review.
Ask a specific question about this device
(78 days)
Shenzhen Wisonic Medical Technology Co., Ltd.
The Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.
The Navi e/ Navi s/Navi X Diagnostic Ultrasound System is a touch screen controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, Color-Mode, Power (Dirpower)-Mode, PW-Mode, CW-mode, and the combined mode. 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 Navi e/ Navi x/Navi X Diagnostic Ultrasound System consists of the main unit named Navi series, ultrasound probes, power adapter, connecting cable, probe extender, needle-guided bracket, batteries, mobile trolley, ECG module and batteries. Three models for the main units are included in this submission, that is Navi s, Navi e and Navi X. Eight different models of probes are available for the Navi series.
The provided text describes the Navi e/Navi s/Navi X Diagnostic Ultrasound System and its substantial equivalence to predicate devices, but it does not contain detailed acceptance criteria or a specific study proving the device meets those criteria, especially not in the context of AI/ML performance.
Instead, the document outlines various non-clinical tests conducted to ensure the device's safety and performance in a general sense, largely by comparing it to predicate ultrasound systems.
Here's an analysis of what information is available and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a specific table of acceptance criteria with corresponding performance metrics for the device. It generally states that "all of the tested parameters met the predefined acceptance criteria" for performance testing, but the criteria themselves are not enumerated.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable as no specific test set (e.g., imaging dataset for AI/ML evaluation) is mentioned. The performance testing refers to general ultrasound system performance.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no ground truth establishment for a test set (in the context of AI/ML or specific clinical performance evaluation) is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set with ground truth requiring adjudication is mentioned.
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:
- MRMC Study: No, an MRMC comparative effectiveness study was not done.
- Effect Size: Not applicable, as there's no mention of AI assistance for human readers or a study evaluating it.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. The document does not describe any specific AI/ML algorithms that would require such a study. The software verification and validation are for the overall system software, deemed "moderate" level of concern.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The document discusses regulatory compliance, biocompatibility, electrical safety, and general performance of the ultrasound system, not the performance of an AI/ML component against a clinical ground truth.
8. The sample size for the training set:
Not applicable, as no AI/ML training set is mentioned or described.
9. How the ground truth for the training set was established:
Not applicable, as no AI/ML training set or its ground truth establishment is mentioned.
Summary of what the document does include regarding performance:
The document primarily focuses on demonstrating substantial equivalence to predicate ultrasound devices through:
- Biocompatibility testing: According to ISO 10993-1, ISO 10993-5, and ISO 10993-10, for cytotoxicity, sensitization, and skin irritation of probes and glue.
- Electrical safety and electromagnetic compatibility (EMC) testing: Compliance with IEC 60601-1:2012 and IEC 60601-1-2:2007.
- Performance testing: According to IEC 60601-2-37:2007 for ultrasonic medical diagnostic and monitoring equipment. It also mentions evaluation of "clinic measurement accuracy and system sensitivity" where "all of the tested parameters met the predefined acceptance criteria."
- Acoustic output measurement and real-time display: Compliance with NEMA UD 2:2004 and NEMA UD 3:2004.
- Software Verification and Validation Testing: Conducted per FDA guidance for "moderate" level of concern software.
Conclusion:
This submission for the Navi e/Navi s/Navi X Diagnostic Ultrasound System is for a conventional ultrasound imaging system. It does not describe any AI/ML components or their performance characteristics. Therefore, the specific information requested about AI acceptance criteria, clinical study designs (MRMC, standalone), ground truth, and training data is not present in the provided text. The "performance testing" mentioned refers to the general technical and functional performance of the ultrasound system itself, not the diagnostic performance of an AI algorithm.
Ask a specific question about this device
(368 days)
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
The Clover 50/Clover60/Clover70 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediative patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.
The Clover 50/Clover60/Clover70 Diagnostic Ultrasound System is a mobile software controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, Color-Mode, Power (Dirpower)-Mode, PW-Mode, CW-mode, and the combined mode. 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 Clover 50/Clover60/Clover70 Diagnostic Ultrasound System consists of the main unit named clover series, ultrasound probes, power adapter, connecting cable, probe extender, needle-guided bracket, batteries, mobile trolley and travelling case.
Three models for the main units are included in this submission that is Clover 50, Clover 60 and Clover 70. Seven different models of probes are available for the Clover series.
The provided text describes the Clover 50/Clover60/Clover70 Diagnostic Ultrasound System and its substantial equivalence to predicate devices, focusing on non-clinical performance testing. It does not contain information about acceptance criteria and a study proving the device meets acceptance criteria in a clinical setting with human subjects, nor does it detail a standalone algorithm performance, MRMC study, or ground truth establishment relevant to AI.
However, it does describe the performance testing criteria and results for various measurement accuracies and modes of operation. It considers these performance tests as evidence for substantial equivalence, implying they serve as acceptance criteria for the device's technical functionality relative to the predicate devices.
Here's a breakdown of the information that can be extracted, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance was compared against the listed predicate device (Mindray M7/M7T, K131690). The "acceptance criteria" are implied by the performance of the predicate device, which the new device aims to be "substantially equivalent" to or better. The table shows the performance of the Clover 70 model and compares it to the predicate device.
Note: The predicate device's performance appears to set the acceptance criteria for the new device. Both devices are marked 'S' (Same) indicating substantial equivalence in these performance metrics.
| Items | Acceptance Criteria (from predicate M7/M7T) | Clover 70 Reported Performance | Substantial Equivalence |
|---|---|---|---|
| Precision of 2D Images | |||
| Distance | Within ±3%; or when the measured value is less than 40mm, the error is less than 1.5mm | Max Error: 1.4% (Full screen) | S |
| Area (Trace) | Within ±7%; or when the measured value is less than 16 cm², the error is less than 1.2 cm² | -5.11% (Full screen) | S |
| Area (ellipse, circle) | Within ±7%; or when the measured value is less than 16 cm², the error is less than 1.2 cm² | 0.8% (Full screen) | S |
| Circumference | Within ±7%; or when the measured value is less than 16 cm², the error is less than 1.2 cm² | -0.47% (Full screen) | S |
| Angle | Within ±3% | -1.89% (Full screen) | S |
| Volume | Within ±10%; or when the measured value is less than 64 cm³, the error is less than 6.4 cm³ | 0.51% (Full screen) | S |
| Basic Time/Motion measurements | |||
| Distance | Within ±3%; or when the measured value is less than 40mm, the error is less than 1.5mm | -2% (Full screen) | S |
| Time | Within ±2% | 0 (Timeline Display) | S |
| Heart rate | Within ±4% | 0 (15-999 beats per minute) | S |
| Velocity (PW mode) | When angle ≤ 60°, ≤5% | C5-1: 4.3% max; L15-4: 3.3% max; LH15-6: 3.1% max; P4-1: 4.8% max; EV10-4: 3.3% max; P7-3: 5.0% max | S |
| Velocity (CW mode) | When angle ≤ 60°, ≤5% | P4-1: 4.8% max; P7-3: 4.3% max | S |
2. Sample size used for the test set and the data provenance
The document refers to "Performance testing was conducted on the Clover 50/Clover60/Clover70 Diagnostic Ultrasound System, to evaluate the clinic measurement accuracy and system sensitivity, and all of the tested parameters met the predefined acceptance criteria." However, it does not specify the sample size used for this performance testing. It also does not mention data provenance (e.g., country of origin, retrospective or prospective) as this was non-clinical performance data, likely gathered in a lab or testing environment rather than a clinical dataset from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The ground truth for this type of performance testing would typically be based on highly accurate physical measurements using calibrated equipment rather than expert human interpretation.
4. Adjudication method for the test set
This information is not provided. Given it's non-clinical performance metrics, an adjudication method (like 2+1, 3+1) would not be applicable in the same way as for clinical studies involving human interpretation.
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
There is no mention of an MRMC comparative effectiveness study or any AI component. The device described appears to be a traditional diagnostic ultrasound system and not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no mention of a standalone algorithm or AI performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance testing metrics (distance, area, velocity, etc.), the ground truth would likely be established using precise physical phantoms and calibrated measurement tools, rather than clinical expert consensus, pathology, or outcomes data. The document does not explicitly state the method, but this is standard for ultrasound system calibration and performance verification.
8. The sample size for the training set
There is no mention of a training set, as this is not an AI/ML device.
9. How the ground truth for the training set was established
There is no mention of a training set or its ground truth, as this is not an AI/ML device.
Ask a specific question about this device
Page 1 of 1