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SwissMembrane X is intended for the following uses:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth;
• guided bone regeneration in dehiscence defects; and
• guided tissue regeneration procedures in periodontal defects.

SwissMembrane X Socket is intended for the following uses:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth;
• guided bone regeneration in dehiscence defects.

SwissMembrane X and SwissMembrane X Socket are resorbable collagen membranes made of porcine collagen. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membranes are made of collagen without further cross-linking and are sterilized by gamma irradiation.

SwissMembrane X is provided in the following variants and sizes:

• SwissMembrane X D-Line
  • 13 x 25 mm (rectangle)
  • 25 x 15/25 mm (trapezoid)
  • 30 x 25/40 mm (trapezoid)
• SwissMembrane X Socket D-Line
  • 14 x 24 mm

The provided FDA 510(k) Clearance Letter for SwissMembrane X and SwissMembrane X Socket indicates that the device has been cleared based on substantial equivalence to a predicate device, Geistlich Bio-Gide® and Geistlich Bio-Gide® Shape (K212463).

This type of clearance (510(k)) generally means that the device does not require new detailed performance data to prove safety and effectiveness if it can demonstrate through comparison that it is as safe and effective as a legally marketed predicate device. Therefore, the document does not describe acceptance criteria for performance, nor does it detail a study proving device performance against specific metrics in the way one might expect for a novel device or a device involving an AI component.

The document explicitly states:

"Non-clinical data was not deemed necessary to support the extension to the product line. As the subject devices fall within the range of size configurations cleared under the predicate device, there is no new worst-case configuration."

"Results from biocompatibility, sterilization, shelf-life, packaging validation, bench and clinical performance studies from the applicant's own predicate device (K212463) were leveraged in support of substantial equivalence."

Because the clearance is based on substantial equivalence to an existing and already cleared device, the typical requirements for a new performance study with specific acceptance criteria, test sets, and ground truth establishment (as is common for AI/ML-driven devices or novel diagnostic tools) are not present or reported in this 510(k) summary.

Therefore, the following information cannot be extracted from this document as no new performance study, in the sense of demonstrating a device's de novo performance against predefined metrics, was conducted or reported for this submission.

Based on the provided document, the following information cannot be extracted for the reasons stated above:

1. A table of acceptance criteria and the reported device performance: Not applicable. Performance data against specific acceptance criteria for a new study is not provided, as substantial equivalence was based on the predicate device's data.

2. Sample sized used for the test set and the data provenance: Not applicable. No new test set for proving performance was described. The submission leveraged existing data from the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new ground truth establishment process for a performance study is described.

4. Adjudication method for the test set: Not applicable. No new test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. No MRMC study described. The device is a physical bone grafting material/membrane, not one that typically involves human readers assisted by AI.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is involved.

7. The type of ground truth used: Not applicable. No new performance study requiring independent ground truth is described.

8. The sample size for the training set: Not applicable. This is not an AI/ML device; therefore, no training set is relevant.

9. How the ground truth for the training set was established: Not applicable. No training set is relevant.

Summary of what the document DOES state regarding "performance data":

The "Performance Data" section (Page 7) explicitly states that "Non-clinical data was not deemed necessary to support the extension to the product line." It further clarifies that "Results from biocompatibility, sterilization, shelf-life, packaging validation, bench and clinical performance studies from the applicant's own predicate device (K212463) were leveraged in support of substantial equivalence."

This means the acceptance criteria and performance data for this particular 510(k) submission refer back to the studies and their results that supported the initial clearance of the predicate device (K212463). The current submission argues that since SwissMembrane X and SwissMembrane X Socket are essentially variants (different shapes and sizes within an existing range) of the already cleared predicate device, no new performance studies are required. They are considered "substantially equivalent" based on identical materials, manufacturing, sterilization, and similar use cases, and the safety and efficacy of the underlying technology have already been established by the predicate device's clearance.

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