(203 days)
MBCP™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. MBCP™ can be used with autograft as a bone graft extender. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
MBCP™ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.
When packed into a bony site, MBCP™ gradually resorbs and is replaced with bone during the healing process.
in addition, when used with appropriate opening osteotomy system devices, plates and screws, MBCP™ is intended to be used as a bone void filler in femoral or tibial osteotomies.
MBCP™ is to be used in association with adequate post-operative immobilization.
MBCP™ is a bone graft substitute. MBCP™ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hydroxyapatite (HA) and 40% beta-Tricalcium Phosphate (ß-TCP). MBCP™ is available in various shapes and sizes.
MBCP™ granules are packaged in vials or syringes.
MBCP™ may be used with physiological saline, patient's own serum, whole blood, or bone marrow aspirate (BMA).
MBCP™ is provided sterile for single patient use.
This document is a 510(k) Summary of Safety and Effectiveness for the MBCP™ device. It establishes the device's substantial equivalence to previously cleared devices rather than demonstrating meeting specific acceptance criteria through a new study. Therefore, the information requested regarding a new study showing the device meets acceptance criteria is largely not applicable in this context.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance
This document does not present acceptance criteria and device performance in a tabular format as it's a submission for substantial equivalence, not a report on a new study with specific performance metrics against pre-defined criteria. The primary "acceptance criterion" in a 510(k) is demonstrating substantial equivalence to a predicate device.
The document states:
- "The intended use and material composition of MBCP™ Bone Graft Substitute is the same as previously cleared MBCP™ (K032268, K043005)."
- "MBCP™ Bone Graft Substitute and the predicate devices are substantially equivalent in design, materials of construction and function."
- "The safety and effectiveness of MBCP™ Bone Graft Substitute as modified in this submission is adequately supported by the substantial equivalence information, safety and performance data provided within this Premarket Notification."
2. Sample size used for the test set and the data provenance
- Not Applicable. This document does not describe a new clinical or performance study with a test set. It relies on the substantial equivalence to previously cleared devices (K032268, K043005) and "safety and performance data provided within this Premarket Notification," which typically refers to bench testing, biocompatibility, and information establishing similarity to predicates, rather than a prospective study with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As no new human subject test set is described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No test set with expert adjudication is described.
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
- Not Applicable. The device is a bone graft substitute, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance metrics are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. The device is not an algorithm or software; it's a physical resorbable calcium salt bone void filler.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For a substantial equivalence claim for a bone graft substitute, the "ground truth" relates to the established safety and effectiveness of the predicate devices based on their prior clearances, preclinical data (biocompatibility, resorption characteristics), and potentially historical clinical use data (though not detailed here for a new study).
8. The sample size for the training set
- Not Applicable. As no machine learning or AI algorithm is involved, there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. No training set is involved.
Summary based on the document:
This 510(k) submission for MBCP™ relies on the principle of substantial equivalence to previously cleared predicate devices (K032268, K043005). The "study" proving the device meets acceptance criteria (in the context of a 510(k)) is the comparison of the new MBCP™ to these predicates, demonstrating that the design, materials, function, and intended use are the same. No new clinical efficacy studies with specific performance metrics against novel acceptance criteria are described in this summary. The safety and effectiveness are "adequately supported by the substantial equivalence information, safety and performance data provided within this Premarket Notification" – this data would typically include bench testing, biocompatibility studies, and a comparison demonstrating sameness to the predicates, rather than a new clinical human study with a test/training set, expert ground truth, or MRMC evaluation.
§ 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.