(30 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, pediatric, neonatal cephalic, musculoskeletal (general and superficial), Urology/Prostate and intraoperative (liver, gallbladder, pancreas).
The DC-6 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound mages in B-Mode. M-Mode. Color mode, PW mode, CW mode, Power/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, phased array and convex array with a frequency range of approximately 2 MHz to 12 MHz. The modified DC-6 Diagnostic Ultrasound System also provides Smart3D imaging (Free hand 3D). iScape imaging (panoramic imaging) and Free Xros M imaging (anatomic M).
The provided text describes a 510(k) summary for the Mindray DC-6 Diagnostic Ultrasound System, which focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance metrics or detailed study results against acceptance criteria in the typical sense of AI/ML device evaluations.
The document does not contain explicit acceptance criteria or a study design with reported device performance against those criteria in the context of an AI/ML algorithm evaluation. Instead, it refers to general safety and effectiveness.
However, I can extract information related to the device and its intended use, which can be framed in a table if we interpret "acceptance criteria" as the claimed functionalities and modes of operation for various clinical applications. The "reported device performance" would then be that these functionalities are present and effective (as implied by the declaration of substantial equivalence).
Here's an attempt to structure the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Claimed Functionality/Mode) | Reported Device Performance (Implied by Substantial Equivalence and Features) |
|---|---|
| Device operates in various modes for specific clinical applications (e.g., Fetal, Abdominal, Cardiac, Small organ, etc.) | The DC-6 Diagnostic Ultrasound System supports B-Mode, M-Mode, Color mode, PW mode, CW mode, Power/DirPower mode, and combined modes across a broad range of clinical applications. (Implied: these modes function as expected for diagnostic ultrasound imaging). |
| New imaging features (Smart3D, iScape, Free Xros M imaging) | The modified DC-6 Diagnostic Ultrasound System provides Smart3D imaging (Free hand 3D), iScape imaging (panoramic imaging), and Free Xros M imaging (anatomic M). (Implied: these features are correctly implemented and functional). |
| Acoustic output measurements | Measured and calculated per NEMA UD 2 (2004) and NEMA UD 3 standards. (Implied: device meets these standards). |
| Conformity to medical device safety standards | Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-1. (Implied: device meets these standards). |
| Substantial Equivalence to predicate devices | Conclusion: The device is as safe and effective as the legally marketed predicate devices. |
Study Proving Device Meets Acceptance Criteria:
The document states: "The conclusions drawn from testing of the DC-6 Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices."
This implies that the "study" conducted was primarily focused on demonstrating substantial equivalence to existing, legally marketed ultrasound systems. This typically involves:
- Engineering and Performance Testing: Verifying that the technical specifications, acoustic output, image quality, and functionality of the new device are comparable to the predicate devices.
- Compliance with Safety Standards: Demonstrating adherence to relevant national and international medical device safety standards (e.g., IEC, ISO, NEMA).
- Clinical or Bench Testing (if required for specific aspects): While not explicitly detailed, comparisons for specific features or intended uses might have been performed to show equivalence. However, for a general diagnostic ultrasound system under a 510(k) pathway, extensive clinical performance studies demonstrating superiority or non-inferiority against a gold standard in a new clinical domain are often not required if substantial equivalence can be shown through technical and safety data.
Given the information, the answers to the specific questions are as follows:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document does not specify a sample size for a test set in the context of an AI/ML algorithm or a clinical performance study. The evaluation method described is primarily through technical specifications comparisons and adherence to standards for substantial equivalence.
- Data provenance is not mentioned; it's likely internal engineering and technical testing data rather than patient data from a specific country or study type.
3. 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 / Not mentioned. The document does not describe a clinical study requiring expert ground truth for image interpretation or diagnosis. The assessment is an engineering and regulatory evaluation against predicate devices and standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No mention of an adjudication method, as there's no described clinical study involving multiple readers and a ground truth determination process.
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. The document does not mention any MRMC study or AI assistance. The device described is a general diagnostic ultrasound system, not an AI-powered diagnostic tool. The purpose is to show substantial equivalence of the hardware and core imaging functions.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/ML device, so no standalone algorithm performance evaluation would have been conducted or is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not mentioned. The evaluation focuses on technical performance and safety against engineering standards and comparison with predicate devices, not on diagnostic accuracy against a clinical ground truth like pathology for specific conditions.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, no training set or associated ground truth establishment is relevant to this device's submission.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.