(33 days)
Mineral Collagen Composite Bioactive Extra Moldable is intended for use as a bone void filler for voids or gaps, that are not intrinsic to the stability of the bony structure. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.
For spine application Mineral Collagen Composite Bioactive Extra Moldable is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender.
Mineral Collagen Composite Bioactive Extra Moldable Bone Graft Matrix is composed of anorganic bone mineral, bioactive glass, and type I collagen that can be molded to fit the bone defect. It is an osteroconductive, bioactive, porous implant that allows for bony ingrowth across the graft site. The bone graft matrix is slowly resorbed and replaced by new bone tissue during the natural healing process.
The anorganic bone mineral component of the bone graft matrix is a natural, porous bone graft material of all organic components from bovine bone. The anorganic bone mineral meets ASTM F1581 standard specifications for the composition of anorganic bone for surgical implants. The bioactive glass component of the device is made of 45S5 Bioactive Glass and meeting ASTM F1538 standard specifications for malantation. The purified type I collagen is derived from bovine Achilles tendon.
The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.
The provided 510(k) summary for the "Mineral Collagen Composite Bioactive Extra Moldable" device indicates that no new acceptance criteria or specific studies proving the device meets these criteria were conducted for this submission (K231942).
Instead, the submission relies on the substantial equivalence to predicate devices (K221735 and K182074) and states that the performance data, including sterilization, pyrogenicity, biocompatibility, and animal testing results, remain the same as those previously submitted for the predicate devices. No new clinical studies were required.
Therefore, many of the requested details about acceptance criteria and study particulars for this specific submission are not explicitly provided because the device's performance is asserted to be equivalent to previously cleared devices, and thus relies on their past demonstrations of meeting acceptance criteria.
However, based on the information provided, we can infer some details:
1. Table of Acceptance Criteria and Reported Device Performance:
Since new performance criteria are not explicitly stated for this submission, the "acceptance criteria" here refer to the standards that the predicate devices met, which are then carried over to the current device due to substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Inferred from Predicate Devices) | Reported Device Performance (Inherited from Predicate Devices) |
|---|---|---|
| Sterilization | Achieves a validated Sterility Assurance Level (SAL) of 1x10^-6 | Validated SAL of 1x10^-6 (No changes from predicate) |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic (No changes from predicate) |
| Biocompatibility | Meets established biocompatibility standards | Biocompatibility data remains the same as predicates (No changes from predicate) |
| Animal Testing | Acceptable in vivo performance in animal models (e.g., bone ingrowth, resorption) | Animal testing conducted for predicates is applicable (No new animal testing required) |
| Clinical Performance | Safe and effective for intended use (as demonstrated by predicates) | No new clinical performance data required due to substantial equivalence |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable for this submission as no new testing was conducted to establish acceptance criteria for K231942. The "test set" and corresponding sample sizes would have been part of the predicate device submissions (K221735 and K182074). The document states, "In vivo and in vitro testing of the subject device was conducted to demonstrate substantial equivalence of the subject device and remains the same as that submitted for the primary predicate device (K221735) and the secondary predicate device (K182074)."
- Data Provenance: Not specified for this submission, as it relies on previous submissions. It's not stated whether the original predicate studies were retrospective or prospective, or their country of origin.
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable as no new specific ground truth establishment for a test set was detailed for this submission.
4. Adjudication Method for the Test Set:
- Not applicable as no new specific test set and adjudication method were detailed for this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was NOT done. The device is a "Resorbable Calcium Salt Bone Void Filler Device," which is a physical implant, not an AI or imaging diagnostic device that would typically involve human reader studies.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance:
- No, a standalone performance study was NOT done. This is not an algorithmic or AI device.
7. Type of Ground Truth Used:
- Not explicitly defined for this submission in the context of a new test set. For the predicate devices, the "ground truth" for demonstrating performance would likely involve histopathology (for bone ingrowth and resorption in animal studies), material characterization data (for biocompatibility and physical properties), and microbiological testing (for sterility).
8. Sample Size for the Training Set:
- Not applicable as this is a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable as this is a physical medical device, not a machine learning model.
In summary, this 510(k) relies entirely on the demonstration of substantial equivalence to previously cleared predicate devices, asserting that the change (improved moldability) does not alter the fundamental performance as previously established. Therefore, no new primary studies to define and meet acceptance criteria were conducted or reported in this specific submission.
§ 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.