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510(k) Data Aggregation
(266 days)
The SonoMax Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D/3D/4D), B/M, M, B+CFM, B+CPA(PD), B+DPD, B+PW, B+CW, B+CFM+D(PW)/CW, B+CPA(PD)+D(PW)/CW, TDI and Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic imaging instrument intended for use by appropriately-trained qualified healthcare professionals for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Cardiac (adult, pediatric), Musculoskeletal (Conventional, Superficial), Peripheral Vascular, Trans-esophageal, Trans-vaginal, OB/GYN and Urology, which is intended to be used in a hospital or medical clinic.
The SonoMax Series Digital Doppler Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image in B(2D/3D/4D), B/M, M, B+CFM, B+CPA(PD), B+DPD, B+PW, B+CW, B+CFM+D(PW)/CW, B+CPA(PD)+D(PW)/CW, TDI, Fusion Harmonic lmaging modes or a combination of these mode.
The FDA 510(k) summary for the SonoMax Series Digital Color Doppler Ultrasound System (K233697) indicates that no clinical testing was required to demonstrate substantial equivalence. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets performance criteria beyond non-clinical testing and comparison to a predicate device.
Specifically, under "7. Clinical Test:" on page 6, it explicitly states: "No clinical testing was required."
Given this, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or ground truth for the training set from the provided text for this cleared device. The substantial equivalence determination was based on non-clinical tests (electrical, mechanical, thermal, electromagnetic compatibility, biocompatibility, and acoustic output) and a comparison of the device's technical specifications and indications for use to those of a predicate device (XBit 90 Digital Color Doppler Ultrasound System, K200780).
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(122 days)
The SonoAir Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D),B/M,M,B+CFM,B+CPA (PD),B+DPD,B+PW,B+CFM + D (PW),B+CPA(PD) + D (PW), Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic intended for use by an appropriatelytrained qualified clinician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid, testes ), Adult Cephalic, Cardiac Adult. Musculo-skeletal(Conventional, Superficial).Peripheral Vascular, Trans-vaginal and Urology,which is intended to be used in a hospital or medical clinic.
The SonoAir Series Digital Doppler Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (2D), Fusion Harmonic Imaging, M-Mode, Pulsed Doppler (PW) Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode or a combination of these mode.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SonoAir Series Digital Color Doppler Ultrasound System, structured to answer your questions:
Important Note: The provided document is a 510(k) Summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission generally relies on demonstrating that the new device is as safe and effective as existing devices, often without requiring new large-scale clinical trials measuring specific performance metrics against pre-defined acceptance criteria in the way a novel AI algorithm might.
1. A table of acceptance criteria and the reported device performance
The document does not provide explicit acceptance criteria and corresponding performance metrics for the SonoAir Series Digital Color Doppler Ultrasound System in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications, safety standards, and intended uses.
The "acceptance criteria" in this context are broadly related to meeting established medical device safety and performance standards, and having comparable features and indications for use as the predicate device. The "reported device performance" is essentially that it complies with these standards and operates similarly to the predicate.
Here's a table based on the provided information, focusing on the comparisons made for substantial equivalence, rather than specific performance metrics against diagnostic acceptance criteria:
| Acceptance Criterion (Implicit) | Reported Device Performance (SonoAir Series) |
|---|---|
| Indications for Use (Substantially Equivalent to Predicate) | Comparable to predicate devices (EBit 90 & XBit 90) with minor differences. Differences analyzed and deemed not to raise new safety/effectiveness concerns. |
| Design | Same autocorrelation for color processing, FFT for pulse/CW Doppler, supporting linear, curve, phase array probes, Cine playback, image archive. |
| Operational Controls | Same design as predicate. Minor differences in setting ranges (e.g., depth range, color wall filter, color baseline, PW sweeping speed, PW sample volume, PW angle correction, baseline) exist but comply with standards and meet clinical requirements. |
| Safety Compliance | Complies with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993 (various parts). |
| Operational Modes | Comparable operational modes (B mode, M mode, CFM, PW, CPA(PD), DPD, Triplex, HPRF, FHI, etc.) to predicate devices. |
| Measurements | Similar 2D, M-mode, and Doppler measurements to predicate devices. |
| Transducer Types & Connectors | Convex Array, Phased Array, Linear Array, 4 ports. Considered similar to predicate (differing slightly in volume probe and number of ports). |
| Users / Sites | Hospitals, clinics usage (same as predicate). |
| Acoustic Output | Track 3; MI, TIS, TIC, TIB (Derated Ispta: 720mW/cm² max, TIS/TIB/TIC: 0.1-4.0 Range, Mechanical Index: 1.9 Max, Derated Isppa: 190 W/cm² max) - same as predicate. |
| Power Requirements | Power requirements: AC: 100V-240V, Freq: 50-60Hz; Operating temp: 10-38°C; relative humidity 30-75%; Barometric pressure: 700 to 1060hPa. Operating temperature is within the scope of the predicate. |
| Software Documentation (Moderate Level of Concern) | Included and reviewed per FDA guidance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical testing was required." This means there was no specific clinical test set used to evaluate the device against diagnostic performance metrics. The evaluation was based on non-clinical tests demonstrating compliance with recognized standards and a comparison of technical specifications with predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since no clinical testing was required, there were no "experts" in the context of establishing ground truth for a diagnostic test set. The evaluation relied on regulatory compliance and engineering comparisons.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a general diagnostic ultrasound system, not an AI-assisted diagnostic device, and no clinical studies of this nature were conducted or required for this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a general diagnostic ultrasound system, not an AI-driven algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this 510(k), the "ground truth" for demonstrating substantial equivalence was adherence to recognized medical device standards and the technical specifications and operational characteristics of the legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is a general diagnostic ultrasound system; there is no mention of an AI component or a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable, as no training set was identified.
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(245 days)
When properly worn, the surgical face mask is intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate material. This device is non sterile and for single use only.
Not Found
The provided document is an FDA 510(k) clearance letter for a Surgical Face Mask. It is not a document describing an AI/ML medical device, nor does it contain information about acceptance criteria, study designs, sample sizes, expert ground truth establishment, or any of the other technical details typically associated with the evaluation of AI/ML devices.
Therefore, I cannot extract the requested information from the provided text. The document pertains to a Class II medical device (M1 Surgical Face Mask) and focuses on its substantial equivalence to predicate devices, regulatory compliance, and indications for use, without any mention of AI/ML components or their performance evaluation.
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(230 days)
The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, Color Doppler, Combined(B+Color), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Pediatrics, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid.
The Digital Color Doppler Palm Ultrasound System is intended for use in environments where is provided by healthcare professionals.
The SonoEye P1/ SonoEye P1-G/ SonoEye V1-G/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System is a mobile, general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The Digital Color Doppler Palm Ultrasound System is a portable system facilitating point of care ultrasound applications.
The Digital Color Doppler Palm Ultrasound System includes:
- A commercial off-the-shelf (COTS) Android mobile device .
- . CHISON Ultrasound software is running as an app (Android) on the COTS device
- . The SonoEye P1, SonoEye V1, SonoEye G1, SonoEye P1-G, SonoEye V1-G, SonoEye G1-G Linear array USB transducer.
The provided text is a 510(k) Summary for the CHISON Medical Technologies Co., Ltd. SonoEye P1/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study (or lack thereof) to prove the device meets these criteria, based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in the format of specific performance metrics with target values. Instead, it demonstrates compliance by comparing the subject device's features and safety adherence to those of legally marketed predicate devices. The "acceptance criteria" are implied to be the standards and functionalities met by the predicate devices and general medical device regulations.
The provided comparison table shows similarities in various aspects between the subject device and the predicate devices. Below is a summarized table reflecting the reported device performance as per the comparison table, where "Same" indicates alignment with predicate devices, and specific values are given where differences are noted.
Table 1: Reported Device Performance vs. Implied Acceptance Criteria (via Predicate Comparison)
| Acceptance Criteria Category (Implied by Predicate Features & Standards) | Reported Device Performance (SonoEye Digital Color Doppler Palm Ultrasound System) |
|---|---|
| Indications for Use | Pediatrics, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid (Same as some predicate indications, subset of others) |
| Design Fundamentals | Autocorrelation for color processing, FFT for pulse Doppler processing, Supporting Linear probe, Cine play back capability, Image file archive (Same as predicates) |
| TGC Functionality | STC (Same as predicates' TGC) |
| Depth Range | 1.0 to 9.9cm (Different from predicate ranges, but "meets clinical requirements") |
| Shades of Gray | 256 (Same as predicates) |
| Gain Control | Gain: 0-255, 1/step (Same as predicates) |
| Focus Control | Adjustable (Same as predicates) |
| ROI Adjustment | Adjustable (Same as predicates) |
| Baseline | Present (Same as predicates) |
| Cine Control | Step, play backward, play continuously (Same as predicates) |
| Freeze Control | Toggling freeze key (Same as predicates) |
| Safety Compliance | ANSI/AAMI ES60601-1, IEC60601-1, IEC60601-2-37, IEC60601-1-2, ISO 10993-1 (Same as predicates) |
| Operation Modes | B mode, PW mode, B/M mode, CFM mode, FHI (Same as predicates, FHI corresponds to predicate's IQ) |
| Image Controls | Gain, Depth, STC, Compound, Frequency Scaling, Freeze/Unfreeze, Zoom (Same as predicates) |
| Measurements (2D mode) | Depth, Distance, Area, Volume (Same as predicates, volume mentioned which some predicates have) |
| Measurements (Doppler mode) | Velocity, Time, B/M mode: Distance, Time, HR (Same as predicates) |
| Specialized Measurement Packages | Vessel measure package, Small Organ measure package (Same as predicates) |
| Reporting | General report, Vessel report, Small Organ report (Same as predicates) |
| User Interface Features | Multi-language Interface, Clipboard (Thumbnail), Instant AIO (iTouch), Biopsy Guide, SonoRemote (Reacts Session Views), SonoNeedle (iNeedle), SuperNeedle (NeedleEnhance), Save Cine, Save Image, Cine Loop, Annotation, Bodymark, Arrow Mark, Patient management, Voice/Angle/Baseline on PW, Physical key, Setting, Archives (Patient database), Tutorials, Easyview (Review), Demo, About, Sample Gate adjustments (Same as predicates, with some naming differences) |
| Display Annotations | Logo; Hospital Name; Exam date; Exam time; Mechanical index; Thermal index; Probe model; STC; Focus position; Imaging parameters; System status; Gray/Color bar (Same as predicates, STC vs TGC) |
| Transducer Types & Connectors | Linear Array, USB interface (Subset of predicate types) |
| Users / Sites | Hospitals, clinics usage (Same as predicates) |
| Acoustic Output | Track 3, Ispta.3 ≤ 720 mW/cm², MI ≤ 1.9, TI ≤ 6.0 (Same as predicates) |
| Power Requirements | DC 5V, Operating temperature: 10-38°C, Relative humidity: 30-75%, Barometric pressure: 700 to 1060 hPa (Different from predicate, but verified compliant with standards) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical testing was required." This indicates that there was no test set involving human subjects or clinical data for performance evaluation in the usual sense of a clinical study. The evaluation focused on non-clinical tests and comparisons to predicate devices. Therefore, information on sample size, data provenance, or retrospective/prospective nature of a clinical test set is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since no clinical testing was performed, there was no "test set" in the context of clinical images requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical testing and no clinical test set were used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a "Digital Color Doppler Palm Ultrasound System," which is a diagnostic imaging system, not an AI-assisted diagnostic tool for interpretation. The document does not mention any AI capabilities or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is an ultrasound system with human-in-the-loop operation for image acquisition and interpretation. There's no "algorithm only" performance reported in the context of a diagnostic interpretation task. The non-clinical tests indicate standalone performance of the device in terms of safety and technical specifications, but not diagnostic accuracy of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical testing was performed for diagnostic accuracy. The ground truth for the non-clinical tests would be the established engineering and safety standards (e.g., IEC 60601-1, ISO 10993-1) against which the device's technical performance was measured.
8. The sample size for the training set
Not applicable. The document does not indicate the use of machine learning or AI models requiring a training set for diagnostic purposes. The software mentioned is a "CHISON Ultrasound software" running as an Android app, which enables the device's functionalities, not a learning algorithm.
9. How the ground truth for the training set was established
Not applicable, as no training set for AI/ML was mentioned or implied.
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(226 days)
The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, CFM, Combined (B+CFM), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for Abdominal, Neonatal Cephalic, Adult Cephalic, Cardiac Adult, Cardiac Pediatric.
The Digital Color Doppler Palm Ultrasound System is intended for use in environments where is provided by healthcare professionals.
The SonoEye P3/ SonoEye V3/ SonoEye G3 Digital Color Doppler Palm Ultrasound System is a mobile, general purpose, softwarecontrolled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The SonoEye P3/ SonoEye V3/ SonoEye G3 Digital Color Doppler Palm Ultrasound System is a portable system facilitating point of care ultrasound applications. The SonoEye P3 Series Digital Color Doppler Palm Ultrasound System includes:
- · A commercial off-the-shelf (COTS) Android mobile device
- CHISON Ultrasound software is running as an app (Android ) on the COTS device
- The SonoEye P3, SonoEye V3, SonoEye G3 Phase array USB transducer
The provided text does not include information about AI/ML models or clinical studies involving human readers and AI assistance. Instead, it describes a 510(k) Premarket Notification for a medical device (Digital Color Doppler Palm Ultrasound System) and demonstrates its substantial equivalence to predicate devices, primarily through non-clinical testing and comparison of technical specifications.
Therefore, many of the requested categories for AI/ML model acceptance criteria and study design cannot be filled from the provided document. The document explicitly states: "No clinical testing was required." This indicates that the FDA clearance for this device was based on demonstrating similar technical and safety characteristics to already approved devices, rather than a clinical effectiveness study involving human users or AI.
However, I can extract the information that is present according to the prompt's structure:
Device: SonoEye P3/ SonoEye V3/ SonoEye G3 Digital Color Doppler Palm Ultrasound System
1. A table of Acceptance Criteria and the Reported Device Performance
Based on the provided document, the acceptance criteria are adherence to recognized medical device safety and performance standards and demonstration of substantial equivalence to predicate devices. The "reported device performance" is primarily the statement of compliance with these standards and the comparison of specifications.
| Category | Acceptance Criteria (Stated Requirements/Standards Met) | Reported Device Performance (as stated in the 510(k) summary) |
|---|---|---|
| General Compliance | Substantial equivalence to legally marketed predicate devices. | Concluded as substantially equivalent to predicate devices (Lumify Diagnostic Ultrasound System K192226, Clarius Ultrasound System K192107, TE7 Diagnostic Ultrasound System K160381) with regard to safety and effectiveness. |
| Electrical Safety | Compliance with IEC 60601-1 (Medical Electrical Equipment - Part 1: General Requirements for Safety) and ANSI/AAMI ES60601-1:2005. Transducers to meet Type BF isolated applied part requirements. When used with IEC 60950-1 compliant COTS devices, the system meets IEC 60601-1 Class II requirements. | Transducer and software, with representative device, verified compliant with IEC 60601-1. Transducers meet Type BF isolated applied part requirements. When used with IEC 60950-1 compliant COTS devices, the system meets IEC 60601-1 requirements for Class II equipment. The subject device passed hardware test for voltage and complied with IEC60601-1 & IEC60601-2-37 requirements. Passed temperature test and complied with IEC60601-1 & IEC60601-2-37 requirements. Complied with humidity requirements (IEC60601-1 & IEC60601-2-37) and within normal range. |
| EMC | Compliance with IEC 60601-1-2: 2014 (Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests). Classified as Group 1, Class A equipment per CISPR 11 for radiated and conducted electromagnetic disturbances. When used with IEC 55032 compliant COTS devices, the system meets IEC 60601-1-2 requirements for Group 1, Class A. | Transducer and representative Android device classified as Group 1, Class A equipment in accordance with CISPR 11. When used with IEC 55032 compliant COTS devices, the system meets IEC 60601-1-2 requirements for Group 1, Class A equipment. |
| Biocompatibility | Compliance with ISO 10993-1:2009 (Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process) and FDA guidance "Use of International Standard ISO 10993-1..." | Device found to conform to applicable medical device safety standards in regards to biocompatibility, and conforms to ISO 10993-1. |
| Ultrasound Specific | Compliance with IEC 60601-2-37: 2007 (Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment) and FDA guidance "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers". Acoustic Output: Track 3; Ispta.3 ≤ 720 mW/cm², MI ≤ 1.9, TI ≤ 6.0. | Device found to conform to applicable medical device safety standards in regards to thermal and mechanical safety, and fulfills the requirement of IEC 60601-2-37. Acoustic output meets criteria (Track 3; Ispta.3 ≤ 720 mW/cm², MI ≤ 1.9, TI ≤ 6.0). |
| Software | Compliance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate Level of Concern) and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". COTS Android devices: output current ≥ 1.5A, output voltage 5V±5%, full compliance with USB 2.0 standard. Representative Android devices (Samsung Galaxy A70s, Huawei MatePad Pro) configured as specified (CPU, RAM, ROM, resolution, WLAN, OS, Bluetooth). | Software Documentation for a Moderate Level of Concern included. Representative Android devices meet specified current, voltage, and USB 2.0 compliance. Samsung Galaxy A70s and Huawei MatePad Pro configurations are detailed. |
Note: The performance metrics provided relate to the operational specifications of the device (e.g., depth range, shades of gray, gain, focus, measurement types, transducer types, acoustic output limits, power requirements) and were deemed "Same" or had "SE (Substantial Equivalence) Analysis" where differences were addressed and determined not to affect safety or effectiveness.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of this 510(k) summary, as it explicitly states "No clinical testing was required." The "testing" referred to is non-clinical verification of compliance with standards and comparison to predicate devices, not a study on a human patient population or a dataset for AI.
- Data Provenance: Not applicable, as there was no clinical test set data. The device itself is manufactured in China (CHISON Medical Technologies Co., Ltd., Wuxi, Jiangsu, China).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as "No clinical testing was required" and therefore no human expert-established ground truth was part of the submission for clinical performance. The ground truth for engineering/safety testing would be derived from standard test equipment and protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical test set requiring adjudication was performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was done. The document explicitly states "No clinical testing was required." This premarket notification is for a general diagnostic ultrasound system, not an AI-powered diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone algorithm performance study was done. This device is a hardware ultrasound system with integrated software, not an AI algorithm intended for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests conducted (electrical safety, EMC, biocompatibility, acoustic output), the "ground truth" would be the specifications and requirements defined by the international standards (IEC, ISO, ANSI/AAMI, CISPR) and FDA guidance documents. These are objective engineering and physical measurements. Clinical ground truth for diagnostic accuracy was not established or required for this 510(k) clearance.
8. The sample size for the training set
- Not applicable, as there is no mention of an AI/ML model for which a training set would be used.
9. How the ground truth for the training set was established
- Not applicable, as there is no mention of an AI/ML model requiring a training set.
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(226 days)
The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, Color Doppler, Combined(B+Color), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Pediatrics, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid.
The Digital Color Doppler Palm Ultrasound System is intended for use in environments where healthcare is provided by healthcare professionals.
The SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System is a mobile, general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System is a portable system facilitating point of care ultrasound applications. The Digital Color Doppler Palm Ultrasound System includes:
- A commercial off-the-shelf (COTS) Android mobile device
- CHISON Ultrasound software is running as an app (Android) on the COTS device
- The SonoEye P2, SonoEye V2, SonoEye G2 Linear array USB transducer
The provided FDA 510(k) summary (K201967) for the CHISON SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System does not contain information regarding acceptance criteria or a study proving the device meets specific performance criteria for AI-assisted image analysis.
The document focuses on demonstrating substantial equivalence to predicate devices for its general diagnostic ultrasound imaging capabilities, particularly in B (2D), B/M, Color Doppler, Combined (B+Color), Pulsed Wave, and Fusion Harmonic Imaging modes. The non-clinical tests mentioned primarily relate to electrical, mechanical, thermal, electromagnetic compatibility, and biocompatibility safety, as well as acoustic output.
Specifically, the document states:
- "No clinical testing was required." This indicates that no clinical study was performed to assess the device's diagnostic performance, let alone an AI component.
- The "Comparison Analysis" and "Substantially Equivalent Conclusion" sections primarily compare the device's technical specifications and operating controls to predicate devices, noting differences in value ranges (e.g., depth, voltage, temperature, humidity) and confirming compliance with safety standards (IEC60601-1, IEC60601-1-2, IEC60601-2-37, ISO 10993-1).
Therefore, based on the provided text, I cannot extract the requested information about acceptance criteria and a study proving a device's performance, as such details are not present for an AI component. The device described appears to be a diagnostic ultrasound system whose substantial equivalence is established through engineering and safety comparisons, not performance metrics from a clinical or AI evaluation study.
If an AI component is implied, it is not explicitly detailed with performance metrics or studies in this document. The listed product codes (IYN, IYO, ITX) are for general ultrasonic imaging systems and transducers, not specifically for AI/CADx devices.
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(225 days)
The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, CFM, Combined(B+CFM), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for Fetal, Abdominal, OB/GYN, Urology, Cardiac.
The Digital Color Doppler Palm Ultrasound System is intended for use in environments where healthcare is provided by healthcare professionals.
The SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System is a mobile, general purpose, softwarecontrolled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The Digital Color Doppler Palm Ultrasound System is a portable system facilitating point of care ultrasound applications.
The SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System includes:
- · A commercial off-the-shelf (COTS) Android mobile device
- CHISON Ultrasound software is running as an app (Android ) on the COTS device
- The SonoEye P5/ SonoEye V5/ SonoEye G5 Convex array USB transducer
This is an FDA 510(k) summary for the SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System. It details the device's substantial equivalence to predicate devices, but it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as it is not an AI/ML device needing such validation.
Here's a breakdown of why the requested information is not present and what is provided:
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A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with general medical device safety standards. It does not provide specific performance metrics or acceptance criteria for an AI/ML component.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This premarket notification does not involve an AI/ML device that would require clinical validation with a test set of data.
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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. Ground truth establishment for an AI/ML test set is not part of this submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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: Not applicable. This device is not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no mention of a standalone algorithm for diagnostic performance.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
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The sample size for the training set: Not applicable. There is no mention of an AI/ML component requiring a training set.
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How the ground truth for the training set was established: Not applicable.
Information that is provided in the document:
The document outlines the submission for a Digital Color Doppler Palm Ultrasound System, which is a general diagnostic ultrasound system. It demonstrates substantial equivalence to predicate devices (Lumify Diagnostic Ultrasound System, Clarius Ultrasound System, TE7 Diagnostic Ultrasound System) by comparing:
- Indications for Use: The device has similar indications for use (Fetal, Abdominal, OB/GYN, Urology, Cardiac) as the predicate devices.
- Design: It uses similar autocorrelation for color processing and FFT for pulse Doppler processing, supporting convex probes, and features like cine playback and image archiving.
- Operating Controls: Similar controls such as TGC (STC), Depth Range, shades of gray, Gain, Focus, Color box size/position, Baseline, Cine control, and Freeze control. Some differences in value ranges for depth, gain, etc., are noted but deemed substantially equivalent.
- Safety Compliance: The device conforms to applicable medical device safety standards like ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-1, which are the same standards adhered to by the predicate devices.
- Operation Modes: Similar modes including B mode, PW mode, B/M mode, CFM mode, and Fusion Harmonic Imaging (FHI).
- Measurements and Reporting: Similar measurement capabilities (2D distance, area, circumference, volume, M-mode, PW-mode measurements) and reporting packages (Vessel, Abdomen, Obstetrics, Cardiac reports, General report).
- Transducer Types: The submission device uses Convex Array USB interface, compared to various array types in the predicate devices.
- Users/Sites: Intended for use in hospitals and clinics, similar to predicates.
- Acoustic Output: Compliant with Track 3, Ispta.3 ≤ 720 mW/cm², MI ≤ 1.9, TI ≤ 6.0, consistent with predicate devices.
- Power Requirements: Differences in specific voltage, humidity, and temperature ranges are discussed, but the device passed relevant hardware tests and complies with safety standards, leading to a conclusion of substantial equivalence.
In summary, this FDA 510(k) submission establishes the safety and effectiveness of a conventional ultrasound system by demonstrating its substantial equivalence to already legally marketed devices, focusing on technical specifications, operational features, and compliance with general medical device safety standards, rather than AI/ML performance criteria.
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(225 days)
The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, CFM, Combined(B+CFM), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for Cardiac, Abdomen. The Digital Color Doppler Palm Ultrasound System is intended for use in environments where healthcare is provided by healthcare professionals.
The SonoEye P6/SonoEye V6/SonoEye G6 Digital Color Doppler Palm Ultrasound System is a mobile, general purpose, softwarecontrolled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The SonoEye P6/SonoEye V6/SonoEye G6 is a portable system facilitating point of care ultrasound applications. The Digital Color Doppler Palm Ultrasound System includes: - A commercial off-the-shelf (COTS) Android mobile device. - CHISON Ultrasound software is running as an app (Android) on the COTS device. - The SonoEye P6/SonoEye V6/SonoEye G6 support Convex array transducer.
This is a 510(k) summary for a medical device (SonoEye P6/SonoEye V6/SonoEye G6 Digital Color Doppler Palm Ultrasound System) and does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the way typically found for an AI/ML medical device.
The document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria for a novel AI function. As such, many of the requested fields cannot be filled.
Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific quantitative acceptance criteria or reported performance for the SonoEye P6/SonoEye V6/SonoEye G6 Digital Color Doppler Palm Ultrasound System in terms of diagnostic accuracy (e.g., sensitivity, specificity for detecting particular conditions). Instead, it establishes substantial equivalence by comparing its features and compliance with safety standards to predicate devices.
The comparisons provided are primarily focused on:
- Indications for Use: The submitted device has a more limited set of indications (Cardiac, Abdomen) compared to the predicate devices, but these are "Same" as a subset of the predicate's indications.
- Design and Operating Controls: Features like color processing, Doppler processing, probe types, cine playback, image archiving, gain, focus, ROI adjustment, freeze control, and operation modes are largely deemed "Same" or comparable in design. Differences in value ranges for depth and power requirements are noted but considered substantially equivalent due to compliance with relevant electrical and medical standards.
- Safety Compliance: The device conforms to the same international safety standards (ANSI/AAMI ES60601-1, IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2, ISO 10993-1) as the predicate devices.
- Acoustic Output: All devices are Track 3 and have similar maximum ISPTA.3 (≤ 720 mW/cm²) and MI (≤ 1.9), and TI (≤ 6.0 in the submission device's case, continuously displayed for one predicate, but generally aligned within safety limits).
Since this is a substantial equivalence submission for a diagnostic ultrasound system (not an AI/ML algorithm with specific diagnostic performance tasks), direct quantitative "acceptance criteria" for diagnostic accuracy are not presented in this document. The "acceptance criteria" are implicitly the demonstration that the device's characteristics and performance are comparable to (substantially equivalent to) legally marketed predicate devices, particularly concerning safety and effectiveness according to established standards.
2. Sample size used for the test set and the data provenance
Not applicable. The document explicitly states: "No clinical testing was required." Therefore, there is no test set for clinical performance mentioned. The "tests" performed were non-clinical (electrical, mechanical, thermal, electromagnetic compatibility, biocompatibility, and acoustic output).
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 testing was performed for this submission.
4. Adjudication method for the test set
Not applicable, as no clinical testing was performed for this submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a Digital Color Doppler Palm Ultrasound System, not an AI-assisted diagnostic tool in the sense of an AI/ML algorithm for image interpretation that would enhance human reader performance. No MRMC study or AI assistance effect size is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a diagnostic ultrasound system, which inherently involves a human operator acquiring and interpreting images. It is not an "algorithm only" device within the context of AI/ML performance.
7. The type of ground truth used
Not applicable, as no clinical testing for diagnostic performance was conducted. The "ground truth" referenced in the provided text relates to compliance with engineering and safety standards, where the "truth" is whether the device meets the specified technical and safety requirements.
8. The sample size for the training set
Not applicable. This document does not describe the development or training of an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. This document does not describe the development or training of an AI/ML algorithm.
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(133 days)
The XBit Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B (2D/3D/4D),B/M,M,B+CFM,B+CPA (PD),B+DPD,B+PW,B+CW,B+CFM +D (PW)/CW, B+ CPA(PD) + D (PW)/CW, TDI and Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified clinician for evaluation of Fetal ,Abdominal,Pediatric,Small Organ (breast, thyroid,testes ), Neonatal Cephalic , Adult Cephalic, Cardiac (adult , pediatric), Musculo-skeletal (Conventional , Superficial) , Peripheral Vascular, Transesophageal, Trans-rectal, Trans-vaginal, OB/GYN and Urology.
The XBit Series Digital Color Doppler Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with keyboard control panel, power supply module, color LED monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (including Fusion Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, contrast imaging, 3D/4D. Auto Follicle, SonoBeam, SonoColor, and SonoFusion, these four features are all semi-automated functions, they need to be modified during processing.
The provided text is a 510(k) Summary for the CHISON XBit Series Digital Color Doppler Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results designed to prove device performance against specific acceptance criteria.
Therefore, the document does not contain the acceptance criteria or a detailed study proving the device meets those criteria in the way typically expected for a novel AI/ML device. The focus here is on the similarity of the new device to existing, already cleared ultrasound systems.
Specifically, the document states:
- "7. Clinical Test: No clinical testing was required." This explicitly indicates that no clinical study was conducted for this submission.
Given this, I cannot extract the information required for accepting a device, particularly regarding a study that proves the device meets specific performance acceptance criteria related to AI/ML features. The "Acceptance Criteria" in this context would likely refer to the FDA's requirements for demonstrating substantial equivalence (e.g., similar indications for use, technological characteristics, and safety/performance as a legally marketed predicate device).
However, I can extract information related to the device's assessment of its substantially equivalent nature, which includes functional comparisons. The "SE Analysis" sections do describe what the device's "semi-automated functions" do and compare them to predicate features. These comparisons serve as the basis for the declaration of substantial equivalence, which is the "acceptance" in a 510(k) context.
Let's break down what can and cannot be answered based on the provided text, assuming the "AI" features refer to the "semi-automated functions" mentioned in section 4 and detailed in the SE Analyses (e.g., Auto Follicle, SonoBeam, SonoColor, SonoFusion).
Summary of what can be extracted from the document:
The document describes the XBit Series Digital Color Doppler Ultrasound System, which includes "semi-automated functions" like Auto Follicle, SonoBeam, SonoColor, and SonoFusion. For a 510(k) submission, the "acceptance criteria" revolve around demonstrating substantial equivalence to legally marketed predicate devices rather than proving performance against novel, quantitatively defined acceptance metrics. Indeed, the document explicitly states: "No clinical testing was required."
However, the "SE Analysis" sections serve as the basis for demonstrating that these "semi-automated functions" are substantially equivalent to features found in predicate devices. This is the closest the document comes to describing how the device "meets acceptance criteria" for these features.
1. A table of acceptance criteria and the reported device performance:
Since "No clinical testing was required," there are no explicit quantitative acceptance criteria or reported device performance metrics in the traditional sense (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence is claimed based on functional similarity.
Here's how the document frames the comparison for the "semi-automated functions":
| Feature (Subject Device) | Claimed Functionality (Subject Device) | Predicate Device Analogue(s) | Predicate Functionality | Basis for Equivalence (Implicit Acceptance Criteria) |
|---|---|---|---|---|
| Auto Follicle | Automatically identifies, traces, and calculates area and circumference of follicles after user positions ROI. Output values can be modified (semi-automated). | Acuson x700 Diagnostic Ultrasound System (synqo® Auto Follicle measurement option) | Automated measurement technique for fast, accurate assessment of multiple follicles. Measurement methods supported: Distance, 2Dist + Avg, 3Dist + Avg, 2Dist Avg, 3Dist Avg, Area, Volume, Circumference. | Both can get area and circumference of follicles. The semi-automated nature of the subject device is noted but doesn't affect substantial equivalence. |
| SonoFusion | (Implied: Makes real-time ultrasound image match with CT/MR image.) | Resona 7 Diagnostic Ultrasound System (Fusion Imaging) | (Implied: Makes real-time ultrasound image match with CT/MR image.) | Both improve diagnostic efficiency by matching images (despite differences in "navigation device and navigation bracket"). |
| SonoColor | Recognizes vessel angle automatically. | Resona 7 Diagnostic Ultrasound System (Color Vol) | (Implied: Requires user control for vessel angle recognition.) | Both can get point velocity and meet clinical requirements, despite differences in automation level for angle acquisition. |
| SonoBeam | Improved version of Q-beam, multi-beam blood flow high frame rate function based on traditional dual beamformer principle. Improves processing speed, increases frame rate, reduces noise. | CBit 9 Digital Color Doppler Ultrasound System (Q-beam) | Q-beam is implied to be a less advanced multi-beam technology for blood flow. | Both improve image quality. The subject device's improvement is noted but does not invalidate substantial equivalence. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The document states "No clinical testing was required." The "test set" for demonstrating substantial equivalence is the comparison of functional specifications and safety data to predicate devices.
- Data Provenance: Not applicable for a clinical test set. The regulatory submission data provenance is CHISON Medical Technologies Co., Ltd. from China. The comparison is based on the declared specifications and previously cleared status of predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical testing with ground truth establishment was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical testing was performed for which adjudication would be relevant.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. The document explicitly states "No clinical testing was required." Therefore, no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. No standalone performance evaluation for these "semi-automated functions" is mentioned or appears to have been required. The functions are described as "semi-automated," implying a human-in-the-loop is always present.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. As no clinical testing was performed, no ground truth needed to be established for performance evaluation. Ground truth for the predicate devices' original clearances would have been established, but this document does not detail that.
8. The sample size for the training set:
- Not applicable. The document does not provide information on the training set for the "semi-automated functions" (AI/ML components). This level of detail is typically not required for a 510(k) submission unless the AI/ML algorithm represents a significant change in technology or indications from the predicate.
9. How the ground truth for the training set was established:
- Not applicable. As no information on the training set is provided, how its ground truth was established is also not detailed.
In conclusion, this 510(k) summary for an ultrasound system relies on demonstrating substantial equivalence to predicate devices, and explicitly states that no clinical testing was required. Therefore, the detailed and quantitative information typically sought for AI/ML device acceptance criteria and performance studies (sample sizes, expert ground truth, MRMC studies, etc.) is not present in this document. The "acceptance" of this device is based on its similarity to already cleared devices in terms of indications, technology, and safety/performance characteristics.
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(126 days)
The device is a general-purpose ultrasonic imstrument intended for use by a qualified clinician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid,testes ), Neonatal Cephalic, Cardiac (adult , pediatric),Musculo-skeletal (Conventional , Superficial) ,Peripheral Vascular,Trans-esophageal,Trans-rectal, Trans-vaginal, OB/GYN and Urology.
The CBit Series Digital Color Doppler Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array . This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (including Fusion Harmonic Imaging). M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, 3D/4D.
The provided text is a 510(k) Summary for the CHISON CBit Series Digital Color Doppler Ultrasound System. It describes the device, its intended use, non-clinical tests conducted, and a comparison to predicate devices to establish substantial equivalence. However, it does not contain a study that proves the device meets specific acceptance criteria in terms of quantitative performance metrics for AI algorithms. Instead, the document focuses on regulatory compliance and substantial equivalence to previously cleared devices.
Therefore, many of the requested details about acceptance criteria, their proof, and study specifics for AI performance cannot be extracted from this document as it does not describe such a study.
Here's a breakdown of what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with reported device performance in terms of AI algorithm accuracy, sensitivity, specificity, or other quantitative metrics. The "acceptance criteria" presented are primarily regulatory compliance standards and substantial equivalence to predicate devices, rather than performance benchmarks for AI features.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document explicitly states: "No clinical testing was required." Therefore, there is no test set for AI performance, sample size, or data provenance mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical testing and no test set with ground truth establishment for AI performance is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical testing and no test set with ground truth establishment for AI performance 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. No MRMC study involving AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The document does not describe a standalone AI algorithm performance study. The device is a diagnostic ultrasound system with several operating modes and features, some of which are likely enhanced by AI (features like "Auto IMT," "Auto NT," "Stress Echo," "Strain," "Q-Image," "Q-flow," "Q-beam," "AIO," and "LV tracking" hint at AI analysis or automation), but no specific standalone performance metrics for these AI components are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical testing with ground truth establishment for AI performance is described.
8. The sample size for the training set
Not applicable. The document does not describe the development or training of any AI algorithms, therefore no training set sample size is provided.
9. How the ground truth for the training set was established
Not applicable, as no training set or its ground truth establishment is mentioned.
Summary of Device Features and Non-Clinical Tests (as presented in the document):
The CHISON CBit Series Digital Color Doppler Ultrasound System is a general-purpose ultrasonic imaging instrument. It is noted to include features like "Elastography," "3D/4D," "TDI Mode," "Auto IMT," "Stress Echo," "Strain," "Q-Image," "Q-flow," "Q-beam," "AIO," and "LV tracking," which often imply some level of algorithmic or AI-assisted processing.
The study presented focuses on non-clinical tests to ensure safety and performance equivalence to predicate devices. These tests evaluated:
- Electrical safety (according to IEC 60601-1: 2005)
- Electromagnetic compatibility (according to IEC 60601-1-2: 2014)
- Basic safety and essential performance of ultrasonic medical diagnostic equipment (according to IEC 60601-2-37: 2007)
- Acoustic output measurements (according to NEMA UD 2:2004)
- Real-time display of thermal and mechanical acoustic output indices (according to NEMA UD3: 2004)
- Biocompatibility (according to ISO 10993-1:2009, ISO 10993-5, ISO 10993-10)
- Software Documentation for a Moderate Level of Concern.
The document states that "The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility."
The "Substantially Equivalent Conclusion" is reached based on:
- Favorable comparison of Indications for Use with predicate devices.
- Similar operation modes and controls (with some differences in value range, or additional features like LV tracking, LGC, Breast measurement package, which are deemed not to raise new safety or effectiveness concerns as they align with existing functionalities or general measurement packages of predicate devices).
- Compliance with the same safety standards as predicate devices.
The document does not detail any performance studies that would typically involve specific acceptance criteria for AI algorithm performance or metrics derived from clinical data. The focus is on regulatory equivalence concerning the device's overall functionality and safety, not on specific AI performance evaluation against ground truth data.
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