(283 days)
The MTF New Bone Void Filler is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. The MTF New Bone Void Filler is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. It is for use in the posterolateral spine only, for posterolateral spine fusions. The MTF New Bone Void Filler must be used in the spine with bone marrow aspirate.
The MTF New Bone Void Filler is for single patient use only.
The MTF New Bone Void Filler is processed human bone that has been demineralized and combined with gelatin and sodium hyaluronate, which are naturally derived materials that are biocompatible and biodegradable. The sodium hyaluronate used in the manufacturing of the MTF New Bone Void Filler is not of animal origin. The MTF New Bone Void Filler comes in the form of a mixture of demineralized bone with gelatin and sodium hyaluronate, and a spatula that is necessary to mix the components. A hydrating agent can be used with the MTF New Bone Void Filler. Upon addition of a hydrating agent, the MTF New Bone Void Filler will achieve a flowable or moldable consistency. The resultant putty can then be manipulated by a surgeon into various shapes for ease and flexibility of use during surgical application.
The provided text does not contain detailed acceptance criteria, device performance data in a quantitative format, or descriptions of a study that would specifically prove the device meets such criteria in the manner typical of AI/medical imaging device submissions. The submission is for a "Bone Void Filler" and focuses on demonstrating substantial equivalence to predicate devices through material properties and in vitro or animal model testing, rather than human clinical trials with strict performance metrics.
Specifically, there is no mention of:
- A table of acceptance criteria with reported device performance for metrics like sensitivity, specificity, AUC, etc.
- Sample sizes for test sets (as there isn't a human clinical test set described in the context of device performance metrics).
- Data provenance for a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Sample size or ground truth establishment for a training set (as this is not an AI/machine learning device).
However, I can extract the information that is present and frame it in a way that aligns with the spirit of your request, interpreting "acceptance criteria" as implicitly tied to the demonstration of substantial equivalence and safety/effectiveness for this type of device.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
Given that K110003 is a 510(k) premarket notification for a Bone Void Filler, the primary "acceptance criterion" is demonstrating substantial equivalence to legally marketed predicate devices, along with evidence of safety and effectiveness. This is achieved by comparing the new device's technological characteristics, intended use, and performance to those of the predicate.
The key study mentioned is an animal model study, and lot release testing, to support the substantial equivalence claim.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Substantial Equivalence and Safety/Effectiveness) | Reported Device Performance/Evidence |
|---|---|
| Material Composition comparable to predicates | The device is processed human bone demineralized and combined with gelatin and sodium hyaluronate, which are naturally derived, biocompatible, and biodegradable. The sodium hyaluronate is not of animal origin. This composition is compared to DBX and DBX Strip. |
| Intended Use comparable to predicates | Intended for use as a Demineralized Bone Matrix for voids or gaps not intrinsic to bony structure stability, for surgically created or traumatic osseous defects. Indicated for posterolateral spine only, in posterolateral spine fusions, and must be used with bone marrow aspirate. This matches the indication claims of the predicate devices. |
| Osteoconductivity | The MTF New Bone Void Filler is stated to be osteoconductive. |
| Osteoinductive Potential (as demonstrated in an in vivo model) | Demonstrated osteoinductive potential in an athymic mouse model. Every lot of final product is tested to ensure this potential; standard testing in an athymic mouse model must prove positive for lot release. |
| Sterility | Aseptically processed and passes USP Sterility Tests. |
| Viral Clearance/Inactivation | Viral inactivation testing demonstrated suitable viral inactivation potential of the processing method for a wide spectrum of potential human viruses. The BVF process further reduces risk beyond donor testing and screening. |
| Biocompatibility | Materials (gelatin, sodium hyaluronate) are naturally derived, biocompatible, and biodegradable with an established history of use. |
| Performance in an in vivo model (comparative) | The study "New Generation DBX Putty (DBM Putty III) Tested in a Rabbit Model of Posterolateral Lumbar Fusion" demonstrated the new device to be substantially equivalent to its predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The primary "test set" in the context of demonstrating equivalence for this non-AI bone graft device is an in vivo animal study combined with in vitro testing.
- Sample Size: The specific sample size for the "Rabbit Model of Posterolateral Lumbar Fusion" study is not provided in the given text.
- Data Provenance: The study was conducted in a rabbit model, implying an animal study rather than human data. The geographical origin of the study is not specified, but it's presented by a US-based foundation (Musculoskeletal Transplant Foundation). It is inherently a prospective study if referring to the animal experimentation conducted to compare the new device to predicates.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts & Qualifications: This section is not applicable as the ground truth for an animal model study (e.g., fusion success, bone formation) would typically be established by veterinary pathologists, histologists, and/or radiologists specializing in animal models, not human medical experts in the context of clinical interpretation. The text does not provide these details.
4. Adjudication Method for the Test Set
- Adjudication Method: This is not applicable as the data presented is not based on expert interpretation of images or clinical outcomes in human subjects requiring an adjudication panel. Outcomes in an animal fusion model would typically be assessed objectively (e.g., imaging, histology, biomechanical testing).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret patient cases with and without AI assistance to measure reader performance improvement. This device is a bone void filler, not a diagnostic imaging AI.
6. Standalone Performance Study (Algorithm Only)
- Standalone Study: No, a standalone performance study (algorithm only) was not done. This is also relevant for AI/machine learning algorithms. The device is a physical bone void filler.
7. Type of Ground Truth Used
- Ground Truth Type:
- For Osteoinductive Potential: The ground truth is established by positive results in an athymic mouse model (likely histological evidence of ectopic bone formation).
- For the Rabbit Model of Posterolateral Lumbar Fusion: The ground truth for fusion outcomes would typically be based on a combination of radiographic evidence, CT imaging, and potentially histopathological analysis of explanted spines after a defined healing period. The specific details are not provided in the summary.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a physical medical device, not an AI/machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable. As there is no AI/machine learning component, there is no training set or ground truth establishment for such a set.
§ 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.