(107 days)
BIOGENNIX osteoSPAN Morpheus is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process. When used in the posterolateral spine, osteoSPAN Morpheus must be used as a bone graft extender, mixed in a one to one ratio with autogenous bone graft.
osteoSPAN Morpheus is a moldable, osteoconductive bone graft substitute composed of 1-2mm osteoSPAN granules suspended in a resorbable organic binder. The osteoSPAN granules used in osteoSPAN Morpheus are a composite of calcium carbonate with a thin calcium phosphate layer, in the form of hvdroxvapatite, coating on all the surfaces of the interconnected porosity. The interconnected pores are approximately 500 microns in diameter and occupy approximately 65% of the volume. The biocompatible, organic binder used in osteoSPAN Morpheus facilitates placement and containment of the implant and is rapidly resorbed in-situ, leaving behind the osteoSPAN granules without affecting their osteoconductive or resorbable properties.
The provided document is limited in scope and only describes the OsteoSPAN Morpheus device and its expanded indication for use. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a comprehensive study proving the device meets those criteria.
Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment are not available in the provided text.
However, I can extract what is available and indicate what information is missing.
Here's a summary based on the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device through supplementary preclinical performance testing. The reported performance is a qualitative assessment of this equivalence.
| Performance Metric | Acceptance Criteria (Not explicitly stated numerically, but implied as "substantially equivalent" to predicate) | Reported Device Performance (Summary of findings) |
|---|---|---|
| Bone Ingrowth | Substantially equivalent to predicate osteoSPAN in a posterolateral spine model. | Confirmed substantially equivalent to its predicate osteoSPAN when used in a posterolateral spine model. |
| Tissue Reaction | Substantially equivalent to predicate osteoSPAN in a posterolateral spine model. | Confirmed substantially equivalent to its predicate osteoSPAN when used in a posterolateral spine model. |
| Mechanical Strength | Substantially equivalent to predicate osteoSPAN in a posterolateral spine model. | Confirmed substantially equivalent to its predicate osteoSPAN when used in a posterolateral spine model. |
| Residual Material | Substantially equivalent to predicate osteoSPAN in a posterolateral spine model. | Confirmed substantially equivalent to its predicate osteoSPAN when used in a posterolateral spine model. |
| Osteoconductive | Identical to osteoSPAN predicate device (K093342). | The osteoSPAN predicate device (K093342), which is the primary component, has identical osteoconductive potential to the current device. |
| Resorbable Properties | Unaffected by organic binder. | The organic binder does not affect the osteoSPAN granules' resorbable properties. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Supplementary preclinical performance testing confirmed..." but does not provide details on the sample size for this testing. It only mentions the "posterolateral spine model."
The data provenance is within the context of a 510(k) submission to the FDA, suggesting the data was generated specifically for supporting this regulatory submission. It does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable/Not provided. The document describes preclinical performance testing in a "posterolateral spine model," implying animal or in-vitro models were used, rather than human data requiring expert ground truth establishment for diagnostic purposes.
4. Adjudication Method for the Test Set
Not applicable/Not provided. As the testing appears to be preclinical performance testing, an adjudication method for human interpretation of results is not relevant or described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention any MRMC study or any study involving human readers with or without AI assistance. This device is a bone void filler, not an imaging or diagnostic AI device.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study
Not applicable. This device is a physical medical device (bone void filler), not an algorithm or AI. The concept of "standalone performance" for an algorithm does not apply here.
7. Type of Ground Truth Used
For the preclinical performance testing, the "ground truth" would likely be based on:
- Histopathology/Microscopic analysis: To assess bone ingrowth and tissue reaction in the experimental models.
- Mechanical testing standards: For measuring mechanical strength.
- Material analysis techniques: For determining residual material.
However, the specific methods for establishing this "ground truth" are not detailed in the document beyond stating "preclinical performance testing confirmed."
8. Sample Size for the Training Set
Not applicable/Not provided. This device is a physical medical device and does not involve AI or machine learning models that require a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable/Not provided. (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.