(136 days)
MagnetOs Putty is an implant intended to fill bony voids or gaps of the skeletal system i.e., the extremities, pelvis and posterolateral spine. In the posterolateral spine, MagnetOs Putty must be used with autograft as bone graft extender. In extremities and pelvis, MagnetOs Putty is used alone. These osseous defects may be surgically created of of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MagnetOs Putty resorbs and is replaced with bone during the healing process.
MagnetOs Putty is a synthetic, resorbable and osteoconductive bone void filler for the repair of bony defects, containing 65-75% beta-Tri-Calcium Phosphate (TCP, Ca3(PO4)2) and 25-35% Hydroxyapatite (HA, Ca5(PO4)3OH) granules, premixed with a synthetic polymeric binder that provides cohesion between the granules.
MagnetOs Putty is gamma-sterilized, comes in several sizes in block form and is sterile packaged for single use only.
This is a premarket notification (510(k)) for a medical device (MagnetOs Putty), not an AI/ML powered device. Therefore, the information requested in terms of acceptance criteria, study details, ground truth, and training data is not directly applicable in the format typically used for AI/ML devices.
However, I can extract and present the relevant information from the provided document regarding the device's performance, testing, and basis for substantial equivalence to its predicate devices, as if this were a non-AI medical device submission.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the quantitative terms typically found for AI/ML device performance. Instead, it demonstrates substantial equivalence based on a comparison to predicate devices, supported by various tests. The reported performance is that the device is "equivalent" to the predicate devices.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Chemical composition equivalent to predicate | Demonstrated equivalent chemical composition |
| Physical properties equivalent to predicate | Demonstrated equivalent physical properties |
| Biocompatibility in accordance with ISO 10993 series and USP | Assessed using the specified methodologies; no adverse indications or results reported. |
| Performance in a posterolateral spine fusion animal model equivalent to predicate | Demonstrated equivalent performance to predicate. |
| Performance as a standalone bone void filler in a critical sized femoral animal model equivalent to predicate | Demonstrated equivalent performance to predicate. |
| Safety and effectiveness equivalent to predicate devices | Indicated no adverse indications or results; determined to be as safe and effective. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Animal Studies: The document mentions "a posterolateral spine fusion animal model" and "a critical sized femoral animal model." It does not specify the exact number of animals used in these studies, nor their country of origin. It is implied these were prospective studies as they were conducted to support the 510(k) submission.
- Bench Testing: No "sample size" in the conventional sense is stated for bench tests. These tests are performed on the device material itself.
- Data Provenance: Not explicitly stated for either animal studies or bench testing, but likely associated with the manufacturer (Kuros Biosciences B.V., Netherlands) or testing facilities they contracted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This concept of "experts establishing ground truth" is not applicable in this context. The "ground truth" for the device's performance in animal models would be based on histological analysis, imaging, and biomechanical assessments conducted by animal study researchers and pathologists, whose qualifications are not detailed in this summary. For chemical and physical properties, the "ground truth" is derived from established analytical methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is typically relevant for human reader studies or clinical trials involving subjective human assessment.
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 medical device (bone void filler), not an AI/ML powered diagnostic or therapeutic aid. No human reader studies or AI assistance are involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm. Performance of the device itself was evaluated in bench and animal studies (standalone in terms of the device's function as a biological implant).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Biocompatibility: Ground truth is established by adherence to recognized ISO standards (ISO 10993 series) and USP , which define acceptable biological responses.
- Chemical/Physical Properties: Ground truth is established by validated analytical methods (XRD, FTIR, NMR, ICP/MS, SEM, SBF immersion, mercury intrusion porosimetry) and comparison to the known properties of the predicate devices.
- Animal Studies: Ground truth for performance (e.g., bone fusion, defect repair) would be based on pathological assessment (histology, imaging) and potentially functional outcomes in the animal models, as evaluated by veterinary surgeons and pathologists. The document states "demonstrated that the performance of the subject device was equivalent to that of the predicate," implying direct comparative assessment of these outcomes.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.