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510(k) Data Aggregation
(119 days)
TEX20/TEX20 Pro/TEX20S/TEX20 Exp/TEX20 Elite/TEX10 Pro/TEX10S/TEX10S/TEX10T/TEX10 Exp/ TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic, fetal, abdominal, thoracic, and vascular), Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-vaginal, musculo-skeletal(conventional, superficial), ThoracicPleural (For detection of fluid and pleural motion/sliding.), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology exams.
The TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite 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, Smart3D, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), and Contrast imaging (Contrast agent for Liver).
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ The Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X TEX10 Lite Diagnostic Ultrasound System 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 does not contain information about acceptance criteria or a specific study proving the device meets those criteria. The provided text is a 510(k) summary for a Mindray diagnostic ultrasound system, focusing on demonstrating substantial equivalence to predicate devices rather than reporting on a study with acceptance criteria.
The document states: "Not applicable. The subject of this submission, TEX20/TEX20 Pro/TEX20S/ TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ TEX10 / TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."
Therefore, I cannot provide the requested information.
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(93 days)
Resona 19/Resona 19 Exp/Resona I9T/Resona 19 Easi/Resona 19 Nasa/Resona IV/Imagyn 19/Imagyn 19/Imagyn 19S/ Imagyn 19 Easi/Nuewa 19/Nuewa 19T/Nuewa 19 Exp/Nuewa 19 Easi/Anesus 19/Anesus 19 Easi/Eagus 19 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, transvaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, urology and Thoracic/Pleural exams.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, 4D(Reape View, TDI, Color M, Strain Elastography, Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).
The Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp. Nuewa I9 Easi. Anesus I9, Anesus I9 Easi. Eagus I9 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, Smart3D, 4D(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STO, Contrast imaging (Contrast agent for Liver).
The Resona I9, Resona I9 Exp. Resona I9S, Resona I9T, Resona I9 Easi, Resona 19 Nasa, Resona IV, Imagyn 19, Imagyn 19S, Imagyn 19 Easi, Nuewa 19, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.
The provided text is a 510(k) summary for the Resona I9 series Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of features. It explicitly states that clinical studies were not required or performed for this submission.
Therefore, many of the requested elements regarding acceptance criteria and a study proving the device meets these criteria (especially those related to AI performance, human reader improvement, and ground truth establishment) cannot be found in this document. The device described is a general-purpose diagnostic ultrasound system, not an AI-powered diagnostic tool, which further explains the absence of such information.
However, I can extract the general acceptance criteria for this type of device based on the non-clinical tests performed to demonstrate safety and effectiveness.
Here's a breakdown of the information available and the parts that are explicitly stated as "Not Applicable" or absent:
Acceptance Criteria and Device Performance
Since this is a 510(k) for a diagnostic ultrasound system and not an AI-driven device with specific performance metrics like sensitivity/specificity, the acceptance criteria are related to safety, electrical performance, acoustic output, and compatibility. The "reported device performance" is the manufacturer's claim that the device passed these tests and conforms to the standards.
While there isn't a table of specific numerical performance criteria (e.g., minimum diagnostic accuracy), the general acceptance is based on conformity to recognized medical device standards and comparability to predicate devices.
| Acceptance Criterion (General) | Reported Device Performance (as stated in the document) |
|---|---|
| Acoustic Output Safety (below FDA limits) | "The acoustic power levels of Resona I9... are below the limits of FDA, which are the same as the predicated device Resona 7 (K171233)." |
| Biocompatibility (for patient contact materials) | "The patient contact materials of the transducers and needle-guided brackets... are the same to the predicate devices or tested under ISO 10993-1." |
| Cleaning and Disinfection Effectiveness | "Resona I9... has been evaluated for... cleaning and disinfection effectiveness." (Implied acceptance by passing evaluation) |
| Electrical Safety (conforms to standards) | "Resona I9... is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device Resona 7 (K171233)." |
| Thermal Safety | "Resona I9... has been evaluated for... thermal... safety." (Implied acceptance by passing evaluation) |
| Mechanical Safety | "Resona I9... has been evaluated for... mechanical safety." (Implied acceptance by passing evaluation) |
| Electromagnetic Compatibility (EMC) | Confirms compliance with IEC 60601-1-2 Edition 4.0 2014-02 for electromagnetic disturbances. |
| Usability (conforms to standards) | Confirms compliance with IEC 60601-1-6 Edition 3.1 2013-10 (usability) and IEC 62366-1 Edition 1.0 2015-02 (usability engineering). |
| Software Life Cycle Processes (conforms to standards) | Confirms compliance with IEC 62304 Edition 1.1 2015-06 for medical device software. |
| Risk Management (conforms to standards) | Confirms compliance with ISO 14971 Second edition 2007-03-01 for risk management. |
| Quality System Conformance | "The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems." |
Study Details (Based on the Provided Document)
-
Sample size used for the test set and the data provenance:
- Not Applicable / Not Provided. The document states "Non-clinical Tests" were performed, but does not provide details on specific sample sizes for these tests (e.g., how many transducers were tested for acoustic output, or how many materials for biocompatibility). The document describes the system and its features, not a clinical trial or performance study based on patient data.
- Data Provenance: Not specified, as it's not a clinical data study. Non-clinical tests are typically performed in a lab setting by the manufacturer.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As this is a 510(k) based on non-clinical testing and comparison to a predicate device, there is no mention of expert-established ground truth for a test set in the context of diagnostic accuracy.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set with human assessment and adjudication is mentioned.
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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. The document explicitly states: "Clinical Studies: Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool that would typically undergo MRMC studies for AI performance improvement.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a diagnostic ultrasound imaging system, not a standalone AI algorithm. While it mentions "new software and hardware options" and features like "Smart Scene 3D" or "High frame rate STE," these are described as "improvements or enhancement based on the cleared functions to facilitate users," implying integrated features within the ultrasound system, not a separate AI algorithm requiring standalone performance validation against a ground truth. None of these features are presented as standalone diagnostic algorithms.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For the non-clinical tests, "ground truth" would be the established scientific/engineering standard for a given test (e.g., a calibrated device for acoustic output measurements, or a specified biochemical reaction for biocompatibility). There is no clinical ground truth (like pathology or outcomes data) mentioned, as no clinical studies were performed.
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The sample size for the training set:
- Not Applicable. The document does not discuss a "training set" in the context of machine learning or AI.
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How the ground truth for the training set was established:
- Not Applicable. No training set is mentioned in the context of machine learning.
In summary, the provided 510(k) document is for a general diagnostic ultrasound system and asserts substantial equivalence via non-clinical testing and comparison to predicate devices, not through clinical performance studies involving a test set, expert readers, or AI algorithm validation against ground truth.
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(119 days)
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative, Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph.(Cardiac), peripheral vessel and urology exams.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained 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, iScape, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).
The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, CW-Mode, CW-Mode, Color-Mode , Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).
This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array probe.
The provided document is a 510(k) Summary for a diagnostic ultrasound system. It outlines the device's features, intended use, and comparison to predicate devices, but it explicitly states that no clinical studies were performed.
Therefore, I cannot provide information on:
- Acceptance criteria and reported device performance based on clinical studies.
- Sample size, data provenance, ground truth establishment, or expert details for a test set.
- Adjudication method or MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Training set details (sample size, ground truth establishment).
The document explicitly states:
8. Clinical Studies
Not applicable. The subject of this submission, M9/M9CV/M9T/M8 Elite/M10 /M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.
This indicates that the substantial equivalence determination for this ultrasound system was based on non-clinical tests (acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, and mechanical safety, and compliance with recognized standards) and a comparison of technical characteristics and intended uses with legally marketed predicate devices, rather than a study proving the device meets specific acceptance criteria for AI-assisted performance or human-in-the-loop improvements.
The "acceptance criteria" for this device, as implied by the document, are primarily related to safety and effectiveness being substantially equivalent to predicate devices through engineering and design validation, and adherence to relevant industry standards. There are no performance metrics provided that would typically be seen for an AI/ML-driven device requiring clinical validation against specific performance targets.
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(198 days)
Resona R9/Resona R9 Exp/Resona R9S/Nuewa R9/Nuewa R9/Nuewa R9 Pro/Nuewa R9 Pro/Nuewa R9S/Resona 7/ Resona 7CV/Resona 7EXP/Resona 70B/Resona 7PRO/Imagyn 7/Resona Y Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. If is intended for use in fetal, abdominal. Intraoperative, pediatic, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, musculoskeletal(conventional, superficial), adult and pediatic cardiac, trans-esoph. (Cardiac), peripheral vessel, urology exams.
This device is a general purpose diamostic 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.
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, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).
The Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 70B, Resona 7PRO, Imagyn 7, Resona Y Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system.
This system is a Track 3 device that employs an array of probes that include linear array, Phased array, pencil phased and convex array.
The provided document is a 510(k) Summary for a Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and performance data for a new AI/CADe device. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics (especially for AI/CADe tools) is not present in this document.
However, I can extract information related to the device's broader regulatory and non-clinical testing.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the document as a set of quantified acceptance criteria and corresponding performance metrics for a specific function or feature. The document extensively compares the device to predicate devices and lists various non-clinical tests performed, implying that meeting standards is the "acceptance criteria."
However, I can infer the "acceptance criteria" based on the listed non-clinical tests and the "performance" as compliance with these standards and equivalence to predicate devices.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Acoustic Output: Below FDA limits (NEMA UD 2-2004 (R2009)) | "The acoustic power levels of [Device Names] are below the limits of FDA, which are the same as the predicated device Resona 7 (K171233)." (Page 9) |
| Electrical and Physical Safety: Compliance with AAMI / ANSI ES60601-1:2005/(R)2012, IEC 60601-1-2 Ed. 4.0, IEC 60601-1-6 Ed. 3.1, IEC 60601-2-37 Ed. 2.1 | "Resona R9...is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device Resona 7 (K171233)." (Page 9) |
| Biocompatibility: Transducer materials tested under ISO 10993-1. Specific testing for ELC13-4U transducer. | "The patient contact materials of the transducers are tested under ISO 10993-1." (Page 9) "The materials used in the new transducers (except for ELC13-4U) and needle-guided brackets were the same as in the predicate device. And the ELC13-4U transducer was testing for biocompatibility." (Page 5) |
| Cleaning and Disinfection Effectiveness: Provided instructions for end-user. | "All the transducers and needle-guided brackets were provided non-sterile to the end user. And all the disinfection/sterilization methods for the new transducers and needle guide brackets were provided to the end user and the users are notified that disinfection /sterilizaiton are necessary in the Operation Manual." (Page 5) |
| Risk Management: Compliance with ISO 14971 | "This device has been tested and evaluated under the following standards: ...ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices." (Page 11) |
| Software Life Cycle Processes: Compliance with AAMI / ANSI / IEC 62304:2015 | "This device has been tested and evaluated under the following standards: ...AAMI / ANSI / IEC 62304:2015, medical device software - software life cycle processes." (Page 11) |
| Usability Engineering: Compliance with IEC 62366-1 Edition 1.0 2015-02 | "This device has been tested and evaluated under the following standards: ...IEC 62366-1 Edition 1.0 2015-02 medical devices - application of usability engineering to medical devices." (Page 11) |
| Overall Safety and Effectiveness Profile: Similar to predicate device. | "Based on the performance data as documented in the study, the Resona R9 series Diagnostic Ultrasound system was found to have a safety and effectiveness profile that is similar to the predicate device." (Page 12) "The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems." (Page 12) |
| Functional Equivalence: Same intended uses, basic operating modes, technological characteristics, imaging modes, and comparable key safety and effectiveness features as predicate devices (e.g., Resona 7 (K171233), DC-80 (K192152), RS85 (K192903), etc., for specific features like AutoEF, Ultra-Micro Angiography, Smart Fetal HR). Transducers are similar or cleared. New features are comparable to features in other cleared predicate/reference devices. | "Resona R9...has the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes." (Page 8) "The subject device also has the same intended uses and basic operating modes as the predicate devices." (Page 8) "The Resona R9...has the same imaging modes as the predicated devices." (Page 10) "The Resona R9...has the same functions as the predicated devices." (Page 10) "The Resona R9...has similar tranducers with the predicated devices." (Page 10) |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This document does not describe a clinical study with a test set of patient data. The evaluation is based on non-clinical engineering and performance testing against recognized standards and comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No human expert ground truth was established for a test set, as no clinical study is presented.
4. Adjudication method for the test set
Not applicable/Not provided. No test set or ground truth was established that would require adjudication.
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/Not provided. This document explicitly states: "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." (Page 11). Therefore, no MRMC study was conducted or reported. The device is a diagnostic ultrasound system, not specifically an AI/CADe tool for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable/Not provided. The document does not describe a standalone algorithm performance evaluation. Some features listed (e.g., Smart V Trace, Smart ICV, AutoEF, Smart Fetal HR, Smart Caliper, Smart Trace) imply quantitative analysis capabilities, but no performance metrics for these "smart" features are provided in a standalone context. These are likely integrated functions within the ultrasound system, not standalone AI algorithms intended for independent evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. For the non-clinical tests conducted, the "ground truth" would be the specifications and requirements of the referenced standards (e.g., NEMA UD 2, IEC 60601 series, ISO 10993-1).
8. The sample size for the training set
Not applicable/Not provided. This document describes a traditional medical device (ultrasound system) and its non-clinical testing for substantial equivalence, not the development or training of an AI/ML algorithm. Therefore, no training set information is provided.
9. How the ground truth for the training set was established
Not applicable/Not provided. As no training set is discussed, there's no information on how its ground truth might have been established.
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(125 days)
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.
| Feature | Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|---|
| New Applications | Performance of new applications (e.g., ophthalmic, CW to fetal, abdominal, fetal to specific transducers) is comparable to that of predicate devices where these applications were already cleared. | The ophthalmic application has already been cleared with L12-4s in the predicate device TE7/TE5 (K180912). |
| The fetal application with CW has already been cleared with SP5-1s in the predicate device TE7/TE5 (K180912). | ||
| The abdominal application has already been cleared with L13-3s in the predicate device MX7 (K200001). | ||
| The fetal application has already been cleared with L9-3U in the predicate device Resona 7 (K171233). | ||
| Smart 3D | Performance comparable to existing Smart 3D inpredicate devices. | This feature has been cleared with L16-4Hs in the predicate device M9 (K171034). Functionality described: operator moves probe for scanning, system reconstructs and displays a single frame of 3D image. |
| LVO mode | Performance comparable to existing LVO mode in predicate devices. | This feature has been cleared with L10-5 in predicate device ZS3 (K192410). |
| iScape View | Performance comparable to existing iScape View in predicate devices. | The feature has been cleared on the predicate device M9 (K171034). Functionality described: extends field of view by piecing together multiple B images into a single, extended B image. |
| Smart IVC | Automated measurement of IVC inner diameter and calculation of change rate in B mode image is accurate and reliable. | The feature has been cleared on the predicate device MX7 (K200001). Functionality described: automatically measure the IVC inner diameter and calculate the change rate in the B mode image. |
| Smart VTI | Calculation of CO of LVOT to evaluate cardiac function is accurate and reliable. | The feature has been cleared on the predicate device MX7 (K200001). Functionality described: used to calculate the CO (cardiac output) of the LVOT (left ventricular output tract), so as to quickly evaluate the cardiac function. |
| Smart B-Line | Detection of B-line of the lung in B mode (real-time and freeze) is accurate and reliable. | The feature has been cleared on the predicate device MX7 (K200001). Functionality described: used to detect the B line of the lung in B mode; supports B-line detecting in both real-time and freeze modes. |
| EPSS | Accurate measurement of the distance between point E and Interventricular Septum when mitral valve is fully open. | The feature has been cleared on the predicate device MX7 (K200001). Functionality described: measures the distance between point E and Interventricular Septum when mitral valve is fully open. |
| Smart Trace | Accurate tracing of contours of normal anatomical regions, automatic recognition of margins, and measurement of lengths, area, and circumference. | This feature is similar to the cleared feature Trace on the predicate device Resona 7 (K171233). Functionality described: helps the operator to trace the contour of the normal anatomical regions by automatically recognizing the margin of the target and measures the lengths of major axis, area and circumference of the closed region. |
| Auto GA | Accurate identification of gastric antrum boundary and calculation of its area. | This feature is similar to the feature Area trace on the predicate device TE7/TE5 (K180912). Functionality described: After acquired image(s) of gastric antrum, by freezing image and tapping the Auto GA button, the feature shows boundary of gastric antrum and calculates the area of gastric antrum. |
| Smart Bladder | Accurate measurement of urine volume in the bladder. | The feature has been cleared on the predicate device DC-40 (K183377). Functionality described: used to measure the volume of the urine in the bladder. |
| Smart FHR OB1 | Automatic measurement of fetal heart rate is accurate and reliable. | It is similar to the cleared feature OB FHR (M) on the predicate device Resona 7 (K171233). Functionality described: to measure the fetal heart rate automatically. |
| Acoustic Power | Below FDA limits. | The acoustic power levels of TE7/TE5/TE7 Max/TE5 Max/TE9 are below the limits of FDA, which is the same as the predicated device TE7/TE5 (K180912). |
| Safety (electrical, physical) | Compliance with FDA recognized electrical and physical safety standards. | TE7/TE5/TE7 Max/TE5 Max/TE9 is designed in compliance with the FDA recognized electrical and physical safety standard, which is the same as the predicated device TE7/TE5 (K180912). Compliance with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62366, IEC 60601-1-6, ISO14971. |
| Biocompatibility | Materials of probes and needle-guided brackets are tested under ISO 10993-1 or are the same as predicate. | The materials of probes and needle-guided brackets of TE7/TE5/TE7 Max/TE5 Max/TE9 are the same to the predicate device or tested under ISO 10993-1. |
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.
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