(141 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 structures. 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.
MBCP™ is a bone graft substitute. MBCP™ is a microporous and macroporous biphasic calcium phosphate bone graft substitute consisting of 60% hydroxyapatite (HA) and 40% beta tricalcium phosphate (β-TCP). MBCP™ is available in granules or blocks. MBCP™ is provided sterile for single patient use. MBCP™ presents a multidirectional interconnected porosity structure, similar to that of human cancellous bone. MBCP™ implant slowly resorbs during the remodeling and bone defect repair process and is progressively replaced by bone. The progressive resorption of the filler is intended to prevent premature resorption.
The provided text is a 510(k) Summary for a medical device called MBCP™, a resorbable calcium salt bone void filler. This document describes the device, its intended use, safety information, and a summary of its safety and effectiveness.
Here's an analysis of the provided text to fulfill your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable format with target values. Instead, it focuses on demonstrating safety and effectiveness through conformance to standards, biocompatibility, and evidence of osseous rehabilitation.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| P-1: Chemical Safety | |
| Conformance to recognized consensus standard for ceramic hydroxylapatite. | MBCP™ conforms to ASTM F1185, meeting required specifications for heavy metals and trace elements. |
| P-2: Biocompatibility | |
| Non-toxic, non-allergenic, biocompatible, no inflammation, no adverse effects/foreign body reactions. | Biocompatibility of HA, β-TCP, and the mixture (MBCP™) is well-documented. Proven to be non-toxic, non-allergenic, biocompatible, and elicits no inflammation. No adverse effect or foreign body reactions reported. |
| P-3: Osseous Rehabilitation (Bone Ingrowth) | |
| Evidence of bone ingrowth and eventual transformation/remodeling into new bone. | After 6 weeks, bone ingrowth appeared essentially in the cortical part of the implant, invading all macropores. After 12 weeks, the implant was transformed into new cortical bone, and bone remodeling was observed (in dogs). |
| P-4: Substantial Equivalence | |
| Similar material characteristics and same intended use as predicate devices. | The device is substantially equivalent based on similar material characteristics and the same intended use. Animal studies and clinical data support its safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions a study on "canines of dogs [1]" (likely a typo and meant “canines” or “dogs”) for osseous rehabilitation. However, a specific numerical sample size for this study is not provided.
- Data Provenance: The osseous rehabilitation study was conducted on "dogs," indicating an animal study. The country of origin for the data is not specified. The study type is prospective in nature, as it tracks bone ingrowth and remodeling over a set period (6 and 12 weeks).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications for establishing ground truth for the osseous rehabilitation study. It only states that "Radiological, histological and analytical techniques were used to evaluate the bone ingrowth."
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for evaluating the results of the osseous rehabilitation study. Results appear to be based on direct observation and analysis using the stated techniques.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or reported in this 510(k) summary. The document does not mention any studies involving human readers, AI assistance, or effect sizes related to human performance improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No standalone (algorithm-only) performance was done. This device is a bone graft substitute, not an AI or software algorithm. Therefore, "algorithm only" performance is not applicable.
7. The Type of Ground Truth Used
- For the osseous rehabilitation study, the ground truth was established through direct scientific observation and analysis using:
- Radiological techniques
- Histological techniques (examining tissue microstructures)
- Analytical techniques (likely biochemical or biomechanical assessments)
- This is a form of experimental evidence and pathological assessment (histology).
8. The Sample Size for the Training Set
- This device is not an AI/ML algorithm; thus, the concept of a "training set" in the context of an algorithm does not apply. The document does not mention any training sets for either human readers or algorithms.
9. How the Ground Truth for the Training Set Was Established
- As the concept of a "training set" for an algorithm is not applicable, the method of establishing ground truth for a training set is also not relevant to this document.
§ 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.