Search Results

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel, intra-operative (abdominal, thoracic, and vascular) and urology exams.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

Modes of operation include: B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart 3D, 4D(Reape View, TDI, Color M. Strain Elastography, Contrast imaging (Contrast imaging (Contrast agent for LVO), STE,STQ.

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. This system is a Track 3 device that employs an array of probes that include linear array. convex array, pencil phased and phased array.

The provided text is a 510(k) Summary for a Diagnostic Ultrasound System, which is a general-purpose diagnostic imaging device. For such devices, the FDA typically relies on non-clinical performance data (e.g., electrical safety, acoustic output, electromagnetic compatibility, software validation) to demonstrate substantial equivalence to a predicate device, rather than clinical studies with specific acceptance criteria related to diagnostic performance metrics like sensitivity or specificity.

Therefore, the document explicitly states: "8. Clinical Tests: Not Applicable."

This means that the type of study for proving the device meets acceptance criteria, in the context of diagnostic performance metrics, was not performed for this submission. The "acceptance criteria" discussed in the document are primarily related to safety, electrical performance, and adherence to recognized standards, rather than clinical diagnostic efficacy.

Given the information in the provided document, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

As clinical tests were "Not Applicable" and no specific diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) are reported for this device's efficacy, a table of diagnostic acceptance criteria and performance cannot be generated from the provided text.

However, the document lists compliance with various regulatory and safety standards, which can be seen as the "acceptance criteria" the device met for its substantial equivalence determination. The "reported device performance" is its demonstration of compliance with these standards and its similarity to the predicate device.

• IEC 60601-1-2 Edition 4.0 2014-02, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
• IEC 60601-2-37 Edition 2.1 2015, medical electrical equipment - part 2-37: particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
• IEC 62304 Edition 1.1 2015-06, medical device software software life cycle processes.
• ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices.
• NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3.
• AAMI / ANSI / ISO 10993-1: 2018, biological evaluation of medical devices - part 1: evaluation and testing within a risk management process.
• IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
• IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | - The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical and mechanical safety.
• The device was found to conform with applicable medical safety standards (listed above).
• The acoustic power levels are below FDA limits, similar to the predicate device.
• The device is designed in compliance with FDA-recognized electrical and physical safety standards, similar to the predicate device.
• The device's safety and effectiveness profile is found to be similar to the predicate device. |

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

• Sample Size for Test Set: Not applicable for diagnostic performance as no clinical tests were performed.
• Data Provenance: Not applicable for diagnostic performance. For safety and performance evaluations, the data would typically come from internal engineering and lab testing conducted by the manufacturer (Shenzhen Mindray Bio-Medical Electronics Co., LTD in China).

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 tests or diagnostic performance evaluations requiring expert ground truth were conducted or reported in this 510(k) summary.

4. Adjudication method for the test set

• Not applicable as no clinical tests or diagnostic performance evaluations requiring adjudication were conducted or reported in this 510(k) summary.

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 comparative effectiveness study was done or reported. This device is a general diagnostic ultrasound system, not an AI-assisted diagnostic tool that would typically undergo such a study for 510(k) clearance.

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

• Not applicable. This is a diagnostic ultrasound system, not an standalone algorithm. The device has "Smart" features (e.g., Smart 3D, Smart Planes FH, Smart Pelvic, iClear+), but these are integrated functionalities of the ultrasound system itself, not standalone algorithms requiring separate "algorithm-only" performance evaluation in the context of this 510(k). The regulatory pathway for this device does not necessitate such a study as it's a general-purpose ultrasound.

7. The type of ground truth used

• Not applicable for diagnostic performance metrics, as no clinical efficacy studies were conducted. For the non-clinical tests, the "ground truth" would be the established specifications and limits defined by the international and national standards to which the device was tested for compliance.

8. The sample size for the training set

• Not applicable. This document describes a traditional diagnostic ultrasound system. While it has "Smart" features that likely involve internal algorithms some of which might be trained, the document does not provide details on algorithm training, or a "training set" in the context of a machine learning model submitted for software as a medical device (SaMD) clearance.

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

• Not applicable, as a training set for a machine learning model is not discussed or required for this type of 510(k) submission for a general diagnostic ultrasound system.

Ask a specific question about this device

The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-75/ DC-78/ DC-70S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel , intra-operative(abdominal, thoracic, and vascular) and urology exams.

DC-70/ DC-70T /DC-70 Pro/ DC-70 Exp/ DC-75/ DC-78/ DC-70S is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, P CW-Mode, Color-Mode , Power/Dirpower Mode, THI, Smart3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver and LOV) or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include Linear array, Convex array, Phased array, Volume and Pencil probe.

Here's an analysis of the provided information regarding the acceptance criteria and supporting studies for the Shenzhen Mindray Bio-medical Electronics Co., LTD DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System.

Important Note: This document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness as a PMA (Premarket Approval) application would. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily related to safety, performance aspects comparable to the predicate, and adherence to relevant standards. Clinical effectiveness studies are explicitly stated as "Not applicable."

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the acceptance criteria are not typically expressed as specific performance metrics (like sensitivity/specificity) for a diagnostic task, but rather as compliance with safety standards and equivalence to predicate devices in terms of intended use and technological characteristics.

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

The submission explicitly states: "8. Clinical Studies Not applicable. The subject of this submission, DC-70/ DC-70T/ DC-70 Pro/ DC-70 Exp / DC-75/ DC-78/ DC-70S Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."

Therefore, there is no mention of a traditional test set of patient data, sample size, or data provenance (country of origin, retrospective/prospective) for proving device performance in a diagnostic context. The assessment relies on engineering and performance testing against standards and comparison to predicate devices.

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

As clinical studies were "Not applicable," there is no mention of experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used for diagnostic performance evaluation.

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 submission explicitly states no clinical studies were required or performed. There is no mention of AI features (other than "Smart3D", "Smart face", "Smart plane CNS", which are likely imaging enhancement features rather than AI for diagnostic interpretation) that would necessitate a comparative effectiveness study with human readers.

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

Not applicable, as no clinical studies were conducted for diagnostic performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For a 510(k) for an ultrasound system, the "ground truth" for demonstrating substantial equivalence primarily relates to:

• Compliance with recognized standards: The physical and electrical safety, acoustic output, and electromagnetic compatibility are tested against established engineering and medical device standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62366, IEC 60601-1-6, ISO14971, UD 2, UD 3, ISO 10993-1).
• Performance specifications: The ultrasound system's various modes (B-Mode, M-Mode, etc.) and transducer capabilities are assessed against their defined technical specifications and compared to those of predicate devices.
• Physical and material properties: Biocompatibility, cleaning/disinfection effectiveness are evaluated according to relevant standards.

8. The Sample Size for the Training Set

Not applicable. No AI/ML model requiring a training set is described as the primary subject of the 510(k) for demonstrating substantial equivalence as a diagnostic device. The "Smart" features mentioned are likely integrated software functionalities rather than standalone AI for diagnostic interpretation requiring significant training data submitted for review.

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

Not applicable, as no training set for an AI/ML model for diagnostic interpretation is discussed.

Ask a specific question about this device

The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-75/ DC-78/ DC-70S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-esoph(Cardiac), musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams.

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode , Power/Dirpower Mode, THI, iScape,4D, Smart3D,TDI, Color M, Elastography, Biopsy Guidance, Contrast imaging or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 2.0 MHz to 10.0 MHz.

This document describes the premarket notification (510(k)) for the Mindray DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System. It is a submission to the FDA for substantial equivalence to legally marketed predicate devices.

The information provided focuses on the technical specifications, intended uses, and compliance with safety standards, rather than a study proving the device meets specific acceptance criteria related to AI performance or diagnostic accuracy in the way described in the prompt's request. Crucially, the document explicitly states that no clinical studies were performed.

Therefore, I cannot fulfill all parts of your request as the provided text does not contain data on AI performance, human reader improvement with AI assistance, or specific acceptance criteria met through clinical trials. It primarily addresses the substantial equivalence of an ultrasound imaging system in terms of its features, safety, and technological characteristics compared to predicate devices.

However, I can extract the information relevant to the device's stated performance and the basis for its acceptance from a regulatory perspective, focusing on the equivalence to existing devices and compliance with safety standards.

Here's an attempt to answer using the provided text, while noting the limitations:

Acceptance Criteria and Device Performance (based on provided text):

The document does not define specific "acceptance criteria" for diagnostic accuracy or AI performance in the traditional sense, nor does it report "device performance" in terms of metrics like sensitivity, specificity, or AUC, as it's a 510(k) submission primarily focused on substantial equivalence (safety and efficacy similar to existing devices). Instead, the acceptance is based on demonstrating the device's technical characteristics, safety, and intended uses are comparable to already cleared predicate devices and comply with relevant standards.

Table of "Acceptance Criteria" (interpreted as demonstrated compliance/equivalence) and "Reported Device Performance" (interpreted as features/capabilities):

Study Details (based on provided text):

1. Sample size used for the test set and the data provenance: Not applicable. The document explicitly states "Clinical Studies: Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." The evaluation relies on non-clinical (engineering, safety, and performance) testing and comparison to predicate devices, not diagnostic performance on a test set of patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical studies or test sets with ground truth were used or are described.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical studies or test sets were used.

4. 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 document is for a diagnostic ultrasound system, not an AI or CAD (Computer-Aided Diagnosis) device providing analytical results that would assist human readers in a diagnostic task. The "Smart3D" and "iScape" features mentioned are imaging modes/enhancements, not necessarily AI for diagnostic assistance. There is no mention of such a study or effect size.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI diagnostic algorithm; it's an ultrasound imaging device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical studies or test sets for diagnostic accuracy were performed or are detailed.

7. The sample size for the training set: Not applicable. This is not an AI/ML device that underwent training on a dataset for a diagnostic task.

8. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission primarily relies on demonstrating substantial equivalence to existing, legally marketed ultrasound devices through non-clinical testing (e.g., electrical safety, acoustic output, biocompatibility, software validation) and detailed comparison of technological characteristics and intended uses. It does not involve AI performance evaluation or clinical studies that would generate data for the specific "acceptance criteria" and "study proving device meets acceptance criteria" as outlined in your prompt for AI/diagnostic accuracy studies.

Ask a specific question about this device

The DC-70/DC-70T /DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams.

DC-70/DC-70T /DC-70 PRO/DC-70 EXP is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.0 MHz to 10.0 MHz.

This document is a 510(k) summary for the Shenzhen Mindray Bio-medical Electronics Co., LTD DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System. It details the device's substantial equivalence to previously cleared predicate devices.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative acceptance criteria (e.g., minimum accuracy rates for detecting certain conditions) or detailed device performance metrics in a typical table format like one would expect for a diagnostic AI algorithm. Instead, it relies on demonstrating substantial equivalence to predicate devices by asserting that the subject device has the same technological characteristics, comparable safety and effectiveness features, and the same intended uses and basic operating modes.

The performance is implicitly "met" by showing compliance with various medical device safety and performance standards. The key reported "performance" is the sameness of features and capabilities with the predicate device.

Here's an attempt to structure it based on the available information:

• Acoustic Power Levels: Below FDA limits and same as predicate DC-8 (K132341).
• Electrical & Physical Safety: Compliant with FDA recognized standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37) and same as predicate DC-8 (K132341).
• Special Functions: Identical to predicate devices DC-8 (K132341) and DC-N2 (K132779).
• Image Annotation/Reporting: Same capacity as predicate DC-8 (K132341).
• Probes: Has similar/same probes as predicate DC-8 (K132341), specifically listing C5-2E, C7-3E, C11-3E, P4-2E, P7-3E, V11-3E, V11-3BE, V11-3WE, L12-3E, L14-6NE, L14-6WE, D6-2E, DE10-3E, CW5s.
• Measurement & Calculation Functions: Same as predicate DC-8 (K132341). |
  | Quality System Compliance: Manufacturing processes adhere to recognized quality standards. | The design, development, and quality process of the manufacturer conforms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. |
  | Biocompatibility: Demonstrated biocompatibility. | Evaluated for biocompatibility and designed to conform with applicable medical safety standards, including ISO 10993-1. |
  | Cleaning and Disinfection Effectiveness: Effectiveness evaluated. | Evaluated for cleaning and disinfection effectiveness. |
  | Risk Management: Application of risk management processes. | ISO14971 Medical devices - Application of risk management to medical devices was applied. |
  | Software Life Cycle: Software development adheres to recognized standards. | IEC 62304 Medical device software - Software life cycle processes were followed. |
  | Usability Engineering: Usability considered in design. | IEC 62366 Medical devices - Application of usability engineering to medical devices was applied. |

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

The document explicitly states: "7. Clinical Studies Not applicable. The subject of this submission, DC-70/DC-70T /DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."

Therefore, there is no test set of clinical images or patient data used for evaluating the device's performance in terms of diagnostic accuracy or clinical outcomes. The evaluation is based on non-clinical tests (acoustic output, electrical safety, biocompatibility, software standards, etc.) and comparison to predicate device specifications.

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

Since no clinical test set was used, there were no experts used to establish ground truth in the context of diagnostic accuracy for this submission.

4. Adjudication Method 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, and the effect size of how much human readers improve with AI vs. without AI assistance

Not applicable. This device is a diagnostic ultrasound system (hardware and software for image acquisition and display), not an AI-assisted diagnostic tool that modifies human reader performance. No MRMC study was conducted or mentioned.

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

Not applicable. This is a complete diagnostic ultrasound system, not an AI algorithm for standalone interpretation. The system itself generates the images that a human interprets.

7. The Type of Ground Truth Used

Not applicable in the context of diagnostic performance (e.g., pathology, outcomes data). The "ground truth" for the non-clinical tests would be the established specifications and limits defined by the various engineering, safety, and performance standards listed (e.g., maximum acoustic output levels, electrical safety limits).

8. The Sample Size for the Training Set

Not applicable. As a diagnostic ultrasound system that relies on physical principles of sound wave generation and detection, and image processing, it does not use a "training set" in the context of machine learning. The system's design and software are developed based on engineering principles and validated through adherence to standards.

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

Not applicable, as there is no machine learning "training set". The performance is established through adherence to recognized medical device standards and demonstrating equivalence to a legally marketed predicate device.

Ask a specific question about this device

The DC 7 laser and accessories are indicated for General Surgery, Dermatology & Plastic Surgery, and Podiatry: Excision, ablation, vaporization, and photocoagulation of skin lesions, hemostasis; incision, excision, vaporization, and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue, and dermabrasion, such as: Matrixectomy Excision of neuromas Excision of periungual and subungual warts Excision of plantar warts Excision of Keloids Excision of cutaneous lesions Photocoagulation of telangiectasia, venulectasia of the legs and face Superficial benign vascular lesions including Telangiectasias, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi

The DC International, LLC DC 7 is a medical grade, solidstate, infrared diode lasers (AlGaAs). The lasers are designed to deliver continuous or pulsed laser energy with a wavelength at 980 nm. The touch screen display consists of a user interactive screens that allows selection of continuous, pulsed and the, repetition rates, aiming beam on/off, procedural information display keys, a Standby/Ready key, the manual emergency stop button and the master key switch.

The provided text is a 510(k) summary for the DC 7 Diode Laser Therapy System. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

Based on the document, here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Device Performance

The DC 7 device is a diode laser therapy system. The acceptance criteria are based on substantial equivalence to predicate devices rather than meeting specific performance metrics in a clinical study. The device meets "acceptance criteria" by demonstrating that its technical and functional characteristics are either identical or sufficiently similar to legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness.

Table of Acceptance Criteria (based on comparison to predicate devices) and Reported Device Performance (DC 7):

Study Details

The provided document (510(k) summary) explicitly states:

• Non clinical Performance Data: None
• Clinical Performance Data: None

This means that a traditional "study" to prove the device meets acceptance criteria in terms of performance was not performed in the context of this 510(k) submission. Instead, the "study" demonstrating that the device meets criteria is a comparative analysis proving substantial equivalence to predicate devices, which is sufficient for 510(k) clearance for this type of device.

Given the absence of clinical/non-clinical performance data, the following points cannot be addressed as no such studies were conducted or presented in this summary:

1. Sample size used for the test set and the data provenance: Not applicable, as no test set data from performance studies were provided. The "test set" here would implicitly be the specifications of the predicate devices.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device performance was not established via expert review in this submission.
3. Adjudication method for the test set: Not applicable.
4. 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 surgical laser, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical laser.
6. The type of ground truth used: For the purpose of this 510(k), the "ground truth" for proving substantial equivalence comes from the established safety and effectiveness of the legally marketed predicate devices, against which the DC 7's technical specifications are compared.
7. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
8. How the ground truth for the training set was established: Not applicable.

In summary, the clearance for the DC 7 is based on a demonstration of substantial equivalence to predicate devices through a detailed comparison of technical specifications, rather than new performance studies with specific acceptance criteria that would typically involve test sets, expert ground truth, or statistical analysis of clinical outcomes.

Ask a specific question about this device

The DC-7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, cardiac, small organ (breast, testes, thyroid, etc.), peripheral vascular, fetal, transvaginal, pediatric, transcranial (adult cephalic and neonatal cephalic), musculoskeletal (conventional and superficial), intraoperative, and urology exams.

The DC-7 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, Color mode, Color M mode, CW mode, CW mode, Power/DirPower mode, TDI mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array probe, convex array probe, phased array probe and volume probe with a frequency range of approximately 1.8 MHz to 12.0 MHz. This modification will provide users with 3 additional transducers, some additional optional features called STIC, Stress Echo, iPage, and etc. These modifications all lead to overall quality and image enhancement.

The DC-7 Diagnostic Ultrasound System is a general purpose ultrasound system with various transducers and modes of operation. The provided text is a 510(k) summary for this device, seeking substantial equivalence to predicate devices, and outlines its intended use, non-clinical tests, and technological characteristics. The document does not contain specific acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/CADe device.

Instead, the document details the Indications for Use (IFU) for the DC-7 Diagnostic Ultrasound System and its various transducers across different clinical applications and modes of operation. The "acceptance criteria" here are implicitly that the new system and its transducers can perform these functions ("P" for previously cleared, "N" for new indications) safely and effectively, demonstrating substantial equivalence to the listed predicate devices.

Here's a breakdown based on your request, interpreting "acceptance criteria" as the claimed capabilities and "study" as the information provided for regulatory clearance:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) clearance for a general-purpose ultrasound system and not a specific AI/CADe algorithm with performance metrics like sensitivity/specificity, the "acceptance criteria" are the claimed modes of operation and clinical applications for each transducer. The "reported device performance" is that the system and transducers are capable of these indicated uses, demonstrating substantial equivalence to predicate devices.

The tables for each transducer (e.g., 3C5A, C5-2, V10-4, L12-4, P7-3, etc.) list the following "acceptance criteria" (indicated by 'P' for previously cleared or 'N' for new) and their reported performance (the presence of 'P' or 'N' in the table signifies the device meets these criteria for the given transducer):

Notes:

1. Tissue Harmonic Imaging: The feature does not use contrast agents.
2. Smart3D: (Likely a 3D imaging feature)
3. 4D (Real-time 3D): (Real-time 3D imaging)
4. iScape: (Likely an extended field of view imaging feature)
5. TDI (Tissue Doppler Imaging): (Cardiac function assessment)
6. Color M: (Color M-mode)
7. Biopsy Guidance: (Assistance for biopsy procedures)

P = Previously cleared by FDA; N = New indication (for this specific K-number, it implies new to this device or transducer combination)
Entries are filled based on the collective information from all transducer tables where "P" or "N" is indicated for at least one transducer. Some specific cells might be blank for certain transducers, meaning that mode/application is not indicated for that specific transducer.

The "study" proving these criteria are met is the "Non-clinical Tests" and the demonstration of "Technological Characteristics" being substantially equivalent to predicate devices.

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

• The 510(k) summary does not describe a specific "test set" in terms of patient data for a clinical study comparing performance metrics.
• Instead, the submission relies on non-clinical tests (acoustic output, biocompatibility, cleaning/disinfection, thermal/electrical/mechanical safety) and comparison of technological characteristics to predicate devices to establish substantial equivalence.
• Data provenance: Not applicable in the context of a clinical test set from patient data. The provenance for the non-clinical tests would be internal laboratory testing by the manufacturer.

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

• Not applicable. This is a clearance for a general diagnostic ultrasound system based on technological equivalence and safety standards, not an AI/CADe device requiring expert-established ground truth for a clinical performance study.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical test set requiring expert adjudication is described in the provided summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

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

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

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

7. The Type of Ground Truth Used

• Not applicable. The clearance is based on adherence to medical safety standards (IEC, ISO), acoustic output, biocompatibility, and demonstrated technological equivalence to legally marketed predicate devices, rather than comparison to a clinical ground truth like pathology or outcomes data for a specific diagnostic task.

8. The Sample Size for the Training Set

• Not applicable. This is a hardware/software system, not an AI/CADe algorithm requiring a training set from patient data in the context of medical imaging.

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

• Not applicable. As above, this is not an AI/CADe algorithm with a training set.

In summary: The provided 510(k) summary for the Mindray DC-7 Diagnostic Ultrasound System is for a general-purpose diagnostic imaging device, not an AI or CADe product. Therefore, the "acceptance criteria" and "study" described align with the requirements for establishing substantial equivalence for such a device, focusing on safety, performance, and technological similarity to already cleared predicate devices, rather than detailed performance metrics from clinical trials or AI algorithm validation.

Ask a specific question about this device

The DC-3/DC-3T diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetrics, abdominal, pediatric, small parts(breast, thyroid, testicle, etc), neonatal cephalic, transcranial, cardiac, transrectal,peripheral vascular, intraoperative, urology, orthopedics, and musculoskeletal (conventional and superficial) exams.

The DC-3/DC-31 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, PW mode, Power mode, DirPower mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 2.0 MHz to 12.0 MHz.

The provided text is a 510(k) summary for the Mindray DC-3/DC-3T Diagnostic Ultrasound System. It is a declaration of substantial equivalence to previously cleared devices, rather than a study outlining acceptance criteria and device performance. As such, the input does not contain the information needed to directly answer all parts of your request.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document is a 510(k) summary, which a regulatory submission to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This type of submission does not typically include a table of acceptance criteria or quantitative performance metrics from a specific study designed to prove the device meets these criteria. Instead, it asserts equivalence based on technological characteristics and adherence to safety standards.

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

No studies with a "test set" are described, nor is there information about sample sizes or data provenance (e.g., country of origin, retrospective/prospective). The 510(k) relies on comparison to existing predicate devices and compliance with recognized standards.

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

Since no specific study evaluating the device's diagnostic performance against a ground truth is described, there is no information on the number or qualifications of experts used for establishing ground truth.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned as no specific test set-based study is presented.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No MRMC comparative effectiveness study is described in this 510(k) summary. The document focuses on establishing substantial equivalence based on technological characteristics and adherence to safety standards, not on demonstrating improved human reader performance with AI assistance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This device is a general-purpose diagnostic ultrasound system, not an AI-powered algorithm. Therefore, a standalone algorithm-only study is not applicable and not mentioned. The declaration is for the complete ultrasound system.

7. The Type of Ground Truth Used:

No ground truth is mentioned as no specific diagnostic performance study is presented. The "ground truth" in a 510(k) for a general ultrasound system is typically considered to be compliance with established safety and performance standards for diagnostic ultrasound and equivalence to predicate devices.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a traditional ultrasound system, not an AI model that requires a training set of data.

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

This information is not applicable for the same reasons as (8).

Summary of available information from the document:

• Acceptance Criteria/Performance: The submission claims the device "has been found to conform with applicable medical safety standards" (UD 2, UD 3, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4, ISO 10993-1, and IEC 62304) and is "substantially equivalent" to predicate devices (Mindray DC-7(K101041), Mindray DC-3/DC-3T (K091941) and Mindray M5(K102991)). This implies that the 'acceptance criteria' are primarily regulatory compliance and demonstration of equivalence to existing devices.
• Study Design: This is a 510(k) summary, which is a regulatory submission asserting substantial equivalence, not reporting a clinical study with detailed performance metrics. It does not describe a clinical study in the format one might expect for device performance evaluation against specific metrics.
• Intended Use: The device is broadly applicable for adults, pregnant women, pediatric patients, and neonates for various exams including gynecology, obstetrics, abdominal, cardiac, vascular, and small parts.
• Transducers: A list of compatible transducers (3C5A, 6C2, 7L5, 6CV1, 6LE7, 7LT4, 7L4A, 6LB7, D6-2, 7L6, 3C1, 10L4, 2P2) is provided, each with specific "Indications for Use" forms detailing the clinical applications and modes of operation they support. "P" indicates previously cleared by FDA for that application/mode.

Ask a specific question about this device

The DC-7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, cardiac, small organ (breast, testes, thyroid, etc.), peripheral vascular, fetal, transvaginal, pediatric, nconatal cephalic, musculoskcletal(conventional and superficial), intraoperative and transcranial exams.

The DC-7 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, Color mode, Color M mode, PW mode, CW mode, Power/DirPower mode, TDI mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array probe, convex array probe, phased array probe and volume probe with a frequency range of approximately 1.8 MHz to 12.0 MHz.

The provided text is a 510(k) summary for the Mindray DC-7 Diagnostic Ultrasound System. This document focuses on establishing substantial equivalence to existing devices and details the device's features, intended use, and safety considerations. It does not contain information about specific "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of performance metrics like sensitivity, specificity, or accuracy for diagnostic tasks.

Instead, the document primarily addresses:

• Manufacturing and Safety Standards: The device conforms to acoustic output standards (NEMA UD 2:2004, NEMA UD 3:2004) and medical device safety standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4, and ISO 10993-1). These are the "acceptance criteria" for the safety and basic functionality of the ultrasound system itself, not for a specific diagnostic performance.
• Substantial Equivalence: The primary "proof" of meeting acceptance criteria for market clearance is the demonstration that the DC-7 is "as safe and effective as the legally marketed predicate devices" (Mindray DC-7 (K#092691), Mindray DC-3 (K#091941), GE Logiq PS (K#060993), GE Voluson 730 (K#041688)). This is not a study measuring diagnostic accuracy but rather a comparison of technical characteristics and intended uses.

Therefore, many of the requested details about a performance study are not present in this type of regulatory submission. I will answer the questions based on the information available and explicitly state when information is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for an ultrasound system and not a specific diagnostic algorithm or AI, the "acceptance criteria" are related to safety, electrical, and acoustic performance, and functional equivalence to predicate devices, rather than diagnostic accuracy metrics. The document states that the device was tested to meet recognized international and national standards.

Regarding diagnostic performance studies, the document contains no information on the following points:

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

No details on a specific diagnostic performance test set are provided. The "testing" mentioned refers to safety and functional compliance, and comparison to predicate devices, not clinical diagnostic accuracy of an algorithm.

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 diagnostic performance study is described.

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

Not applicable as no diagnostic performance study 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 a general-purpose ultrasound system, not an AI-powered diagnostic algorithm or an assist tool.

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

Not applicable. This device is a general-purpose ultrasound system, not an AI-powered diagnostic algorithm.

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

Not applicable as no diagnostic performance study is described.

8. The sample size for the training set

Not applicable. This device is a general-purpose ultrasound system. Any "new algorithm" mentioned in section 3 (page 1) would likely refer to internal signal processing or imaging algorithms, not a machine learning model trained on a large dataset for diagnostic output. No details about such training are provided.

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

Not applicable as no training set for a diagnostic algorithm is mentioned.

Ask a specific question about this device

The DC-7 diagnostic ultrasound system is designed for M, B, pulsed doppler, continuous Doppler, color Doppler, power Doppler modes, and combined modes (i.e. B/M Mode). The system is indicated for fetal, abdominal, pediatric, small organ (breast, thyroid, and testes), cephalic (neonatal and adult), transvaginal, peripheral vascular, musculo-skeletal (conventional and superficial), and cardiac (neonatal and adult). The system includes optional biopsy needle guides that attach to the transducers.

The DC-7 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasound diagnostic system. This system is a Track 3 device that employs an array of probes that include linear array probe, convex array probe, phased array probe and volume probe with a frequency range of approximately 2.0 MHz to 12.0 MHz.

This document refers to the Mindray DC-7 Diagnostic Ultrasound System (K092691).

Acceptance Criteria and Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing specific quantitative acceptance criteria for performance metrics. The core statement is that "The conclusions drawn from testing of the DC-7 Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices."

The "Indications for Use" section (pages 4-11 of the original document) lists the clinical applications and operating modes for the device and its various transducers. These serve as the functional requirements the device needs to meet.

Study Information

The document describes the type of information typically provided for a 510(k) submission, which focuses more on substantial equivalence to existing devices rather than a standalone clinical trial with specific performance metrics. Therefore, detailed information about a dedicated study meeting the requested criteria is largely absent.

Here's an analysis based on the provided text:

1. Sample size used for the test set and the data provenance: Not explicitly stated in the provided document. The submission is based on engineering tests and comparison to predicate devices, not data from a specific patient test set in the way an AI/CADe device would typically require. The data provenance would be internal engineering verification and validation data, not patient data in the context of clinical performance evaluation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not explicitly stated. For a diagnostic ultrasound system, "ground truth" typically refers to the physical and functional performance of the device against engineering specifications and industry standards, rather than expert interpretation of images for a specific disease. The "ground truth" for compliance with standards would be established by internal engineering and quality control teams.

3. Adjudication method for the test set: Not applicable or not explicitly stated. This concept (e.g., 2+1, 3+1) is typically relevant for studies involving human interpretation where discrepancies need to be resolved, usually for AI/CADe devices. This is not a performance study as would be conducted for an AI device.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI or CADe device, but a general-purpose diagnostic ultrasound system. Hence, no MRMC study or AI-assistance effect size is mentioned.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an ultrasound system, not an algorithm, and is designed for human-in-the-loop operation.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" in this context refers to compliance with safety and performance standards for an ultrasound system. This includes:

   • Engineering specifications and test results: Measuring acoustic output (NEMA UD 2 & 3), electrical safety (IEC 60601 series), and biocompatibility (ISO 10993-1).
   • Functional performance: Verifying the device's ability to operate in the stated modes (B, M, Doppler, etc.) and for the specified clinical applications, likely through phantom testing and internal verification.
   • Comparison to predicate devices: Demonstration that its performance is "as safe and effective" as established, legally marketed predicate devices, implying similar image quality and diagnostic capabilities.

7. The sample size for the training set: Not applicable. This device is a traditional hardware and software diagnostic ultrasound system, not an AI/machine learning product that requires training data in the AI sense.

8. How the ground truth for the training set was established: Not applicable, as it's not an AI/machine learning device.

Ask a specific question about this device