(90 days)
The SMI Cardiovascular Patch is intended for cardiovascular patching.
The Solinas Medical, Inc. SMI Cardiovascular Patch is indicated for cardiovascular patching.
The SMI Cardiovascular Patch is designed for cardiovascular patching. The SMI Cardiovascular Patch is comprised of a knitted polyethylene terephthalate (polyester) fabric covered silicone sheet reinforced with a thin sheet of polyester embedded in the silicone and optionally with a thin nickel-titanium (nitinol) alloy mesh. It is provided in various sizes and as flat and curved sheets.
The Solinas Medical, Inc. SMI Cardiovascular Patch is a physical device intended for cardiovascular patching, not a software device or AI algorithm. Therefore, the questions related to AI/algorithm performance metrics, sample sizes for training/test sets, ground truth establishment by experts, adjudication methods, and MRMC studies are not applicable.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes a 510(k) submission, which focuses on demonstrating substantial equivalence to predicate devices, rather than establishing absolute performance acceptance criteria for a novel device. The "acceptance criteria" here are implicitly tied to demonstrating mechanical properties comparable to existing, legally marketed devices.
| Acceptance Criteria (Implicit - based on predicate device performance) | Reported Device Performance |
|---|---|
| Mechanical properties (Tensile Strength, Burst Strength, Suture Pullout, and Water Permeability) substantially equivalent to predicate devices (W.L. Gore & Associates, Inc. ACUSEAL Cardiovascular Patch, Meadox Medicals, Inc. Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch, C.R. Bard DeBakey Elastic Knit Fabric, Teleflex, Inc. Cottony Silky II Polydeck Tevdek) | "Mechanical testing, including: Tensile Strength, Burst Strength, Suture Pullout, and Water Permeability Tests, demonstrates the applicant device has strength values that are substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the mechanical tests. The data provenance is not explicitly mentioned, but it would have been generated from laboratory testing of the SMI Cardiovascular Patch.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not Applicable (N/A). The "ground truth" for the mechanical properties of a physical device is established through standardized laboratory testing, not by expert consensus or interpretation in the way it applies to AI/image analysis.
4. Adjudication Method for the Test Set
N/A. This concept is not applicable to the mechanical testing of a physical medical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
N/A. MRMC studies are typically used for evaluating diagnostic imaging systems or AI software where human interpretation is involved. This is a physical cardiovascular patch.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for demonstrating the device's performance was based on the objective measurements of its mechanical properties (Tensile Strength, Burst Strength, Suture Pullout, and Water Permeability) against the established performance of legally marketed predicate devices.
8. The Sample Size for the Training Set
N/A. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
N/A. This is a physical medical device, not an AI model.
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).