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The HD80 Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment.

The systems support the following clinical applications:

The HD80 series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vessel, and urology exams.

Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

The HD80 Series consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor and optional image storage and printing device. It includes a variety of electronic array transducers operating in linear, curved, sector/phase array, and real time 3D transducer. HD80 series is a Track 3 diagnostic ultrasound system. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through LAN or Wireless with WIFI adapter module.

The provided text is a 510(k) summary for the Hisense HD80 Series Ultrasound Diagnostic System. It aims to demonstrate substantial equivalence to a predicate device, the Hisense HD60 Series Ultrasound Diagnostic System (K213862), rather than providing detailed acceptance criteria and proof of their meeting by a specific study in the context of an AI/human-in-the-loop diagnostic device.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, performance studies with sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a diagnostic AI device.

The document primarily focuses on:

• Device Description and Intended Use: General purpose ultrasound system for various clinical applications.
• Comparison to Predicate Device: Highlighting similarities in intended use, physical characteristics, modes of operation, and basic functions.
• Differences and Justification: Discussing minor differences (e.g., new functions like Ribbon flow imaging, 3D PW, SCV, and the addition of WIFI and battery) and explaining why these do not affect substantial equivalence or raise new safety/effectiveness concerns.
• Non-clinical Testing: Listing various safety and performance standards the device complies with (e.g., electrical safety, EMC, biocompatibility, usability, software life cycle).
• Absence of Clinical Studies: Explicitly stating that clinical studies were not required for this 510(k) submission.

**In summary, there is no information in the provided text to fulfill your request for: **

1. A table of acceptance criteria and reported device performance: This document does not present such a table because it's a 510(k) summary for an ultrasound system, not an AI diagnostic device with specific performance metrics like sensitivity or specificity.
2. Sample sizes used for the test set and data provenance: No test set data or provenance is mentioned.
3. Number of experts used to establish ground truth and their qualifications: Not applicable as no diagnostic AI performance study is described.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study and effect size: Not applicable.
6. Standalone performance study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

The document states: "The subject of this premarket submission, did not require clinical studies to support substantial equivalence." This means the submission relies on demonstrating that the HD80 Series is similar enough to a previously cleared device (HD60 Series) that no new safety or effectiveness questions are raised, and therefore, specific performance studies (like those for an AI diagnostic algorithm) were not necessary for its clearance.

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The HD60 Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment.

The systems support the following clinical applications:

The HD60 series Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. It is intended for use in fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, trans-rectal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vessel, and urology exams.

Modes of operation include: 3D/4D Imaging mode. B. M. PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/Color/PWD or CWD, B/Power/PWD.

The HD60 Series consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor and optional image storage and printing device. It includes a variety of electronic array transducers operating in linear, curved, sector/phase array, and real time 3D transducer. HD60 series is a Track 3 diagnostic ultrasound system. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through LAN or Wireless with WIFI adapter module.

The provided text is a 510(k) summary for the Qingdao Hisense Medical Equipment Co., Ltd's HD60 Series Ultrasound Diagnostic System. It outlines the device's technical specifications, indications for use, and a comparison with a predicate device to demonstrate substantial equivalence.

However, the document explicitly states: "The subject of this premarket submission, did not require clinical studies to support substantial equivalence."

This means that the submission for the HD60 Series Ultrasound Diagnostic System does not contain information about acceptance criteria for device performance based on clinical studies, nor does it provide details of a study (clinical or otherwise with human data) that proves the device meets such criteria.

The basis for substantial equivalence is primarily through demonstrating that the new device has "the same intended use, and similar physical characteristics" and "employs the same fundamental scientific technology" as its predicate device. Any new functions or changes are argued to have "no impact on safety or effectiveness" because they are either:

• Equivalent to features found on other already-cleared reference devices.
• New, but their performance "meets the requirements" and does not raise new risks.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them, because this specific 510(k) summary states that no clinical studies were required or conducted for this submission.

To directly answer your numbered points based only on the provided text's stated approach for this 510(k) submission:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document does not describe specific acceptance criteria for performance based on user studies or clinical trials, nor does it report device performance data from such studies. The acceptance is based on substantial equivalence to a predicate device and adherence to regulatory standards for safety and non-clinical performance (e.g., electrical, acoustic, biocompatibility).

2. Sample sizes used for the test set and the data provenance: Not applicable. No clinical or human-data based performance test set is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring ground truth establishment by experts is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an ultrasound diagnostic system, not an AI-assisted diagnostic tool for which MRMC studies are typically conducted. No MRMC study is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a complete ultrasound system, not a standalone algorithm. Performance is assessed through compliance with general safety and performance standards for ultrasound equipment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No explicit "ground truth" as typically understood in performance studies for diagnostic accuracy is mentioned, as no such studies were required or presented.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that would undergo a training phase on a dataset.

9. How the ground truth for the training set was established: Not applicable. No training set is described.

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These products are intended to be used in displaying radiological images for review, analysis and diagnosis by trained medical practitioners. They do not support the display of mammography images for diagnosis.

The Hisense LCD monitors are intended for trained medical practitioners and provides the image viewing and medical diagnostic functions. HMD2C21A, HMD4C27S, HMD6C30D are developed with different resolution:1600 x 1200, 2560 x 1440, 3280 × 2080. So the LCD monitors can be used in different environment according to different resolution requirement. The three models also developed with same features such as energy saving, ambient light induction, front-facing sensor calibration, etc. In particular, HMD4C27S, HMD6C30D have body-inductive energy-saving and auto awake function.

The provided text describes the acceptance criteria and the study conducted for the Hisense LCD monitors (HMD2C21A, HMD4C27S, HMD6C30D) to demonstrate substantial equivalence to predicate devices.

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for the Hisense LCD monitors are based on demonstrating compliance with performance standards and being substantially equivalent to legally marketed predicate devices. The performance is reported through bench testing in accordance with AAPM Task Group 18 (TG18) guidelines.

Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "No" for several other TG18 measurements (g. Luminance at 30° and 45° in diagonal, horizontal, and vertical directions at center and four corners; h. Luminance uniformity or Mura test; i. Stability of luminance and chromaticity response with temperature and time of operation or on-time; j. Spatial noise; k. Reflection coefficient; l. Veiling glare or small-spot contrast; n. Gray tracking (gray shades and white point)), indicating these were not considered part of the acceptance criteria for this submission.

2. Sample size used for the test set and the data provenance

The document does not specify a separate "test set" in the context of clinical images or patient data. The performance evaluation was primarily through bench testing of the devices themselves. Therefore, the "sample size" refers to the number of device models tested, which are HMD2C21A, HMD4C27S, and HMD6C30D.

• Sample size: 3 device models (HMD2C21A, HMD4C27S, HMD6C30D).
• Data provenance: Not applicable in the context of patient data. The data originates from physical measurements and tests conducted on the manufactured medical display devices. The study is prospective in the sense that the tests were performed on the devices to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The study involved bench testing of display performance against established technical standards (AAPM TG18 guidelines, IEC 60601-1, IEC 60601-1-2), not the establishment of ground truth for medical images by human experts. The "ground truth" for the device's technical specifications is the physical characteristics and performance measurements of the monitors in comparison to the predefined standards and predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no test set involving human interpretation of medical images that would require an adjudication method. The evaluation was based on objective physical and electrical measurements of the display devices.

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, an MRMC comparative effectiveness study was not done. The device is a medical LCD monitor, not an AI-powered diagnostic tool. The submission focuses on the display capabilities of the monitor itself, not on its assistance to human readers or AI performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm-only performance study was not done. The device is a monitor, which by its nature requires a human-in-the-loop (a medical practitioner) to interpret the displayed images. There is no algorithm for diagnostic purposes operating independently on the monitor itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is objective technical specifications and performance metrics defined by international standards and guidelines, such as:

• AAPM Task Group 18 (TG18) guidelines: For display performance characteristics like spatial resolution, pixel defects, artifacts, temporal response, luminance, conformance to DICOM GSDF, and color tracking.
• IEC 60601-1: For electrical safety.
• IEC 60601-1-2: For electromagnetic compatibility (EMC).
• Comparison to predicate devices: The "ground truth" for substantial equivalence is that the proposed device's characteristics and performance are comparable to (or better than, without raising new questions of safety or effectiveness) those of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. The device is a medical display monitor, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

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1. The 2MP Monochrome LCD Monitor HMD2G21S is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners.

The device does not support the display of mammography images for diagnosis.

2)The 3MP Monochrome LCD Monitor HMD3G21S is intended to be used in displaying and viewing digital images for diagnosis X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.

Hisense HMD2G21S, HMD3G21S LCD monitor complies with the DICOM Part 14 standard and is applicable to DSA, MRI, DR, CR, CT, and PET medical imaging. It is intended for trained medical practitioners and provides the image viewing and medical diagnostic functions.

Here's a breakdown of the acceptance criteria and study information for the Hisense LCD monitors (HMD2G21S, HMD3G21S), based on the provided document.

It's important to note that this document, a 510(k) Premarket Notification, primarily focuses on demonstrating "substantial equivalence" to predicate devices rather than proving a device meets specific clinical performance acceptance criteria in the way a novel diagnostic algorithm might. In this case, the "acceptance criteria" largely refer to compliance with technical standards and equivalence to existing cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

For medical display monitors, the "acceptance criteria" are generally based on meeting industry standards for display performance for diagnostic radiology. The reported device performance is presented as compliance with these standards and comparison to predicate devices.

Specific quantitative performance metrics (e.g., exact measured contrast ratio, brightness, or MTF values) are indicated as "reported" or "measured" in the testing section, but the actual numerical results are not provided in this summary. The comparison tables (Table 02 and Table 04) show that the proposed devices meet or exceed the performance specifications of the predicate devices for key display parameters like contrast ratio and maximum brightness.

2. Sample Size Used for the Test Set and Data Provenance

This submission is for a medical display monitor, not a diagnostic algorithm that processes medical image data. Therefore, there is no "test set" of medical images or patient data in the conventional sense for evaluating diagnostic performance. The testing involved evaluating the physical and electrical characteristics of the monitors themselves.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As described above, there is no "test set" of medical images requiring expert-established ground truth for diagnostic performance evaluation for a display monitor. The testing involves objective measurements of display characteristics against technical standards.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" requiring 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. This is for a display monitor, not a diagnostic AI algorithm. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a display monitor, not a standalone algorithm.

7. The Type of Ground Truth Used

Not applicable. The "ground truth" for a display monitor is its physical and electrical characteristics conforming to established technical standards (like DICOM Part 14 and AAPM TG18 guidelines), not a clinical diagnosis or outcome.

8. The Sample Size for the Training Set

Not applicable. This is a physical device (monitor), not a software algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

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HMD3C21S : The 3MP Color LCD Monitor HMD3C21S is indicated for use in displaying radiological images for review, and diagnosis by trained medical practitioners. The display is not intended for mammography.
HMD5G21S : The 5MP Monochrome LCD Monitor HMD5G21S is intended to be used in displaying and viewing medical images for diagnosis by trained medical practified personnel. It is intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.

The LCD monitor employs high-luminance LCD panel, and is designed for medical image display.

This document describes the performance assessment of medical LCD monitors (HMD3C21S and HMD5G21S) for displaying radiological images. It is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving clinical effectiveness of an AI algorithm. Therefore, many of the requested elements typically found in AI/ML medical device evaluations (like sample sizes for training/test sets, expert adjudication, MRMC studies, or specific performance metrics using AI) are not applicable or available in this submission.

The "acceptance criteria" here refers to the performance benchmarks for a medical display, ensuring it meets standards for diagnostic imaging. The "study that proves the device meets the acceptance criteria" refers to the bench testing performed on the monitors.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various physical laboratory measurements performed on the monitors to ensure they meet the display requirements. The acceptance criteria are implicit in the tests performed, aiming for performance comparable to existing medical displays. The reported performance is generally "By reporting [method]" or "Measure the [property]", indicating that these measurements were taken rather than providing specific numerical results for each one. This type of submission focuses on demonstrating that the testing was done according to recognized standards.

Implicit Acceptance Criteria (based on tests performed): The monitors must demonstrate adequate performance across these parameters consistent with established medical display standards (e.g., AAPM-TG18, IEC).

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated as a "sample size" in the context of diagnostic performance testing with cases. This submission is for a medical monitor, not an AI diagnostic algorithm. The "testing" refers to the physical bench testing of the device itself.
• Data Provenance: No patient data or clinical images are referenced for the performance testing of the monitor. The testing relates to the physical characteristics and display capabilities of the monitor hardware.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This document is for a medical display device, not an AI algorithm that requires setting ground truth for image interpretation. The "ground truth" for a monitor's performance is established by objective physical measurements against industry standards (e.g., AAPM-TG18).

4. Adjudication method for the test set

• Not Applicable. As no diagnostic performance with images and human readers is being evaluated, no adjudication method is 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

• Not Applicable. This is a medical monitor, not an AI-powered diagnostic device. No MRMC studies were conducted as part of this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a monitor, not an algorithm. Therefore, standalone performance (in the context of an algorithm's diagnostic output) is irrelevant.

7. The type of ground truth used

• Objective Physical Measurements against Industry Standards. The "ground truth" for a display device is its adherence to performance specifications and established industry standards (e.g., DICOM GSDF, AAPM-TG18), verified through physical and optical measurements using specialized equipment.

8. The sample size for the training set

• Not Applicable. This device is a medical monitor, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not Applicable. As there is no training set for an AI algorithm, no ground truth needed to be established in that context.

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The HD60 Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment.

The systems support the following clinical applications:

The HD60 series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, trans-rectal, musculo-skeletal (conventional, superficial), cardiac (adult, peripheral vessel, and urology exams.

Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/ Power/PWD.

The HD60 Series consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor and optional image storage and printing device. It includes a variety of electronic array transducers operating in linear, curved, sector/phase array, and real time 3D transducer. HD60 series is a Track 3 diagnostic ultrasound system. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through LAN.

The provided text is a 510(k) Premarket Notification Submission for the Hisense HD60 Series Ultrasound Diagnostic System. It does not describe a study that proves the device meets specific acceptance criteria for AI/ML performance. Instead, it details the substantial equivalence of the HD60 Series to a predicate device (Mindray DC-80 Ultrasound Diagnostic System, K192152) based on general ultrasound system performance and safety standards.

Therefore, I cannot create a table of acceptance criteria and reported device performance related to AI/ML, nor can I describe study details like sample size, ground truth establishment, expert adjudication, or MRMC studies for AI/ML performance, as this information is not present in the provided document.

The document focuses on:

• Intended Use and Indications for Use: General purpose ultrasound imaging, measurement, display, and analysis for various clinical applications (fetal, abdominal, pediatric, etc.).
• Comparison to Predicate Device: Highlighting similarities in fundamental scientific technology, patient contact materials, modes of operation, and basic measurements.
• Differences: Noting the HD60 Series omitting intra-operative and trans-esophageal applications, and introducing a "Teaching System" feature.
• Non-clinical Tests: Compliance with various safety, biocompatibility, and electromagnetic standards relevant to general medical electrical equipment and ultrasound devices (e.g., AAMI/ANSI ES60601-1, IEC 60601-2-37, ISO 10993).
• Clinical Tests: Stating that no clinical studies were required to support substantial equivalence.

In summary, the provided text does not contain the information required to answer your specific questions about AI/ML acceptance criteria and performance studies, as the device described is a general ultrasound diagnostic system and not explicitly an AI/ML-driven device with such specific performance metrics detailed.

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The 2MP/3MP LCD Monitor (HMD2G21) is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

The 5MP LCD Monitor (HMD5G21) is intended to be used in displaying digital images for review and analysis by trained medical practitioners, including digital mammography.

The 2MP/3MP/5MP LCD Monitor (HMD2G21/HMD3G21) is a display system for medical viewing, with high resolution 1600x1200(HMD2G21)/2048 x 1536(HMD3G21)/ 2560 x 2048(HMD5G21), built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed. The display can support both landscape and portrait mode. The antiglare screen can prevent display from reflection under highlight conditions, make the image and display clearer.

The document describes a 510(k) premarket notification for several Hisense LCD monitor models (HMD2G21, HMD3G21, HMD5G21). The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by compliance with IEC 60601-1 and IEC 60601-1-2 standards, and by demonstrating performance comparable to or better than the predicate devices. The study detailed below focuses on comparing the Hisense monitors' specifications to those of their respective predicate devices.

Here's a consolidated table comparing the proposed Hisense devices (HMD2G21, HMD3G21, HMD5G21) with their identified predicate devices (BARCO Nio 2MP, Nio 3MP, Nio 5MP) based on the provided "General Comparison" tables.

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The 2MP/3MP LCD Monitor (HMD2C21) is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

The 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) is a display system for medical viewing, with high resolution 1600x1200(HMD2C21)/2048 x 1536(HMD3C21), built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed. The display can support both landscape and portrait mode. The antiglare screen can prevent display from reflection under highlight conditions, make the image and display clearer.

This document is a 510(k) summary for the Hisense 2MP/3MP LCD Monitors (HMD2C21/HMD3C21). A 510(k) submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective. This type of submission focuses on comparing the new device's characteristics to a predicate, rather than an independent study to define acceptance criteria and then demonstrate performance against those specific criteria using a test set and ground truth.

Therefore, the requested information cannot be fully provided in the typical format of an AI/ML device study. Instead, I will describe the comparisons made to establish substantial equivalence.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of formal acceptance criteria and device performance as typically seen in a diagnostic AI study, this document compares the technical specifications and intended use of the proposed devices (Hisense HMD2C21 and HMD3C21) against their predicate devices (BARCO Nio 2MP and Nio 3MP). The "acceptance criteria" here is effectively meeting comparable specifications to the predicate device, thereby demonstrating substantial equivalence.

Table 1: Comparison of Proposed Devices (Hisense HMD3C21/HMD2C21) to Predicate Devices (BARCO Nio 3MP/2MP)

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This diagnostic ultrasound system (Hi-Light) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft tissue of small parts in adult patients (thyroid, breast, and testicles) and for superficial muscular skeletal diagnosis.

The system is for prescription use only by a trained sonographer under the direction of a qualified physician or directly by a qualified physician.

The Hi-Light is a portable Diagnostic Ultrasound System, which applies the latest technologies to produce optimal images. The system facilitates a workflow from image acquisition through to archival in a standard DICOM interface to the clinics PACs system. Various image parameter adjustments, a 15 inch high resolution display and custom probes are configured to provide clear and stable images. The modes of operation include B mode.

The provided document is a 510(k) premarket notification for the Hi-Light Diagnostic Ultrasound System. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data to prove the device meets specific acceptance criteria in the same way a novel device might.

Based on the document, here's what can be extracted and inferred regarding the acceptance criteria and supporting studies:

1. A table of acceptance criteria and the reported device performance:

   Acceptance Criteria Type	Criteria/Standard	Reported Device Performance
   Clinical Performance (Imaging)	Not explicitly defined in quantitative metrics for this type of submission. The overarching criterion is "substantially equivalent" to predicate for intended clinical use (evaluating differences in echogenicity of soft tissue of small parts in adult patients (thyroid, breast, and testicles) and superficial musculoskeletal diagnosis).	"applies the latest technologies to produce optimal images."

"configured to provide clear and stable images."
"same fundamental scientific technologies as the predicate device."
"supports the same operating mode (B) and the same measurement functions for anatomic structures." |
| Safety Standards | IEC 60601-1 (Safety Requirements for Medical Equipment, 2012) | In conformance |
| | IEC 60601-1-2 (EMC Requirements for Medical Equipment, 2007) | In conformance |
| | IEC 60601-2-37 (Diagnostic Ultrasound Safety Standards, 2007) | In conformance |
| Acoustic Output | FDA guidance "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers", dated September 9, 2008 | Testing conducted as per guidance |
| Biocompatibility | ISO 10993-1 (Evaluation and testing, 2003) | Acceptable for specified usage of the system |
| | ISO 10993-5 (Tests for in vitro cytotoxicity, 1999) | (Implied acceptable through conformance to ISO 10993) |
| | ISO 10993-10 (Tests for irritation and delayed-type hypersensitivity, 2002) | (Implied acceptable through conformance to ISO 10993) |
| | ISO 10993-11 (Tests for systemic toxicity, 2006) | (Implied acceptable through conformance to ISO 10993) |
| Technological Equivalence | Same intended use and operational characteristics as predicate OR same intended use and different operational characteristics where substantial equivalency can be demonstrated without raising new questions of safety and effectiveness. | "same fundamental scientific technologies as the predicate device"
"narrowed, but still in the scope of the predicate device"
"does not raise any questions regarding its safety and effectiveness" |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • No clinical test set or data provenance is mentioned because the submission explicitly states: "Clinical Test: Clinical testing not required" for this device. The assessment is based on non-clinical testing and comparison to a predicate device.

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 performed and therefore no ground truth was established by experts for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable, as no clinical testing 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:

   • Not applicable. This is a diagnostic ultrasound system, not an AI-powered diagnostic algorithm. No MRMC study was mentioned or performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a hardware diagnostic ultrasound system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable for clinical performance. The "ground truth" for the submission is the established safety and effectiveness of the predicate device (Siemens Acuson S2000, K081148) and adherence to recognized non-clinical safety standards.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

   • Not applicable. This is not an AI/ML device.

Summary of the Study:

The "study" referenced in this 510(k) submission is primarily a non-clinical comparative study demonstrating compliance with recognized safety and performance standards for medical devices and establishing substantial equivalence to a previously cleared predicate device.

• Objective: To demonstrate that the Hi-Light Diagnostic Ultrasound System is substantially equivalent to the Siemens Acuson S2000 Ultrasound System (K081148).
• Methodology:
  • Non-clinical Testing: The device underwent testing to established international and FDA-recognized safety standards, including IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, acoustic output testing per FDA guidance, and biocompatibility testing per ISO 10993 series.
  • Comparative Analysis: A detailed comparison was made between the Hi-Light system and the predicate device (Siemens Acuson S2000) regarding:
    • Indications for Use
    • Intended Use
    • Principles of Operation
    • Device characteristics (e.g., size, weight, transducer specifications like type, frequency, applications, number of elements, modes of operation, array footprint).
  • Basis for Equivalence: The submission argues that the Hi-Light uses the "same fundamental scientific technologies" and has "narrowed, but still in the scope" clinical applications compared to the predicate. The differences (primarily size and some modes of operation) do not raise new questions of safety or effectiveness.
• Outcome: The FDA determined that the device is substantially equivalent to the predicate device based on the non-clinical testing and comparative analysis, and thus did not require clinical testing.

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