(61 days)
The D-Stat Handle is indicated for use with the D-Stat Clamp accessory to assist in the control of bleeding following catheterization or cannulation procedures.
Each D-Stat Handle consists of the following components: - Stainless Steel handle and shaft with a configured press fit attachment for the D-. Stat Dry Clamp accessory.
The provided document is a 510(k) premarket notification for a medical device called the "D-Stat Handle." This document focuses on the regulatory submission process and non-clinical testing, rather than a clinical study with detailed acceptance criteria and performance metrics typically found in clinical trial reports.
Here's an analysis based on the provided text, addressing your points:
Acceptance Criteria and Study for D-Stat Handle (No Clinical Study Performed)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Non-Clinical Testing) |
|---|---|
| Device is reusable (disconnect and reattach to 10 different clamp bases). | The non-clinical testing ensured the device is reusable by being able to disconnect and reattach to 10 different clamp bases. |
| Device weighs less than 1.5 lbs. | It was weight tested, verifying that the device weighs less than 1.5 lbs. |
| D-Stat Clamp base remains attached to D-Stat Handle after vertical shaking for 2 seconds. | The D-Stat Clamp base was tested to confirm that it will stay attached to the D-Stat Handle after vertical shaking for 2 seconds. |
| Device delivers even surface pressure (comparable to current commercial hand-held compression devices). | The D-Stat Handle was tested to ensure that it delivers even surface pressure. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Specific sample sizes for each non-clinical test are not explicitly provided in terms of the number of devices tested beyond "10 different clamp bases" for reusability. For the other tests (weight, shaking, even surface pressure), the sample size is implied to be at least one device, but a precise number is not given.
- Data Provenance: The data is from non-clinical testing conducted by the submitter (Vascular Solutions, Inc.). The country of origin is not explicitly stated but can be inferred as the United States given the submitter's address and the FDA submission. This is retrospective in the sense that the tests were completed before the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This device's evaluation was based on non-clinical engineering and performance testing against predefined specifications, not on expert-adjudicated clinical outcomes or "ground truth" derived from expert consensus.
4. Adjudication Method for the Test Set
- Not applicable. No clinical adjudication was performed, as this was a non-clinical device performance evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document explicitly states: "No clinical evaluations of this product for this use have been conducted." Therefore, no MRMC study was performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a mechanical handle for a clamp, not an AI algorithm. Its performance is inherent to its physical design and operation, and it is intended for human-in-the-loop use.
7. Type of Ground Truth Used
- Engineering/Performance Specifications: The "ground truth" for this device's non-clinical testing was based on predetermined engineering and performance specifications (e.g., weighing less than 1.5 lbs, staying attached after shaking, delivering even pressure).
8. Sample Size for the Training Set
- Not applicable. This is a hardware medical device, not an AI/ML algorithm. There is no training set in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no training set for this type of device.
Summary of Clinical Testing Statement:
The document clearly states: "No clinical evaluations of this product for this use have been conducted." The entire submission relies on non-clinical testing and substantial equivalence to predicate devices (D-Stat Clamp Accessory, FemoStop, EZ Hold) to demonstrate safety and effectiveness.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).