Search Results

EquivaBone is a bone graft substitute that combines synthetic calcium phosphate and demineralized bone. It is resorbed and replaced with new bone during the healing process. It is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral 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.

EquivaBone is a biocompatible bone graft substitute material consisting of Calcium Phosphate (CaP3), Carboxymethylcellulose (CMC) and Demineralized Bone Matrix (DBM). EquivaBone is supplied in a single use kit as sterile powders and hydration that are mixed together at the time of use in the operating room to form flowable putty which is implanted manually or can be extruded through a syringe. After implantation the product hardens at body temperature and remodels during the healing process.

The provided text describes a 510(k) premarket notification for a medical device called EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone). The primary purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device.

Regarding acceptance criteria and a study to prove the device meets these criteria, the document focuses on changes to the device's De-mineralized Bone Matrix (DBM) source and a new method for assessing osteoinductivity.

Here's a breakdown of the requested information based on the provided text:

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

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size for the test set used in the correlation study for osteoinductive potential or for the comparison of DBM sources.

The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is a correlation study comparing an in vitro assay (C2C12) to an in vivo assay (athymic rat implantation) to establish a new test method.

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

The document does not provide information on the number of experts or their qualifications for establishing ground truth. The "ground truth" for the osteoinductive potential correlation study appears to be the in vivo osteoinduction (OI) score of 1 from the athymic rat implantation model for the predicate device.

4. Adjudication method for the test set

The document does not describe any adjudication method.

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

No MRMC comparative effectiveness study was conducted or mentioned in the document. This device is a bone graft substitute, not an AI-assisted diagnostic tool.

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

This question is not applicable as the device is a bone graft substitute, not an algorithm.

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

For the osteoinductive potential, the ground truth was based on the in vivo osteoinduction (OI) score of 1 from the athymic rat implantation model for the predicate device. For DBM source equivalence, the ground truth appears to be the established chemical composition, physical properties, and performance characteristics of the DBM from the original source (AlloSource).

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of device performance or an algorithm. For the osteoinductive potential correlation study, the document describes a validation effort for a new assay method, but not a separate training set.

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

As there's no mention of a traditional "training set" in the context of a machine learning algorithm, this question is not directly applicable. The correlation study established a relationship between an in vitro assay and a previously accepted in vivo method, where the in vivo results define the benchmark for osteoinductivity.

Ask a specific question about this device

CarriGen Porous Bone Substitute Material is an injectable, self setting, macro-porous, osteo-conductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine), and the pelvis that are not intrinsic to the bony structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

CarriGen Porous Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. CarriGen PF is a mixing syringe pre-filled with the previously cleared CarriGen Porous Bone Substitute Material. The CarriGen PF system eliminates the need to transfer the CarriGen powder to the mixing syringe. After mixing, CarriGen is administered to the treatment site by manual application. The material can be shaped into a desired form in situ prior to implantation. After the putty is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. CarriGen Porous Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

This document describes a 510(k) premarket notification for CarriGen® PF, a resorbable calcium salt bone void filler device. The information provided demonstrates the device's substantial equivalence to predicate devices, but it does not contain the detailed information necessary to fully address all parts of your request regarding acceptance criteria and performance studies for an AI/ML medical device.

Specifically, this document does not describe:

• A table of acceptance criteria and reported device performance in the context of an AI/ML algorithm. The acceptance criteria mentioned are for the physical properties of a bone void filler.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for an AI/ML test set.
• MRMC or standalone studies for an AI/ML algorithm.

Therefore, I can only provide the information that is available in the document, which primarily pertains to the physical and chemical properties of the bone void filler, not an AI/ML device.

Here's an analysis of the provided text based on your request, highlighting what is present and what is missing:

Acceptance Criteria and Device Performance (Based on Device Type - Bone Void Filler)

The document primarily focuses on the physical and chemical performance characteristics of the CarriGen® PF bone void filler, not an AI/ML algorithm.

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

The document states that "The information summarized in the Design Control Activities Summary demonstrates that the CarriGen PF meets the pre-determined acceptance criteria for the verification activities." However, it does not provide a table with specific acceptance criteria values and corresponding reported performance values. It only lists the types of performance testing conducted:

2. Sample sizes used for the test set and the data provenance

• Sample Size for Test Set: Not specified in the provided text. The testing mentioned is for the physical and chemical properties of the material, not a data-driven AI test set.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable or not specified, as this is for material testing, not patient data for an AI/ML algorithm.

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

• Not applicable. This information is relevant for AI/ML performance studies involving human expert interpretations of data (e.g., medical images). The document describes testing of a physical medical device.

4. Adjudication method for the test set

• Not applicable. This information is relevant for AI/ML performance studies involving multiple human readers.

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 document describes a traditional medical device (bone void filler), not an AI/ML software.

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

• Not applicable. This document describes a traditional medical device (bone void filler), not an AI/ML software.

7. The type of ground truth used

• For material properties: The ground truth for the performance testing (e.g., working time, setting time, compression strength, biocompatibility, endotoxin levels) would be established by standardized testing methods and specifications (e.g., ASTM standards, ISO standards, USP monographs for biocompatibility and endotoxin). The "truth" is determined by the physical and chemical measurements aligning with the pre-defined acceptable ranges for these properties.
• For AI/ML: Not applicable in this document.

8. The sample size for the training set

• Not applicable. This document describes a traditional medical device (bone void filler), which does not have a "training set" in the context of an AI/ML algorithm. Its properties are inherent to its formulation and manufacturing process.

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

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

In summary, the provided FDA 510(k) clearance letter and summary describe the regulatory review of a physical medical device (a bone void filler). It details the device's indications for use, description, predicate devices, and the types of performance testing conducted to demonstrate substantial equivalence of its physical and chemical properties. It does not contain any information relevant to the development, testing, or performance of an artificial intelligence or machine learning-based medical device.

Ask a specific question about this device

CarriCell® is indicated for filling bone voids or defects of the sketal system (i.e., extremities and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. CarriCell® may be hydrated with saline or autologous blood prior to implantation. CarriCell® is a bone graft substitute that resorbs and is replaced with new bone during process.

CarriCell® Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of hydration solution to form a putty. No mixing is required. The putty can be administered to the treatment site by syringe or manual application. The material can be shaped into a desired form prior to implantation. After the putty is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a chemical and crystalline structure similar to that of natural bone minerals. CarriCell® Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a quantifiable table of acceptance criteria with specific numerical targets. Instead, it refers to a guidance document for Class II Special Controls and summarizes the findings.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set (In-vivo Study): The document mentions "an in-vivo study was performed as part of the assessment of the subject CarriCell® device" in a "femoral core defect model." It does not specify the sample size (number of animals or defects) used in this study.
• Data Provenance: The document states "an in-vivo study was performed." Animal studies are typically prospective in nature. The country of origin of the data is not specified, but given the FDA submission, it would likely be from studies conducted under US or internationally recognized guidelines.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• The document does not provide information on the number of experts, their qualifications, or how ground truth was established for the in-vivo study. It only states the "study concluded that CarriCell® material did perform as intended with proper osteointegration with host bone." This suggests an assessment by relevant scientific or medical professionals, but specifics are absent.

4. Adjudication Method for the Test Set

• The document does not specify any adjudication method for the in-vivo study. It simply states the study concluded with a positive finding regarding performance and osteointegration.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No, an MRMC comparative effectiveness study was not done. This document describes a submission for a bone graft substitute material, not an AI or imaging device. Therefore, the concepts of human readers, AI assistance, or effect sizes in that context are not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone algorithm performance study was not done. As mentioned above, this is for a bone graft substitute, not an AI or software device.

7. The Type of Ground Truth Used

• For the in-vivo study, the ground truth would have been established through histological analysis, radiographic imaging, and potentially biomechanical testing performed on the animal models. The conclusion of "proper osteointegration with host bone" implies such biological and structural evidence formed the basis of the assessment.

8. The Sample Size for the Training Set

• This question is not applicable as the device is a bone graft substitute material, not a machine learning or AI algorithm that requires a training set. The "testing" refers to non-clinical bench testing and in-vivo animal studies to demonstrate material properties and biological performance.

9. How the Ground Truth for the Training Set Was Established

• This question is not applicable for the same reason as point 8.

Ask a specific question about this device

The ETEX Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

The ETEX Mixing and Delivery System is comprised of a commercially available disposable medical piston syringe (syringe barrel with female luer, plunger). The ETEX Mixing and Delivery System is provided sterile, for single use only.

Here's a breakdown of the acceptance criteria and study information for the ETEX Mixing and Delivery System, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

• Sample Size for Test Set and Data Provenance: The document states that "All testing was performed on test units representative of finished devices." However, it does not specify the exact number of units tested for each criterion, nor does it provide information on data provenance (e.g., country of origin, retrospective/prospective).
• Number of Experts for Ground Truth and Qualifications: Not applicable. This device is a piston syringe, and the testing performed relates to its physical performance rather than diagnostic accuracy or human interpretation. Therefore, expert ground truth as typically defined for medical image analysis or similar tasks is not relevant here.
• Adjudication Method for Test Set: Not applicable. The tests performed are engineering performance tests, not studies requiring expert adjudication.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This type of study is typically conducted for diagnostic devices or AI systems where human reader performance is being evaluated, often with and without AI assistance. This device is a mechanical delivery system.
• Standalone (Algorithm Only) Performance Study: Not applicable. This device is a physical, mechanical system, not an algorithm.
• Type of Ground Truth Used: The "ground truth" for the tests performed would be defined by the pre-specified limits or requirements for each performance characteristic (e.g., a specific volume range for "Volume Verification," a minimum force for "Separation Force Testing," or absence of leaks for "Liquid Leak Testing"). These are engineering specifications.
• Sample Size for Training Set: Not applicable. This device is a physical product and does not involve machine learning or an "algorithm" in the sense that would require a training set.
• How Ground Truth for Training Set was Established: Not applicable, as no training set was used.

Ask a specific question about this device

Beta-bsm Injectable Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects 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. Beta-bsm Injectable Bone Substitute Material is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.

Gamma-bsm Moldable Bone Substitute Material is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects 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. Gamma-bsm Moldable Bone Substitute Material is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.

EquivaBone Osteoinductive Bone Graft Substitute is an implantable synthetic calcium phosphate bone graft material that forms a nano-crystalline matrix combined with demineralized bone matrix that resorbs and is replaced with new bone during the healing process. It is indicated for use in filling and/or augmentation of bone voids, gaps or defects 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. EquivaBone Osteoinductive Bone Graft Substitute is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include, but are not limited to, periodontal/infrabony defects; alveolar ridge augmentation (osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.

Beta-bsm Injectable Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a paste. Mixing is facilitated by a syringe-to-syringe mixing system. The resulting paste can be administered to the treatment site under direct visualization using the syringe or manual application. The material can be shaped into a desired form in-situ prior to implantation. After the paste is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. Beta-bsm Injectable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

Gamma-bsm Moldable Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a putty. The resulting putty is administered to the treatment site by manual application. The material can be shaped into a desired form in-situ prior to implantation. After the putty is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. Gamma-bsm Moldable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

EquivaBone is a biocompatible bone graft substitute material consisting of synthetic calcium phosphate, carboxymethyl cellulose (CMC) and human demineralized bone matrix (DBM). It is supplied in a single use kit as sterile powders and hydration solution that are mixed together at the time of use in the operating room to form flowable putty which is implanted manually or can be extruded through a syringe. After implantation the product hardens at body temperature and resorbs and remodels during the healing process. Each lot of DBM contained within EquivaBone is assayed for osteoinductive potential in an athymic nude mouse model. This may or may not be predictive of EquivaBone osteoinductivity in humans.

Here's an analysis of the provided text to extract the acceptance criteria and study information for the Beta-bsm, Gamma-bsm, and EquivaBone devices:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for these devices are primarily based on demonstrating substantial equivalence to predicate devices, especially regarding their intended use and technological characteristics. The performance data is assessed against the requirements outlined in the "Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005)."

The reported device performance, for all three devices (Beta-bsm, Gamma-bsm, and Equivabone), is that they are "safe and effective for its intended use and performs as well as the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

The documents state that non-clinical testing was performed "consistent with Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005)."

• Sample Size: The specific sample sizes for non-clinical tests (e.g., in-vitro, bench studies, animal studies) are not detailed in the provided summaries. The summaries only state that testing was performed according to the guidance.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that they are non-clinical studies for device clearance, they would typically involve studies conducted in a controlled lab environment.

For EquivaBone specifically: There's mention of DBM being "assayed for osteoinductive potential in an athymic nude mouse model." This indicates an animal model study was part of the non-clinical testing for this specific characteristic. The sample size for this mouse model is not provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

No information is provided regarding traditional "ground truth" establishment by experts in the context of diagnostic performance or clinical outcomes for these devices.

Since the submission is for a "Special 510(k) Submission - Alternate Hydration Solution" and relies on non-clinical testing and substantial equivalence, the "ground truth" is established by demonstrating that the modified device (with the alternate hydration solution) maintains the same performance characteristics as the predicate device and meets established material and biological safety standards. This is typically assessed by regulatory bodies (like the FDA) and their expert reviewers, rather than external clinical experts establishing a ground truth for a test set in the way one might for an AI diagnostic device.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical trial involving human subject adjudication of diagnostic findings. The regulatory review process involves evaluation of non-clinical data by regulatory scientists and engineers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study is not mentioned as it is not typically required for this type of device modification (alternate hydration solution) and regulatory pathway (Special 510(k) based on substantial equivalence and non-clinical data). The focus is on demonstrating that the new hydration solution does not negatively impact the established performance and safety of the device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. These are inert/resorbable bone graft substitute materials, not AI algorithms or diagnostic devices.

7. Type of Ground Truth Used

The "ground truth" in this context is implicitly "performance equivalence to the predicate device and adherence to recognized material and biological safety standards." This is established through non-clinical testing (e.g., material characterization, biocompatibility testing, mechanical properties, resorbability studies) as outlined by the "Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices."

For EquivaBone, an additional "ground truth" element for osteoinductivity is established via the athymic nude mouse model for each lot of DBM.

8. Sample Size for the Training Set

Not applicable. These are physical medical devices, not AI models that require training sets. The "training" for the device's development would involve R&D and engineering, but not in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of AI. The development process for these medical devices involves established engineering and scientific principles, quality systems, and regulatory guidelines to ensure safety and effectiveness.

Ask a specific question about this device