(19 days)
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The Hemo-Dop® consists of two parts. A proctoscope with implemented ultrasound probe and a basic unit which processes and displays the ultrasound signals. The processes of 360° can be insonated. When the ultrasound radiation meets a blood vessel, the frequency shift can be heard and it is graphically displayed. With the bullent of the vessel but also the depth in which it hows. Through the user not only Knows the exact position of the vessel. Since in the area behind the linear the procloscope the user can logate the roose. The can be treated as outpatient of the black defitate the pattent doesn't ficed a general or lobal thabethesia and reliable evaluation of the blood flow signals of the extracranial and peripheral vessels.
Here's an analysis of the provided documents regarding the Hemo-Dop® device's acceptance criteria and study information, structured to address your questions.
Important Note: The provided text is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results for the device itself. Therefore, many of your requested items (like specific acceptance criteria for a performance study, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) are not present in this type of document. The 510(k) process relies on demonstrating the device is as safe and effective as a legally marketed predicate, often through comparisons of technical characteristics and existing clinical use of the predicate.
Hemo-Dop® 510(k) Summary Analysis
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) summary, formal "acceptance criteria" for a specific performance study of the Hemo-Dop® device against a diagnostic benchmark are not explicitly stated in the way you might find in a clinical trial report. Instead, the "performance" discussed primarily relates to acoustic output measurements and substantial equivalence to predicate devices.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance (Hemo-Dop®) |
|---|---|
| Acoustic output within FDA recommended limits | 8MHz Pencil Probe PW mode: |
| ISPTA.3: 334 mW/cm² (Max Value), Power: 10.2 mW | |
| ISPTA.1: 1.86 mW/cm² (Max Value), Power: 10.2 mW | |
| (Stated: "acoustic output is under by the FDA recommended limit and power level is displayed all the time.") | |
| 8MHz Proctoscope Probe PW mode: | |
| ISPTA.3: 8.1 mW/cm² (Max Value), Power: 0.74 mW | |
| SPPA.3: 0.04 W/cm² (Max Value), Power: 0.74 mW | |
| (Stated: "acoustic output is under by the FDA recommended limit and power level is displayed all the time.") | |
| Substantial equivalence to predicate ultrasound Doppler systems | Identified predicate devices: KOVEN TECHNOLOGY INC.; Model KM-25 (K951449) and DWL Elektronische Systeme GmbH; Multi-Dop® L (K930458). |
| (Conclusion states: "the Hemo-Dop is safe and effective and substantially equivalent to predicate devices described herein.") | |
| Conformance to voluntary electrical safety and EMC standards | Conforms to EN60601-1, EN60601-1-1, EN60601-1-2. |
| Biocompatibility of patient contact materials | All specified materials (PMP, PPSU black, EP42HT, Photobond 4442 for proctoscope; San, ABS, EP42HT for pencil probe) are USP class VI. |
| Functionality as a pulsed Doppler ultrasound system | Device described to process and display ultrasound signals, indicating frequency shift when meeting a blood vessel, showing exact position and depth. |
| Software operating system | MS-Dos. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable / Not Provided: A dedicated "test set" in the context of a performance study with specific metrics (like sensitivity, specificity, accuracy) is not described. The 510(k) relies on comparison to predicate devices and adherence to safety standards.
- Data Provenance: The acoustic output measurements were performed on the Hemo-Dop® device itself (implied to be in Germany, given the manufacturer's address). The claims of safety and effectiveness are based on design controls, comparison to predicate devices, and adherence to recognized standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable / Not Provided: As there is no described performance study with a test set requiring expert ground truth establishment for diagnostic accuracy, this information is not present. The "ground truth" for acoustic output measurements would be the physical measurements themselves.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided: No test set or related adjudication method is detailed in this 510(k) summary.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
- No: An MRMC comparative effectiveness study is not mentioned or implied in this 510(k) summary. The context is a device submission focused on substantial equivalence, not a detailed clinical comparative study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not Applicable / Not Provided: The Hemo-Dop® is a hardware device (ultrasound system with probes) that provides real-time information to a human operator. It is not an "algorithm only" device, so a standalone performance study in that context would not be relevant. The stated purpose is for medical professionals to detect blood vessels and assist in procedures.
7. The Type of Ground Truth Used
- Process-Oriented / Scientific Measurement: The "ground truth" in this submission primarily revolves around engineering and safety parameters:
- Acoustic Output: Measured values against FDA recommended limits.
- Material Biocompatibility: Conformance to USP class VI standards for patient contact materials.
- Electrical Safety and EMC: Conformance to specified EN standards.
- Functional Description: How the device processes and displays ultrasound signals.
- There is no mention of "expert consensus, pathology, outcomes data" as ground truth for a diagnostic performance claim in this summary.
8. The Sample Size for the Training Set
- Not Applicable / Not Provided: This device is an ultrasound system, not a machine learning algorithm that requires a "training set" of data in the typical sense.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Provided: See point 8.
§ 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.