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510(k) Data Aggregation
(11 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Intra-operative (Cardiac), Trans-vaginal, Trans-rectal, Gynecological, Pediatric, Laparoscopic, and Neonatal Cephalic applications. The device is not indicated for Ophthalmic applications.
The SSD-3500 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer type keyboard, specialized controls and a display.
Here's an analysis of the provided information regarding the Aloka SSD-3500 Ver. 7.8 Diagnostic Ultrasound System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) premarket notification for a diagnostic ultrasound system. In a 510(k) submission for a device like this, the "acceptance criteria" are generally that the new device (Aloka SSD-3500 Ver. 7.8) demonstrates substantial equivalence to a previously cleared predicate device (Aloka SSD-3500 Ver. 7.0). This means the new device must have the same intended use, similar technological characteristics, and demonstrate similar safety and effectiveness.
Since this is a substantial equivalence claim for an ultrasound system, the acceptance criteria don't typically involve specific performance metrics like sensitivity or specificity in a diagnostic task, but rather confirmation that the device functions as intended and meets relevant safety standards.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as stated in the submission) |
|---|---|
| Safety: | |
| - Conformance to applicable medical device safety standards (acoustic output, biocompatibility, cleaning & disinfection, electromagnetic compatibility, electrical, mechanical safety). | "The device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform with applicable medical device safety standards." Additionally, "The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance." |
| Effectiveness: | |
| - Same intended uses as the predicate device. | "It has the same... intended uses... as the predicate device." The system's intended uses are: Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Intra-operative (Cardiac), Trans-vaginal, Trans-rectal, Gynecological, Pediatric, Laparoscopic, and Neonatal Cephalic applications. (Ophthalmic applications are excluded). |
| - Similar technological characteristics and basic operating modes as the predicate device. | "The Aloka SSD-3500 Ver. 7.8 is technically comparable and substantially equivalent to the current Aloka SSD-3500 Ver. 7.0 -(K060059). It has the same technological characteristics, key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate device." The device description mentions it is a "full feature imaging and analysis system" providing acquisition, processing, and display capability through a "computer type keyboard, specialized controls and a display." The specific operating modes (A, B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined) are listed for each transducer and clinical application. |
| - No new questions of safety or effectiveness are raised compared to the predicate device. | "Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effectiveness performance. Therefore, it is the opinion of Aloka Co., Ltd. that the Aloka SSD-3500 Ver. 7.8 Ultrasound System and its transducers are substantially equivalent with respect to safety and effectiveness to its predicate and other currently cleared Aloka systems." |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states: "2. Clinical Tests: None Required."
Therefore, there is no test set, sample size, or data provenance related to clinical performance testing for this submission. The device's substantial equivalence is based on technical specifications and comparison to a predicate device, not on new clinical performance data from a specific test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since no clinical tests were required, there was no test set and therefore no ground truth established by experts for performance evaluation in this submission.
4. Adjudication Method for the Test Set
As there was no clinical test set, no adjudication method was used for establishing ground truth.
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 conducted or required for this 510(k) submission. This device is a diagnostic ultrasound system, not an AI-powered diagnostic application that would typically undergo such a study to evaluate human reader improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm performance study was conducted. This device is a conventional diagnostic ultrasound system, not an artificial intelligence algorithm that would typically have a standalone performance evaluation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
As mentioned above, no specific clinical ground truth was established for performance evaluation in this 510(k) submission because clinical testing was not required. The "ground truth" for the submission is the regulatory acceptance of its predicate device (Aloka SSD-3500 Ver. 7.0) and the demonstrated technical equivalence and adherence to safety standards.
8. The Sample Size for the Training Set
Since no AI/machine learning algorithm is part of this submission, there is no training set mentioned or used.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/machine learning algorithm in this submission.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study that proves the Aloka SSD-3500 Ver. 7.8 Diagnostic Ultrasound System meets its acceptance criteria is a technical and regulatory comparison study against a legally marketed predicate device, the Aloka SSD-3500 Ver. 7.0 (K060059).
The manufacturer (Aloka Co., Ltd.) provided documentation and analysis demonstrating that the new version is "technically comparable and substantially equivalent" to the predicate. This involved:
- Documentation of Shared Characteristics: Confirming that the Aloka SSD-3500 Ver. 7.8 has the "same technological characteristics, key safety and effectiveness features, and has the same intended uses and basic operating modes" as the predicate device.
- Non-Clinical Testing: The device and its transducers underwent various non-clinical evaluations to confirm compliance with applicable medical device safety standards. These tests covered:
- Acoustic output
- Biocompatibility
- Cleaning & disinfection effectiveness
- Electromagnetic compatibility
- Electrical safety
- Mechanical safety
- Quality System Conformance: The manufacturer confirmed that their design, development, and quality processes align with 21 CFR 820, ISO 9001:2000, and ISO 13485 quality systems.
The FDA's review of this submission found that "the device is substantially equivalent... to legally marketed predicate devices," thus confirming it meets the regulatory acceptance criteria for market clearance. Clinical testing was not required because the device was demonstrating equivalence to an already approved device and no new questions of safety or effectiveness were raised.
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(14 days)
The device is intended for use by a qualified physician for ultrasound evaluation of abdominal, cardiac, small parts (breast, testes, thyroid, etc.), peripheral vascular, fetal, transrectal, transvaginal, intraoperative (abdominal, thoracic, and vascular etc.), pediatric, neonatal cephalic, musculoskeletal (general and superficial).
The M5 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, CW 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 describes a 510(k) Pre-Market Notification for the KOS-3001 M5 Diagnostic Ultrasound System. It asserts substantial equivalence to predicate devices and describes the intended use and safety considerations. However, it does not contain any information regarding acceptance criteria or a specific study proving the device meets those criteria.
The document mainly focuses on:
- Device Identification: Name, submitter, date prepared.
- Classification: Regulatory class, review category, product codes.
- Marketed Devices: Listing predicate devices for substantial equivalence.
- Device Description: General description, modes of operation, probe types, and frequency range.
- Intended Use: Clinical applications for which the device is intended.
- Safety Considerations: Compliance with FDA guidance and medical device safety standards (NEMA UD 2, NEMA UD 3, IEC 60601-1, etc.).
- FDA Clearance Letter: Formal letter from the FDA stating substantial equivalence and listing cleared transducers and their clinical applications.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study proving these criteria are met, as this information is not present in the provided text.
To answer your specific questions in the context of this document:
- A table of acceptance criteria and the reported device performance: Not available in the provided text. The document asserts safety and effectiveness through compliance with standards and substantial equivalence to predicate devices, but no specific performance criteria or results are listed.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in the provided text.
- 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 available in the provided text.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in the provided text.
- 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 available in the provided text. This device is a diagnostic ultrasound system, not an AI-powered image analysis tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as there is no mention of an algorithm for standalone performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available in the provided text.
- The sample size for the training set: Not applicable as there is no mention of a training set for an AI algorithm.
- How the ground truth for the training set was established: Not applicable.
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(55 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/OB; Abdominal; Intra-operative (abdominal, thoracic, and vascular); Intra-operative Neuro; Pediatric; Small Organ (Thyroid, Breast, Testes, etc.); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-cranial, trans-esoph (cardiac/noncardiac), musculo-skel conventional & superficial 3D/4D. cardiac adult & pediatric and other applications as shown in section 4.3.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative, Pediatric, Small organ/parts (breasttestes, thyroid, etc), Transrectal, Transcranial, Trans-esoph, Trans-urethral, OB/GYM, Cardiac, Pelvic, Neonatio. Vascular, 3D/4D, Tissue elasticity, Musculoskeletal (cardias, Superficial Musculoskeletal, and Peripheral Vascular applications.
The z.one Ultra is a general purpose diagnostic ultrasound system. It consists of a portable scanner approximately 8 inches wide and 3 inches high that can be held by the user in one hand and includes buttons for controlling the system and a screen that display ultrasound mages and user interface. The portable scanner can be held by the user in one hand accommodates a removable transducer module. Signals received from the transducer module are digitized and preprocessed. The transducer module comes into contact with the patient and receive ultrasound energy.
The docking station (aka carts) provides holders for the portable scanner, and transducer modules, as well as battery chargers and other accessories. The modification for this submission include new features and functionality that will enhance user convenience and work flow as well as provide clinicians with new indications of use.
The provided document is a 510(k) premarket notification for the ZONARE z.one Ultra Ultrasound System. This type of submission is for demonstrating substantial equivalence to legally marketed predicate devices, not for proving the device meets acceptance criteria through clinical studies in the same way a new, high-risk device might.
The document explicitly states: "Clinical Tests: Non Required" and then elaborates: "ZONARE designs and develops their products according to 21 CFR 820, ISO 13485:2003 quality systems. The device conforms to applicable medical device safety standards and compliance for safety and effectiveness is verified through defined evaluation and market surveillance. Conforming to the required worldwide ultrasound standards, enables ZONARE to state that the ZONARE z.one Ultra Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices current cleared for market."
Therefore, many of the requested categories related to clinical study design and performance metrics cannot be directly extracted from this document, as such studies were not required for this type of submission. The "acceptance criteria" here largely refer to the device's ability to perform its intended functions similarly to predicate devices and adherence to safety standards.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since formal clinical studies with specific performance metrics are not required and therefore not reported in this 510(k), I can only infer the "acceptance criteria" as meeting the general capabilities and safety standards demonstrated by predicate devices.
| Acceptance Criterion (Inferred from 510(k) context) | Reported Device Performance and Compliance |
|---|---|
| Intended Use Equivalence: The device must perform the same diagnostic ultrasound imaging or fluid flow analysis for the human body as predicate devices across various clinical applications and modes of operation. | The ZONARE z.one Ultra is reported as "comparable and substantially equivalent to the currently marketed ZONARE z.one and the Voluson i, Siemens Acuson S2000, and Philips iU22 in terms of portability, features and functionality." The document provides detailed tables for each transducer type (Curvilinear, Phased Array, Endo-Cavity, Linear, Tran-Esophageal, AUX CW) showing the clinical applications and modes of operation. |
Each table indicates whether an application is a "P" (previously cleared by FDA 510k # 022858, implying equivalence to the existing ZONARE z.one) or "N" (new indication). For "P" indications, the device is considered to perform equivalently to the predicate. For "N" indications, the device is being introduced for those uses, likely based on similarity to other cleared devices or demonstrating safety and basic functionality in non-clinical tests.
Examples of supported modes for various transducers include:
- B¹ (B-Mode and Harmonic Imaging): P (Previously cleared) or E (Added under Appendix E) or N (New indication) across most applications.
- M (M-Mode): P or E or N across most applications.
- PWD² (Pulsed Wave Doppler and HPRF): P or E or N across most applications.
- CWD (Continuous Wave Doppler): P or N for specific applications (e.g., Fetal, Abdominal, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac Adult & Pediatric, Peripheral Vascular for the main system, and specific entries for some transducers).
- Color Doppler³ (Color Doppler, Directional Power Doppler, Power Doppler): P or E or N across most applications.
- Combined Modes⁴: P or E or N across most applications.
- Other⁵,⁸ (e.g., Color M-Mode, Freehand tissue elasticity): P or E or N for relevant applications.
The presence of "P" or "E" in these tables fundamentally means that for those indications and modes, the ZONARE z.one Ultra performs equivalently to the already cleared ZONARE z.one (K022858) or other cleared predicate devices. The "N" indications represent new proposed uses for the system or specific transducers, which are deemed safe and effective through substantial equivalence to other devices or non-clinical testing. |
| Safety and Effectiveness Standard Adherence: The device must conform to applicable medical device safety standards. | "The device has been evaluated according to the applicable medical device safety standards for acoustic output, biocompatibility, cleaning, and disinfection effectiveness as well as thermal, electrical, and mechanical safety."
"The device conforms to applicable medical device safety standards and compliance for safety and effectiveness is verified through defined evaluation and market surveillance."
"ZONARE designs and develops their products according to 21 CFR 820, ISO 13485:2003 quality systems." |
| Predicate Device Features Equivalence: The device must have the same important safety and effectiveness features, design, materials, and construction as predicate devices. | "Additionally, they [ZONARE z.one Ultra and predicate devices] have the same important safety and effectiveness features, as well as design, materials, and construction." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical test set (in the sense of patient data for performance evaluation) was specified as "Clinical Tests: Non Required."
- Data Provenance: Not applicable. No clinical data was used for a test set. The validation relies on substantial equivalence and adherence to safety standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable, as no clinical test set requiring expert ground truth was performed for this 510(k) submission.
4. Adjudication Method for the Test Set
- Not applicable, as no clinical test set requiring adjudication was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, 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-assisted device, and no MRMC study was conducted or required.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This is not an algorithmic/AI device; it's a hardware system.
7. The Type of Ground Truth Used
- Ground Truth: In the context of this 510(k), the "ground truth" for the device's safety and effectiveness is established by its substantial equivalence to legally marketed predicate devices and its compliance with recognized medical device safety standards. This is not a "ground truth" in the clinical data sense (e.g., pathology, outcomes data). The existing ZONARE z.one (K022858), GE Voluson i (K053435), Philips iU22 (K042540), and Siemens Acuson S2000 (K072786) served as predicates.
8. The Sample Size for the Training Set
- Not applicable. The device is a diagnostic ultrasound system, not an AI/machine learning model that typically undergoes a "training" phase with a dataset.
9. How the Ground Truth for the Training Set was Established
- Not applicable for the same reason as above.
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(15 days)
QLAB Quantification software is a software application package. It is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
OLAB version 6.0 adds the OLAB MVO Plug-in and OLAB TMO/TMOA Plug-ins to the cleared QLAB software.
QLAB MVQ Plug-in (MVQ stands for Mitral Valve Quantification) Tool to assess lengths, distances, areas, volumes and angles of mitral valve structures from a Philips Ultrasound system 3D dataset.
QLAB TMQ/TMQA Plug-ins (TMQ and TMQA stands respectively for Tissue Motion Quantification and Tissue Motion Quantification Advanced) TMQ and TMQA plug-ins are an addition to the existing 2DQ plug-in already described on the iE33 510(k) submission K042540. The QLAB TMQ/TMQA plugins provide ultrasound tracking algorithm using pattern-matching method of wall lengthening, shortening and displacement in a set of 2D image. Radial, longitudinal, circumferential, lengths and strains are computed as well as rotation and rotation gradient and absolute speed. TMQ provides only one myocardial layer and 17 segmentation model only; TMQA will provide Multi Myocardial Layers and a choice of Segmentation on and off. CAK (Cardiac Annular Kinesis) feature is an addition to the existing 2DQ plug-in already described on the iE33 510(k) submission K042540. CAK will be a feature of existing 2DQ plug-in as well as TMQ and TMQA plug-ins. CAK is Quick survey tool of global function assessment.
The provided text does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria.
The document is a 510(k) Premarket Notification for the QLAB Quantification Software. It outlines the administrative information, device description, performance standards (or lack thereof), safety and effectiveness concerns, substantially equivalent devices, and software development processes. It concludes that the software is designed to meet United States and international standards for display and quantification of images acquired on Philips Ultrasound devices and incorporates features of legally marketed devices without raising new safety or effectiveness issues.
Missing information includes:
- Acceptance Criteria and Reported Device Performance: No specific numerical or qualitative acceptance criteria are provided for the QLAB Quantification Software, nor are there any reported performance metrics against such criteria.
- Sample Size and Data Provenance for Test Set: The document does not mention a test set, its sample size, or the provenance of any data used for testing.
- Number and Qualifications of Experts for Ground Truth: There is no information about experts used to establish ground truth.
- Adjudication Method: No adjudication method is described.
- MRMC Comparative Effectiveness Study: The document does not mention an MRMC study or any effect size for human readers with or without AI assistance.
- Standalone Performance Study: No details of a standalone (algorithm-only) performance study are provided.
- Type of Ground Truth Used: The document does not specify the type of ground truth used for any evaluations.
- Sample Size for Training Set: There is no mention of a training set or its sample size.
- How Ground Truth for Training Set was Established: This information is not present.
The document primarily focuses on regulatory compliance, device description, and claims of substantial equivalence to predicate devices, rather than detailed performance study results against specific acceptance criteria.
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(11 days)
QLAB Quantification software is a software application package. It is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
The Parametric Imaging feature is an addition to the existing Cardiac 3DQ Advanced Plug-in already described on the iE33 510(k) submission K042540. The QLAB 5.0 3DQA plug-in Parametric Imaging provides the user with easy-to-use color-coded representations of regional left-ventricular (LV) segmental Timing and Excursion parameters displayed on the standard AHA/ASE 17-segment Bull's-eye display. The Parametric display may be used in assisting the clinician to visualize directly LV regional function in a user-friendly format.
This document does not contain information about acceptance criteria or a study proving device performance against such criteria. It is a 510(k) premarket notification for a software device, and primarily focuses on administrative details, device description, and a claim of substantial equivalence to a predicate device.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and performance study details. The provided text explicitly states there are "No performance standards for PACS systems or components have been issued under the authority of Section 514" for this device category.
Here's how I would respond if such information were present:
Table of Acceptance Criteria and Reported Device Performance:
Not available in the provided text.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not available in the provided text.
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 available in the provided text.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not available in the provided text.
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 available in the provided text.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not available in the provided text.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not available in the provided text.
The sample size for the training set:
Not available in the provided text.
How the ground truth for the training set was established:
Not available in the provided text.
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