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NovaBone Putty - Bioactive Synthetic Bone Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine, and intervertebral disc space). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during process. When used in intervertebral disc space, NovaBone Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

NovaBone Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

NovaBone Putty - Bioactive Synthetic Bone Graft is an osteoconductive, bioactive, bone void filler device. It is composed of a calcium-phosphorus-sodium-silicate (Bioglass) particulate mixed with a synthetic binder that acts as a temporary binding agent for the particulate. The particulate and binder are provided premixed as a pliable cohesive material. On implantation, the binder is absorbed to permit tissue infiltration between the Bioglass particles. The particles then are slowly absorbed and replaced by new bone tissue during the healing process. The mixed device is supplied sterile and is provided in a PETG tray, disposable plastic syringe, or a prefilled cartridge delivery system (MIS delivery system).

The provided text is a 510(k) summary for the NovaBone Putty - Bioactive Synthetic Bone Graft. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for a new, innovative device that requires extensive clinical validation. Therefore, many of the requested elements for describing acceptance criteria and proving device performance through a study (such as specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods) are not explicitly detailed in this type of regulatory submission.

However, based on the information provided, here's what can be inferred and stated regarding the device's acceptance criteria and the "study" (or rather, the justification for substantial equivalence):

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

The document doesn't provide a table of precise quantitative acceptance criteria in the format typically seen for a new device's efficacy or safety trial. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices. The "reported device performance" is essentially the claim that the NovaBone Putty exhibits functional characteristics similar to the predicate devices and meets general safety and efficacy requirements for this class of device.

2. Sample sized used for the test set and the data provenance:

The document does not describe a "test set" in the context of a prospective clinical trial with a defined sample size for the current submission. Instead, it relies on:

• Prior functional animal model performance: This data provenance is mentioned to address differences in material composition. The specific sample size for this animal model is not provided.
• Previously cleared devices (K240404, K082672): Data for sterility, shelf-life, endotoxin, pyrogenicity, biocompatibility, and bench performance are leveraged from these reference devices. The original sample sizes for these tests are not provided in this summary.
• Prior posterolateral spine fusion studies: Mentioned to support performance in the intervertebral body space. No specific sample size or provenance for these studies is given.

Given this is a 510(k) submission, the data is likely a combination of pre-clinical (animal) data, bench testing, and potentially existing clinical data from predicate or reference devices, rather than a new, large-scale prospective clinical study specifically for this submission. The provenance (country of origin, retrospective/prospective) is not detailed for these underlying studies.

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

This information is not provided. Since no new clinical "test set" requiring expert ground truth establishment is described for this submission, these details are absent. The FDA's review process inherently involves experts, but not in the context of establishing ground truth for a discrete test set for the device's performance in this document.

4. Adjudication method for the test set:

Not applicable, as no described new clinical test set requiring adjudication is presented in this document.

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 NovaBone Putty is a medical implant (bone graft) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI assistance is irrelevant to this device.

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

Not applicable. The NovaBone Putty is a medical implant, not an algorithm.

7. The type of ground truth used:

For this 510(k) submission, the "ground truth" for the device's substantial equivalence is established by regulatory standards and existing data on the predicate devices. The safety and effectiveness claims are based on:

• Functional animal model performance data: This would typically involve histological analysis, biomechanical testing, and potentially imaging to assess bone regeneration.
• Previous characterization, bench performance, and biocompatibility studies: These tests follow recognized standards and guidance documents (e.g., ISO standards for biocompatibility (pathology), ASTM standards for material properties (bench data)).
• Clinical experience with predicate and reference devices: The FDA considers the established safety and efficacy profile of the legally marketed predicate device as part of the ground truth for substantial equivalence.

8. The sample size for the training set:

Not applicable. The NovaBone Putty is not an AI/machine learning device that requires a training set.

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

Not applicable, as there is no training set for this device.

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NovaBone Putty - Bioactive Synthetic Bone Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

NovaBone Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

NovaBone Putty is an osteoconductive, bioactive, bone void filler device. It is composed of a calcium-phosphorus-sodium-silicate (Bioglass) particulate mixed with a synthetic binder that acts as a temporary binding agent for the particulate. The particulate and binder are provided premixed as a pliable cohesive material. On implantation, the binder is absorbed to permit tissue infiltration between the Bioglass particles then are slowly absorbed and replaced by new bone tissue during the healing process. The mixed device is supplied sterile and is packaged in single-use containers in multiple formats.

The device modification of the current submission adds an attachable applicator tip to the NovaBone Putty pre-filled cartridge delivery system (MIS delivery system). The tip provides for more precise control of NovaBone Putty placement.

The provided text is a 510(k) summary for a medical device called "NovaBone Putty - Bioactive Synthetic Bone Graft." It outlines the device, its indications for use, technological characteristics, and a summary of performance testing.

However, the document explicitly states: "Human clinical testing was not conducted or relied upon for determining substantial equivalence for this premarket notification."

This means that the provided document does not contain any information about a study that proves the device meets specific acceptance criteria based on human performance data, clinical outcomes, or expert assessments. The clearance for this device was based on demonstrating substantial equivalence to a predicate device through non-clinical performance evaluations (cytotoxicity, bioburden, and bench tests for mechanical integrity).

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance based on the specific points you raised (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth). The information necessary to answer those questions is not present in the provided text.

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NovoGen Wound Matrix is indicated for the management of wounds including:
· Partial and full-thickness wounds

• Pressure ulcers
• Venous ulcers
• · Diabetic ulcers
• · Chronic vascular ulcers
• · Tunneled/undermined wounds
• · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
• · Trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears)
• · Draining wounds

NovoGen Wound Matrix is a an absorbable, non-pyrogenic, sterile, single use device intended for use in local management of cutaneous wounds. It is manufactured from bovine type I collagen and 45S5 bioactive glass. When hydrated with wound exudate or sterile water, this product transforms into a soft conforming layer which is naturally incorporated into the wound over time.

The provided text describes the NovoGen Wound Matrix, a medical device, and its substantial equivalence determination by the FDA. However, it does not contain a study that proves the device meets specific acceptance criteria in the way described in the prompt (e.g., performance metrics, sample sizes, expert adjudication, MRMC studies, or standalone algorithm performance).

Instead, it outlines the device's characteristics, its comparison to a predicate device, and a summary of non-clinical performance testing. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to a predicate device based on similar intended use, technological characteristics, and safety and performance testing.

Here's a breakdown of the information provided, formatted to address your request as much as possible, with explicit notes where the requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Since there are no explicitly stated numerical acceptance criteria or thresholds in the document, this table will reflect the types of performance tests conducted and their qualitative results as stated in the submission.

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

• Porcine Wound Healing Study: "A full thickness porcine wound healing study" - Sample size (number of animals or wounds) is not specified. Data provenance is animal study (porcine).
• Biocompatibility (ISO 10993-1): Sample size not specified. Provenance is in vitro and in vivo (e.g., animal tests for systemic toxicity, implantation).
• Human Repeat Insult Patch Test (HRIPT): "Based on the test population who completed the study" - Sample size (number of human subjects) is not specified. Provenance is prospective human study. Specific country of origin is not specified.

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

This type of information is not provided in the document. The studies performed (animal, biocompatibility, HRIPT) would typically involve trained personnel, but the specific number and qualifications of "experts" to establish a ground truth in the sense of clinical interpretation are not mentioned, as these are primarily laboratory and animal studies.

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

This information is not applicable/not provided. The studies described are not of a diagnostic nature requiring expert adjudication of results.

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

An MRMC study was not done. This device is a wound matrix, not an AI-assisted diagnostic tool for human readers.

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

This is not applicable. The device is a physical wound matrix, not an algorithm.

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

• Porcine Wound Healing Study: The "ground truth" for wound healing would be based on direct observation and measurement of wound closure, tissue regeneration, and potentially histopathology in the porcine model. It's compared to a predicate device and untreated controls for equivalence.
• Biocompatibility Studies: Ground truth is established by standardized laboratory test results against established safety thresholds (e.g., cell viability in cytotoxicity, immune response in sensitization, absence of fever in pyrogenicity).
• HRIPT: Ground truth is clinical observation of skin reactions (irritation/sensitization) in human subjects.

8. The sample size for the training set

This is not applicable as the device is not an AI/machine learning algorithm requiring a training set.

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

This is not applicable as the device is not an AI/machine learning algorithm.

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NovaBone IRM - Bioactive Synthetic Bone Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone IRM (Irrigation Resistant Matrix) is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

NovaBone IRM is an osteoconductive bioactive device used for grafting osseous defects. It is a premixed composite of bioactive calcium-phospho-silicate particulate and a synthetic, absorbable binder. The bioactive particulate is composed solely of elements that exist naturally in normal bone (Ca, P, Na, Si, O). The device requires no mixing or preparation prior to application. NovaBone IRM is supplied ready-to-use, to be applied directly to the intended graft site. The binder is then absorbed from the site such that only the bioactive particulate remains.

Upon absorption of the binder, the remaining particulate material undergoes a timedependent kinetic modification of the surface that occurs when implanted in living tissue. Specifically, a series of surface reactions results in the formation of a calcium phosphate layer on the particles that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect. Animal testing has demonstrated that the majority of the particulate material is absorbed within six months of implantation, with >98% of the material being absorbed by twelve months. The timeframe for full absorption in humans has not been determined, but is expected to be at least twelve months.

The provided document is a 510(k) premarket notification from the FDA regarding the NovaBone IRM device. It details the device's indications for use, technological characteristics, and a conclusion of substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of an AI/ML device.

The document describes a medical device (bone void filler) and its regulatory clearance process, not an AI/ML system. Therefore, most of the requested information about acceptance criteria for AI algorithms, test set sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details are not applicable to this document's content.

Here's how I would answer based on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance (as inferred from a non-AI context):

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (NovaBone Putty K112773). For a traditional medical device like NovaBone IRM, the "acceptance criteria" are implicitly met by demonstrating that it is as safe and effective as the predicate device.

The performance is primarily evaluated through:

• Biocompatibility: Supporting safety.
• Functional in vivo results: Demonstrating performance in a rabbit femoral defect model. This shows the device's ability to resorb and be replaced by bone during the healing process, and fill osseous defects.
• Technological Characteristics: Matching the composition and particle sizes to cleared devices.

Table of Acceptance Criteria and Reported Device Performance (as inferred for this specific device):

Responses to Specific Questions (Many are not applicable to this document as it's not an AI/ML device):

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

   • See the table above. The "acceptance criteria" are implicitly those necessary to demonstrate substantial equivalence to a predicate device, primarily focusing on safety and function as a bone void filler.

2. Sample sized used for the test set and the data provenance:

   • The document mentions "Animal testing" and "a rabbit femoral defect model." It does not specify the precise sample size (number of rabbits) or exact data provenance beyond being an animal model. There is no "test set" in the context of an AI/ML algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. This is not an AI/ML device requiring expert ground truth for image interpretation. The "ground truth" for this device's performance would be the biological outcome in the rabbit model (e.g., bone formation, material resorption), likely assessed by pathologists or researchers in the field, but the document does not detail this.

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

   • Not applicable. This is not an AI/ML device relying on diagnostic interpretations.

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 is a physical medical device, not an AI/ML system that assists human readers.

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

   • Not applicable. This is a physical medical device, not an algorithm.

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

   • For the animal study, the "ground truth" would be direct biological observation and analysis (e.g., histology, imaging) of the defect sites in the rabbits, which falls under "pathology" or "outcomes data" in a broad sense. The document states: "Animal testing has demonstrated that the majority of the particulate material is absorbed within six months of implantation, with >98% of the material being absorbed by twelve months." This is an outcome.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device; there is no "training set" in the AI sense.

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

   • Not applicable. As there's no AI training set, there's no ground truth establishment for it.

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NovaBone MacroFORM bone graft devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone MacroFORM is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. NovaBone MacroFORM must be hydrated with autogenous bone marrow prior to implantation. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

NovaBone MacroFORM is an osteoconductive bioactive device used for grafting osseous defects. It is a composite of bioactive calcium-phospho-silicate granules and a collagen binder. The bioactive particulate is composed solely of elements that exist in normal bone (Ca, P, Na, Si, O). The collagen binder consists of bovine collagen. When mixed with bone marrow aspirate, the device forms a non-hardening graft that is applied directly to the intended graft site.

During absorption of the collagen binder, the particulate material remaining undergoes a time-dependent kinetic modification of the surface to stimulate osteoblast activity and guide the formation of bone across the graft site. Specifically, a series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect. During healing, the graft particulate is absorbed and remodeled into new bone.

MacroFORM BIOACTIVE MIS is provided in an MIS Cartridge (tube) for delivery using the NovaBone MIS Cartridge Handle accessory, supplied separately. The graft formulation is identical to MacroFORM BIOACTIVE moldable composite (K140946, primary predicate). The MIS Cartridge/Handle system is equivalent to that of NovaBone Putty MIS (K112773, reference predicate).

This document is a 510(k) premarket notification for the NovaBone MacroFORM BIOACTIVE MIS, a resorbable calcium salt bone void filler device. The purpose of this notification is to establish substantial equivalence to legally marketed predicate devices, not to perform a new device study proving the device meets specific acceptance criteria in a clinical setting.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, as typically found in clinical trials or performance studies for AI/software devices, is not applicable to this regulatory submission.

This 510(k) submission primarily relies on demonstrating that the new device has "substantially equivalent" technological characteristics and intended use to existing predicate devices, and that it raises no new questions of safety or effectiveness.

Here’s a breakdown of why each requested point cannot be directly extracted from this document regarding a clinical performance study:

1. Table of acceptance criteria and the reported device performance:

• This document does not specify quantitative clinical acceptance criteria (e.g., bone healing rates, specific measures of defect fill) that the device would need to meet in a study. Its "performance" is assessed in terms of substantial equivalence to predicates.

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

• No clinical "test set" in the context of device performance is described. The document refers to a "hydration study" and "biocompatibility testing," which are engineering/materials tests, not clinical studies with patient data.

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

• Not applicable as there is no clinical test set or ground truth established by experts in this type of submission.

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

• Not applicable.

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:

• This device is a bone void filler, not an AI or imaging diagnostic device, so MRMC studies are not relevant.

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

• This is not an algorithm or AI device.

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

• Not applicable, as no clinical performance data requiring a ground truth determination is presented.

8. The sample size for the training set:

• Not applicable, as this is not an AI/ML device requiring a training set.

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

• Not applicable.

What the document does provide in terms of device validation and comparison:

The document focuses on demonstrating substantial equivalence through:

• Identical Indications for Use: The indications for use for NovaBone MacroFORM BIOACTIVE MIS are identical to its primary predicate, NovaBone MacroFORM BIOACTIVE moldable composite (K140946).
• Identical Graft Formulation: The device has the same bioactive component (Bioglass® 45S5) and bovine collagen source as the primary predicate.
• Biocompatibility Testing: Testing (cytotoxicity, genotoxicity, intracutaneous irritation) was performed and passed for the graft in its new cartridge packaging format, mitigating risks associated with the packaging change.
• Hydration Study: A study was conducted to determine optimal hydration fluid amounts and setting times for the graft in the MIS Cartridge, leading to updated instructions for use.
• Accessory Handle Equivalence: The accessory handle is identical to that of a reference predicate (NovaBone Putty MIS, K112773), with only packaging graphics changed.
• Sterilization: The device is supplied sterile (SAL 10^-6) using irradiation, similar to predicates.

In summary, this 510(k) notification is a premarket submission demonstrating equivalence to existing devices, not a clinical study proving device performance against specific clinical acceptance criteria.

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Dental Collagen Wound Dressings (NovaTape and NovaPlug) are intended for the management of oral wounds and sores, including:

• · Denture sores
• · Oral Ulcers (non-infected or viral)
• · Periodontal surgical wounds
• · Suture sites
• · Burns
• · Extraction sites
• · Surgical wounds
• Traumatic wounds

Dental Collagen Wound Dressings are soft, white to off-white, resorbable collagen dressings produced from cross-linked, purified collagen derived from bovine hide. The thickness and pore structure of the device allow it to absorb fluids and blood at the defect site. Dental Collagen Wound Dressings are supplied sterile, non-pyrogenic, and are for single use only.

This document is a 510(k) summary for NovaBone Products, LLC's Dental Collagen Wound Dressing (NovaTape and NovaPlug), seeking substantial equivalence to a legally marketed predicate device. The information provided is for regulatory clearance and focuses on demonstrating equivalence, rather than establishing new performance criteria for a novel device. As such, the structure of the provided text does not directly align with a typical acceptance criteria study for a novel device.

However, based on the provided text, I can extract and infer information to address your request in the context of demonstrating substantial equivalence to a predicate device.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k), the "acceptance criteria" is essentially demonstrating equivalence to the predicate device in key areas. The "reported device performance" refers to how NovaTape/NovaPlug compares to the predicate.

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

The primary "test set" for performance equivalence was an animal study:

• Sample Size: The document does not explicitly state the number of animals (minipigs) used in the study. It refers to a "porcine (minipig) model."
• Data Provenance: The study was an animal study (in vivo) conducted in compliance with GLP regulation (21 CFR Part 58). The country of origin is not specified, but GLP compliance implies a controlled, prospective study environment.

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

• The document does not mention the use of human experts to establish ground truth in the context of an animal study for performance assessment. The "ground truth" for the animal study was based on histological findings and observations of local reaction and material absorption, likely assessed by veterinary pathologists or similar specialists. However, their specific number or detailed qualifications are not provided.

4. Adjudication Method for the Test Set

• Again, as the study is an animal performance study focused on histological and observational comparison, a human-reader adjudication method (like 2+1, 3+1) is not typically applicable or described here. The evaluation of histological findings would be performed by trained professionals following established pathology protocols.

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, an MRMC comparative effectiveness study was not done. This device is a physical wound dressing, not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

• Not applicable. As stated above, this is a physical medical device (wound dressing), not an algorithm or AI.

7. The Type of Ground Truth Used

• For the animal performance study: The ground truth was established through histological findings and direct observation of local tissue reaction and material absorption in the minipig model. This is a form of biological/pathological ground truth.
• For biocompatibility: Ground truth was established through standardized in vitro and in vivo biocompatibility tests in accordance with ISO 10993.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/machine learning model, so there is no "training set." The development of the device would involve materials science and engineering principles, not data training.

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

• Not applicable. (See point 8).

In summary, this 510(k) emphasizes demonstrating that the NovaTape/NovaPlug device is substantially equivalent to a predicate device, focusing on a robust comparison of materials, intended use, and performance in an animal model and biocompatibility testing, rather than establishing novel performance criteria with human subject data.

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NovaBone Bioactive Strip bone graft devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Bioactive Strip is indicated to be gently placed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NovaBone Bioactive Strip must be hydrated with autogenous bone marrow aspirate prior to implantation. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

NovaBone BIOACTIVE Strip is an osteoconductive bioactive device used for grafting osseous defects. The device is a mixture of bioactive calcium-phosphosilicate granules and a collagen binder. The bioactive glass particulate is composed solely of elements that exist in normal bone (Ca, P, Na, Si, O). The binder consists of bovine collagen. When hydrated with bone marrow aspirate, the device absorbs fluids to form a flexible graft matrix that is applied directly to the intended graft site. During healing, the graft particulate is absorbed and remodeled into new bone.

BIOACTIVE Strips are flexible after hydration and are not intended to be loadbearing. Therefore, bulk physical /mechanical properties such as compressive and tensile strengths are not applicable to device properties. The device is sterilized to a sterility assurance level of 100 using ethylene oxide.

I am sorry, but the provided text only refers to a medical device's 510(k) premarket notification and its substantial equivalence to predicate devices, focusing on regulatory aspects, material composition, and intended use. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment as would be relevant for an AI/ML powered device. Therefore, I cannot fulfill your request to describe those details based on the given document.

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NovaBone MacroFORM bone graft devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone MacroFORM is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NovaBone MacroFORM must be hydrated with autogenous bone marrow prior to implantation. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

NovaBone MacroFORM is an osteoconductive bioactive device used for grafting osseous defects. It is a composite of bioactive calcium-phospho-silicate granules and a collagen binder. The bioactive particulate is composed solely of elements that exist in normal bone (Ca, P, Na, Si, O). The collagen binder consists of bovine collagen. When mixed with bone marrow aspirate, the device forms a non-hardening graft that is applied directly to the intended graft site. The device is slowly absorbed during graft site healing.

During absorption of the collagen binder, the particulate material remaining undergoes a time-dependent kinetic modification of the surface to stimulate osteoblast activity and guide the formation of bone across the graft site. Specifically, a series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect. During healing, the graft particulate is absorbed and remodeled into new bone.

MacroFORM is provided in three basic forms: loose granules, a composite plug and a composite block.

The provided document is a 510(k) summary for the NovaBone MacroFORM BIOACTIVE bone graft devices. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices based on technological characteristics and performance.

However, the document does not contain the kind of information typically found in studies designed to establish specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) or to quantify improvement with an AI system. This document is a regulatory submission focused on demonstrating substantial equivalence, not on detailed performance analysis against a set of quantitative acceptance criteria in the way you've framed the request.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them in the way you've outlined, according to the provided text. The information required for points 1-9 (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study details, standalone performance, type of ground truth, training set sample size, how training ground truth was established) is absent from this regulatory document.

Summary of what can be gleaned from the document regarding performance:

• Device Performance Claim: The document states that "Functional in vivo testing in an animal model (rabbit tibia defect) was performed on MacroFORM using the primary predicate (K090731, NovaBone Porous) as a control. The results demonstrate that bone remodeling process for MacroFORM is equivalent to that of NovaBone Porous."
• Acceptance Criteria (Implicit): The implicit acceptance criterion appears to be "equivalence" in bone remodeling to the predicate device (NovaBone Porous) in the specified animal model. No specific quantitative metrics (e.g., percentage of bone fill, density, etc.) are provided as acceptance thresholds.
• Study Details:
  • Type of Study: Functional in vivo testing in an animal model.
  • Model: Rabbit tibia defect.
  • Comparison: MacroFORM was compared to the primary predicate, NovaBone Porous (K090731), as a control.
  • Ground Truth: The "bone remodeling process" was assessed, but the method of assessment (e.g., histology, imaging, quantitative measures) and how ground truth was established are not detailed.
  • Sample Size: Not specified for the animal study.
  • Training Set/AI Specifics: Not applicable as this is not an AI/software device.
  • Adjudication/Experts/MRMC: Not applicable.

In conclusion, while the document confirms a study was done for in vivo performance and biocompatibility to support substantial equivalence, it does not provide the granular details relevant to an AI/diagnostic device's acceptance criteria and validation study as requested.

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The intended use of NovaBone Dental Morsels is to provide a safe, biocompatible synthetic bone graft material for use in oral, dental intraosseous, and maxillofacial bone defects. It is used in a manner comparable to autogenous bone graft chips or allograft bone particulate (Demineralized Freeze Dried Bone). Typical uses include:

• · Periodontal / infrabony defects
• · Ridge augmentation (sinusotomy, osteotomy, cystectomy)
• (ridge maintenance/augmentation, sites implant preparation/ · Extraction placement)
• · Sinus lifts
• · Cystic cavities
• · Oral and maxillofacial augmentation

NovaBone Dental Morsels is an osteoconductive, bioactive, bone void filler device. The device is intended for dental intraosseous, oral, and maxillofacial bony defects. It is a one-component, resorbable bone void filler composed of a synthetic calcium phospho-silicate (Bioglass) particulate, fused into a bulk porous form having a multidirectional interconnected porosity. The device is supplied sterile, packaged in a disposable PET-G tray with heat-sealed lid. On implantation, NovaBone Dental Morsels undergoes a time-dependent surface modification, resulting in the formation of a calcium phosphate layer on the device surfaces. The device acts as a scaffold, with new bone infiltrating the porous structure. NovaBone Dental Morsels is progressively resorbed and replaced by new bone tissue during the healing process.

The provided document is a 510(k) summary for the NovaBone Dental Morsels – Bioactive Synthetic Bone Graft, which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance acceptance criteria and a study to prove meeting those criteria in the way a clinical study for a diagnostic algorithm might.

Here's an analysis based on the information provided, highlighting what's present and what is not typically part of this type of submission:

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

This type of table, common for outlining quantitative performance metrics of a device against pre-defined thresholds, is not present for the NovaBone Dental Morsels in the provided document. The submission focuses on a comparative analysis with predicate devices to establish substantial equivalence.

Instead, the document provides a "Substantial Equivalence Comparison" (Table 3.1) of the new device (NovaBone Dental Morsels) to two predicate devices (PerioGlas and NovaBone Porous) across various characteristics:

The acceptance criteria are implicitly that the NovaBone Dental Morsels are substantially equivalent to the predicate devices in terms of these characteristics. The reported device performance is described within each row of Table 3.1.

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

The document mentions "in vivo bone void testing" and "Additional supporting in vitro data were supplied." However, it does not specify the sample size, country of origin, or whether the in vivo study was retrospective or prospective. The focus is on demonstrating similar behavior to existing devices rather than a detailed clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The "in vivo bone void testing" would likely involve histological analysis by pathologists, but details on the number and qualifications of experts involved in establishing ground truth are absent.

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

This information is 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

This type of study is not applicable to this device. The NovaBone Dental Morsels is a bone graft material, not an AI-powered diagnostic device. Therefore, there are no "human readers" in the context of interpretation of images with or without AI assistance.

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

This is not applicable as the device is a physical bone graft material, not a standalone algorithm.

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

The "in vivo bone void testing" suggests that histological analysis (a form of pathology) would be used to assess new bone formation, material resorption, and tissue infiltration. The document states: "In vivo study data were presented supporting the osteoconductive nature of the device demonstrating new bone formation at early post-implantation periods, with no evidence of local or systemic adverse effects related to the device observed." This indicates a pathology-based ground truth for the in-vivo study.

8. The sample size for the training set

This information is not applicable as there is no "training set" in the context of this type of device submission. The device is not an AI/ML algorithm.

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

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

In summary:

The provided document is a 510(k) summary demonstrating substantial equivalence for a medical device (bone graft material). It outlines the device's characteristics and compares them to predicate devices. It briefly mentions "in vivo bone void testing" and "biocompatibility results" (ISO 10993) to support its safety and effectiveness, implying a pathology-based ground truth for the in-vivo studies. However, it does not contain the detailed performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods typically required for AI/ML or diagnostic device submissions. The "acceptance criteria" here are fundamentally met by demonstrating substantial equivalence to already marketed devices.

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NovaBone Putty - Bioactive Synthetic Bone Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

NovaBone Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

NovaBone Putty is an osteoconductive, bioactive, bone void filler device. It is composed of a calcium-phosphorus-sodium-silicate (Bioglass) particulate mixed with a synthetic binder that acts as a temporary binding agent for the particulate. The particulate and binder are provided premixed as a pliable cohesive material. On implantation, the binder is absorbed to permit tissue infiltration between the Bioglass particles. The particles then are slowly absorbed and replaced by new bone tissue during the healing process. The mixed device is supplied sterile and is packaged in single-use containers in multiple formats.

The device modification of the current submission packages the device in prefilled cartridges that are interchangeably attached to a dispensing handle. The length of the cartridges provides direct access application of the Putty to more remote defect sites.

This document is a 510(k) premarket notification for a modification to an existing medical device, NovaBone Putty. The modification specifically concerns the packaging (new pre-filled cartridges and dispensing handle) and not the material composition or intended use of the bone graft itself.

Therefore, the document does not contain information typically found in a study proving a device meets acceptance criteria related to its clinical efficacy or diagnostic performance. Instead, it demonstrates substantial equivalence to a predicate device based on material composition, intended use, and technological characteristics.

Here's an breakdown based on the provided text, addressing your questions where possible and indicating when the information is not present:

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

This document does not describe specific acceptance criteria and device performance metrics in the way one would for a new clinical or diagnostic device. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to a predicate device, which primarily relies on regulatory standards and comparison of attributes.

The core "performance" demonstrated is that the device modification (packaging) does not alter the fundamental characteristics or safety/effectiveness of the bone graft material itself.

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

• Sample Size: Not applicable. This submission is for a packaging modification, not a clinical study involving a "test set" of patients or data in the typical sense. The document refers to "animal testing" for absorption but does not provide sample sizes or explicit details of the study for this specific submission; it refers to properties of the existing material.
• Data Provenance: Not applicable for a "test set" in this context. The "animal testing" referenced appears to be from previous submissions/data for the original material, not new data generated for this specific packaging modification.

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

Not applicable. No "ground truth" was established by experts for a clinical "test set" within this submission. The FDA's review process involves their own experts assessing the substantial equivalence.

4. Adjudication method for the test set

Not applicable. No "test set" or adjudication method 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. This is not an AI-based device or a diagnostic device that would undergo an MRMC study.

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

Not applicable. This is not an AI algorithm.

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

Not applicable. No ground truth in the clinical study sense. The "truth" for this submission is established through comparison to the predicate device and demonstration that the modification does not change material properties or intended use, evaluated against regulatory standards.

8. The sample size for the training set

Not applicable. No training set as this is not an AI device or a device requiring a new clinical trial.

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

Not applicable. No training set.

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