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510(k) Data Aggregation
(233 days)
XPAND BIOTECHNOLOGY BV
MagnetOs is an implant intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. MagnetOs must be used with autograft as a bone graft extender in the posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MagnetOs resorbs and is replaced with bone during the healing process.
MagnetOs is a synthetic, osteoconductive and resorbable bone void filler for the repair of bony defects, containing 65-75% Tri-Calcium Phosphate (TCP, Ca3(PQ4)2) and 25-35% Hydroxyapatite (HA, Cas(PO4)3OH).
MagnetOs is gamma sterilized, comes in various sizes in granular or chip form and is sterile packaged for single use only.
This document is a 510(k) premarket notification for a medical device called MagnetOs. It's a regulatory submission to the FDA, not a study report demonstrating the device meets a specific acceptance criterion with detailed performance metrics. Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, and ground truth establishment are not present in this type of document.
However, I can extract the information that is available and clarify what is not.
Key takeaway: This document asserts "substantial equivalence" to predicate devices based on non-clinical testing and an animal model study, rather than providing numerical acceptance criteria for a specific performance metric and demonstrating the device meets them with a clinical study.
Here's the breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not provide a table of explicit numerical acceptance criteria for specific performance metrics (e.g., a certain percentage of bone growth, or a measured strength value) and corresponding device performance data to meet those criteria.
Instead, the document's central claim is "substantial equivalence" to predicate devices. The "performance" is stated in terms of equivalence to predicates in various tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Chemical Composition Equivalence to predicates | Equivalent chemical composition (XRD, FTIR, ICP/MS analyses performed) |
| Physical Properties Equivalence to predicates | Equivalent physical properties (SEM, porosimetry, dissolution analyses performed) |
| Biocompatibility Equivalence to predicates (ISO 10993 series) | Assessed using ISO 10993-1, -3, -5, -6, -10, -11 methodologies. Results demonstrate equivalence. |
| Performance in Animal Model Equivalence to predicates | "The results of the study demonstrated that the performance of the subject device was equivalent to that of the predicate." (Posterolateral spine fusion animal model) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of a numerical count for each test. For the animal study, the sample size is not provided.
- Data Provenance: The studies were non-clinical (chemical, physical, biocompatibility) and pre-clinical (animal model). The country of origin for the data is not specified, but the applicant (Xpand Biotechnology B.V.) is based in The Netherlands. The studies are retrospective or prospective depending on when they were conducted in relation to the submission date, which is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. "Ground truth" in the context of device performance would likely refer to objective measurements of material properties, biological responses, or animal outcomes, not typically expert panel consensus in the way it applies to image analysis algorithms.
4. Adjudication method for the test set:
Not applicable or not described. This is not a study involving human readers or interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a bone void filler device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- For chemical, physical, and biocompatibility tests: The ground truth is the scientific measurement or established biological response according to internationally recognized standards (e.g., ISO 10993 standards for biocompatibility).
- For the animal model: The ground truth would be histological analysis, imaging results, or other objective measures of bone fusion and new bone formation observed in the animals.
8. The sample size for the training set:
Not applicable. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
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