(167 days)
The indications for use for the Safeguard 24 cm pressure assisted dressing are to assist in obtaining and maintaining hemostasis. The device is also indicated in the reduction of active compression time in femoral artery cannulation following diagnostic and interventional procedures, with an ACT of 140 seconds or less, using using a 6 French and smaller sheath size.
The Safeguard 24 cm pressure assisted dressing is a sterile single use pressure bandage which has a medical grade polyurethane window and bladder, a clear medical grade PVC flexible fill tube, and a pressure sensitive, self adhesive peel backing. A luer valve on the end of the fill tube enables a syringe to be connected to inflate the centrally located bladder with air to provide pressure to the puncture site. A check valve allows the fill volume to stay in the bladder after injection from the syringe. The Safeguard 24 cm pressure assisted dressing has a clear window that facilities visualization of the access site without removal or manipulation of the device.
This is a medical device, not an AI/ML device. The provided text describes a 510(k) premarket notification for a medical device called the "Safeguard™ 24 cm pressure assisted dressing," a hemostasis compression device. The information requested (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, MRMC, standalone performance) is typically associated with studies for AI/ML-powered devices, not for traditional medical devices like the one described here.
Therefore, many of the specific questions about AI/ML device performance and testing are not applicable to the information provided in this document.
However, I can extract information related to the device's intended use and the general types of testing performed to establish substantial equivalence.
Here's a breakdown of the relevant information from the provided text, addressing the questions where possible and noting when a question is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the way one would for an AI/ML model (e.g., minimum accuracy, sensitivity, specificity). Instead, it defines its intended use and then states that clinical testing was conducted to support one of these indications. The "performance" is implicitly deemed acceptable by the FDA's substantial equivalence determination.
| Acceptance Criteria (Stated Indication/Goal) | Reported Device Performance (Implied by study conclusion) |
|---|---|
| Primary Indication: Assist in obtaining and maintaining hemostasis. | "The Safeguard 24 cm pressure assisted dressing is as safe, as effective, and performs as well as the predicate devices." (This statement from the conclusion implies the device successfully assists in obtaining and maintaining hemostasis, similar to its predicates). |
| Secondary Indication: Reduction of active compression time in femoral artery cannulation following diagnostic and interventional procedures, with an ACT of 140 seconds or less, using a 6 French and smaller sheath size. | "Clinical testing with the Safeguard 24 cm pressure assisted dressing was conducted in support of the indication for reduction of active compression time in femoral artery compression following diagnostic and interventional procedures." |
| "The results of all testing demonstrate that the Safeguard 24 cm pressure assisted dressing is as safe, as effective, and performs as well as the predicate devices." (This implies the clinical testing supported the claim of reduced active compression time, achieving performance comparable to predicates within the specified parameters.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. The document refers to "Clinical testing" but does not give a number of participants.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It only states "Clinical testing... was conducted."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This is a physical medical device, not an AI/ML algorithm requiring expert-established ground truth on a dataset. The "ground truth" for its performance would be direct clinical outcomes (e.g., hemostasis achieved, compression time).
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI-assisted device for human readers. It's a physical hemostasis device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device. It is used by a human clinician. The "standalone" concept doesn't apply.
7. The Type of Ground Truth Used
- The document implies that the ground truth for its clinical testing relates to clinical outcomes such as successful hemostasis and measured active compression time in actual patients.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical medical device, not an AI/ML algorithm that is "trained" on data. Its development involved "Requirements specification review," "Performance bench testing," and "Design verification."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
§ 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).