Search Results
Found 3 results
510(k) Data Aggregation
(323 days)
OPUS 5100 Diagnostic Doppler Ultrasound System is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdomen; Pediatric; Small Organ(breast, thyroid, tests); Cephalic (adult and neonatal); Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional and Superficial); Ob/GYN; Urology; Cardiac (adult and pediatric) and Peripheral Vascular.
OPUS 5100 Diagnostic Doppler Ultrasound System is a compact and portable diagnostic ultrasound device, have integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. The major features include: 128 Channel all digital beam former; progressive dynamic receive focusing; wide band all digital demodulation; native frequency digital scan converter; hand carried for portable use; remote access image management through LAN port: USB 2.0 drive for image storage and retrieving; Supports 2D Bmode (including Tissue Harmonic image, M-mode, TDI, Color Flow Doppler, Power Doppler, Pulse wave Doppler and Continuous Wave Doppler, or a combination of these modes, 3D/4D.
Here's a summary of the acceptance criteria and study information for the OPUS 5100 Diagnostic Doppler Ultrasound System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or device performance metrics for diagnostic accuracy. Instead, the "acceptance criteria" are implied by the successful testing against established safety and performance standards. The reported device performance is that it met these standards.
| Acceptance Criteria (Implied) | Reported Device Performance (as stated in document) |
|---|---|
| Compliance with IEC 60601-1:2005 (Safety) | Complies with IEC 60601-1 |
| Compliance with IEC 60601-1-2:2007 (Electromagnetic Compatibility) | Complies with IEC 60601-2 |
| Compliance with IEC 60601-2-37:2008 (Performance of Ultrasound) | Complies with IEC 60601-2-37 |
| Compliance with NEMA UD3:2004 (Acoustic Output Indices) | Complies with NEMA UD3 |
| Compliance with NEMA UD2:2004 (Acoustic Output Measurement) | Complies with NEMA UD2 |
| Compliance with ISO 10993-5:2009 (Cytotoxicity) | Complies with ISO 10993-5 |
| Compliance with ISO 10993-10:2010 (Irritation & Skin Sensitization) | Complies with ISO 10993-10 |
| Acoustic Output (Derated Ispta ≤ 720 mW/cm²) | 720 mW/cm² (max.) |
| Acoustic Output (TIS/TIB/TIC range 0.2 ~ 4.0) | 0.2 ~ 4.0 (Range) |
| Acoustic Output (Mechanical Index ≤ 1.9) | 1.9 (max.) |
| Acoustic Output (Derated Isppa ≤ 190 W/cm²) | 190 W/cm² (max.) |
2. Sample Size Used for the Test Set and Data Provenance
No patient-specific test set or data provenance (country of origin, retrospective/prospective) is mentioned in the document. The testing described is limited to laboratory and standard compliance testing, not clinical studies involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The document explicitly states "No clinical testing was required." The "ground truth" for the device's technical specifications was established by the technical standards themselves and verified through laboratory testing.
4. Adjudication Method for the Test Set
Not applicable. As no clinical test set was used, no adjudication method was mentioned or required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The document clearly states that "No clinical testing was required." Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
Not applicable. This device is a diagnostic ultrasound system, which inherently involves a human operator (a qualified physician) for its intended use. There is no mention of an AI algorithm or standalone performance being evaluated. The device performance is assessed through its compliance with safety and performance standards for ultrasound equipment.
7. The Type of Ground Truth Used
The ground truth used for this submission is related to adherence to established national and international safety, electromagnetic compatibility, acoustic output, and biocompatibility standards for medical electrical equipment and diagnostic ultrasound equipment. This is effectively technical and performance standard compliance.
8. The Sample Size for the Training Set
Not applicable. This document describes a traditional medical device (ultrasound system) clearance, not an AI/ML-driven device. Therefore, no training set for an algorithm is mentioned or relevant.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned, there is no information on how its ground truth would have been established.
Ask a specific question about this device
(264 days)
"ComMed" Series Dental Implant System is intended for surgical placement in the maxilla or mandible to provide for prosthetic attachment to restore a patient's chewing function. "ComMed" Series Dental Implants are intended only for delayed loading.
The Chang Gung "ComMed" Series Dental Implant System includes threaded root-form endosseous dental implants (fixtures) and dental implant abutments (healing abutment, standard abutment, angle abutment). The implants are cylindrical and tapered posts made of Grade 4 Pure Titanium. The abutments are made of Ti6Al4V. The system features an internal hex with Morse Taper 8° connection, platform switching, and fine thread in the neck. Various diameters (3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm) and lengths (10, 11, 12, 13, 14, 15, 16 mm) are available for the implants. The surface treatment is blasted with Aluminum Oxide and Acid Etched, and it is also anodized. Implants are sterilized by Gamma irradiation, and abutments are sterilized by moist heat sterilization before use by clinicians.
The provided text describes the Chang Gung "ComMed" Series Dental Implant System and its clearance through the 510(k) pathway, which establishes substantial equivalence to legally marketed predicate devices. This type of submission relies on demonstrating that the new device is as safe and effective as existing ones, rather than providing extensive de novo clinical trials typical for novel medical devices. Therefore, the information provided focuses on non-clinical testing rather than studies involving human subjects, AI performance, or expert ground truth.
Here's a breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in numerical terms for the non-clinical tests. Instead, it refers to conformity with relevant ISO and ASTM standards. The reported device performance is that it met these standards, supporting substantial equivalence.
| Test Category | Test Performed | Relevant Standard(s) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | In vitro cytotoxicity study, Intracutaneous reactivity study, Skin sensitization study, Acute systemic toxicity, Pyrogenicity study, 14-day repeated dose systemic toxicity study, In vitro haemolysis study, In vitro bacterial reverse mutation (AMES) study, In vitro chromosome aberration study, In vitro mammalian cell gene mutation study, Bone formation and histological study (for Implant/Abutment) | ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-4, ISO 10993-3, ISO 10993-6 | Conformed to relevant ISO standards, supporting biocompatibility. (Implied: accepted by FDA) |
| Static and Dynamic Fatigue Loading | Static and dynamic fatigue test (for Implant and standard abutment) Static and dynamic fatigue test (for Implant and angle abutment) | ISO 14801 | Conformed to ISO 14801, indicating mechanical durability. (Implied: accepted by FDA) |
| Sterilization Validation | Sterilization validation of Gamma irradiation (for Implant) Moist heat validation - microbiological performance qualification (for Abutment) | ISO 11737-1, ISO 11737-2, ISO 17665-1 | Conformed to relevant ISO standards, ensuring sterility. (Implied: accepted by FDA) |
| Packaging Shelf Life Validation | Burst and creep tests, Dye penetration test, Seal peel test, Microbial ranking test (initially and after 2, 3, and 5 years of accelerated aging) | ASTM F1140, ASTM F1929, ASTM F88/F88M, ASTM F1608, ASTM F1980 | Conformed to relevant ASTM standards, ensuring packaging integrity and shelf life. (Implied: accepted by FDA) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in the provided text. The non-clinical testing described typically involves specific numbers of samples (e.g., implants, abutments, packaging units) tested in a lab setting, but these quantities are not detailed.
- Data Provenance: The tests are non-clinical, meaning they are lab-based or in-vitro/in-vivo animal studies (for biocompatibility in some cases, though specific animal models are not detailed). The testing was conducted to support the substantial equivalence submission for a device manufactured by Chang Gung Medical Technology Co., Ltd. in Taiwan.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of this 510(k) submission. The "test set" here refers to the physical devices and materials subjected to non-clinical tests, not a dataset requiring human expert annotation for ground truth. The evaluation of compliance with standards is done by testing laboratories and regulatory bodies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept typically refers to how disagreements among human reviewers (e.g., radiologists) are resolved in clinical studies or AI evaluations. For engineering and biocompatibility testing, the "adjudication" is based on whether the test results meet the specified criteria of the referenced standards.
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 dental implant system (hardware), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies or AI performance metrics are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's non-clinical testing is adherence to the specified performance characteristics as defined by international standards (ISO, ASTM) for mechanical strength, biocompatibility, sterility, and packaging integrity.
8. The sample size for the training set
Not applicable. Training sets are relevant for machine learning algorithms, which this device is not.
9. How the ground truth for the training set was established
Not applicable.
Ask a specific question about this device
(64 days)
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen;Pediatric;Small Orqan(breast.tests.thyroid);heart soft tissue; Peripheral Vascular; Musculo-skeletal(conventional); Ob/Gyn and Urology.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: General (TRACK 1 ONLY), Specific (TRACKS 1 & 3)
Mode of Operation: B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Other* Combined, Tissue Harmonic Imaging
Specific Applications: Ophthalmic, Fetal, Abdominal, Intra-operative Specify, Intra-operative Neuro, Laparoscopic, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph.(non-Card), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Intravascular, Other (Ob/GYN), Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Other (specify), Peripheral vessel, Other (specify)
Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD
The CGMC OPUS 5000 diagnostic doppler ultrasound system is a compact and portable diagnostic ultrasound device,have integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The user interface includes a specialized control keyboard and color 15-inch LCD display. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows costeffective system integration to a variety of upgrade-able options and features.
The major features of the CGMC OPUS 5000:
- · 64 Channel all digital beam former
- · Progressive dynamic receive focusing
- · Wide band all digital demodulation
- Native frequency digital scan converter
- . OPUS 5000 can be hand carried for portable use
- Remote access image management through LAN port
- USB2.0 flash drive for image transport and software upgrade
- Supports 2D B-mode, M-mode, Harmonic Image, Color, Power Doppler, . Pulse wave Doppler, and CW.
This K102989 510(k) submission for the CGMC OPUS 5000 Diagnostic Doppler Ultrasound System and its associated transducers focuses on substantial equivalence to a predicate device, the SonoScape Ultrasound System SSI-1000 (K042369). The submission primarily justifies equivalence through technological characteristics and intended uses, rather than presenting a performance study with explicit acceptance criteria for a new clinical claim. Therefore, the information provided below reflects that context.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for an ultrasound system, the acceptance criteria are typically related to the device meeting established performance standards for diagnostic ultrasound, ensuring image quality, acoustic output safety, and electrical safety comparable to a predicate device. The submission does not present specific quantitative acceptance criteria for clinical performance metrics (e.g., sensitivity, specificity for a particular disease) nor does it provide a formal performance table against such criteria. Instead, it asserts equivalence based on fulfilling recognized industry standards and having similar technological characteristics and intended uses as the predicate device.
| Acceptance Criteria (Inferred from 510(k) process for ultrasound systems) | Reported Device Performance (as stated or implied in the submission) |
|---|---|
| Compliance with IEC 60601-1 (Safety of Medical Electric Equipment) | OPUS 5000 has been designed to meet IEC 60601-1 |
| Compliance with AIUM/NEMA UD2 (Acoustic Output Measurement Standard) | OPUS 5000 has been designed to meet AIUM/NEMA UD2 |
| Compliance with AIUM NEMA UD3 (Real-time Display of Acoustic Output) | OPUS 5000 has been designed to meet AIUM NEMA UD3 |
| Compliance with AIUM 1998 (Acoustic Output Measurement and Labeling) | OPUS 5000 has been designed to meet AIUM 1998 |
| Compliance with EN 60601-1, EN 60601-1-1, EN 60601-1-2, EN 60601-2-37 | OPUS 5000 has been designed to meet these EN standards |
| Compliance with ISO 10993 (Biocompatibility) | OPUS 5000 has been designed to meet ISO 10993 |
| Ability to produce high detail resolution imaging | Device is "capable of producing high detail resolution" |
| Functionality across stated display modes, measurements, and controls | General Device Description and Technological Characteristics sections describe full functionality for these modes, measurements, and controls. |
| Acoustic Output within safe limits | Acoustic output parameters (Derated Ispta: 720mW/cm2 max, MI: 1.9 max, etc.) are specified. |
| Substantial Equivalence to predicate device (SonoScape SSI-1000) | Stated as "of a comparable and substantially equivalent type" with "same technological characteristics, key safety and effectiveness features, physical design, and has the same intended uses and basic operating modes." |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not describe a clinical performance study with a test set of patient data to evaluate the device's diagnostic accuracy or clinical effectiveness. The assessment of the device's performance against the acceptance criteria is based on engineering verification and validation, adherence to recognized standards, and comparison of technical specifications to a predicate device. Therefore, no sample size for a test set of patient data or data provenance (country of origin, retrospective/prospective) is explicitly mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical performance study with a specific test set is described, there is no mention of experts being used to establish a ground truth for such a set.
4. Adjudication Method for the Test Set
As there is no described test set requiring ground truth establishment, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not conducted and is not discussed in this submission. The submission primarily focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and safety standards, not on proving improved clinical effectiveness with human-AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study, as typically understood for an AI algorithm (without human-in-the-loop performance), was not conducted or described. This submission is for a general-purpose diagnostic ultrasound system, not an AI-powered diagnostic algorithm.
7. Type of Ground Truth Used
Given the nature of the submission (510(k) for a general-purpose ultrasound, relying on substantial equivalence to a predicate and compliance with technical standards), the "ground truth" used is the adherence to established engineering and medical device safety and performance standards (e.g., IEC, AIUM/NEMA standards) and the technical specifications of the predicate device. There is no mention of clinical ground truth (e.g., pathology, outcomes data, or expert consensus on patient cases) being used in a formal study within this document.
8. Sample Size for the Training Set
This submission does not discuss a training set. The device is a traditional ultrasound imaging system, not an AI/ML-based device that would require a training set of data for algorithm development.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned, the method for establishing its ground truth is not applicable.
Ask a specific question about this device
Page 1 of 1