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510(k) Data Aggregation
(97 days)
Resona I9, Resona I9 Exp. Resona I9T. Resona I9 Easi, Resona I9 Nasa, Resona IV. Imagyn I9, Imagyn I9S, Imagyn 19 Easi, Nuewa 19, Nuewa 19T, Nuewa 19 Exp, Nuewa 19 Easi, Anesus 19, Anesus 19, Anesus 19, Resona 19W, Recho 19, Recho 19 Exp, Recho 19S, Recho 19T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative (includes abdominal, thoracic, and vascular), Laparoscopic, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), Thoracic/Pleural, adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology 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, STO, Contrast imaging (Contrast agent for Liver).
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healtheare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
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 19, Resona I9W, Recho 19, Recho 19 Pro, Recho 19 Exp, Recho 19S, Recho 19T 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(Realtime 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 19, Resona 19 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, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T 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.
I'm sorry, but this document does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a diagnostic ultrasound system. It outlines the device's indications for use, its substantial equivalence to predicate devices based on non-clinical tests (acoustic output, biocompatibility, electrical/mechanical safety, etc.), and applicable safety standards it conforms to.
However, it explicitly states under "8. Clinical Studies": "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence."
Therefore, there is no information in this document regarding:
- Acceptance criteria tables with reported device performance for an AI/algorithm-related study.
- Sample sizes for test sets or data provenance.
- Number of experts for ground truth establishment or their qualifications.
- Adjudication methods.
- MRMC studies or effect sizes of AI assistance on human readers.
- Standalone algorithm performance studies.
- Type of ground truth used.
- Sample size for training sets.
- How ground truth for training sets was established.
This document is a regulatory clearance for a general purpose diagnostic ultrasound system, not a document detailing the performance and validation of an AI/ML component within such a system.
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(97 days)
Resona I8W, Resona I8, Resona I8S, Resona I8S, Resona I8T, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa 18, Nuewa 18 Exp, Nuewa 18T, Imagyn 18, Imagyn 18T, Imagyn 18T, Imagyn 18 Exp, Nuewa 1Y Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. It is intended for use in fetal, abdominal, Intra-operative (includes abdominal, Laparoscopic, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), Thoracic/Pleural, adult and pediatic cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology 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 imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
The Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY 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(Realtime 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 I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY 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.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
Important Note: The provided document is a 510(k) Premarket Notification from the FDA, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving direct performance against specific numerical acceptance criteria for a new, breakthrough device. Therefore, the "acceptance criteria" here refer to the criteria for demonstrating substantial equivalence to the predicate device, primarily through non-clinical testing and comparison of features. The "study" refers to these non-clinical tests and comparisons.
Description of Acceptance Criteria and the Study that Proves the Device Meets Them
The Shenzhen Mindray Bio-medical Electronics Co., LTD's Resona I8W and associated systems (subject device) seek to prove substantial equivalence to predicate devices, primarily the Resona I9 (K210699). The acceptance criteria are largely focused on demonstrating that the subject device's intended use, technological characteristics, safety, and effectiveness are comparable to the legally marketed predicate devices.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Implicitly Derived from 510(k) Content) | Reported Device Performance (Summary from 510(k)) |
|---|---|---|
| Intended Use Equivalence | Intended uses are consistent with predicate devices. | The subject device has the same intended uses as the predicate device Resona I9 (K210699), applicable for adults, pregnant women, pediatric patients and neonates for various exams (fetal, abdominal, intra-operative, small organ, cardiac, etc.) and modes of operation (B, M, PWD, CWD, Color, etc.). |
| Technological Characteristics Equivalence | Device operates using the same fundamental scientific technology. | Both subject and predicate systems transmit ultrasonic energy, perform post-processing to generate onscreen display of anatomic structures and fluid flow. They both allow for specialized measurements and calculations. |
| Safety - Material Biocompatibility | Patient contact materials of transducers and needle-guided brackets are the same as predicate devices. | The patient contact materials of the transducers and needle-guided brackets of the subject device are the same as the predicate devices. |
| Safety - Acoustic Output | Acoustic power levels are below FDA limits and are the same as predicate devices. | Acoustic power levels of the subject device are below FDA limits and are the same as the predicate device Resona I9 (K210699). |
| Safety - Electrical, Thermal, Mechanical | Device complies with recognized electrical and physical safety standards. | The subject device is designed in compliance with FDA recognized electrical and physical safety standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 14971, ISO 10993-1, IEC 62304, IEC 62366-1). This is stated to be the same as the predicate device Resona I9 (K210699). |
| Performance - Features and Functions | Equivalent features and functions, or new features cleared in other predicate/reference devices. | The subject device has equivalent features and functions to predicate devices. Specific advanced features (USAT, HRI+, HiFR CEUS, CEUS Chrono-Parametric Mode, TCMR, 3D-Print Format, Ultra-Micro Angiography, DICOM Pediatric SR, DICOM Urology SR, Biopsy Grid) were previously cleared in Resona R9 (K222928). Smart Bladder and ClamAV were cleared in Consona N9 (K221300). IOTA was cleared in Voluson E10 (K181985). |
| Non-clinical Tests | Device evaluated for acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, and mechanical safety. | Non-clinical tests were performed based on recognized international and national standards (NEMA UD 2-2004, ANSI AAMI ES60601-1, IEC 60601-1-2, IEC TR 60601-4-2, IEC 60601-1-6, IEC 60601-2-37, ISO 14971, ISO 10993-1, IEC 62304, IEC 62366-1). The results support substantial equivalence. |
| Clinical Studies | Not required to support substantial equivalence if non-clinical data is sufficient. | No clinical studies were deemed necessary or performed to support substantial equivalence for this submission. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The document explicitly states "Not applicable" for clinical studies. This submission relies on non-clinical performance data and comparison to predicate devices, rather than a clinical test set with patient data. The "test set" in this context refers to the device itself being tested for compliance with safety standards and functional equivalence.
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" with patient data was used to establish ground truth, this information is not relevant to this 510(k) submission. Ground truth, in the traditional sense of medical image interpretation, was not established for this device's comparison.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set requiring expert adjudication was conducted.
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. No MRMC study was conducted. The device is a diagnostic ultrasound system, not an AI-assisted interpretation tool. The submission does not describe any AI features that would necessitate an MRMC study to evaluate human reader improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a diagnostic ultrasound system. While it has software controls and analysis packages, it does not represent a standalone "algorithm only" device that provides interpretations without human interaction. Its performance is demonstrated through its ability to acquire and display ultrasound images and facilitate measurements for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable (in the clinical sense). Ground truth, in this context, is established through compliance with recognized safety standards and functional equivalence to predicate devices, not through clinical diagnostic verification against pathology or outcomes data for new clinical claims. The "ground truth" for the device's acceptable performance is its adherence to industry standards and its comparability to existing, legally marketed ultrasound systems.
8. The sample size for the training set:
- Not Applicable. This document does not describe a machine learning algorithm that underwent training with a specific dataset. It refers to a diagnostic ultrasound system.
9. How the ground truth for the training set was established:
- Not Applicable. Since there is no described machine learning training set, the establishment of its ground truth is not relevant here.
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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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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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(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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(126 days)
The DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. It is intended for use in fetal, abdominal. intra-operative (abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, cardiac(adult, pediatric), trans-soph. (Cardiac), peripheral vessel, and urology exams.
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/ DC-TQ is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CCW-Mode, Color-Mode , Power/Dirpower Mode, THI, Smart3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Strsin Elastography, Contrast imaging (Contrast agent for Liver and LVO), STE, STQ, Ultrasound Fusion Imaging, GYN/Pelvic and 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, Phased array, Volume and Pencil probe.
Here's a breakdown of the acceptance criteria and the study information for the DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1 | Evaluated and conducted in accordance with ISO 10993-1. |
| Electrical Safety | IEC 60601-1 | Complies with IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | Complies with IEC 60601-1-2. |
| Ultrasound Specific Safety | IEC 60601-2-37 | Complies with IEC 60601-2-37. |
| Acoustic Power Output | FDA Guidance for Industry and FDA Staff "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" | Below the limits recommended by FDA guidance. |
| Software General Safety | IEC 62304 and FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | Software verification and validation testing were conducted and documentation was provided. |
| Usability | IEC 62366 and IEC 60601-1-6 | Designed in compliance with these standards. |
| Risk Management | ISO 14971 | Application of risk management as per ISO 14971. |
| Quality Systems | 21 CFR 820, ISO 9001, ISO 13485 | Conforms with these quality systems. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not explicitly state specific sample sizes for test sets for the performance data. The sections on performance data refer to compliance with standards and guidelines rather than specific study parameters involving patient data.
Regarding data provenance, the document mentions non-clinical tests (biocompatibility, electrical safety, EMC, acoustic power, software verification/validation) and compliance with international standards. There is no mention of patient data (retrospective or prospective) or countries of origin for test data in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The non-clinical tests described involve compliance with established standards, which don't typically involve human expert ground truth for comparative performance in the same way clinical studies do.
4. Adjudication Method for the Test Set:
This information is not provided in the document. The tests performed are primarily technical and regulatory compliance checks.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improving with AI vs. without AI assistance:
This information is not provided in the document. The document explicitly states: "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." An MRMC study would be a type of clinical study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The document describes the device as a "software controlled, ultrasonic diagnostic system" with various "Main Added Features" (e.g., Ultrasound Fusion Imaging, Smart Pelvic Floor, STE/STQ, Strain Elastography, Smart Face, Smart Planes FH, Glazing Flow, Fusion RESP). While these features are algorithm-based, the document does not explicitly detail standalone performance studies for these specific algorithms, nor does it refer to them as "AI" in the context of standalone performance evaluation. The evaluation focuses on overall system compliance with safety and effectiveness standards, and the capabilities of these features as part of the system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests detailed, the "ground truth" is implied by the international and regulatory standards themselves (e.g., IEC, ISO, FDA guidance limits). For instance, acoustic power output is compared against specified limits, and electrical safety against defined safety requirements. There is no mention of clinical ground truth (like pathology or outcomes data) because clinical studies were not conducted.
8. The Sample Size for the Training Set:
This information is not provided in the document. The document describes specific software features but does not delve into the development or training of any potential machine learning components within these features.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the document, as details about training sets and their ground truth establishment are absent.
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