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510(k) Data Aggregation
(225 days)
HEBU MEDICAL GMBH
Vascular Clamps are indicated for use for temporary or partial occlusion of blood vessels during open surgical procedures.
HEBUmedical Vascular Clamps are reusable stainless steel ring-handled clamps provided in a wide variety of shapes, sizes and lengths to accommodate the individual needs of the surgeon and the procedure. based on the anatomy of the site and type of occlusion. The length and angles are design features that can be important to keep the handles and shanks out of the field of vision of the operative site. The handle is provided with a ratchet closure, which permits the surgeon to adjust the amount of tension applied to the vessel. The device is provided non-sterile for sterilization by the user.
The provided 510(k) summary for HEBUmedical GmbH's Vascular Clamps does not describe a study involving an AI/software device, clinical data analysis, or a comparison with human readers. Instead, it describes a medical device (vascular clamps) that is a physical instrument, and its performance evaluation is based on bench testing.
Therefore, most of the requested information (sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth for training/test sets, effect size of human improvement with AI) is not applicable to this submission.
However, I can extract the information relevant to the provided text regarding the device and its performance relative to acceptance criteria.
Analysis of Acceptance Criteria and Device Performance for HEBUmedical Vascular Clamps
The 510(k) summary for the HEBUmedical Vascular Clamps focuses on demonstrating substantial equivalence to predicate devices through technological and performance characteristics, primarily assessed via bench testing. The "acceptance criteria" here are implicitly defined by the similar performance of the predicate devices in the described characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are not quantitative thresholds but rather qualitative comparisons to existing predicates, demonstrating similar characteristics to establish substantial equivalence.
| Characteristic | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (HEBUmedical Vascular Clamps) |
|---|---|---|
| Design | Multiple jaw tips and orientation, ratchet lock on handle, ring handle | Multiple jaw tips and orientation, ratchet lock on handle, ring handle |
| Principle of Operation | Clamp jaw applied to vessel; tension for occlusion/partial occlusion adjusted by ratchet closure | Clamp jaw is applied to the vessel. The amount of tension applied to the vessel for occlusion or partial occlusion is adjusted by means of the ratchet closure. |
| Material | Stainless Steel (one predicate also includes Titanium) | Stainless Steel |
| Sterility | Non-sterile | Non-sterile |
| Reusable | Yes | Yes |
| Functional Performance | Adequate clamp force and occlusion (demonstrated by bench testing) | Bench testing was performed to assess clamp force and occlusion. The device has similar technological and performance characteristics as the predicate devices. |
2. Sample Size and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of a "test set" for data or images. The evaluation was based on bench testing of the physical vascular clamps. The number of clamps tested (sample size for bench testing) is not specified.
- Data Provenance: The data provenance is from bench testing performed by the manufacturer, HEBUmedical GmbH, in Germany. This is an engineering/physical performance evaluation, not clinical data from patients. It is implicitly a prospective evaluation in the sense that the new device's performance was tested.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. This submission is for a physical medical device (vascular clamp) and relies on bench testing for performance evaluation, not expert-labeled clinical data or images. Ground truth was established through physical measurements of clamp force and occlusion during bench testing.
4. Adjudication Method for the Test Set
- Not Applicable. As no clinical image or data review requiring human expert interpretation was performed, there was no need for an adjudication method. Bench test results are typically objective measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study was not conducted as this device is a physical surgical instrument, not an AI/software product, and its evaluation did not involve human readers interpreting clinical cases.
6. Standalone Performance (Algorithm Only)
- Not Applicable. This is a physical device, not an algorithm or software. Its "standalone performance" refers to its physical characteristics and functionality, which were assessed via bench testing for clamp force and occlusion.
7. Type of Ground Truth Used
- Objective Bench Testing Measurements. The ground truth for evaluating the device's performance was derived from objective measurements obtained during bench testing of the physical clamp force and occlusion capabilities, compared against the characteristics of predicate devices.
8. Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of this physical device's evaluation. The device itself is manufactured, not "trained."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is not relevant.
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