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The ACCUVIX V7 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: General, Obstetrics, Gynecology, Extremity, Urology, Breast. Renal, Vascular, Pediatric, Abdomen, Cardiac, Neonatal, Fetal Echo, Carotid, Varicose, Fetal Abdominal, Small organ, Intra-operative, Cephalic, Muscular-skeletal, Trans-rectal, Trans-vaginal, Contrast Agent, Transesophageal and Peripheral-vascular applications.

The ACCUVIX V7 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler imaging, Power Doppler imaging, Harmonic imaging, and PW Spectral Doppler mode on the CRT display. It also provides the 3D imaging mode using the 3D probe in the Mechanical scan mode. The ACCUVIX V7 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals.

The provided document is a 510(k) Premarket Notification for the ACCUVIX V7 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical studies with specific acceptance criteria and performance metrics typically associated with novel device approvals.

Therefore, the document does not contain details about acceptance criteria or a study proving the device meets them in the context of clinical performance like sensitivity, specificity, or reader studies. Instead, the "acceptance criteria" for a 510(k) are generally the demonstration of substantial equivalence to a predicate device and compliance with applicable recognized standards.

Here's an analysis based on the provided text, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance:

No such table is provided in the document. The submission focuses on demonstrating equivalence to predicate devices and adherence to relevant safety and performance standards for ultrasound equipment.

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

Not applicable. The document does not describe a clinical performance study with a test set of patient data to evaluate algorithmic performance. The evaluations mentioned are primarily engineering and safety compliance tests.

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

Not applicable. There is no mention of a test set with ground truth established by experts for clinical performance evaluation.

4. Adjudication method for the test set:

Not applicable. No test set for clinical performance is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the impact of AI on human reader performance, which is not relevant to a 510(k) for a general diagnostic ultrasound system.

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

Not applicable. The ACCUVIX V7 is a diagnostic ultrasound system, not an AI algorithm intended for standalone performance evaluation in a clinical decision-making context.

7. The type of ground truth used:

Not applicable in the context of clinical performance metrics. The "ground truth" for this submission revolves around:

• Compliance with recognized standards: UL 60601-1, CSA C22.2 No. 601.1, IEC60601-2-37, EN/IEC60601-1, EN/IEC60601-1-2, NEMA UD 2-2004, NEMA UD 3-2004, IEC 61157, ISO10993 (as listed in Section 4).
• Substantial equivalence to predicate devices: ACCUVIX XQ Diagnostic Ultrasound System (K052911) and SA8000 Diagnostic Ultrasound System (K013627). This is the primary "ground truth" for a 510(k) – that the new device is as safe and effective as existing legally marketed devices.

8. The sample size for the training set:

Not applicable. This device is a diagnostic ultrasound system and not an AI/ML algorithm that undergoes training on a dataset in the typical sense.

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

Not applicable, as no training set for an AI/ML algorithm is mentioned.

Summary of Device Acceptance and Evidence from K060087:

The acceptance of the ACCUVIX V7 Diagnostic Ultrasound System is based on demonstrating substantial equivalence to predicate devices (ACCUVIX XQ Diagnostic Ultrasound System, K052911; and SA8000 Diagnostic Ultrasound System, K013627) and compliance with relevant safety and performance standards.

Acceptance Criteria (as implied by a 510(k) submission):

• Technological Characteristics: The device must have technological characteristics similar to the predicate device, or if different, demonstrate that these differences do not raise new questions of safety or effectiveness.
• Intended Use: The device must have the same intended use as the predicate device, or if different, demonstrate that this difference does not raise new questions of safety or effectiveness.
• Performance Standards: The device must demonstrate compliance with recognized industry and international safety and performance standards for diagnostic ultrasound equipment.
• Acoustic Output: Acoustic output levels must be within established limits for diagnostic ultrasound equipment, often verified through measurement against NEMA UD 2 and IEC 61157 standards.
• Biocompatibility: Materials in contact with patients must meet biocompatibility standards (e.g., ISO10993).
• Electrical Safety and EMC: The device must comply with electrical safety and electromagnetic compatibility standards (e.g., UL 60601-1, IEC60601-1, IEC60601-1-2).

Study/Evidence that Proves the Device Meets Acceptance Criteria:

The document implicitly refers to various forms of evidence:

• Substantial Equivalence Argument: The core of the 510(k) is the argument (in Section 6) that the ACCUVIX V7 is substantially equivalent to the predicate devices. This typically involves comparing design features, materials, energy source, and intended uses. The letter from the FDA confirms this determination.
• Compliance with Standards (Section 4): Medison Co. Ltd. states that the ACCUVIX V7 has been designed to meet a comprehensive list of product safety standards, including:
  • UL 60601-1 (Safety for Medical Equipment)
  • CSA C22.2 No. 601.1 (Safety for Medical Equipment)
  • IEC60601-2-37 (Diagnostic Ultrasound Safety Standards)
  • EN/IEC60601-1 (Safety for Medical Equipment)
  • EN/IEC60601-1-2 (EMC for Medical Equipment)
  • NEMA UD 2-2004 (Acoustic Output Measurement Standard)
  • NEMA UD 3-2004 (Real-Time Display of Acoustic Output Indices)
  • IEC 61157 (Declaration of Acoustic Output)
  • ISO10993 (Biocompatibility)
• Acoustic Output Measurements: The FDA's clearance letter explicitly requires a "postclearance special report" containing "complete information, including acoustic output measurements based on production line devices, requested in Appendix G" of their guidance document. This indicates that actual measurements are a critical component of verifying safety for acoustic output.
• Indications for Use (Sections 5-25): The detailed tables outlining the clinical applications and modes of operation for the main system and each transducer (e.g., C1-4EC, L4-7EL, MPT4-7AC) demonstrate how the device's intended use aligns with established practices and the predicate devices. "N" indicates a new indication, implying Medison provided justification for its safe inclusion, while "P" indicates previously cleared indications (through predicate devices).

In summary, for a traditional diagnostic ultrasound system like the ACCUVIX V7, "acceptance criteria" are met through a demonstration of engineering compliance to recognized standards and a showing of substantial equivalence to already cleared devices, rather than through extensive clinical trials with statistical endpoints.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal (including infertility monitoring of follicle development), Abdominal, Intra-operative (Abdominal, Vascular), Intra-operative (Neurological), Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (Non cardiac, Cardiac), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Cardiac (Adult, Pediatric), Peripheral-vascular.
Typical examinations performed using the system are: General abdominal and pelvic studies including organ surveys, assessment, and retro-peritoneal cavity studies. Study of small parts including breasts, shoulders, thyroid, and the abdominal wall. Pediatric scans of organs and bony structures. Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery. Monitoring procedures for infertility studies (other than in vitro fertilization). First, second and third trimester pregnancy studies. Prostate, prostate biopsy guidance, and rectal wall studies. Neonatal head studies. Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries. Cardiac studies in adults and children. Biopsy guidance for tissue or fluid sampling. Conventional podiatry scans. Intra-operative application including soft tissue structures.

The SA 9900 scanner is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Continuous (CW) Doppler, Pulsed (PW) Doppler, Power Doppler, and 3D imaging or as a combination of these modes. The SA 9900 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. All modes of operation have been previously cleared in 510(k) K002185. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals. The control panel has not changed from the description in the SA9900 Ultrasound System Operator's Manual, submitted in the 510(k) Special Report, Add-to-File for K002185. Various different models of transducers are available and any four may be connected at the same time. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. The SA-9900 uses digital beamforming technology, and supports a variety of Linear, Convex, Phased Array and Static probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz. These probes can be applied to a variety of clinical applications such as fetal, abdominal, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-rectal, trans-vaginal, peripheral-vascular, muscular-skeletal. The same clinical uses were cleared for the predicate device, SA8800/HD11500 (K974269). The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the expected date of delivery by using BPD (biparietal diameter), OFD (occipitofrontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APTD (anteroposterior trunk diameter), TTD (transverse trunk diameter), GS (gestational sac), LMP (last menstural period.), Cardiac Analysis (volume by area/length, Simpson biplane and single plane, M-mode analysis, Doppler: peak and mean gradients, pressure half time, E/A ratio and continuity equation) and Vascular Analysis (resistive index, pulsatility index, % stenosis, ICA/CCA ratio, Volume flow). Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. M-mode uses the scroll display method which has its images flow from the right to the left on the monitor. The SA9900 supports the Cine function (capable of storing up to 256 sequential images) and real-time zoom function to the region-ofinterest. The system provides the ability to perform remote viewing of images, without compression, via a DICOM 3.0 compatible output. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

The provided text is a 510(k) summary for the Medison SA9900 Ultrasound System and its associated transducers. It describes the device, its intended uses, and claims substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, especially in terms of diagnostic performance or clinical effectiveness.

The document focuses on regulatory compliance, electromechanical safety standards, and acoustic output limits. It lists various clinical applications and modes of operation, indicating whether these were "new indications" (N) or "previously cleared" (P) under a prior 510(k) (K002185). The FDA's letter confirms substantial equivalence based on the provided information, but this refers to regulatory equivalence, not a direct demonstration of performance against specific clinical acceptance criteria in a study.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted from this document.

Here's an attempt to fill in what can be gleaned, and explicitly state what is missing:

Acceptance Criteria and Device Performance Study (Medison SA9900 Ultrasound System)

The provided 510(k) summary does not include specific quantitative acceptance criteria related to diagnostic performance or clinical effectiveness, nor does it detail a study that evaluates such performance against those criteria.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (SA8800/HDI1500 System, K974269) by showing compliance with:

• Intended Use: The SA9900 has similar intended uses and clinical applications as the predicate.
• Technological Characteristics: The device operates in an identical manner (piezoelectric material, sound wave reflection, electrical signal processing) and has similar features (B-mode, M-mode, Doppler, 3D imaging, measurements, analysis packages).
• Safety Standards: The device meets electromechanical safety standards (e.g., EN 60601-1, UL 2601-1, IEC 61157).
• Acoustic Output Limits: The device's acoustic output limits (ISPTA: 720 mW/cm2, MI: 1.9) are the same as predicate Track 3 devices and are within regulatory limits.

Table of Acceptance Criteria and Reported Device Performance (as inferable from the document):

Missing Information:

1. Sample size used for the test set and the data provenance: Not mentioned. No specific "test set" in the context of diagnostic performance is described.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. No ground truth for diagnostic performance is described.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
4. 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 document pertains to a diagnostic ultrasound system, not an AI/CAD device, and no MRMC study is mentioned.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
7. The sample size for the training set: Not applicable. This is a hardware/software system, not a machine learning model requiring a specific training set as typically understood in AI/ML contexts. The "training" here would refer to engineering and development.
8. How the ground truth for the training set was established: Not applicable.

Summary:

The provided K012867 document is a 510(k) summary demonstrating regulatory substantial equivalence to a predicate device (SA8800/HDI1500 System, K974269) based on identical technological characteristics, intended uses, compliance with safety standards, and acoustic output limits. It focuses on the technical and regulatory aspects required for market clearance rather than providing data from a clinical performance study with specific diagnostic acceptance criteria. A post-clearance special report for acoustic output measurements on production line devices was requested by the FDA, indicating that further safety compliance confirmation was needed after the initial clearance.

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