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510(k) Data Aggregation
(67 days)
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult & pediatric); Peripheral Vascular (PV); and Urology (including prostate).
E-CUBE 9 product is an ultrasound imaging system for medical diagnosis. This product can be used for the applications of abdominal, obstetrics, gynecology, small parts, cardiology, vascular, etc. The system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality
The provided documentation does not contain detailed acceptance criteria for specific performance metrics of the E-CUBE 9 ultrasound system in a clinical context. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K060993 LOGIQ P5/A5 Diagnostic Ultrasound System) through non-clinical tests and a declaration that clinical studies were not required.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for clinical performance cannot be extracted from this document.
The document mainly highlights:
- Non-Clinical Tests: Evaluation for biocompatibility, acoustic output, thermal, electrical, electromagnetic, and mechanical safety, conforming to applicable medical device safety standards.
- Voluntary Standards Compliance: The device's application complies with voluntary standards as detailed in the premarket submission.
- Quality Management System Measures: Mention of Medical Device Risk Management, Requirements Reviews, Design Reviews, Component Verification, Integration Review (System Verification), Performance Testing (System Verification), Safety Testing (Compliance Test), and Design Validation.
The key statement regarding clinical data is:
"The subject of this premarket submission, E-CUBE 9, did not require clinical studies to support substantial equivalence."
This indicates that the FDA granted clearance based on non-clinical data and the device's technical similarity to a previously cleared device, rather than requiring new clinical performance studies with specific acceptance criteria that would typically be evaluated in such studies.
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(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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(56 days)
The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, vascular and neuro).
The subject device consists of a mobile console with keyboard. specialized controls, a color video LCD display with electronicarray transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 generalpurpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.
The provided 510(k) summary for the GE Healthcare LOGIQ P5 BT11 Ultrasound System (K101878) does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria.
This document is a premarket notification for a new device, asserting substantial equivalence to previously cleared predicate devices. The focus of this type of submission is to demonstrate that the new device is as safe and effective as existing legally marketed devices, rather than proving performance against specific acceptance criteria through a clinical validation study.
Here's a breakdown of why the requested information is not present and what the document does provide:
Key Takeaways from the Document:
- Substantial Equivalence: The primary assertion is that the LOGIQ P5 BT11 employs the "same fundamental scientific technology as its predicate devices" (K060993 LOGIQ P5/A5 Ultrasound System and K092271 LOGIQ E9 Ultrasound System). This is the basis for its clearance, not individual performance metrics against acceptance criteria.
- No Clinical Studies Required: The document explicitly states: "The subject of this premarket submission, LOGIQ P5, did not require clinical studies to support substantial equivalence." This means there would be no data from a clinical trial to report for acceptance criteria.
- Non-Clinical Tests: The device underwent non-clinical tests for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety, and conformity with applicable medical device safety standards. These are safety and performance standards, but not typically reported as specific acceptance criteria with performance data in this type of summary.
- Quality Assurance Measures: The document lists general quality assurance measures applied during development (Risk Analysis, Requirements Reviews, Design Reviews, various levels of testing, safety testing). These are internal processes to ensure quality, not external validation studies with specific performance metrics.
- Indications for Use: The document clearly outlines the intended uses and clinical applications for the system and its various transducers (e.g., Fetal, Abdominal, Cardiac, Peripheral Vascular). This defines the scope of the device but doesn't quantify its performance within those applications.
Addressing the Specific Questions (based on the provided document):
-
A table of acceptance criteria and the reported device performance:
- N/A. This document does not specify quantitative acceptance criteria or report device performance against such criteria. The "performance" is implicitly deemed equivalent to the predicate devices.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. No clinical test set or data provenance is mentioned as no clinical studies were required.
-
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):
- N/A. No ground truth establishment for a test set is discussed as no clinical studies were performed.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No test set or adjudication method is described.
-
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:
- N/A. This document predates widespread AI in medical devices and is for an ultrasound system, not an AI-powered diagnostic tool. No MRMC study is mentioned.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a hardware-based ultrasound system, not an algorithm. Standalone performance as typically understood for AI algorithms is not applicable here.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. No ground truth is discussed as no clinical studies were performed.
-
The sample size for the training set:
- N/A. This is not an AI/machine learning device, so there is no concept of a "training set" in the context it's usually used for such applications.
-
How the ground truth for the training set was established:
- N/A. Not applicable, as it's not an AI/machine learning device.
In summary, this 510(k) submission primarily focuses on demonstrating that the LOGIQ P5 BT11 Ultrasound System is substantially equivalent to existing, legally marketed predicate devices, thereby not requiring new clinical performance studies or the establishment of new acceptance criteria for efficacy.
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(14 days)
The Sonix Ultrasound Imaging System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial.
The system also provides the ability to measure anatomical structures (fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peribheral vessel, musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The Sonix Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed(PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Morde, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console.
The system has an electrocardiography (ECG) display feature and support for a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording, capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage.
The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes.
The biopsy kits are accessories to the Sonix Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle guides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle guides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands.
I am sorry, but the provided text does not contain specific acceptance criteria, study details, or performance metrics for the Sonix Ultrasound Scanner as you requested. The document is primarily a 510(k) summary for premarket notification, focusing on:
- Device Description: General features and function of the ultrasound system and its accessories.
- Intended Uses: A broad list of clinical applications for the system and various transducers.
- Comparison to Predicate Devices: Establishing substantial equivalence based on intended use, principles of operation, and technological characteristics.
- Safety Considerations: Compliance with general safety standards and acoustic output limits.
- Transducer Specifications: Detailed tables outlining the modes of operation and new/previously cleared indications for each transducer.
There is no mention of:
- Specific acceptance criteria (numerical thresholds for performance).
- Any particular study (e.g., clinical trial, bench study with performance data) to prove device meets acceptance criteria.
- Sample sizes used for test sets or training sets.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts or their qualifications to establish ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- How ground truth was established for the training set.
The document highlights the device's compliance with general safety and acoustic output standards, but these are not presented as performance acceptance criteria in the context of clinical efficacy or diagnostic accuracy.
Therefore, I cannot populate the table or answer the specific questions you've posed based on the provided text.
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(28 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
The GE Vivid S6 are mobile ultrasound consoles having a wide assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular and general ultrasound imaging. Its intuitive user interface, high level of autooptimization along with significantly reduced size and weight maneuverable, efficient and easy to use.
The provided document K092079 is a 510(k) Premarket Notification for the GE Vivid S5 and Vivid S6 Diagnostic Ultrasound System. This submission focuses on establishing substantial equivalence to a predicate device and introducing new transducers and extended indications for use.
Crucially, the document states "Clinical Tests: None required." (Section b) 2. of Attachment B). This indicates that a study proving the device meets specific acceptance criteria, in the traditional sense of a clinical trial with performance metrics and statistical analysis, was not performed. Instead, the submission relies on the concept of substantial equivalence to a previously cleared predicate device (GE Vivid S5 and Vivid S6 Diagnostic Ultrasound System, K071985), and other previously cleared GE ultrasound systems/transducers for the new indications.
Therefore, the following information cannot be extracted from this document: acceptance criteria with reported device performance (beyond established safety standards), sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study details, standalone performance, or training set details.
The acceptance criteria for this submission are fundamentally satisfied by demonstrating that the modifications (new transducers and expanded indications for use) do not raise new questions of safety or effectiveness and perform as well as or better than legally marketed predicate devices.
Here's a breakdown of the available information relevant to "acceptance criteria" and how they were met in the context of a 510(k) submission focused on substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by 510(k) for Substantial Equivalence) | Reported Device Performance (as per submission) |
|---|---|
| Safety: Device must conform to applicable medical device safety standards (e.g., acoustic output, biocompatibility, electrical, thermal, mechanical safety, cleaning/disinfection effectiveness). | "The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards." (Attachment B, Section b) 1.) |
| Effectiveness: Similar intended uses and operating modes to the predicate device, or demonstrated equivalence for new indications based on prior clearance of similar technology. | "The modified GE Vivid S5/S6 is of a comparable type and substantially equivalent to the current GE Vivid S5/S6. It has the same overall characteristics, key safety and effectiveness features, physical design, construction, and materials, and has the same intended uses and operating modes as the predicate device and additional software that are similar to other cleared GE Ultrasound systems." (Attachment B, Section 6.) |
| Expanded Indications: New transducers and their associated clinical applications (e.g., Fetal/Obstetrics, Abdominal, Pediatric, Cardiac, Peripheral Vascular, Small Organ, Musculo-skeletal, Transesophageal, Transvaginal, Intraoperative) must be supported by previous clearances of similar technology. | For each transducer (4C-RS, 8C-RS, E8C-RS, 8L-RS, 12L-RS, 7S-RS, 10S-RS, M4S-RS, 6Tc-RS, i12L-RS, 6S-RS, 9L-RS), the Indications for Use forms clearly mark "N" for new indications, accompanied by a note stating that the transducer or application was "previously cleared" on another specified GE ultrasound system (e.g., Vivid 7 BT05 (K051449), GE LOGIQ Book Ultrasound (K032477), Vivid i/q (K082374), LOGIQ 9 (K011188), Vivid E9 (K081921), LOGIQ P5 (K060993)). "P" indicates indications previously cleared on the predicate device (K071985). |
| Compliance: Design and development process conforms to 21 CFR 820 and ISO13485 quality systems. | "The design and development process of the manufacturer conforms with 21 CFR 820, and ISO13485 quality systems." (Attachment B, Section b) 3.) |
The study that proves the device meets the acceptance criteria is the 510(k) submission itself, where GE Healthcare argues for substantial equivalence based on the points above.
Missing Information (as per the document):
- Sample size used for the test set and the data provenance: Not applicable, as no clinical tests were required or performed.
- 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. The "ground truth" here is the regulatory precedent of previously cleared devices and transducers.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 diagnostic ultrasound system, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the new indications is the precedent of prior FDA clearance for similar technologies and applications on other GE ultrasound systems, signifying recognized safety and effectiveness.
- The sample size for the training set: Not applicable, as no clinical tests or algorithm training were explicitly mentioned as part of this 510(k) submission for new device clearance. The device is a hardware/software system, not a machine learning model requiring a training set in the typical sense.
- How the ground truth for the training set was established: Not applicable.
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