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510(k) Data Aggregation
(119 days)
The DC-40/DC-35/DC-40S/DC-40 Pro 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 cephalic.adult.cephalic.trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo- skeletal (superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.
The DC-40/DC-35/DC-45/DC-40S/DC-40 Pro 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, TDI mode, Color M mode, Biospy Guidance, Elastography, Contrast imaging (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, Phased array and convex array.
This document is an FDA 510(k) summary for a Diagnostic Ultrasound System (DC-40/DC-35/DC-45/DC-40S/DC-40 Pro). The information provided focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than on proving performance against specific acceptance criteria through a clinical study involving AI or human readers.
Therefore, many of the requested categories in your prompt are Not Applicable (N/A) based on the provided text, as this submission is for an ultrasound system, not an AI/CADe device requiring performance metrics.
Here's the breakdown of the available information:
1. Table of acceptance criteria and the reported device performance:
The document does not specify quantitative acceptance criteria for the device performance in terms of diagnostic effectiveness for specific clinical tasks, as it's a general ultrasound system and not an AI or CADe device. Instead, it demonstrates compliance with regulatory standards for safety and fundamental performance.
| Acceptance Criteria Category | Device Performance (Based on provided text) |
|---|---|
| Acoustic Output | Below the limits of FDA |
| Biocompatibility | Transducers and needle-guided brackets tested under ISO 10993-1 |
| Cleaning and Disinfection | Effectiveness evaluated |
| Electrical Safety | Complies with ANSI/AAMI ES60601-1 and related standards |
| Mechanical Safety | Complies with ANSI/AAMI ES60601-1 and related standards |
| Software Life Cycle | Complies with IEC 62304 |
| Usability (Human Factors) | Complies with IEC 62366-1 and IEC 60601-1-6 |
| Risk Management | Complies with ISO 14971 |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable. The document refers to non-clinical tests (e.g., electrical safety, acoustic output), not performance data from a patient test set for diagnostic accuracy.
- Data Provenance: Not applicable. The tests were compliance-based rather than data-driven from patient cases.
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. This information is relevant for studies validating diagnostic algorithms against ground truth established by medical experts (e.g., radiologists, pathologists). The provided document describes the clearance of an ultrasound system, not an AI/CADe product.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as no human reader study or test set requiring adjudication of ground truth 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:
Not applicable. This is not an AI-assisted device. The submission is for a diagnostic ultrasound system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm but a diagnostic ultrasound system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" in this context refers to compliance with established engineering and safety standards, rather than medical diagnostic ground truth.
8. The sample size for the training set:
Not applicable. This device is not an AI/Machine Learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI/ML model described.
In summary: The provided document is a 510(k) summary for a general-purpose diagnostic ultrasound system. It details the device's intended use, modifications from a predicate device, and compliance with various recognized safety and performance standards. It explicitly states, "Clinical Tests: Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." Therefore, the type of performance data and studies requested in your prompt (which are typical for AI/CADe devices) are not included in this document.
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(54 days)
The Z6 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediativ, small organ(breast, thyroid, testes), neonatal and adult cephalic, transrectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel , intraoperative(abdominal, thoracic, and vascular) and urology exams.
Z6 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 and convex array.
This document is a 510(k) premarket notification for the Z6 Diagnostic Ultrasound System, which is a general-purpose ultrasonic diagnostic system. The document states that the device is substantially equivalent to legally marketed predicate devices and does not require clinical studies to support substantial equivalence. Therefore, the information typically associated with acceptance criteria and studies proving the device meets these criteria for a novel AI-driven medical device, such as detailed performance metrics, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, are not explicitly provided or applicable in the context of this specific 510(k) submission.
This 510(k) is primarily focused on demonstrating "substantial equivalence" to existing, legally marketed ultrasound devices (predicates). This means the device is shown to have the same intended use, similar technological characteristics, and be as safe and effective as a predicate device. The performance validation relies on non-clinical tests (acoustic output, biocompatibility, electrical/mechanical safety, etc.) and comparisons to previously cleared devices rather than new clinical efficacy studies.
Based on the provided text, here's what can be extracted regarding the device's validation and "acceptance criteria" in the context of a 510(k):
Acceptance Criteria (Implied by 510(k) Process for Substantial Equivalence):
The acceptance criteria for a 510(k) submission that relies on substantial equivalence are not explicit quantitative performance metrics like those for a novel AI algorithm. Instead, they are met by demonstrating that the new device:
- Has the same intended use as a predicate device.
- Has the same technological characteristics as a predicate device, or if it has different technological characteristics, that those differences do not raise new questions of safety or effectiveness AND the device is as safe and effective as the predicate device.
- Complies with applicable recognized safety standards.
The "Study" Proving the Device Meets Accepted Criteria (as described in the 510(k)):
The "study" here is the overall premarket notification submission process, which includes non-clinical testing and a detailed comparison to predicate devices, rather than a single clinical trial.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) for substantial equivalence and not a De Novo or PMA for a novel AI, there isn't a table of specific performance acceptance criteria like sensitivity, specificity, or AUC for an AI. Instead, the "performance" is demonstrated through adherence to safety standards and equivalence to predicate devices across various modes and applications.
| Acceptance Criteria (Implied by 510(k) Process) | Reported Device "Performance" / Compliance |
|---|---|
| Intended Use Equivalence: Same intended use as predicate devices. | The Z6 system has the same intended uses as the predicate device Z6 (K122010). It is applicable for adults, pregnant women, pediatric patients, and neonates across various anatomical regions (fetal, abdominal, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal, cardiac, peripheral vessel, and urology exams). |
| Technological Equivalence / No New Safety/Effectiveness Questions: Same or comparable technological characteristics as predicates, and any differences don't raise new safety/effectiveness concerns. | Z6 has the same technological characteristics as predicate devices. New added features (ECG, 4D, Smart3D, Contrast imaging, Elastography, Free Xros X, TDI, Color M, iNeedle, Medsight, iWorks, iLive) are deemed "substantially equivalent" to features found in other predicate Mindray devices (DC-30, M7, DC-70). |
| Acoustic Output Safety: Acoustic power levels are below FDA limits. | The acoustic power levels of Z6 are below the limits of FDA, same as predicate device Z6(K122010). |
| Electrical and Physical Safety: Compliance with recognized safety standards. | Z6 is designed in compliance with FDA recognized electrical and physical safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 14971). |
| Biocompatibility: Patient contact materials meet ISO standards. | Patient contact materials of new transducers and needle-guided brackets (NGB-001, NGB-002) are tested under ISO 10993-1. |
| Cleaning and Disinfection Effectiveness: (Implied by general safety requirements) | Evaluated for cleaning and disinfection effectiveness. |
| Usability: (Implied by general safety requirements) | Complies with IEC 60601-1-6 (usability standard). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable in the context of this 510(k). The regulatory pathway for this device (a general-purpose ultrasound system with additional features found in other cleared devices) does not typically require a "test set" of patient data for performance evaluation in the same manner a novel AI algorithm would. Instead, substantial equivalence is primarily demonstrated through non-clinical testing and comparison to existing, cleared devices.
- Data Provenance: Not applicable, as patient data test sets are not described. The validation is based on engineering testing and comparison to predicate device specifications.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. There is no mention of a formal "ground truth" establishment by experts using a test set of patient data for the Z6 Diagnostic Ultrasound System in this 510(k). The submission focuses on device specifications, safety standards, and equivalence to predicate devices.
4. Adjudication Method for the Test Set:
- Not applicable. No test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance:
- No. This 510(k) does not describe an MRMC study. The device is a diagnostic ultrasound system, not an AI-assisted interpretation tool in the manner that would typically necessitate such a study (e.g., for an AI CAD system). The "AI" features mentioned (Smart3D, iNeedle, etc.) are likely integrated functionalities that enhance image acquisition or guidance, not interpretative AI requiring MRMC.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Not applicable for the overall device. The device is an ultrasound system with integrated features. While some features (like "Smart3D" or "iNeedle") might involve internal algorithms, their performance is demonstrated as part of the overall device's functionality and comparison to similar features in predicate devices, not as standalone AI outputs that require independent assessment against a ground truth.
7. The Type of Ground Truth Used:
- Not explicitly defined as a "ground truth" for clinical performance. For a traditional ultrasound system seeking 510(k) clearance via substantial equivalence, the "ground truth" for regulatory purposes often refers to established engineering standards, existing predicate device performance, and the inherent safety/efficacy of ultrasound technology itself, rather than a clinical dataset with adjudicated diagnoses.
8. The Sample Size for the Training Set:
- Not applicable. This submission is for a diagnostic ultrasound system, not a machine learning model developed with a training set of patient data and medical images.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As there is no mention of a training set for an AI model, there is no ground truth establishment for it.
In summary: This 510(k) submission for the Z6 Diagnostic Ultrasound System relies on demonstrating substantial equivalence to existing, legally marketed ultrasound devices. It does so by showing that the device has the same intended use, comparable technological characteristics (with new features demonstrated as equivalent to those found in other cleared predicate devices), and complies with relevant safety and performance standards through non-clinical testing. It does not involve the type of clinical performance studies, test sets, or AI model validation methods typically associated with novel AI-driven devices seeking a different regulatory pathway or greater emphasis on clinical efficacy.
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(115 days)
TE7/TE5 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-esoph. (Cardiac), trans-vaginal, musculo-skeletal (conventional, superficial), urology, Peripheral vessel, Adult and Pediatric cardiac, ophthalmic exams.
TE7/TE5 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, Power/Dirpower Mode, THI, LVO, Color M, Smart 3D, TDI 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 and phased array.
This document describes the Shenzhen Mindray Bio-medical Electronics Co., LTD TE7/TE5 Diagnostic Ultrasound System (K180912) and its substantial equivalence to predicate devices. The information provided heavily references previously cleared devices and standards, indicating that no new clinical study was conducted for this specific submission to establish de novo acceptance criteria or device performance.
Therefore, the requested information elements related to a new study (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, ground truth type for test/training sets, training set sample size, how training ground truth was established) are not applicable as they relate to newly conducted efficacy or performance studies. The submission relies on demonstrating equivalence to existing, cleared devices and compliance with recognized standards.
Here's the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since no new performance study with specific criteria and results is outlined for this submission, the "acceptance criteria" are implied by compliance with safety standards and substantial equivalence to predicate devices. Device performance is considered equivalent to the predicate devices.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Acoustic output within limits | Compliant with NEMA UD 2-2004 (R2009) |
| Biocompatibility | Compliant with AAMI / ANSI / ISO 10993-1:2009/(R)2013 |
| Cleaning and Disinfection effectiveness | Evaluated and found to conform |
| Thermal, Electrical, and Mechanical safety | Compliant with AAMI / ANSI ES60601-1:2005/(R)2012, IEC 60601-1-2 Edition 3, IEC 60601-2-37 Edition 2.0 |
| Software Life Cycle Processes | Compliant with AAMI / ANSI / IEC 62304:2006 |
| Risk Management | Compliant with ISO 14971 Second edition 2007-03-01 |
| Intended Use | Same as predicate devices (e.g., K161525 for TE7/TE5) |
| Basic Operating Modes | Same as predicate devices (e.g., B-Mode, M-Mode, PW-Mode, CW-mode, Color-Mode, etc.) |
| Transducer Materials | Same as predicate devices |
| Needle-Guided Bracket Materials | Same as predicate devices |
Study Proving Device Meets Acceptance Criteria:
The device meets its implied acceptance criteria by demonstrating substantial equivalence to existing legally marketed predicate devices and by compliance with recognized national and international safety and performance standards. The submission explicitly states: "Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards." (Page 31)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No new clinical performance or efficacy studies were conducted for this 510(k) submission. The submission relies on non-clinical tests and equivalence 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)
Not applicable. No new clinical performance or efficacy studies were conducted for this 510(k) submission that would require establishing ground truth from experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new clinical performance or efficacy studies requiring adjudication were conducted for this 510(k) 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 concerns a diagnostic ultrasound system, not an AI-assisted device, and no MRMC study was performed as confirmed by the statement "Clinical Studies: Not applicable. The subject of this submission, TE7/TE5 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." (Page 32).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a diagnostic ultrasound system, not a standalone algorithm, and no such performance study was conducted for this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No specific ground truth establishment for a new performance study is mentioned in this 510(k) submission. The device's safety and effectiveness are established through compliance with existing standards and comparison to predicate devices, which would have had their performance and safety established previously.
8. The sample size for the training set
Not applicable. No new machine learning or AI algorithm development requiring a training set is described in this 510(k) submission.
9. How the ground truth for the training set was established
Not applicable. As no new training set is indicated, this question is not relevant to the provided documentation.
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(61 days)
The DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 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 cephalic, adult cephalic, trans-raginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel, urology and transesophageal (Cardiac) exams.
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, CW mode, Color-mode, Color m-Mode, Power/Dirpower mode, TDI mode, 3D/4D mode, Elastography 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.
The provided text is a 510(k) summary for the Shenzhen Mindray Bio-medical Electronics Co., LTD DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards rather than detailing acceptance criteria and performance data for a novel algorithm or AI-driven feature.
Based on the provided information, the device is a general-purpose diagnostic ultrasound system, and the submission does not describe a study involving specific acceptance criteria for a novel AI-driven feature or algorithm. The document explicitly states "Clinical Tests: Not Applicable." and relies on non-clinical tests to demonstrate substantial equivalence to predicate devices.
Therefore, the requested information regarding algorithm-specific acceptance criteria, reported performance, sample sizes for test/training sets, data provenance, ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies with AI assistance is not present in the provided text.
The document indicates that the device meets safety and performance standards through non-clinical testing for compliance with:
- AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance)
- IEC 60601-1-2 Edition 3: 2007-03 (Electromagnetic Compatibility)
- IEC 60601-2-37 Edition 2.0 2007 (Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment)
- AAMI / ANSI / IEC 62304:2006 (Medical Device Software - Software Life Cycle Processes)
- ISO 14971 Second edition 2007-03-01 (Medical Devices - Application of Risk Management)
- NEMA UD 2-2004 (R2009) (Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment)
- AAMI / ANSI / ISO 10993-1:2009/(R)2013 (Biological Evaluation of Medical Devices)
The performance of the device is implicitly expected to be "substantially equivalent" to the predicate devices (Mindray DC-8 (K170277), Resona 7 (K171233), DC-70 (K163690), and M9 (K171034)) based on shared technology, intended uses, basic operating modes, materials, acoustic power levels, and compliance with safety standards.
In summary, the provided text does not contain detailed information on acceptance criteria and specific study results for a novel AI or algorithm performance, as it is a 510(k) submission focused on demonstrating substantial equivalence through adherence to general safety and performance standards for an ultrasound system.
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(140 days)
The M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 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, trans-rectal, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac pediatric, Trans-esoph.(Cardiac), peripheral vessel and urology exams.
M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System is a general purpose, portable/mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI mode 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.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria.
The document is a 510(k) premarket notification letter from the FDA to Shenzhen Mindray Bio-Medical Electronics Co., Ltd. and a 510(k) summary provided by Mindray. This type of regulatory submission primarily focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than proving performance against specific quantitative acceptance criteria through a clinical study.
The document details:
- Device Name: M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 Diagnostic Ultrasound System
- Regulatory Classification: Class II, Ultrasonic Pulsed Doppler Imaging System (892.1550), Ultrasonic Pulsed Echo Imaging System (892.1560), Diagnostic Ultrasound Transducer (892.1570).
- Intended Use: General diagnostic ultrasound imaging for various applications (fetal, abdominal, intra-operative, small organ, neonatal cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, peripheral vessel, urology exams) across different patient populations.
- Comparison to Predicate Devices: Lists several Mindray ultrasound systems (M7, M5, DC-70, DC-8, M9) and states that the new device has "the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate devices."
- Non-clinical Tests: Mentions evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, and conformance with various medical safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971, NEMA UD 2, ISO 10993-1).
It does not contain:
- A table of acceptance criteria and reported device performance.
- Information on sample sizes for test or training sets, or data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes for AI assistance.
- Standalone algorithm performance data.
- Details on the type of ground truth used (expert consensus, pathology, outcomes data).
- Information on how ground truth for training data was established.
This document serves as a regulatory clearance for a traditional medical device (ultrasound system), not an AI/ML-driven device that typically requires detailed clinical performance studies and acceptance criteria as outlined in your prompt.
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