(384 days)
SKaffold NMX is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SKaffold NMX is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The device provides a bone void filler that resorbs and is replaced by bone during the healing process.
SKaffold NMX is a pre-mixed moldable and biocompatible putty/paste bone void filler. SKaffold NMX consists of a mixture of calcium phosphate powder in a bioinert polyethylene glycol (PEG) based polymer that resorbs and is replaced with bone during the healing process. The 5 cc and 10 cc SKaffold NMX kits are provided sterile and are for single use only.
The provided document is a 510(k) premarket notification for a medical device called SKaffold NMX, a resorbable calcium salt bone void filler.
Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a tabulated format with numerical targets. Instead, the approach for demonstrating substantial equivalence is through comparison of critical specifications with a predicate device. The implicit acceptance criteria are that the device's critical specifications (chemistry, crystallinity, physical form, porosity, and solubility) should be "substantially equivalent" or "the same as" those of the predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance (SKaffold NMX vs. Predicate) |
|---|---|
| Chemistry (e.g., elemental composition, molecular structure) | "Substantially equivalent" to Callos Bone Void Filler (K051123) by FTIR and XRD. |
| Crystallinity (e.g., crystalline structure, degree of order) | "Substantially equivalent" to Callos Bone Void Filler (K051123) by XRD. |
| Physical Form (e.g., microstructure, surface morphology) | "Substantially equivalent" to Callos Bone Void Filler (K051123) by SEM. |
| Porosity (e.g., pore size, distribution, total pore volume) | "Substantially equivalent" to Callos Bone Void Filler (K051123) by Mercury Intrusion Porosimetry. |
| Solubility/Dissolution (e.g., rate of degradation/resorption) | "Substantially equivalent" to Callos Bone Void Filler (K051123) by in vitro dissolution measuring Ca2+ ion concentration. |
| Biocompatibility | Met requirements of ISO 10993-1. |
| Sterility Assurance Level (SAL) | Validated to SAL 10⁻⁶ in accordance with ISO 11137-2006. |
| Resorption and Bone Ingrowth (in vivo) | Resorbed over time and allowed bone ingrowth in a rabbit model. Normal bone healing and no abnormal tissue responses in large animal study. |
| Safety Profile | Maintains the safety profile of the predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Non-clinical tests (material characterization): The document does not specify sample sizes for the analytical tests (FTIR, XRD, SEM, Mercury Intrusion Porosimetry, in vitro dissolution). These are typically laboratory tests on material samples, not patient data. Data provenance (country of origin) is not mentioned.
- Biocompatibility: The ISO 10993-1 tests involve various in vitro and in vivo models, but specific sample sizes for these tests are not provided in the summary. Data provenance is not mentioned.
- In vivo, pre-clinical, large animal studies: The document mentions "large animal studies" and "well-defined rabbit model," but specific sample sizes (number of animals) are not provided. The studies were prospective animal model studies. Data provenance (country of origin) is not mentioned.
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 section is not applicable as the device is a bone void filler and the studies described are non-clinical (material characterization, animal studies). There is no "ground truth" established by human experts in the context of diagnostic performance or interpretation as would be the case for an AI device. The ground truth in animal studies would be histopathological findings and radiographic assessments by veterinary pathologists/radiologists, but specific details on the number or qualifications of these experts are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no human interpretation of results requiring adjudication in the context of this 510(k) summary for a bone void filler.
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
This is not applicable. The device is a bone void filler, not an AI-assisted diagnostic tool. No MRMC studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a bone void filler, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical material characterization tests, the "ground truth" is derived from established scientific measurement techniques (e.g., FTIR, XRD, SEM, Porosimetry) that quantify material properties.
For the in vivo pre-clinical animal studies, the ground truth would be established through histological, radiographic, and histopathologic analyses of tissue samples and imaging performed on the animals.
8. The sample size for the training set
This is not applicable. The device is a medical implant, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. As no training set exists for this type of device.
In summary, the document describes a substantial equivalence pathway for a bone void filler based on extensive non-clinical laboratory testing and animal studies, rather than clinical trials or AI performance evaluations. The "acceptance criteria" are implicitly met by demonstrating that the critical specifications and performance of SKaffold NMX are substantially equivalent to a legally marketed predicate device (Callos Bone Void Filler K051123), and by meeting biocompatibility and sterilization standards. No AI-specific evaluation metrics or studies were performed.
§ 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.