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The SpineMedica Paradis Vaso Shield™ is indicated as a cover for vessels following anterior vertebral surgery.

The SpineMedica Paradis Vaso Shield™ is a flexible sheet of 30 Wt.1% 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.

The provided 510(k) summary for the SpineMedica Paradís Vaso Shield™ indicates that performance standards were met and testing was performed to demonstrate substantial equivalence to predicate devices. However, the document does not describe specific acceptance criteria or a detailed study that proves the device meets those criteria with quantitative results.

Instead, the submission relies on the concept of "substantial equivalence" to previously cleared devices. This means the device is considered safe and effective because it has the same indications for use, design, function, and/or materials as legally marketed predicate devices. The 510(k) summary explicitly states: "Testing performed indicates the SpineMedica Paradis Vaso Shield™ is substantially equivalent to predicate devices."

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text, nor can I answer questions about sample sizes, expert ground truth establishment, or specific study methodologies (like MRMC or standalone performance) because these details are not present in the provided document.

The 510(k) process for this device did not involve presenting new clinical or performance data against specific acceptance criteria in the same way a de novo or PMA submission might. The FDA's letter (K093551) confirms substantial equivalence and primarily focuses on labeling requirements and limitations regarding claims not established (e.g., reducing adhesion formation).

Summary of what can be inferred from the document:

The 510(k) submission for the "SpineMedica Paradís Vaso Shield™" demonstrates substantial equivalence to predicate devices rather than presenting a study with explicit acceptance criteria and corresponding performance data. The document does not contain the detailed information necessary to answer the questions posed regarding specific acceptance criteria, study methodology, sample sizes, expert qualifications, or ground truth establishment.

The FDA's review concluded that the device is substantially equivalent based on its stated indications for use, design, function, and materials being similar to pre-existing, legally marketed devices. The FDA's letter primarily focused on clarifying labeling requirements and limitations, especially concerning unproven claims.

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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

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.

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