(30 days)
SwissGraft X is intended for the following uses:
- augmentation or reconstructive treatment of the alveolar ridge
- filling of infrabony periodontal defects
- filling of defects after root resection, apicoectomy, and cystectomy
- filling of extraction sockets to enhance preservation of the alveolar ridge
- elevation of the maxillary sinus floor
- filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
SwissGraft X is a biocompatible bone mineral matrix and is manufactured from purified spongiosa (cancellous) bovine bone mineral granules. SwissGraft X serves as a matrix consisting of interconnected macro- and micropores. The material is highly porous, hydrophilic, and has a large inner surface area. SwissGraft X is sterilized by x-ray irradiation. SwissGraft X is provided in granule form.
The provided document is an FDA 510(k) clearance letter for a bone grafting material called "SwissGraft X." It does not describe an AI medical device or present a study comparing the device's performance against acceptance criteria in the manner typically expected for AI/software-as-a-medical-device (SaMD) clearances.
Instead, this document describes a traditional medical device (bone grafting material) seeking clearance based on substantial equivalence to a predicate device. The performance data section refers to standard biocompatibility, sterilization, shelf-life, and packaging validation, along with characterization of structural, mechanical properties, and granule size distribution – all common for a physical medical product.
Therefore, many of the requested elements (e.g., acceptance criteria for diagnostic performance, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for training/test sets) are not applicable to the information contained in this specific FDA clearance letter for SwissGraft X.
Here's an analysis based on the available information, with notes where information is not present or not applicable to an AI device:
1. Table of Acceptance Criteria and Reported Device Performance
As "SwissGraft X" is a bone grafting material and not an AI or diagnostic device, the acceptance criteria relate to its physical and biological properties rather than diagnostic performance metrics (like sensitivity, specificity, AUC). The document refers to "testing against final product specifications" and "characterization of structural and mechanical properties" for the new product line's smaller granule sizes and different filling weights compared to the predicate device. Specific numerical acceptance criteria or performance values are not detailed in this summary, but the conclusion states that these evaluations support substantial equivalence.
| Acceptance Criteria Category (Implied from Performance Data) | Reported Device Performance |
|---|---|
| Material Biocompatibility | Results from applicant's own predicate device (K240661) were leveraged. Implied to meet established standards. Specific results not provided in this summary. |
| Sterilization Efficacy | Results from applicant's own predicate device (K240661) were leveraged. Implied to meet established standards for X-ray sterilization. Specific results not provided in this summary. |
| Shelf-Life Stability | Results from applicant's own predicate device (K240661) were leveraged. Implied to demonstrate stability over its intended shelf life. Specific results not provided in this summary. |
| Packaging Validation | Results from applicant's own predicate device (K240661) were leveraged. Implied to ensure package integrity and sterility. Specific results not provided in this summary. |
| Final Product Specifications | "Testing against final product specifications" undertaken. Implied to meet all defined specifications for the device. Specific numerical specifications or results not provided in this summary. |
| Pore, Surface, and Internal Structure Characteristics | "Characterization of structural and mechanical properties" undertaken. Implied to be comparable to the predicate device within acceptable ranges. Specific results not provided in this summary. |
| Liquid Uptake | "Characterization of structural and mechanical properties" undertaken. Implied to be comparable to the predicate device within acceptable ranges. Specific results not provided in this summary. |
| Granule Size Distribution | "Characterization of structural and mechanical properties" undertaken (including Granule size distribution). The device has a reduced granule size range (0.25-0.6 mm) compared to the predicate (0.25-1.0 mm, 1.0-2.0 mm), but this was the specific change being evaluated and found to be sufficiently similar for substantial equivalence. Specific results not provided in this summary, but the conclusion of substantial equivalence implies acceptable performance. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary as it typically would be for a clinical validation or AI performance study. The "Performance Data" section states that results from the applicant's own predicate device (K240661) were "leveraged" for biocompatibility, sterilization, shelf-life, and packaging validation. For the specific differences (granule size and filling weights), "testing against final product specifications" and "characterization of structural and mechanical properties" were undertaken. The exact sample sizes for these bench tests are not disclosed.
Data Provenance: The manufacturer is "Geistlich Pharma AG" based in Wolhusen, Switzerland. The predicate device's data was used, but details on the provenance of those original studies are not given here. The studies mentioned are primarily bench/laboratory based for material characterization, not typically clinical or retrospective/prospective data sets in the AI sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not applicable here. The device is a physical bone grafting material, not a diagnostic AI that requires expert-established ground truth for performance evaluation. Its performance is assessed through laboratory tests (e.g., material characterization, sterilization validation) against technical specifications, not against expert clinical diagnoses.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the context of expert adjudication for diagnostic accuracy.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a clearance for a bone grafting material, not an AI device, so MRMC studies are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. "SwissGraft X" is not an algorithm or software. It is a physical bone grafting material.
7. The Type of Ground Truth Used
For a physical device like SwissGraft X, "ground truth" refers to established scientific/engineering principles, material standards, and validated test methods (e.g., for biocompatibility, sterility, material properties) rather than clinical ground truth (like pathology or expert consensus). The product is evaluated against its own "final product specifications" and characterization results are compared against those of the predicate device.
8. The Sample Size for the Training Set
Not applicable. The device is a physical product, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. The device is a physical product, not an AI model that requires a ground truth for a training set.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.