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510(k) Data Aggregation
(20 days)
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):
| Clinical Application | B Mode | M Mode | PWD | CWD | Color Doppler | Amplitude Doppler | Combined Mode | Other Features |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,3,4,6,7 |
| Abdominal | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,3,4,5,6,7 |
| Intraoperative (includes abdominal, thoracic, vascular) | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,6,7 |
| Pediatric | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,5,6,7 |
| Small Organ (breast, testes, thyroid) | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,6,7 |
| Neonatal Cephalic | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,5,6,7 |
| Adult Cephalic | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,5,6,7 |
| Trans-rectal | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,3,4,6,7 |
| Trans-vaginal | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,3,4,6,7 |
| Musculoskeletal Conventional | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,6,7 |
| Musculoskeletal Superficial | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,6,7 |
| Cardiac Adult | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,5,6,7 |
| Cardiac Pediatric | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,5,6,7 |
| Peripheral Vascular | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,6,7 |
| Other (Urology) | N | N | N | N | N | N | N | Note 1,2,4,6,7 |
Notes:
- Tissue Harmonic Imaging: The feature does not use contrast agents.
- Smart3D: (Likely a 3D imaging feature)
- 4D (Real-time 3D): (Real-time 3D imaging)
- iScape: (Likely an extended field of view imaging feature)
- TDI (Tissue Doppler Imaging): (Cardiac function assessment)
- Color M: (Color M-mode)
- 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.
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(39 days)
Esaote's Model 7340 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 7340 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
Esaote's Model 6150 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6150 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
The 7340 and 6150 system designs remain the same as those previously cleared by FDA via K081794, K051308, K052805, K060827, and K081386, respectively, except for those features being added via this submission.
The 6150 is a mainframe ultrasound system, and the 7340 is a portable ultrasound system, both are used to perform diagnostic general ultrasound studies. Their primary modes of operation are: B-Mode, M-Mode, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The systems are equipped with a LCD Color Display and are capable of operating Linear, Convex, and Phased array probes.
The 7340 and 6150 systems are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.
The provided 510(k) summary for the Esaote 7340 & 6150 Systems is a premarket notification for new features added to previously cleared ultrasound imaging systems. It does not contain information about an in-depth study with acceptance criteria and device performance metrics in the way one might expect for a novel AI/ML device. Instead, it demonstrates substantial equivalence to predicate devices based on technological characteristics and intended use.
Therefore, the requested information elements related to detailed study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance for meeting acceptance criteria (as typically expressed for new performance claims) are not present in this type of submission. The "acceptance criteria" here are essentially the requirements for demonstrating substantial equivalence to the identified predicate devices for the new features (Elastography and 3D/4D in specific applications).
Here's an analysis based on the provided text, addressing the points where information is available or can be inferred, and noting where it is not applicable for this type of submission:
Acceptance Criteria and Device Performance
The core "acceptance criteria" for this 510(k) are demonstrating substantial equivalence. The device performance is implicitly considered equivalent to the predicate devices for the functionalities being added.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Implied from Predicate Equivalence) |
|---|---|
| New Features (Elastography, 3D/4D): Performance in Elastography (ElaXto) and 3D/4D modality (Transvaginal, Transrectal, Urology) should be substantially equivalent to identified predicate devices. | Elastography (ElaXto) Analysis: Substantially equivalent to Siemens eSie Elasticity Imaging module available with S2000 system (K072786). |
| 3D/4D Modality (Transvaginal, Transrectal, Urology): Substantially equivalent to 3D/4D modality in the same applications available with RIC5-9-D probe of General Electric Voluson E8 system (K061682). These systems are able to provide elastographic analysis on real-time images by applying low compression/retraction movements using the probe. They are able to provide 3D/4D modality in Transvaginal, Transrectal and Urology applications by simultaneously controlling two independent scan planes for volumetric acquisition. | |
| Safety Requirements: Meet IEC60601-1 and IEC60601-2-37 safety standards. | The 7340, 6150, Siemens S2000, and General Electric Voluson E8 systems are designed to meet IEC60601-1 and IEC60601-2-37 safety requirements. |
| Acoustic Output Display: Provide an Acoustic Output Display feature per AIUM/NEMA standards, with equivalent Ispta and MI maximal values. | The 7340, 6150, Siemens S2000, and General Electric Voluson E8 systems provide an Acoustic Output Display feature per AIUM/NEMA standards, with equivalent Ispta and MI maximal values. |
Study Information (Based on the provided Summary)
This document is a 510(k) summary, not a full study report. It focuses on demonstrating equivalence rather than presenting a performance study with acceptance criteria.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. This type of detail is not typically included in a 510(k) summary for a substantial equivalence claim based on predicate device features. It's implied that the predicate devices themselves underwent such testing. The current submission is more focused on the technical design equivalence of the new features.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not provided. Ground truth establishment, if any for specific performance testing, would have been part of the predicate device clearances or internal testing not detailed in this summary.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided. As a substantial equivalence claim, a formal adjudication process for a test set is not described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This document describes features of an ultrasound imaging system, not an AI-assisted diagnostic tool in the sense of a standalone algorithm or a comparative effectiveness study with human readers. The "AI" implied might be the "Elastography (ElaXto) analysis" and "3D/4D modality", but these are presented as imaging modes, not decision-support AI.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is an ultrasound imaging system rather than a standalone algorithm with a distinct performance evaluation. The added features are integral to the imaging process.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided. For a substantial equivalence claim regarding new imaging features like elastography and 3D/4D, technical specifications, image quality assessments, and possibly phantom studies are typically used to demonstrate equivalence rather than clinical ground truth from patient outcomes or pathology, unless explicit new clinical claims are being made.
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The sample size for the training set:
- Not applicable / Not provided. These are ultrasound imaging systems with added features, not machine learning algorithms that typically require a distinct training set. The "training" in this context would likely refer to the general development and calibration process of imaging technologies, not a labeled dataset for AI.
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How the ground truth for the training set was established:
- Not applicable / Not provided. As above, the concept of a "training set" and associated ground truth in the context of an AI/ML device is not directly relevant to this type of ultrasound system submission.
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