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GRAFTON® II eDBM is intended for use as a bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis and extremities) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. GRAFTON®II eDBM is resorbed/ remodeled and is replaced by host bone during the healing process.

GRAFTON®II eDBM is a human bone allograft product containing human demineralized bone matrix (DBM) and surface demineralized cortical bone chips sealed in an absorbable mesh pouch for intraoperative handling. It is intended for use in filling bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. GRAFTON®II eDBM is provided ready-to-use in various package sizes by volume or dimension and is intended for single patient use.

GRAFTON®II eDBM is a demineralized bone product that is osteoconductive as well as osteoinductive in an athymic rat assay. It is prepared via a proprietary processing method of Osteotech, Inc. that has been shown to consistently produce DBM that is osteoinductive in an athymic rat assay. Product and process consistency are confirmed via ongoing testing of GRAFTON®II eDBM finished product for osteoinductivity in this validated athymic rat assay utilizing a five-point linear scale (0,1,2,3,4) to score bone formation at 28 days*. This bone forming activity exhibited by GRAFTON®II eDBM in the athymic rat surrogate assay should not be interpreted as a predictor of human clinical performance.

This document describes a 510(k) premarket notification for the GRAFTON®II eDBM device, a demineralized bone matrix allograft. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel AI/software function. Therefore, much of the requested information regarding AI device performance, sample sizes, ground truth establishment, and expert involvement is not applicable in this context.

Here's an analysis based on the provided text, addressing the relevant sections and indicating where information is not available due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a bone graft substitute, the "acceptance criteria" are primarily related to demonstrating substantial equivalence to legally marketed predicate devices and confirming the osteoinductive properties through an athymic rat assay. There isn't a table of quantitative performance metrics in the way one would see for a diagnostic AI device.

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

The primary performance data cited are from in vivo animal studies and an athymic rat assay.

• Athymic Rat Assay: Used for osteoinductivity testing. The sample size for this assay is not explicitly stated in the provided text, but it's referred to as "ongoing testing."
• In vivo Animal Studies: "The results of in vivo studies in animals showed that GRAFTON®II eDBM performs at least as well as, if not better than, predicate devices and/or autograft." The specific sample sizes for these animal studies are not provided.
• Data Provenance: The athymic rat assay is an in vivo animal model. The country of origin for the animal studies is not specified, but the submission is from a US company to the US FDA. The studies are prospective in the sense that they are conducted to demonstrate characteristics of the product.

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

Not applicable. The performance evaluation relies on biological assays (athymic rat model) and in vivo animal studies, not on interpretations of data by human experts in the context of setting a "ground truth" for a diagnostic algorithm. The osteoinductivity scoring (0-4 scale) would likely be performed by trained lab personnel, but they are not referred to as "experts" in the context of establishing ground truth for an AI/software device.

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

Not applicable. This is not a study requiring adjudication of expert opinions.

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/software device.

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

Not applicable. This is not an AI/software device.

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

The "ground truth" for the device's biological properties is established through:

• Biological Activity (Osteoinductivity): Demonstrated via the athymic rat assay, which is a recognized in vivo model for assessing bone formation potential of DBM. The outcome is assessed by scoring bone formation.
• In Vivo Performance: Demonstrated through animal studies comparing the device to predicate devices and autograft.

8. The sample size for the training set

Not applicable. This is not an AI/software device, so there is no "training set."

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

Not applicable. There is no training set.

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PLEXUR M is intended for use in filling bony voids or gaps of the skeletal 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 or osseous defects created from traumatic injury to the bone. In addition, Plexur M may be used in conjunction with autograft as a bone void filler in the spine. PLEXUR M is resorbed/remodeled and is replaced by host bone during the healing process.

PLEXUR M is a bone void filler product that contains, as a key constituent, processed human bone particles that are mixed with resorbable/biodegradeable non-tissue components. It is intended to be heated at the time of use, whereupon it becomes moldable, thus allowing the surgeon to pack it into the implant site or shape it to accommodate variations in the geometry and size of the particular implant site. As it cools down, the PLEXUR M returns to its normal hardened/rigid state and remains this way at body temperature. The surgeon may further shape, cut or grind PLEXUR M in the hardened state using conventional surgical instruments. PLEXUR M is packaged/provided for single use in a sterile form. PLEXUR M is resorbed/remodeled and is replaced by host bone during the healing process. A compact, single use heater is available as a means to heat the PLEXUR M at the time of use to make it pliable. Alternatively, PLEXUR M may be heated in a water bath.

The provided document, K081227, is a 510(k) summary for the PLEXUR M bone void filler. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing robust performance criteria through comprehensive clinical trials as might be seen for novel devices.

Therefore, the "acceptance criteria" and "device performance" are primarily demonstrated through a comparison to predicate devices and animal study results. There are no explicit quantitative acceptance criteria or detailed human-based performance metrics in this summary.

Here's an analysis based on the provided text, addressing your points:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document refers to "studies in animal" without providing the number of animals or specific details of the study design.
• Data Provenance: The studies were conducted in "animal," indicating an animal model. The country of origin is not specified. The study is described retrospectively in the 510(k) summary (i.e., the results are being reported).

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

Not applicable. This was an animal study focused on histological and biological endpoints, not human expert interpretation of images for diagnosis.

4. Adjudication Method for the Test Set

Not applicable. As described above, it was an animal study, not a study requiring human adjudication for diagnostic ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study (MRMC for human readers with and without AI assistance) is not applicable to an animal study for a bone void filler product demonstrating substantial equivalence.

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

Yes, in a way. The performance data presented refers to the inherent biological and structural properties of the PLEXUR M device itself in an animal model, without direct human intervention in the assessment process, beyond standard pathological evaluations. It's not an "algorithm-only" study in the context of AI, but rather an evaluation of the device's biological function.

7. The Type of Ground Truth Used

• Animal Study for Biological Response: The "ground truth" was established through direct observation and histological analysis of bone in-growth and new bone formation in the animal model. This is akin to pathology/histology and direct biological observation.

8. The Sample Size for the Training Set

Not applicable. This product is a medical device (bone void filler), not an AI algorithm. There is no concept of a "training set" in the context of its development as described here.

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

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

Summary of the Study Proving Acceptance:

The study referenced is an animal study that demonstrated the PLEXUR M device supports bone in-growth and new bone formation. The acceptance criteria were implicitly set by demonstrating that this biological performance was "at least comparable to predicate devices." The data provenance is an unspecified animal model, and the ground truth was established by direct observation and analysis of biological response (e.g., histology). No human-reader or AI-specific studies were conducted or reported in this 510(k) summary. The primary method of establishing "acceptance" for a 510(k) device like this is through the demonstration of substantial equivalence to previously cleared predicate devices, supported by non-clinical (e.g., animal, bench) or, if necessary, clinical data.

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PLEXUR P is intended for use in filling bony voids or gaps of the skeletal system (i.e., spine, pelvis and extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. Plexur P may also be used as a bone graft extender in the spine. PLEXUR P is resorbed/remodeled and is replaced by host bone during the healing process.

PLEXUR P is bone void filler that contains as its principal constituents processed human allograft bone tissue and a resorbable polymer. PLEXUR P is produced in various physical forms/shapes/geometries and may be further shaped or cut by the surgeon to meet the particular needs and preferences of the surgeon. PLEXUR P is intended for use as bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis, and extremities) not intrinsic to the stability of the bony structure. Plexur P mav also be used as a bone graft extender in the spine. PLEXUR P is provided in ready-to-use form in various package sizes by volume or dimension and is intended for single patient use.

The provided text describes the 510(k) summary for the PLEXUR P bone void filler. It indicates that the device has been found substantially equivalent to predicate devices based on certain performance data. However, the document does not include specific acceptance criteria, nor does it detail a study with quantitative results that definitively "proves" the device meets such criteria in the way a clinical trial or a statistically powered non-inferiority study would.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or provide a table of performance metrics. The core of the performance evaluation is based on a comparative, rather than absolute, standard against predicate devices.

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

• Sample Size for Test Set: The document states "studies in animal" but does not specify the number of animals or the overall sample size used in these studies.
• Data Provenance: The studies were conducted "in animal." No country of origin is mentioned, and it is implied to be prospective animal studies, not retrospective human data.

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. The animal studies would likely involve veterinary pathologists or researchers assessing bone healing, but no details are given.

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

This information is not provided in the 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

No such study was conducted. This device is a bone void filler, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable.

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 medical implant, not an algorithm.

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

The ground truth for the animal studies would have been based on biological and histological assessments of bone in-growth and new bone formation, likely through techniques such as histology, histomorphometry, and potentially imaging of the bone healing process. This would fall under pathology/biological outcomes in animal models.

8. The sample size for the training set

This is not applicable as the device is an implant and does not involve machine learning or a training set in the typical sense.

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

This is not applicable as the device is an implant and does not involve machine learning or a training set.

Ask a specific question about this device

PLEXUR M is intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, 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. PLEXUR M is resorbed/remodeled and is replaced by host bone during the healing process.

PLEXUR M is a bone void filler product that contains, as a key constituent, processed human bone particles that are mixed with resorbable/biodegradeable non-tissue components. It is intended to be heated at the time of use, whereupon it becomes moldable, thus allowing the surgeon to pack it into the implant site or shape it to accommodate variations in the geometry and size of the particular implant site. As it cools down, the PLEXUR M returns to its normal hardened/rigid state and remains this way at body temperature. The surgeon may further shape, cut or grind PLEXUR M in the hardened state using conventional surgical instruments. PLEXUR M is packaged/provided for single use in a sterile form. PLEXUR M is resorbed/remodeled and is replaced by host bone during the healing process. A compact, single use heater is available as a means to heat the PLEXUR M at the time of use to make it pliable. Osteotech is seeking approval of this single use heater as part of this 510(k) submission. Alternatively, PLEXUR M may be heated in a water bath.

The provided document is a 510(k) premarket notification for a medical device called PLEXUR M, a bone void filler. It details the device description, intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a diagnostic AI/ML device would.

The "Performance Data" section states: "The results of studies in animals showed that PLEXUR M supports bone ingrowth and new bone formation." This is a general statement about the biological performance of the device rather than a quantitative assessment against predefined acceptance criteria.

Therefore, the requested information cannot be fully provided based on the given text.

Here's an attempt to answer based on the available information, with many points indicating that the information is not present in the document:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable/Not specified. The document refers to "studies in animals" but does not give a sample size, and it's for biological performance, not a diagnostic test set.
• Data Provenance: Studies were conducted "in animals." No country of origin is specified. The studies appear to be for biological evaluation, not clinical efficacy in humans as a "test set" in the context of AI/ML evaluation. Such studies are typically prospective.

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

• Not applicable. The "ground truth" for bone ingrowth and new bone formation in animal studies would typically be established through histological examination or other biological assessments by veterinary pathologists or other relevant scientists, but this information is not detailed.

4. Adjudication Method for the Test Set

• Not applicable. This concept is relevant for human-read data or diagnostic interpretations, which is not the focus of the performance data presented here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. This document does not mention any MRMC study. The device is a bone void filler, not an imaging or diagnostic device that typically undergoes MRMC studies.

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

• No. The device is a physical bone void filler, not an algorithm or AI/ML system.

7. The Type of Ground Truth Used

• The "ground truth" for the animal studies would be related to biological outcomes such as histological evidence of bone ingrowth and new bone formation.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm requiring a training set.

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

• Not applicable. This device is not an AI/ML algorithm requiring a training set.

Summary of what the document does provide:

• Device Name: PLEXUR M
• Intended Use: For filling bony voids or gaps of the skeletal system (extremities, pelvis) that are not intrinsic to the stability of the bony structure.
• Device Description: Contains processed human bone particles mixed with resorbable/biodegradable non-tissue components, becomes moldable when heated, then hardens.
• Performance Data (limited): Animal studies showed it "supports bone ingrowth and new bone formation."
• Viral Inactivation: Processing steps for allograft bone inactivate viruses (HIV, hepatitis B and C, CMV).
• Substantial Equivalence: Based on materials (human allograft bone, resorbable polymer) and heat-moldable characteristics compared to predicate devices.

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PLEXUR P is intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. PLEXUR P is resorbed/remodeled and is replaced by host bone during the healing process.

PLEXUR P is a bone void filler that contains as its principal constituents processed human allograft bone tissue and a resorbable polymer. PLEXUR P is produced in various physical forms/shapes/geometries and may be further shaped or cut by the surgeon to meet the particular needs and preferences of the surgeon. PLEXUR P is intended for use as a bone void filler in bony voids or gaps of the skeletal system (i.e., extremities, pelvis) not intrinsic to the stability of the bony structure. PLEXUR P is provided in ready-to-use form in various package sizes by volume or dimension and is intended for single patient use.

The provided text describes a 510(k) summary for the PLEXUR P bone void filler. This document is related to a medical device's regulatory approval process and includes performance data from animal studies. However, it does not describe an AI/ML device and therefore does not contain information typically associated with studies proving device performance against acceptance criteria for AI/ML models.

Based on the provided text, I can only extract the following relevant information:

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

The provided text does not contain any explicit acceptance criteria in the format typically used for AI/ML device performance (e.g., sensitivity, specificity, AUC thresholds). Instead, for this non-AI bone void filler, the performance is described in terms of its biological function.

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

• Sample size for test set: The text mentions "studies in animals" but does not specify the number of animals or the sample size used.
• Data provenance: "studies in animals" are mentioned, but no country of origin or whether the studies were retrospective or prospective is specified.

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, as this is not an AI/ML device involving expert labeling for ground truth.

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

Not applicable, as this is not an AI/ML device requiring adjudication of expert labels.

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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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

The "ground truth" for the device's function was observed through biological outcomes in animal studies, specifically "bone ingrowth and new bone formation." This could be considered a form of outcome data or histological observation in the context of biological research.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

Ask a specific question about this device

GRAFTON® DBM is intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. GRAFTON® DBM may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. GRAFTON® DBM is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON® DBM is resorbed/remodeled and is replaced by host bone during the healing process.

GRAFTON® DBM is a human bone allograft product containing human demineralized bone matrix (DBM) and an inert additive for intraoperative handling. It is intended to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. GRAFTON® DBM is provided ready-to-use in various physical forms. It is packaged in various sizes by volume or dimension for single patient use. GRAFTON® DBM is a demineralized bone product that is osteoconductive as well as osteoinductive in an athymic rat assay. It is prepared via a proprietary processing method of Osteotech, Inc. that has been validated to consistently produce DBM that is osteoinductive in an athymic rat assay.

This document describes a 510(k) premarket notification for the GRAFTON® DBM (Demineralized Bone Matrix) product. As such, it is not a study proving device meets acceptance criteria in the sense of a clinical trial for a novel AI device. Instead, it is a submission demonstrating substantial equivalence to legally marketed predicate devices, which is a different regulatory pathway.

Therefore, many of the typical questions regarding acceptance criteria, performance studies, sample sizes, expert ground truth, and comparative effectiveness for AI devices are not applicable in this context. The document focuses on demonstrating that GRAFTON® DBM is as safe and effective as existing devices.

However, I can extract the relevant information from the provided text based on the closest applicable concepts:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are generally related to demonstrating substantial equivalence to predicate devices, focusing on materials, intended use, and performance characteristics (like osteoinductivity for DBM products). "Reported device performance" for DBMs typically refers to their biological properties.

*Note on : The document explicitly states: "This bone forming activity exhibited by GRAFTON® DBM in this athymic rat surrogate assay should not be interpreted as a predictor of clinical performance." This highlights that while the assay demonstrates a biological characteristic, it's not a direct measure of clinical success.

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

For the osteoinductivity assay:

• Sample size: Not explicitly stated, but the method describes "ongoing testing of GRAFTON® DBM finished product for osteoinductivity in this validated athymic rat assay". This suggests a continuous testing process rather than a single fixed "test set" in the context of a clinical trial.
• Data provenance: Athymic rat model. This is an animal model, not human data. The specific country of origin is not mentioned, but the associated reference (Edwards et al., 1998) suggests US-based research. Retrospective/prospective is not directly applicable to an ongoing assay of a manufactured product.

For the statement "results of studies in animals and humans show that GRAFTON® DBM performs at least as well as...":

• Sample size: Not specified in this 510(k) summary. These would refer to existing, presumably published or unpublished, studies.
• Data provenance: Mention of "animals and humans" but no further detail on country of origin or retrospective/prospective nature.

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

• For the athymic rat assay: Ground truth (scoring of bone formation) would typically be established by trained laboratory personnel or pathologists specializing in histology. The number of experts and their specific qualifications are not detailed in this summary. The mention of a "five-point linear scale (0,1,2,3,4) to score bone formation" suggests a standardized, objective scoring method.

4. Adjudication method for the test set

• Not specified for the athymic rat assay, nor is it explicitly mentioned for any 'test set' in the context of a human clinical study. Given the nature of a 510(k) summary and the animal model, a formal multi-reader adjudication method as seen in complex clinical imaging trials is unlikely to be detailed here.

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. This document describes a medical device (bone graft material), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

• No. This is a medical device, not an algorithm. This question is not applicable.

7. The type of ground truth used

• For the osteoinductivity evaluation: Histological assessment (scoring of bone formation on a five-point scale) in an athymic rat model, based on a validated assay. This is a surrogate marker for human clinical performance.
• For the broader claim of performing "at least as well as" predicates: This would implicitly rely on clinical outcomes data (e.g., fusion rates, healing rates) from animal and human studies, though specific details are not provided in this summary.

8. The sample size for the training set

• This concept is not applicable in the context of a 510(k) for a DBM product. There is no "training set" for an algorithm. The "proprietary processing method" is validated to consistently produce osteoinductive DBM, which implies quality control and process validation, not machine learning model training.

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

• This question is not applicable for the reasons stated in point 8. The "ground truth" for ensuring consistent product quality (i.e., osteoinductivity) is established through the validated athymic rat assay as described in point 7.

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The GraftCage™ TLX is a vertebral body replacement device intended to replace a collapsed, damaged, or unstable vertebral body in the thoracic or lumbar spine (T1-L5). The GraftCage TLX is indicated for a partial or total vertebrectomy for cases of tumor or trauma (i.e., fracture). The GraftCage TLX is intended to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body.

The GraftCage TLX is intended for use with supplemental internal spinal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. These systems include posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems. The use of bone grafting material with the GraftCage TLX is optional.

The GraftCage TLX is a device designed to replace a thoracic or lumbar vertebral body and to support axial compression loads following vertebrectomy for the treatment of spinal tumors and in cases of spinal trauma/fracture. The GraftCage TLX is made from implantable PEEK (polyetheretherketone) polymer.

The GraftCage TLX is rectangular -to- oval in shape, with its anterior aspect slightly convex and posterior aspect slight concave. One central (axial) fenestration and two fenestrations on each anterior and posterior aspect provide locations for the addition of bone grafting material. The superior and inferior aspects have ridges that resist expulsion and /or migration after implantation. The device is nonlordotic (0°) i.e., parallel. The lateral aspects are tapered, or bulleted, for ease of insertion.

Two threaded holes, one at each lateral aspect, interface with the insertion tool. The insertion tool is a shaft attached to a handle. The shaft has a threaded end that matches both threaded holes on the GraftCage TLX and allows the surgeon to hold the GraftCage TLX while implanting it into the patient. Each threaded hole is at a different angle relative to the long axis of the implant. The different angles allow the surgeon to choose the best surgical approach depending upon the specific clinical situation.

This is a medical device 510(k) summary, not a study report for an AI/ML powered device. Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, and training data is not applicable.

A 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparison of intended use, technological characteristics, and performance data if required for novel features or significant differences.

Here's a breakdown of what can be extracted from the provided text, and what cannot:

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

The document does not explicitly state acceptance criteria in a quantitative form, nor does it present specific performance data for the GraftCage™ TLX in a way that would directly correspond to such criteria. The "performance" mentioned is implicitly related to demonstrating substantial equivalence through similar technological characteristics and the belief that it "meets or exceeds functional requirements for a vertebral body replacement device" based on comparison to predicates.

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

Not applicable. This is a medical device submission, not a study involving a test set of data in the context of AI/ML.

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 a medical device submission, not a study involving ground truth established by experts for a test set.

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

Not applicable. This device is an implantable medical device (vertebral body replacement), not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is an implantable medical device.

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

Not applicable.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary of Applicable Information from the Document:

While the direct questions about AI/ML studies are not applicable, we can infer some details relevant to the device's authorization:

• Acceptance Criteria (Implicit): The primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to existing, legally marketed predicate devices. This is achieved by showing that the new device has:
  • The same intended use.
  • Similar technological characteristics (e.g., material, design, mechanical properties inferred from the comparison).
  • No new questions of safety or effectiveness.
• Study That "Proves" Device Meets Criteria: The "study" for a 510(k) is primarily the submission itself, comparing the new device to predicates. The document states:
  • "The GraftCage TLX and the predicate devices have the same intended use and similar technological characteristics."
  • "Performance data demonstrates that the GraftCage TLX meets or exceeds functional requirements for a vertebral body replacement device." (No specific data is presented in this summary, but it implies mechanical testing or other non-clinical performance data was submitted to the FDA to support this claim).
• Predicate Devices Used for Comparison (Analogous to a "Reference" or "Standard"):
  • Synthes Spine's Vertebral Spacer-TR (K011037)
  • Interpore Cross's GEO Structure (K010530)
  • Stryker Spine's AVS TL Spacer (K042571)

In essence, the "proof" for the GraftCage™ TLX is derived from its similarity to devices already deemed safe and effective by the FDA.

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GRAFTON® DBM is intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis and extremities); surgically created defects or defects created by trauma. The voids or gaps may be large or small and may be unicortical or bicortical. GRAFTON® DBM is resorbed/remodeled and is replaced by host bone during the healing process.

GRAFTON®DBM is a human bone allograft product containing human demineralized bone matrix (DBM) and an inert additive for intraoperative use in filling bony voids or gaps of the skeletal system needing structural support. It is intended to be used in bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON® DBM is provided ready-to-use in various physical forms and in various package sizes by volume or dimension. GRAFTON® DBM is a demineralized bone product that is osteoconductive as well as osteoinductive in an athymic rat assay. It is prepared via a proprietary process of Osteotech, Inc. that has been validated to consistently produce DBM that is osteoinductive in an athymic rat assay. Product and process consistency are confirmed via ongoing testing of GRAFTON® DBM product for osteoinductivity in this validated athymic rat assay utilizing a five point linear scale to score bone formation at 28 days.

The provided text describes a 510(k) premarket notification for the GRAFTON® DBM device. This submission process focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through a controlled clinical trial with acceptance criteria for device performance. Therefore, many of the requested categories for a study proving device acceptance criteria are not directly applicable or explicitly stated in this type of submission.

Here's an analysis of the provided information in the context of your request:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" as used in studies proving device performance (e.g., sensitivity, specificity, accuracy) is not explicitly detailed in a 510(k) summary for a demineralized bone matrix allograft. Instead, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices. The "performance data" section in a 510(k) typically refers to evidence supporting the device's functional characteristics and safety compared to predicates, rather than quantifiable metrics against predefined targets.

Table of Acceptance Criteria and Reported Device Performance:

Study Details (as inferable from the 510(k) summary)

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

   • Osteoinductivity: An "athymic rat assay" was used. The sample size for this assay is not specified in the provided text.
   • "Studies in animals and humans": The text mentions "The results of studies in animals and humans showed that GRAFTON® DBM performs as well as, if not better than, predicate devices and/or performs at least as well at load." However, no specific sample sizes or details of these studies are provided.
   • Data Provenance: The athymic rat assay is an animal model. No specific country of origin or whether the animal/human studies were retrospective or prospective is mentioned.

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

   • This information is not provided in the 510(k) summary. For the athymic rat assay, the scoring system ("five point linear bone formation histological scoring system") is referenced, but the experts involved in applying this scoring or their qualifications are not detailed.

3. Adjudication method for the test set:

   • This information is not provided.

4. 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 or AI-assisted study was performed. GRAFTON® DBM is a bone graft product, not an AI-powered diagnostic or assistive device.

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

   • Not applicable, as this is not an AI algorithm.

6. The type of ground truth used:

   • Osteoinductivity: Histological scoring (0-5 scale) of bone formation in an athymic rat model at 28 days. This is a surrogate biological measure.
   • Viral Inactivation: Validation of the proprietary production process to inactivate specific viruses. This involves laboratory testing methods (e.g., spiking studies).
   • Overall Performance: Comparison to "predicate devices and/or performs at least as well at load." The exact ground truth for these comparisons is not specified but would likely involve clinical outcomes or functional assessments used for the predicate devices.

7. The sample size for the training set:

   • Not applicable in the context of this 510(k) submission for a non-AI bone graft. The "proprietary production process" for DBM is mentioned as having been "validated to consistently produce DBM that is osteoinductive," implying a developmental and validation phase, but specific training set sizes are not relevant here.

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

   • Not applicable in the context of this 510(k) submission for a non-AI bone graft. The consistency and osteoinductivity of the product are "confirmed via ongoing testing... utilizing a validated athymic rat assay." The "validation" of the production process implies a ground truth was used to establish its effectiveness in achieving osteoinductivity, likely based on the histological scoring in the athymic rat model.

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VIAGRAF® DBM Paste is intended for use in filling bony voids or gaps of the extremities that are not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. VIAGRAF® DBM Paste is resorbed/remodeled and is replaced by host bone during the healing process.

VIAGRAF DBM Paste is an osteoconductive human bone allograft product consisting of human demineralized bone matrix (DBM) to which an inert starchbased carrier has been added. It is intended for use in filling bony voids or gaps of the extremities not intrinsic to the stability of the bony structure. VIAGRAF® DBM Paste is provided in a ready-to-use paste-like, malleable form that can be molded or manipulated by the user into various shapes. It is provided in various package sizes by volume.

The provided document, K043209, does not contain detailed acceptance criteria or a comprehensive study with specific numerical performance metrics typically found for medical devices with algorithmic components. This 510(k) pertains to a demineralized bone matrix paste (VIAGRAF® DBM Paste), which is a biological product, not a software or AI-driven device. Therefore, the requested information, which is more relevant to AI/ML or diagnostic devices, is not explicitly available in this document.

However, based on the information provided, I can infer the general nature of the performance data and its purpose:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified.
• Data Provenance: The document mentions "animal models" for bone formation studies and "relevant clinical data." No specific country of origin or whether the clinical data was retrospective or prospective is mentioned.

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

• Not applicable/Not specified. The performance evaluation for this product relies on biological outcomes (bone formation) and viral inactivation, not expert interpretation of outputs like images.

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

• Not applicable. This concept is typically relevant for studies where human expert consensus is used to establish ground truth for a diagnostic device.

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/ML or diagnostic device that involves human readers interpreting results.

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

• Not applicable. This is not an algorithmic device.

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

• For bone formation: Biological outcomes in animal models.
• For viral inactivation: Validation of the proprietary process against specific viruses.
• For clinical performance: "Relevant clinical data" (assumed to be patient outcomes/follow-up data).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that uses a training set.

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

• Not applicable.

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The GraftCage™ ACX is a vertebral body replacement device intended to replace a collapsed, damaged, or unstable vertebral body in the thoracic or lumbar spine (TI-L5). The GraftCage™ ACX is indicated for a partial or total vertebrectomy for cases of tumor or trauma (i.e., fracture). The GraftCage™ ACX is intended to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body.

The GraftCage™ ACX is intended for use with supplemental internal spinal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. These systems include posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems.

The use of bone grafting material with the GraftCage™ ACX is optional.

The GraftCage™ ACX is a device designed to replace a thoracic or lumbar vertebral body and to support axial compression loads following vertebrectomy for the treatment of spinal tumors and in bases of spinal trauma/fracture. The GraftCage™ ACX is made from implantable PEEK-OPTIMA (polyetheretherketone) polymer.

The GraftCage™ ACX is basically rectangular in shape. One central (axial) fenestration and one fenestration on each lateral aspect (on certain sizes) provide locations for the addition of bone grafting material. The superior and inferior aspects have ridges that resist expulsion and for migration after implantation. The device offers lordotic and non-lordotic i.e., parallel configurations. The posterior aspect of both design configurations is tapered, or bulleted, for ease of insertion.

A single threaded hole at the posterior aspect interfaces with the insertion tool. The insertion tool is a shaft attached to a handle. The shaft has a threaded end that matches the threaded hole on the GraftCage™ ACX and allows the surgeon to hold the GraftCage™ ACX while implanting it into the patient.

The provided text is a 510(k) summary for the GraftCage™ ACX, a vertebral body replacement device. It details the device's description, intended use, and comparison to predicate devices, and includes the FDA's clearance letter. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through empirical data.

The text primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices rather than providing detailed performance study data against defined acceptance criteria. The statement "Performance data demonstrates that the GraftCage™ ACX meets or exceeds functional requirements for a vertebral body replacement device" is made, but no specifics of this data, the requirements, or the study methodology are provided in this document.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them with the information given. All the requested points (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for training set) are not present in this document.

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