(28 days)
TE7 Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. It is intended for use in fetal, abdominal,Intra-operative(abdominal, thoracic, and vascular) , Pediatric,small organ(breast, thyroid, testes), neonatal and adult cephalic,trans-esoph. (Cardiac), trans-raginal, musculo-skeletal(conventional, superficial), urology,Peripheral vessel, Adult and Pediatric cardiac exams.
TE7 is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Power/Dirpower Mode, THI, LVO or the combined mode (i.e. Color-Mode , B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.0 MHz to 10.0 MHz.
The provided text is a 510(k) summary for the Mindray TE7 Diagnostic Ultrasound System. This type of submission to the FDA focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a traditional clinical study with defined performance metrics in the way a novel AI algorithm might.
Therefore, the information requested in your prompt regarding acceptance criteria, training/test sets, expert adjudication, and MRMC studies is not typically found or required in a 510(k) submission for an ultrasound system like the TE7, which is primarily demonstrating equivalence in terms of its technological characteristics and safety/effectiveness features to existing devices.
The document states:
- "Not applicable. The subject of this submission, TE7 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." This directly addresses the study aspect.
- The comparison is based on "technological characteristics," "key safety and effectiveness features," "intended uses and basic operating modes," and compliance with "applicable medical safety standards."
However, I can extract information related to the device's performance through its comparison to predicate devices and compliance with standards, which implicitly serves as its "acceptance criteria" and "proof" for substantial equivalence.
Here's an interpretation based on the provided document:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, "acceptance criteria" are generally that the new device is as safe and effective as the predicate device. The "reported device performance" is demonstrated by showing identical or comparable features and adherence to safety standards.
| Acceptance Criteria Category (Derived from 510(k) process) | Reported Device Performance (as stated in the document) |
|---|---|
| Intended Use Equivalence | TE7 Diagnostic Ultrasound System has the same intended uses as the predicate device M7 (K131690), applicable for adults, pregnant women, pediatric patients, and neonates for various exams (fetal, abdominal, intra-operative, pediatric, small organ, neonatal/adult cephalic, trans-esoph. (Cardiac), trans-rectal, trans-vaginal, musculo-skeletal, urology, peripheral vessel, Adult and Pediatric cardiac exams). |
| Technological Characteristics Equivalence | TE7 has the same technological characteristics as the predicate devices. It is a software-controlled ultrasonic diagnostic system acquiring and displaying ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Power/Dirpower Mode, THI, LVO or combined modes (Color-Mode, B/M-Mode, B/PW-mode, B/PW/Color). It employs an array of probes (linear, convex) with a frequency range of approximately 3.0 MHz to 10.0 MHz. Specific probes are identical or similar to those on predicate devices M9 (K141010) and M7 (K131690). |
| Safety and Effectiveness Features Equivalence | TE7 has comparable key safety and effectiveness features as the predicate devices. This includes: |
- Same patient contact material as predicate M7 (K131690).
- Acoustic power levels are below FDA limits, same as predicate M7 (K131690).
- Designed in compliance with FDA recognized electrical and physical safety standards, same as predicate M7 (K131690).
- Same imaging modes as predicate M7 (K131690): B, M, Color Doppler, PWD, CWD, Amplitude Doppler, Anatomical M Mode and combined mode.
- Special functions (LVO, iNeedle) are identical to predicate M9 (K141010).
- Same capacity for comments, body marks, and reporting as predicate M7 (K131690).
- Conforms to applicable medical safety standards (UD 2, UD 3, AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO14971, ISO 10993-1, IEC 62366, IEC 62304). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided in the 510(k) summary. For ultrasound systems, performance is typically verified through technical bench testing and comparison to existing, cleared devices, not with clinical test sets or data provenance in the way an AI algorithm might require.
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)
This information is not applicable and not provided. Ground truth established by experts is a concept relevant to performance studies where a diagnosis or measurement needs validation, typically for novel algorithms or significant changes in diagnostic capabilities. This 510(k) submission does not describe such a study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are used in clinical studies with human readers to establish a gold standard or resolve discrepancies, which is not part of this 510(k) submission.
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
There is no MRMC comparative effectiveness study mentioned. The document explicitly states: "Clinical Studies: Not applicable. The subject of this submission, TE7 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." This type of study would be highly relevant for AI-assisted interpretation, which is not the primary focus of this ultrasound system's regulatory submission for substantial equivalence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The TE7 is a diagnostic ultrasound system, not an AI algorithm. Its performance is inherent in its imaging capabilities and modes, which are compared to predicate ultrasound devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the context of this 510(k) submission. The "ground truth" for demonstrating substantial equivalence lies in comparing its technical specifications and performance during non-clinical testing against established medical device standards and the technical attributes of predicate devices.
8. The sample size for the training set
This is not applicable and not provided, as the device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable and not provided, as the device is not an AI algorithm requiring a training set or ground truth establishment in that context.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.