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DBX Putty is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX Putty is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.

DBX Putty can be used alone in the pelvis and extremities. DBX Putty can also be used as an extender in the pelvis and extremities with autograft or allograft. DBX Putty can be used with bone marrow. DBX Putty is for single patient use only.

DBX Inject is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.

DBX Inject can be used alone in the pelvis and extremities. DBX Inject can also be used as an extender in the pelvis and extremities with autograft or allograft. DBX Inject can be used with bone marrow. DBX Inject is for single patient use only.

DBX Putty is composed of Demineralized Bone Matrix and sodium hyaluronate. The demineralized bone allograft in this product is prepared from tissue procured from a deceased donor using aseptic surgical techniques. The bone used in DBX Putty is cortical bone. Sodium hyaluronate is a naturally derived material that is biocompatible and biodegradable. The sodium hyaluronate is mixed in a phosphate buffered saline and is added to the demineralized bone to aid in maintaining physiological pH as well to improve the handling characteristics of demineralized bone.

DBX Inject is composed of Demineralized Bone Matrix and sodium hyaluronate. The demineralized bone allograft in this product is prepared from tissue procured from a deceased donor using aseptic surgical techniques. The bone used in DBX Inject is cortical bone. Sodium hyaluronate is a naturally derived material that is biocompatible and biodegradable. The sodium hyaluronate is mixed in a phosphate buffered saline and is added to the demineralized bone to aid in maintaining physiological pH as well to improve the handling characteristics of demineralized bone.

The provided text describes two medical devices, DBX® Demineralized Bone Matrix Putty and DBX® Demineralized Bone Matrix Inject. Both are bone void fillers containing human demineralized bone matrix (DBM) and sodium hyaluronate. The 510(k) submission (K103784) was for an expansion of their indications for use in the pelvis and extremities, specifically allowing their use with autograft or allograft.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The text mentions "Recent in vivo studies conducted by MTF" for the equivalence assessment of the expanded indications. However, it does not provide the sample size for these in vivo studies.

The data provenance for these in vivo studies is not explicitly stated in terms of country of origin, nor whether they were retrospective or prospective. Given that they are described as "recent in vivo studies conducted by MTF," it implies a prospective study design primarily for this submission.

For the osteoinductive potential testing, the "test set" is described as "Every lot of final DBX Putty/Inject product." This is a continuous quality control measure rather than a single study with a fixed sample size. The testing is done in an "athymic mouse model" or an "alkaline phosphatase assay."

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for the in vivo equivalence studies. For the osteoinductive potential, the "ground truth" is defined by the outcome of the athymic mouse model or alkaline phosphatase assay, which are objective biological tests rather than expert interpretation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the in vivo equivalency studies or for the osteoinductive potential testing. These processes appear to rely on direct measurement or observation rather than subjective review requiring adjudication.

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

No MRMC comparative effectiveness study was done as this device is a bone void filler, not an imaging or diagnostic device that would typically involve human readers interpreting cases. Therefore, there is no discussion of human readers improving with or without AI assistance.

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

This question is not applicable. The device is a physical bone void filler, not a software algorithm or AI-based diagnostic tool. The performance evaluation focuses on its biological and physical properties in in vivo models, not on an algorithm's performance.

7. The Type of Ground Truth Used

• For Equivalence for expanded indications: The ground truth is established by the outcome of the "in vivo studies" demonstrating equivalence to the predicate (DBX Putty/Inject alone). The specific metrics or "ground truth" criteria for equivalence (e.g., bone formation, histological assessment) are not detailed in the provided text.
• For Osteoinductive Potential: The ground truth is the outcome of the "athymic mouse model" or the "alkaline phosphatase assay." These are biological assays that provide a quantitative or qualitative result indicative of osteoinduction.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. These devices are regulated based on their physical and biological properties and performance in in vivo models, not on machine learning algorithms that require training data.

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

This question is not applicable as there is no "training set" for these types of medical devices.

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DBX Putty is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX Putty is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.

DBX Putty can be used alone in the posterolateral spine. DBX Putty can also be used as an extender in the spine with autograft or allograft. DBX Putty can be used with bone marrow. DBX Putty is for single patient use only.

DBX Inject is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.

DBX Inject can be used alone in the posterolateral spine. DBX Inject can also be used as . an extender in the spine with autograft or allograft. DBX Inject can be used with bone marrow. DBX Inject is for single patient use only.

DBX Putty is composed of Demineralized Bone Matrix and sodium hyaluronate. The demineralized bone allograft in this product is prepared from tissue procured from a deceased donor using aseptic surgical techniques. The bone used in DBX Putty is cortical bone. Sodium hyaluronate is a naturally derived material that is biocompatible and biodegradable. The sodium hyaluronate is mixed in a phosphate buffered saline and is added to the demineralized bone to aid in maintaining physiological pH as well to improve the handling characteristics of demineralized bone.

DBX Inject is composed of Demincralized Bone Matrix and sodium hyaluronate. The demineralized bone allograft in this product is prepared from tissue procured from a deceased donor using aseptic surgical techniques. The bone used in DBX Inject is cortical bone. Sodium hyaluronate is a naturally derived material that is biocompatible and biodegradable. The sodium hyaluronate is mixed in a phosphate buffered saline and is added to the demineralized bone to aid in maintaining physiological pH as well to improve the handling characteristics of demineralized bone.

The provided text is a 510(k) summary for two medical devices: DBX® Demineralized Bone Matrix Putty and DBX® Demineralized Bone Matrix Inject. It describes their intended use, device description, and safety/effectiveness information.

However, the document does not contain the acceptance criteria or a study proving that the device meets specific performance criteria in the way that would typically be presented for an AI/ML device (e.g., sensitivity, specificity, F1 score, etc.). Instead, this document focuses on the bio-compatibility, osteoinductive potential, and viral clearance of the bone matrix products, essentially demonstrating that they are safe and effective for their intended biological function as bone void fillers.

Here's an analysis of the provided information in relation to your request, acknowledging that much of the requested detail for an AI/ML device is not applicable or present in this type of submission.

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

Important Note: The document focuses on the biological and safety aspects of a medical device (demineralized bone matrix) rather than analytical performance associated with an AI/ML diagnostic or predictive tool. There are no performance metrics like sensitivity, specificity, or F1 score.

Given that this is a 510(k) summary for a bone void filler and not an AI/ML device, most of the remaining requested information is not applicable. I will address what can be inferred or state its non-applicability.

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

• Test Set Sample Size: Not explicitly stated for specific studies. The lot release testing for osteoinductive potential is conducted on "every lot of final DBX Putty product," implying continuous testing rather than a single pre-market test set. The "recent in vivo study" mentioned for the expanded indications does not specify a sample size.
• Data Provenance: The document does not specify the country of origin for the "recent in vivo study" or the "long history of safe and effective clinical use." The athymic mouse model is a laboratory model.
• Retrospective or Prospective: Not specified. The "long history of safe and effective clinical use" would imply retrospective data accumulation, but the "recent in vivo study" could be prospective.

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 is not applicable as the studies described are biological/in vivo and laboratory tests, not assessments requiring expert interpretation for ground truth establishment in the context of an AI/ML inference.
• For the osteoinductive potential in the athymic mouse model or alkaline phosphatase assay, the ground truth is established by the assay's biochemical or biological outcome.

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

• Not applicable. This concept relates to resolving discrepancies in expert interpretations, which is not relevant to the types of studies described (in vivo biological models, laboratory assays).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a bone void filler, not an AI/ML diagnostic or assistive tool for human readers. Therefore, no MRMC study or AI assistance effect size is mentioned.

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

• Not applicable. There is no algorithm; this is a biological product.

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

• Biocompatibility: Established through adherence to ISO 10993 standards and a history of clinical use. This effectively uses a combination of established standards and historical outcomes data.
• Sterility: USP microbiological testing standards.
• Osteoinductive Potential: The positive outcome in an athymic mouse model or an alkaline phosphatase assay serves as the "ground truth" for lot release.
• Viral Clearance: Laboratory assessment of viral inactivation potential using model viruses.
• Expanded Indications: Based on "a recent in vivo study," implying direct biological outcomes in a living system (likely animal model as it's not a human clinical trial summary).

8. The sample size for the training set

• Not applicable. This medical device is not an AI/ML algorithm 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 an AI/ML algorithm.

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DBX® Inject is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used as follows:
Ridge augmentation
Filling of extraction sites
Craniofacial augmentation
Mandibular reconstruction
Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture
Filling resection defects in benign tumors, benign cysts, or other osseous defects in the alveolar ridge wall
Filling of cystic defect
Filling of lesions of periodontal origin
Filling of defects of endodontic origin
DBX® Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Inject can be used with bone marrow. DBX® Inject is for single patient use only.

DBX® Inject is osteoconductive, and has been shown to have osteoinductive potential in an athymic mouse model. Every lot of final DBX® Inject Paste will be assayed in vivo for osteoinductive potential. - Every lot of final DBX® Inject Putty product will be tested in an athymic mouse model or in an alkaline phosphatase assay, which has been shown to have a positive correlation with the athymic mouse model, to ensure the osteoinductive potential of the final product. Standard testing performed in an athymic mouse or alkaline phosphatase assay must prove positive for lot release. It is unknown how the osteoinductive potential, measured in the athymic mouse model or the alkaline phosphatase assay, will correlate with clinical performance in human subjects.
DBX® Inject is single-donor processed. The donor suitability criteria used to screen this donor are in compliance with the FDA regulations published in 21 CFR Part 1270 and Part 1271 Human Tissue Intended for Transplantation.

This 510(k) summary describes a traditional medical device (Bone Void Filler) and not an AI/ML powered device. As such, the requested information (sample sizes, ground truth establishment, expert qualifications, HRMC studies, etc.) is not applicable and is not present in the provided document.

However, I can extract the acceptance criteria and refer to the studies mentioned in the document that were performed to demonstrate the device meets these criteria.

Acceptance Criteria and Reported Device Performance

Every lot of final DBX® Inject Putty product must be tested in an athymic mouse model or in an alkaline phosphatase assay (which has a positive correlation with the athymic mouse model) to ensure osteoinductive potential, and prove positive for lot release.

Note: It is unknown how the osteoinductive potential, measured in these models, will correlate with clinical performance in human subjects. | DBX® Inject is osteoconductive and has been shown to have osteoinductive potential in an athymic mouse model. Standard testing will be performed in an athymic mouse or alkaline phosphatase assay for lot release. |
| Viral Clearance and Inactivation | The processing method for the demineralized bone matrix must provide significant viral inactivation potential for a wide range of potential viruses. | The DBM processing methods were determined to provide significant viral inactivation potential for a wide range of potential viruses, as evaluated with a panel of model potential human viruses representing various types, sizes, shapes, and genomes. |
| Donor Suitability | Donor suitability criteria used to screen donors must be in compliance with FDA regulations published in 21 CFR Part 1270 and Part 1271 Human Tissue Intended for Transplantation. | DBX® Inject is single-donor processed, and the donor suitability criteria used are in compliance with FDA regulations 21 CFR Part 1270 and Part 1271. |

Statements regarding AI/ML specific information (as it pertains to a traditional medical device):

1. Sample size used for the test set and the data provenance: Not applicable. The studies mentioned are laboratory tests, not clinical trials with human patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for osteoinductivity and viral inactivation is established through standardized laboratory assays.
3. Adjudication method for the test set: Not applicable. Laboratory assays follow predefined protocols.
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: Not applicable. This is not an AI-powered device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-powered device.
6. The type of ground truth used:
   • Osteoinductive potential: Athymic mouse model results or alkaline phosphatase assay results.
   • Viral clearance and inactivation: Results from standard viral inactivation assays using model viruses.
   • Donor suitability: Compliance with FDA regulations (21 CFR Part 1270 and Part 1271).
7. The sample size for the training set: Not applicable. This is not an AI-powered device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI-powered device.

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DBX® Inject is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used as follows:

DBX® Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Inject Putty can be used as an extender in the spine with autograft. DBX® Inject can be used with bone marrow. DBX® Inject is for single patient use only.

DBX® Inject is completely resorbable and is composed of donated cortical and cancellous bone. The bone granules are mixed with sodium hyaluronate (Hy). DBX® Inject consists of DBX Putty or Paste with a separate, sterile plastic syringe for delivery directly into the operative site.

The provided text is a 510(k) summary for the DBX® Inject device, a bone void filler. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with specific acceptance criteria and performance metrics typically seen in studies for diagnostic or AI-powered devices.

Therefore, the information required to populate the requested table and answer the study-related questions for a device performance study as described in the prompt is not present in the provided document. The 510(k) summary describes regulatory compliance, device characteristics, and comparisons to predicate devices.

However, I can extract information related to the device's biological potential and safety testing, which are forms of performance evaluation for this type of medical device.

Here's what can be gathered from the document, acknowledging the difference in scope from the prompt's implied request for clinical performance study details:

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 in the context of a clinical study on device performance in humans. The testing mentioned is for lot release (biological properties) and viral inactivation.
  • For osteoinductive potential: "Every lot of final DBX® Inject Paste will be assayed," and "Every lot of final DBX® Inject Putty product will be tested." The specific number of samples per lot test is not provided, nor is the number of lots tested in the submission.
  • For viral clearance: A "panel of model potential human viruses" was evaluated. The specific number of virus types/samples used is not detailed.
• Data Provenance:
  • Osteoinductive potential: In vivo (athymic mouse model) and in vitro (alkaline phosphatase assay).
  • Viral clearance: In vitro (evaluated DBM processing methods).
  • Donor suitability: Refers to compliance with FDA regulations for human tissue donors.

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

• Not applicable. The ground truth here relates to biological activity (osteoinductivity) and viral inactivation, which are determined by laboratory assays and scientific protocols, not expert consensus on interpretations of images or clinical outcomes.

4. Adjudication Method for the Test Set:

• Not applicable. This concept applies to human expert adjudication in clinical or diagnostic studies. The tests mentioned are laboratory-based.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., images), and the device aims to assist or improve their performance. DBX® Inject is a bone void filler, not a diagnostic device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• No, a standalone performance study in the context of an algorithm or AI is not applicable. DBX® Inject is a physical medical device. The "performance" evaluated relates to its biological properties and manufacturing safety.

7. The Type of Ground Truth Used:

• Osteoinductive Potential: The "ground truth" is established by the qualitative result of the athymic mouse model (positive/negative for osteoinductivity) or the alkaline phosphatase assay, which is correlated to the mouse model. This is a scientific, biological assay result.
• Viral Clearance: The "ground truth" is the measured reduction/inactivation of various model viruses by the DBM processing methods. This is based on laboratory virology assays.
• Donor Suitability: Compliance with regulatory standards (21 CFR Part 1270 and Part 1271).

8. The Sample Size for the Training Set:

• Not applicable. This device is not an AI/ML algorithm that requires a "training set." The biological tests are on the final product lots.

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

• Not applicable, as there is no "training set" for this type of device submission.

In summary: The provided 510(k) summary for DBX® Inject addresses its safety and effectiveness through demonstrating substantial equivalence to predicate devices, biological activity (osteoinductive potential), and viral inactivation capabilities. It does not contain information on clinical trials with human subjects, device performance metrics, or reader studies that would typically apply to diagnostic or AI-powered devices. The "studies" described are primarily laboratory-based assessments of the product's inherent properties and manufacturing process safety.

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DBX® is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the:

DBX® is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Putty can be used as an extender in the spine with autograft. DBX® can be used with bone marrow. DBX® is for single patient use only.

DBX® Demineralized Bone Matrix is available in three forms: Paste, Putty and Mix. DBX® products are completely resorbable. DBX® Paste and Putty are composed of donor cortical bone; the DBX® Mix is composed of donor corticocancellous bone. The bone granules are mixed with sodium hyaluronate (Hy) in varying combinations to form the DBX® Putty, Paste, and Mix.

This 510(k) summary describes a change in the osteoinductivity assay for the DBX® Demineralized Bone Matrix Putty, Paste, and Mix. The device itself is a bone void filler containing human demineralized bone matrix (DBM). The primary focus of the provided document is on the validation of the new osteoinductivity assay as a surrogate for the previously accepted in vivo athymic mouse model, not a study of the overall clinical performance of the device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly provide a "test set" sample size in the traditional sense of a clinical study for device performance. Instead, it discusses the validation of an assay.

• Athymic Mouse Model (In Vivo): Used for original and ongoing validation.

  • Sample Size: Not specified (e.g., number of mice, number of lots tested).
  • Data Provenance: Not specified, but likely laboratory-based.
  • Retrospective/Prospective: Not specified for individual tests, but implies ongoing lot testing.

• BMP-2 ELISA (In Vitro): This is the new assay being validated against the athymic mouse model.

  • Sample Size: "Every final lot of DBX® Putty is tested" or "each lot of DBM incorporated into DBX® Putty is assayed." The number of lots used specifically for the correlation study between the ELISA and the athymic mouse model is not specified.
  • Data Provenance: Laboratory testing.
  • Retrospective/Prospective: The correlation study would have been prospective to establish the link between the new and old methods. Subsequent lot testing would be prospective for quality control.

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

This information is not provided. The "ground truth" here is the osteoinductive potential, as measured by either the athymic mouse model or the BMP-2 ELISA. These are laboratory assays, not interpretations by experts in a clinical context.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of clinical outcomes or image interpretations. The "adjudication" in this context is the comparison between the results of the in vitro ELISA and the in vivo athymic mouse model. The document states that "Results from this immunoassay were correlated to the athymic mouse model." The specific statistical method or criteria for this correlation are not detailed beyond the statement of correlation.

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

No, an MRMC study was not done. This device is a bone graft substitute, and the submission concerns a change in a laboratory assay for osteoinductivity, not a diagnostic imaging or clinical assessment device that would typically involve an MRMC study.

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

Yes, in a way. The "standalone" performance here refers to the new BMP-2 ELISA assay. The study establishes its correlation with the athymic mouse model, suggesting it can function as a standalone test for osteoinductivity in lot release.

7. The Type of Ground Truth Used

The ground truth for determining osteoinductive potential is:

• Biological Assay: The in vivo athymic mouse model. This model has a history of use for assessing osteoinductivity.
• Biochemical Assay: The BMP-2 ELISA, which is being proposed as a surrogate for the biological assay. The "ground truth" for the validation of the ELISA is therefore the athymic mouse model's results.

8. The Sample Size for the Training Set

The document does not explicitly refer to a "training set" in the context of machine learning or algorithm development. The "correlation" between the BMP-2 ELISA and the athymic mouse model implicitly involves a dataset of DBM lots for which both tests were performed. The size of this dataset (i.e., the number of lots used to establish the correlation) is not specified.

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

The "ground truth" for the training/correlation set (the lots used to compare the two assays) was established by:

• Athymic Mouse Model: Historically, this in vivo model was used to determine the osteoinductive potential of DBM. "Standard testing performed in an athymic mouse model... must prove positive for lot release."
• The BMP-2 ELISA results were then compared to these established athymic mouse model results to show correlation. The document implies that the positive/negative outcome of the athymic mouse model served as the gold standard for validating the ELISA's accuracy in predicting osteoinductivity.

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DBX® is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX® Putty, Paste, and Mix may be used in the extremities and pelvis. DBX® Putty may also be used in the posterolateral spine and cranium. DBX® is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Putty can be used as an extender in the spine with autograft. DBX® can be used with bone marrow. DBX® is intended for single patient use only.

DBX® is intended for single patient use only. DBX® Demineralized Bone Matrix is available in three forms: Paste, Putty and Mix. DBX® products are completely resorbable. DBX® Paste and Putty are composed of cadaveric cortical bone; the DBX® Mix is composed of cadaveric corticocancellous bone. The bone granules are mixed with sodium hyaluronate (NaHy) in varying combinations to form the DBX® Putty, Paste, and Mix. DBX® Putty is available in five sizes and DBX® Paste and Mix are available in four sizes.

This document describes the safety and effectiveness of the DBX® Demineralized Bone Matrix Putty, Paste, and Mix, focusing on changes to the osteoinductivity assay for the Putty product. There is no information provided in the given text regarding a complete study design with acceptance criteria and reported device performance in the typical format of a clinical or analytical study. Instead, the information pertains to the regulatory clearance of a medical device based on its substantial equivalence to a predicate device and specific performance tests for osteoinductivity.

Therefore, many of the requested sections (e.g., sample size for the test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, training ground truth establishment) cannot be answered because they are not present in the provided 510(k) summary. The information given focuses on lot release testing and viral inactivation rather than a comprehensive, standalone device performance study as typically understood in the context of clinical trials or AI/diagnostic device validation.

However, based on the provided text, I can extract information related to the osteoinductivity testing aspect, which serves as a critical performance attribute for this device.

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

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

• Osteoinductivity (Athymic Mouse Model/Alkaline Phosphatase Assay): The text states that "Every lot of final DBX® Paste and DBX® Mix product will be assayed in vivo" and "Every lot of final DBX® Putty product will be tested." The exact sample size per lot for these internal quality control tests is not specified, nor is the cumulative number of lots tested.
• Data Provenance: The athymic mouse model is an in vivo animal model. The alkaline phosphatase assay is an in vitro laboratory test. These are internal company assays for lot release, not clinical studies in human subjects. The phrase "long history of safe and effective clinical use" refers to retrospective information but is not tied to a specific "test set" in the context of this 510(k) submission.

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: The evaluation of osteoinductivity in the athymic mouse model or alkaline phosphatase assay does not typically involve human expert consensus for "ground truth" in the way a diagnostic imaging study would. The assays produce objective results (e.g., positive for osteoinduction).

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

• Not Applicable: Adjudication methods are typically used when subjective expert interpretation is a key component of ground truth establishment, often in medical imaging or clinical trials. The described osteoinductivity tests are objective laboratory/animal model assays.

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 device is a bone void filler, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

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

• Not Applicable: This device is a biological implant, not an algorithm. The concept of "standalone performance" for an algorithm is not relevant here.

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

• For Osteoinductivity: The ground truth is biochemical/biological evidence of bone formation (osteoinduction) as demonstrated by the athymic mouse model (an in vivo biological assay) or a validated in vitro alkaline phosphatase assay confirmed to correlate positively with the in vivo model. This is essentially a biological assay outcome.
• For Biocompatibility: Ground truth is established by compliance with ISO 10993 standards and a history of clinical use.
• For Sterility: Ground truth is established by USP microbiological testing.
• For Viral Clearance: Ground truth is established by laboratory studies demonstrating viral inactivation potential.

8. The sample size for the training set:

• Not Applicable in the traditional sense: This device is cleared based on equivalence to a predicate and performance in specific biological assays for lot release, not by a machine learning model that requires a training set. The "modified DBX® Putty" is based on the "fundamental scientific technology... the same as the technology for the unmodified predicate," meaning the prior knowledge and data from the predicate device (K040262) serve as a baseline for the modified product.

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

• Not Applicable: As there is no "training set" in the context of machine learning, this question is not relevant. The substantial equivalence argument relies on prior established safety and effectiveness of the predicate device and the new assays' ability to reliably confirm osteoinductivity.

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DBX® Putty and Paste are intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral/maxillofacial and dental intraosseous defects including: Ridge augmentation, Filling of extraction sites, Craniofacial augmentation, Mandibular reconstruction, Repair of osseous defects of the jaws, Filling of cystic defect, Filling of lesions of periodontal origin, Filling of defects of endodontic origin, Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture, Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall. DBX® Mix is intended for mandibular reconstruction only. DBX® is intended for single patient use only.

DBX® is intended for single patient use only. DBX® Demineralized Bone Matrix is available in three forms: Paste, Putty and Mix. DBX® products are completely resorbable. DBX® Paste and Putty are composed of processed human cortical bone; the DBX® Mix is composed of processed human corticocancellous bone. The bone granules are mixed with sodium hyaluronate ("NaHA") in varying combinations to form the DBX® Putty, Paste and Mix. All versions of DBX® are available in five sizes. DBX® is osteoconductive and has been shown to have osteoinductivity potential in the athymic mouse model. It is unknown how the osteoinductivity potential, measured in the athymic mouse model, will correlate with clinical performance in human subjects.

This document is a 510(k) summary for the DBX® Demineralized Bone Matrix product. It describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information. The provided text is a regulatory submission for a medical device (a 510(k) premarket notification), which typically aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than present a study against specific performance acceptance criteria.

The information you've asked for (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) are commonly found in clinical study reports or performance testing documentation for devices that have undergone such evaluations. This 510(k) summary does not include that level of detail regarding device performance or formal studies as would be expected for demonstrating adherence to specific acceptance criteria.

Key takeaway from the document:

• Device: DBX® Demineralized Bone Matrix (Putty, Paste, and Mix).
• Intended Use: Augmentation of deficient maxillary and mandibular alveolar ridges and treatment of various oral/maxillofacial and dental intraosseous defects.
• Regulatory Decision: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
• Performance Claim: The device is osteoconductive and has shown osteoinductive potential in an athymic mouse model, but it is unknown how this correlates with human clinical performance. It has not been proven osteoinductive in a human model.

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DBX® Demineralized Bone Matrix is intended for use as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. DBX® Putty can be used to fill bone voids in the extremities, posterolateral spine, pelvis and cranium. DBX® Paste and Mix can be used to fill bone voids in the extremities and pelvis. It is indicated for use in the treatment of surgically-created osseous defects or osseous defects created from traumatic injury.

DBX® is intended for use as a Demineralized Bone Matrix for voids or gaps that may be and and sectors. It can be used in the:

It is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.

DBX® is for single patient use only.

DBX® is intended for single patient use only. DBX® Demineralized Bone Matrix is available in three forms: Paste, Putty and Mix. DBX® products are completely resorbable. DBX® Paste and Putty are composed of processed human cortical bone; the DBX® Mix is composed of processed human corticocancellous bone. The bone granules are mixed with sodium hyaluronate ("NaHA") in varying combinations to form the DBX® Putty, Paste and Mix. All versions of DBX® are available in five sizes.

This document is a 510(k) summary for the DBX® Demineralized Bone Matrix products. It focuses on regulatory approval and product description rather than a detailed study proving performance against acceptance criteria in the typical sense of a medical device with measurable outcomes like accuracy or sensitivity.

Instead, the "acceptance criteria" here refer to proving the device's osteoinductive potential to show substantial equivalence to legally marketed predicate devices. The "study" proving this is an in vivo assay.

Here's a breakdown of the requested information based on the provided text, acknowledging that some details common in AI/diagnostic device studies are not applicable or explicitly stated here:

Acceptance Criteria and Device Performance

Note: The provided text is a regulatory submission for a bone void filler focusing on "substantial equivalence" to predicate devices, which means it doesn't typically include a clinical study with traditional acceptance criteria for performance metrics like sensitivity, specificity, or accuracy, as would be found for a diagnostic AI device. The primary "performance" aspect highlighted is the osteoinductive potential, which is a biological activity.

Additional Study Information:

1. 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 "DBX® is assayed in vivo for its osteoinductive potential." This implies an animal model or in vivo biological assay.
   • Sample Size: Not specified for the in vivo assay.
   • Data Provenance: Not specified. Given it's a US regulatory submission, the assay was likely conducted in the US, but this is not explicitly stated.
   • Retrospective or Prospective: Unspecified, but in vivo assays are typically prospective experiments.

2. 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 question is not applicable in the context of an in vivo osteoinductivity assay. Ground truth would be established by histological examination or other biological markers by qualified scientific personnel, not by medical experts interpreting images or clinical data as in a diagnostic study. The document does not provide details on such personnel.

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

   • Not applicable for an in vivo osteoinductivity assay.

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:

   • Not applicable. This device is a bone void filler, not an AI or diagnostic tool.

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

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

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

   • For the osteoinductive potential, the "ground truth" would be the biological evidence of new bone formation obtained through methods like histology, radiography, or biomechanical testing in the in vivo assay. Specifics are not provided in the document beyond "assayed in vivo."

7. The sample size for the training set:

   • Not applicable. This device is a bone void filler, not an AI model requiring a training set.

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

   • Not applicable, as there is no training set for an AI model.

In summary, the provided document is a regulatory submission for a medical device (bone void filler) under a 510(k) pathway, which focuses on demonstrating substantial equivalence. The "study" mentioned refers to an in vivo assay for osteoinductivity, a biological characteristic, rather than a clinical trial or performance evaluation of a diagnostic or AI device. Therefore, many of the requested details, which are standard for AI or diagnostic device studies, are not present or applicable in this regulatory filing.

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