(105 days)
The SpineMedica Paradís Vaso Shield™ is indicated as a cover for vessels following anterior vertebral surgery.
The SpineMedica Paradís Vaso Shield™ is a flexible sheet of 30 Wt.% polyvinyl alcohol (PVA) material with dimensions of 60 ±6 mm X 100 ±10 mm and a thickness of 1.0 ±0.2 mm. The corners of the sheet are rounded. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated in saline solution.
Here's an analysis of the provided text regarding the SpineMedica Paradís Vaso Shield™:
Acceptance Criteria and Study for SpineMedica Paradís Vaso Shield™
This 510(k) summary for the SpineMedica Paradís Vaso Shield™ largely focuses on establishing substantial equivalence to predicate devices rather than proving specific numerical performance metrics through a clinical study with predefined acceptance criteria. The "studies" mentioned are primarily non-clinical evaluations to demonstrate safety and effectiveness in line with its function as a vessel cover.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Acceptable for use as a permanently implanted device. | Testing completed; "acceptable biocompatibility" for permanent implantation. |
| Simulated Clinical Env. | Device design meets user needs. | "Evaluated in a simulated clinical environment to demonstrate that the design of the device meets the needs of the user." |
| Dimensional Analysis | Within specified tolerances: 60 ±6 mm X 100 ±10 mm, thickness 1.0 ±0.2 mm. | "All testing results met required acceptance criteria." (Implies dimensions were within spec). |
| Package Integrity | Maintain sterility and product quality. | "All testing results met required acceptance criteria." |
| Suture Pull Out Strength | Sufficient to maintain device position and integrity. | "All testing results met required acceptance criteria." |
| Pyrogenicity | Non-pyrogenic (i.e., does not cause fever). | "All testing results met required acceptance criteria." |
| Shelf-Life | Maintain properties and sterility over time. | "All testing results met required acceptance criteria." (Initially cleared with a 6-month shelf life). |
| Distribution Simulation | Withstand typical shipping and handling. | "All testing results met required acceptance criteria." |
| Environmental Conditioning | Maintain properties under various environmental conditions. | "All testing results met required acceptance criteria." |
| Sterilization Validation | Achieve and maintain sterility. | "All testing results met required acceptance criteria." |
| Substantial Equivalence | Demonstrated to be substantially equivalent to previously cleared devices. | Shown to be substantially equivalent to predicate devices with the same indications for use, design, function, and/or materials. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify sample sizes for any of the non-clinical tests. Since these were laboratory and engineering tests, the concept of "data provenance" (country of origin, retrospective/prospective) in the clinical sense doesn't directly apply here. The tests were likely conducted in a controlled laboratory environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For non-clinical tests like dimensional analysis or biocompatibility, "ground truth" is typically established by validated testing methods and adherence to recognized standards, rather than expert consensus in the way it's used for diagnostic imaging studies.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies involving interpretation of data (e.g., medical images) by multiple experts. The tests performed for this device were primarily objective engineering or biological assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of AI vs. Without AI Assistance
No. This device is a physical medical device (vessel shield), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. As noted above, this is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests:
- Engineering Specifications: For dimensional analysis, package integrity, suture pull out strength, shelf-life, distribution simulation, environmental conditioning, and sterilization validation, the ground truth was established by predetermined engineering specifications, national/international standards, and regulatory requirements (e.g., ISO standards for biocompatibility/sterilization).
- Biological Response: For biocompatibility and pyrogenicity, ground truth was established by observing the biological response of cells/animals to the material in accordance with established biological safety testing protocols (e.g., ISO 10993 series).
- User Feedback (simulated clinical environment): For the simulated clinical environment, ground truth was likely based on user (surgeon) feedback and assessments that the device's design met their needs, though the specifics of this evaluation are not detailed.
8. The Sample Size for the Training Set
This information is not applicable and not provided. As a physical device, there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing process would be informed by material science, engineering principles, and clinical need.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided. There is no "training set" for this type of device.
§ 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).