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MBCP+™ is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region.

These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

MBCP+™ can be used with autogenous bone grafting materials.

Typical uses include:

• Periodontal/Infrabony defects
• Ridge augmentation
• Extraction sites (implant preparation/placement)
• Sinus lifts
• Cystic cavities

MBCP+™ is a bone graft material used in dental applications. The MBCP+™ product consists of a biphasic ceramic (e.g hydroxyapatite and tricalcium phosphate beta). MBCP+™ dental product is a synthetic device, available in different sizes of granules. MBCP+™ product is available sterile for single use.

This document is a 510(k) premarket notification for a bone grafting material, MBCP+™. It establishes substantial equivalence to previously marketed devices and does not contain information about acceptance criteria or a study proving the device meets said criteria.

The document primarily focuses on:

• Device identification: Product name (MBCP+™), classification, product code, and relevant regulations.
• Intended use: Description of dental applications for which MBCP+™ is intended.
• Comparison to predicate devices: Stating that it has the same intended use, principle of operation, and similar technological characteristics to listed predicate devices (OsSatura™, Cerasorb™ Dental, MBCP™).
• Non-clinical performance data: Mentioning that testing was performed according to the "Guidance Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices" to support substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies demonstrating that the device meets them, as this specific document does not contain that level of detail. It simply states that non-clinical performance data supports substantial equivalence based on regulatory guidance for dental bone grafting materials. There are no performance metrics, sample sizes, ground truth information, or multi-reader studies described in this filing.

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TRIBONE 80™ 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. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

TRIBONE 80™ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.

When packed into a bony site, TRIBONE 80™ gradually resorbs and is replaced with bone during the healing process.

TRIBONE 80™ is to be used in association with adequate post-operative immobilization.

TRIBONE 80™ is provided sterile for single patient use.

TRIBONE 80™ is a bone graft substitute. TRIBONE 80™ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 20% Hydroxyapatite (HA) and 80% beta-Tricalcium Phosphate (ß-TCP). TRIBONE 80™ is available in granules, sticks and blocks. TRIBONE 80™ may be used with physiological saline, patient's own serum, whole blood, or bone marrow aspirate (BMA). TRIBONE 80™ can also be mixed with autograft. TRIBONE 80™ is provided sterile for single patient use.

This document is a 510(k) summary for TRIBONE 80™, a resorbable bone substitute. It details the device's identification, predicate devices, description, and intended use, as well as the substantial equivalence information. The document does not contain specific information regarding acceptance criteria, a study that proves the device meets those criteria, or details of algorithm performance (as it is a bone substitute, not an AI/software device).

Therefore, I cannot provide the requested information for acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details like MRMC or standalone performance, as this type of information is not present in the provided text for a medical device that is a physical bone substitute.

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MBCP* ™ is intended for use as 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. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
MBCP+TM is provided sterile for single patient use.

MBCP+™ is a non structural bone graft substitute, which is resorbable and able to be replaced by newly-formed bone. The MBCP+™ is a ceramic constituted of two-phase of calcium phosphate 20 % hydroxyapatite and 80 % tricalcium phosphate beta. MBCP+™ is presented in a porous form.
There are two types of porosity in MBCP+TM:
The microporosity (pores smaller than 5μm) is constituted by all the spaces between the ceramic. The microporosity allows the biological fluids to circulate.
The macroporosity (pores diameters bigger than 100µm) provides a porous scaffold upon which bone formation can occur at the expense of the ceramic.

The provided document for K063527 does not contain the detailed acceptance criteria and study information typically associated with AI/ML device evaluations. This submission pertains to a resorbable bone substitute (MBCP+™), which is a medical device and not an AI/ML diagnostic or therapeutic system.

Therefore, the requested information regarding acceptance criteria, performance metrics (like sensitivity, specificity, AUC), sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable to this 510(k) submission.

The submission focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Indications for use: MBCP+™ is intended for use as bone void filler for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure.
• Anatomic sites: Extremities, spine, and pelvis.
• Design: Porous ceramic with microporosity (pores smaller than 5µm for fluid circulation) and macroporosity (pores bigger than 100µm for bone formation).
• Material: Two-phase calcium phosphate (20% hydroxyapatite and 80% tricalcium phosphate beta).
• Function: Resorbable bone substitute replaced by newly-formed bone.

The "acceptance criteria" for this type of device in a 510(k) context are essentially the successful demonstration of substantial equivalence to a legally marketed predicate device, as confirmed by the FDA's clearance letter. This typically involves showing that the new device is as safe and effective as the predicate, often through material characterization, biocompatibility testing, and functional comparisons, rather than AI-specific performance metrics.

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MBCP Gel™ is intended for use as a bone grafting material to fill, augment or reconstruct osseous bone defects in particular in periodontal or oral/maxillofacial applications.

These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

MBCP Gel™ can generally be used for bone filling in closed cavities.

MBCP Gel™ can be used with autogenous bone grafting materials.

Typical uses include but are not limited to:

• . Periodontal/Infrabony defects
• Ridge augmentation .
• Extraction sites (implant preparation/placement) .
• . Sinus lifts
• Cystic cavities .

MBCP Gel™ is a Resorbable Bone Graft Substitute that is rapidly replaced by newly-formed bone. This material is a non self setting gel providing mechanical resistance after healing and osseous rehabilitation.

MBCP Gel™ is composed of biphasic Calcium Phosphate (60% Hydroxyapatite (HA) and 40% beta-Tricalcium Phosphate (beta-TCP)) particles associated with an excipient with pharmaceutical grade quality (hydroxypropylmethylcellulose in an aqueous solution). The carrier acts as a spacer and a binder of the particles. MBCP Gel™ provides an environment for bone ingrowth. On time MBCP Gel™ is fully resorbable.

MBCP Gel™ is provided sterile for single patient use in a syringe.

This document is a 510(k) Summary of Safety and Effectiveness for the MBCP Gel™ device. It outlines the general information, predicate devices, device description, and intended use. However, it does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement as requested.

Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria, as this information is not present in the provided text.

The document primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting detailed performance study results against specific criteria.

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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.

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MBCP™ is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.

These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

MBCP™ can be used with autogenous bone grafting materials.

Typical uses include:

• Periodontal/Infrabony defects .
• Ridge augmentation .
• Extraction sites (implant preparation/placement) .
• Sinus lifts .
• Cystic cavities .

MBCP™ is a Resorbable Bone Graft Substitute.

MBCP™ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of Hydroxyapatite (HA) and beta-Tricalcium Phosphate (ß-TCP).

MBCP™ presents a multidirectional interconnected porosity structure, similar to that of human cancellous bone.

MBCP™ is presented in a porous form required for the biological exchanges particularly for bone ingrowth and mineralization.

The balance of a stable component (HA) and a more bioactive component (B-TCP) allied to the porosity involves the controlled process of ceramic resorption and bone substitution.

When packed into the bony site, MBCP™ gradually resobs and is replaced with bone during the healing process.

This document is a 510(k) Summary of Safety and Effectiveness for the MBCPTM device, a resorbable calcium salt bone void filler. It describes the device, its intended use, and its substantial equivalence to previously cleared devices. However, the provided text does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo performance studies with pre-defined acceptance criteria for every new submission. In this case, the document states: "The safety and effectiveness of MBCP™ Resorbable Bone Graft Substitute for Dental Bone Grafting is adequately supported by the substantial equivalence information as well as biocompatibility testing, safety and performance data provided within this Premarket Notification." This implies that the 'study' referred to is likely a combination of literature review, in vitro tests (biocompatibility), and possibly a verification of physical/chemical properties that align with the predicate device, rather than a clinical trial with specific performance metrics and acceptance thresholds.

Given the information provided, I cannot populate the table or answer the questions related to specific acceptance criteria, study design, sample sizes, expert involvement, or comparative effectiveness studies. The document emphasizes substantial equivalence based on material composition and intended use.

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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™ 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.

The provided 510(k) summary for MBCP™ (K043005) does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics.

Instead, this submission is a Premarket Notification (510(k)) which focuses on demonstrating substantial equivalence to a predicate device, rather than performing clinical trials to establish device performance against predefined acceptance criteria. The document explicitly states:

"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." (Page 2)

And also, regarding predicate devices:

"The intended use and material composition of MBCP™ Bone Graft Substitute is the same as previously cleared MBCP™ (K032268). MBCP™ Bone Graft Substitute and the predicate devices are substantially equivalent in design, materials of construction and function." (Page 2)

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for proving device performance against specific metrics is not available in this document. The focus of a 510(k) is to show that the new device is as safe and effective as another legally marketed device, not to prove novel performance through a new clinical study with acceptance criteria.

However, based on the provided text, I can infer some points related to the equivalence claim:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria for 510(k) (Inferred): Substantial equivalence in intended use, material composition, design, materials of construction, and function to the predicate device (K032268).
   • Reported Device Performance: The document claims the device "is adequately supported by the substantial equivalence information, safety and performance data provided within this Premarket Notification." (Page 2). Specific quantitative performance metrics (e.g., bone growth rate, resorption rate) that would typically be evaluated against acceptance criteria are not detailed as part of a new study in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable / Not provided. The document does not describe a clinical study with a "test set" in the context of new device performance assessment. The "data" refers to the information supporting substantial equivalence, likely from existing data on the predicate device or bench/animal testing if new non-clinical data was submitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable / Not provided. Ground truth establishment for a test set of data is not described as part of this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable / Not provided.

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. This device is a bone void filler, not an AI-assisted diagnostic or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a bone void filler, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable directly to a new performance study. For a 510(k), the "ground truth" for demonstrating equivalence would be the established safety and effectiveness profile of the predicate device (K032268), which would have been based on clinical data, material testing, and other evidence at the time of its clearance.

8. The sample size for the training set:

   • Not applicable / Not provided. No training set for an algorithm is mentioned.

9. How the ground truth for the training set was established:

   • Not applicable / Not provided.

In summary: This 510(k) submission for MBCP™ is a substantial equivalence submission. It does not present a new study with explicit acceptance criteria for device performance. Instead, it leverages the established safety and effectiveness of a predicate device (K032268) to demonstrate that the current device is equally safe and effective.

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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.

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.

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