(86 days)
MagnetOs Putty is an implant intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. MagnetOs Putty 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 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% Tri-Calcium Phosphate (TCP, Cas(PQ2)>) and 25-35% Hydroxyapatite (HA. Cag(PO2)3OH) granules, premixed with a synthetic polymeric binder that provides cohesion between the granules.
MagnetOs Putty is gamma-sterilized, comes in four sizes in block form and is sterile packaged for single use only.
The provided document is a 510(k) premarket notification for the MagnetOs Putty device. It details the device's substantial equivalence to existing predicate devices, focusing on non-clinical testing. However, it does NOT provide the acceptance criteria or a study that uses such criteria to prove the device meets them in the context of diagnostic accuracy or performance against specific metrics as would be expected for an AI/CADe device.
Therefore, many of the requested sections regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies for AI are not applicable to this document. The document describes a comparison to predicate devices, which is a different type of assessment than proving performance against defined acceptance criteria typically seen for diagnostic devices.
Here's the closest possible interpretation of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that the device must achieve. Instead, it demonstrates "substantial equivalence" to predicate devices through various non-clinical tests. The "performance" is implicitly deemed acceptable if it is found to be equivalent to the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent chemical composition to predicate devices | Achieved through XRD, FTIR, NMR, OVI, ICP/MS analysis |
| Equivalent physical properties to predicate devices | Achieved through Mercury intrusion porosimetry, dissolution, IV analysis |
| Equivalent surface microstructure and bioactivity to predicate devices | Achieved through SEM and in vitro SBF immersion study |
| Biocompatibility in accordance with ISO 10993 standards and USP | Assessed using methodology described in ISO 10993-1, -3, -5, -6, -10, -11 and USP |
| Equivalent performance in a posterolateral spine fusion animal model to predicate devices | Demonstrated in a posterolateral spine fusion animal model |
| Same intended use as predicate devices | MagnetOs Putty has the same intended use. |
| Same product classification and product code (MQV) | MagnetOs Putty has the same classification and product code. |
| Similar Indications for Use as predicate devices | MagnetOs Putty has similar Indications for Use. |
| Same operating principle as predicate devices | MagnetOs Putty uses the same operating principle. |
| Same basic design as predicate devices | MagnetOs Putty incorporates the same basic design. |
| Same or very similar materials as predicate devices | MagnetOs Putty incorporates the same or very similar materials. |
| Manufactured at the same facility using very similar processes as predicate MagnetOs Granules (K161859) | Manufactured at the same facility using very similar processes. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions an "animal model" for the posterolateral spine fusion study. However, it does not specify the sample size (number of animals or cases) used for this test set, nor does it provide details on data provenance beyond acknowledging it was an "animal model." The studies are pre-clinical, meaning they are conducted in a laboratory setting or on animals, not human patients.
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 information is not provided in the document. Given that the testing included an "animal model" and material characterization, the "ground truth" would likely be established by experimental measurements and observations by laboratory personnel or veterinary specialists, rather than clinical experts like radiologists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
No such MRMC comparative effectiveness study was described, as this device is a bone void filler, not an AI/diagnostic imaging device that would assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the MagnetOs Putty device, which is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the material characterization, the "ground truth" would be established by scientific measurement techniques (e.g., XRD, FTIR, SEM, ICP/MS, porosimetry) and comparison to known material properties of the predicate devices. For the animal study, the "ground truth" would be established by histological analysis, imaging, or other relevant assessment of bone healing and fusion in the animal model.
8. The sample size for the training set
The concept of a "training set" is not applicable as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable.
§ 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.