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Accell Evo3c™ is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the posterolateral spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

The Accell Evo3c™ is an extension to the Accell Family of products cleared under 510(k) K061880. The Accell Family of products, including Accell Evo3c™, contain human demineralized bone matrix (DBM) in particulate and dispersed forms. The Accell Evo3c™ is the same as Accell A2i, submitted under 510(k) K061880, with the exception of the inclusion of cancellous bone chips which are added as an osteoconductive scaffold. The Accell A2i is marketed under the brand name "Accell Evo3™," hence the "c" in Accell Evo3c™ denotes the inclusion of cancellous chips in the formulation.

This document is a 510(k) summary for the ACCELL EVO3C™ bone void filler, asserting its substantial equivalence to previously cleared predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study for a diagnostic AI device would.

Instead, the "acceptance criteria" here refer to the regulatory requirements for demonstrating "substantial equivalence" of a new medical device to a predicate device, as per FDA's 510(k) pathway. The "study that proves the device meets the acceptance criteria" refers to the verification testing and characterization that supports this claim of substantial equivalence.

Here's an breakdown based on the provided text, recognizing that the context is a regulatory submission for a bone void filler, not an AI or diagnostic device:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is not a diagnostic AI device, there are no typical performance metrics like sensitivity, specificity, or AUC with corresponding acceptance criteria. Instead, the "acceptance criteria" are related to demonstrating substantial equivalence in terms of technical characteristics, safety, and functionality compared to predicate devices. The "reported device performance" refers to the results of various tests demonstrating these equivalencies.

• Osteoinductive Potential: Each lot of DBM is tested using a quantitative in vitro assay validated to correlate with an athymic mouse osteoinductive potential assay.
• Viral Inactivation Validation: Methods for processing DBM were evaluated for viral inactivation potential against a panel of viruses, demonstrating suitable inactivation. The cancellous bone component, while not demineralized, is processed in AATB-recommended antimicrobial, antiviral, and antiseptic solutions, and multiple safeguards (donor screening, serologic testing, tissue cleaning, terminal sterilization) are in place to mitigate viral transmission risk. |
  | Safety and Effectiveness: No new questions of safety/efficacy. | "All necessary verification testing has been performed for the Accell Evo3c™ product to assure substantial equivalence to the predicate device." The viral inactivation validation demonstrates safety measures against potential pathogens. |

"Study That Proves the Device Meets the Acceptance Criteria":

The "study" cited is the sum of verification testing performed for the Accell Evo3c™ product, specifically mentioned under "5.5 Performance Data". This testing aimed to assure substantial equivalence to the predicate device.

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

This is not applicable in the context of an AI device's test set for a 510(k) submission of a bone void filler.

• The "test set" here refers to the materials used in the specific verification tests (e.g., lots of DBM, samples of cancellous bone).
• For Osteoinductive Potential, each "lot of DBM" is tested. The specific number of lots or samples per lot is not provided. The testing involves an in vitro assay validated against an athymic mouse osteoinductive potential assay.
• For Viral Inactivation Validation, "a selected panel of viruses representing various virus types, sizes, shapes and genomes" was evaluated. The exact number of viruses or samples is not specified.
• Data Provenance: The human DBM is from human donors. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, as these are lab-based verification tests rather than clinical studies.

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

Not applicable. "Ground truth" in the context of this device refers to the established biological and material properties, rather than expert consensus on diagnostic imaging. The "truth" of osteoinductivity is determined by validated in vitro and in vivo (athymic mouse) assays. The efficacy of viral inactivation is determined by established microbiological validation methods.

4. Adjudication Method for the Test Set:

Not applicable. There is no expert adjudication for these types of material property tests. The tests themselves provide objective measurements.

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

No. This is a bone void filler, not a diagnostic imaging device with human readers.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used:

• Osteoinductive Potential: The ground truth is established through a quantitative in vitro assay that has been "validated to correlate to an athymic mouse osteoinductive potential assay." So, an in vitro assay correlated to an animal model.
• Viral Inactivation Validation: The ground truth is the demonstrable reduction or inactivation of a "panel of viruses" by the processing methods, measured using standard microbiological validation techniques.

8. The Sample Size for the Training Set:

Not applicable. This is a medical device (bone void filler) and not an AI 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 this type of device.

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Accell TBM-R is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The products are indicated for use as bone graft extenders, bone void fillers or bone graft substitutes in the extremities, pelvis and spine (i.e. posterolateral spine fusion). The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

The Accell TBM-R is an extension to the Accell Family of Products 510(K) K061880. The Accell Family of Products, including Accell TBM-R, contain human demineralized bone matrix (ground, demineralized cortical bone). The Accell TBM-R is an addition to the Accell product family which has improved ease of use in handling characteristics and manual manipulation of the device.

The provided document describes a Bone Void Filler device called Accell TBM-R, which is an extension of the existing Accell Family of Products. This is a 510(k) submission, indicating a focus on demonstrating substantial equivalence to a predicate device rather than a comprehensive study to establish novel performance criteria. Therefore, the information typically found in a study demonstrating how a device meets specific acceptance criteria for a novel AI/medical imaging device is largely absent.

Below is an analysis based on the provided text, highlighting what is available and what is not in the context of your request:

Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy, or a quantitative measure of bone healing). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to existing legally marketed predicate devices.

Study Information (as requested for an AI/Medical Imaging Device)

Based on the provided text, the following aspects related to a "study proving the device meets acceptance criteria" for an AI/Medical Imaging device are not applicable or not present:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document describes a medical device (bone void filler), not an AI/medical imaging device that would typically have a test set of data. The "test set" here refers to the verification tests for the material properties and biological aspects of the DBM and the product itself.

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): Not applicable. "Ground truth" in the context of an AI/medical imaging device usually refers to expert interpretation of medical images or pathology results. For this bone void filler, the "ground truth" for certain characteristics would be established by scientific testing and biological assays.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of medical images, which is not the subject of this submission.

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-assisted diagnostic or imaging device.

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 material, not a standalone algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the osteoinductive potential, the "ground truth" is a correlation to an athymic mouse osteoinductive potential assay which is considered a validated model. For viral inactivation, the "ground truth" is the effective reduction of a selected panel of viruses. For ease of use/handling, the implied "ground truth" is user feedback or internal assessment comparing it to the predicate.

7. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning.

8. How the ground truth for the training set was established: Not applicable.

Summary of Relevance

This 510(k) submission for Accell TBM-R focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Similar intended use.
• Similar technological characteristics (composition, principle of operation).
• Laboratory testing for biological activity (osteoinductive potential correlating to an animal model) and safety (viral inactivation).
• Improved handling characteristics, which generally means improved ergonomics and ease of application for the user.

The document does not contain the type of clinical study data with detailed acceptance criteria, sample sizes, and ground truth establishment that would be typically found for a novel AI/medical imaging device. The "proof" of meeting "acceptance criteria" is primarily the demonstration of equivalence through bench testing and comparison to predicates, which is standard for 510(k) submissions of this type of medical device. The "acceptance criteria" are broad and relate to safety, efficacy (as demonstrated by biological function and equivalence), and intended use.

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For orthopedic use, the OrthoBlast II Paste and Putty are intended for use as an autograft extender (extremities, spine and pelvis) and as a bone void filler (extremities and pelvis) for bony voids or gaps that are not intrinsic to the stability of the bony structure. The OrthoBlast II products are indicated to be packed gently into bony defects of the skeletal system. These defects may be surgically created or from the result of traumatic injury to the bone

OrthoBlast® II DBM Putty and Paste is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous chips from the same donor, and then formulated to a paste or putty-like consistency.

OrthoBlast® II DBM Putty and Paste are osteoconductive and osteoinductive bone filling material. The osteoinductive potential is demonstrated in athymic mouse model.

The provided text describes a 510(k) premarket notification for a medical device (OrthoBlast® II DBM Putty and Paste), seeking expanded indications for use. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with specific acceptance criteria and detailed quantitative results for the device itself.

Therefore, many of the requested categories related to a performance study for AI devices (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this document.

However, I can extract information related to the device's characteristics, its intended use, and the basis for its clearance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable: This document describes a 510(k) premarket notification for a medical device (bone graft material), not a study evaluating an AI device or a diagnostic test with a "test set" in the context of AI/diagnostics. The primary evidence presented is substantial equivalence to legally marketed predicate devices, material characterization, and an animal model for osteoinductivity.

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

• Not Applicable: See point 2.

4. Adjudication method for the test set

• Not Applicable: See point 2.

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 device.

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

• Not Applicable: This is not an AI device.

7. The type of ground truth used

• For the osteoinductivity claim, the "ground truth" was established through an athymic mouse model. For the overall device clearance, the "ground truth" for safety and effectiveness was largely based on demonstrating substantial equivalence to legally marketed predicate devices, supported by materials data and the results from the animal model.

8. The sample size for the training set

• Not Applicable: There is no "training set" in the context of this traditional medical device submission. The device is manufactured from human bone tissue; the "sample size" of donors or processed material is not detailed as a "training set."

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

• Not Applicable: See point 8.

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OrthoBlast® II is an osteoinductive and osteoconductive bone filling material indicated: OrthoBlast® II is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. OrthoBlast" II is included to be packed gently mo bony gapo in the exercial see defects may be surgically created or from the result of traumatic injury to the bone.

OrthoBlast® II is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous bone from the same donor, and formulated to a gel or putty-like consistency.

Here's a breakdown of the acceptance criteria and the study information for the IsoTis OrthoBiologics OrthoBlast® II device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly define quantitative "acceptance criteria" in the typical sense (e.g., minimum sensitivity, specificity, or specific numerical outcomes). Instead, it describes performance deemed sufficient for substantial equivalence. The "reported device performance" refers to the outcomes of the tests conducted.

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

• Viral Inactivation Validation: Not specified. A "selected panel of viruses" was used. The study type is not explicitly stated as retrospective or prospective, but it's a validation study of the processing methods.
• Osteoinductive Potential:
  • In vitro assay: Not specified regarding the number of samples for the in vitro assay validation itself.
  • In vivo validation (athymic rat model): 67 individual test lots of DBM.
  • Data Provenance: Not specified, but likely from laboratory studies.
• Product Performance Testing (Animal Models): Not specified (e.g., number of animals). "Performance of OrthoBlast II DBM has been evaluated in sheep and rabbit models." The study type is likely prospective animal testing.

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

• Viral Inactivation: Not applicable. Ground truth is determined by lab tests measuring viral inactivation.
• Osteoinductive Potential: Not applicable to human experts. The ground truth for the in vivo validation was "confirmation of intramuscular bone formation" in the athymic rat model, likely assessed by histopathology, which would involve trained histologists, but the number and qualifications are not specified.
• Product Performance Testing (Animal Models): Not applicable to human experts in the context of establishing ground truth for the device's performance directly. The performance was evaluated by "histological methods," which would involve trained histologists, but their number and qualifications are not specified.

4. Adjudication Method for the Test Set

Not applicable to the studies described. The studies are laboratory and animal-based, measured against objective endpoints (viral inactivation metrics, alkaline phosphatase activity, confirmation of bone formation via histology), rather than human interpretation requiring adjudication.

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

No. An MRMC comparative effectiveness study involving human readers is not mentioned.

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

Yes, in a conceptual sense. The studies described (viral inactivation, in vitro and in vivo osteoinductivity, animal performance) assess the device's inherent biological and physical properties and performance characteristics in isolation, without human-in-the-loop interaction as would be relevant for diagnostic AI.

7. The Type of Ground Truth Used

• Viral Inactivation: Laboratory measurements of viral reduction/inactivation.
• Osteoinductive Potential:
  • For the in vitro assay: Alkaline phosphatase activity levels compared to controls.
  • For the in vivo validation: Histological confirmation of intramuscular bone formation in athymic rats.
• Product Performance Testing (Animal Models): Histological assessment of bone healing/ingrowth in sheep and rabbit models.

8. The Sample Size for the Training Set

• Viral Inactivation Validation: Not applicable, as this is a validation of processing methods, not a "training set" for an algorithm.
• Osteoinductive Potential: Not applicable. While the in vitro assay was "validated against" the in vivo model, it's not a machine learning training set. The 67 test lots mentioned are for validating the in vitro assay's correlation with in vivo results, rather than training an algorithm.
• Product Performance Testing (Animal Models): Not applicable. These are performance studies, not training sets.

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

Not applicable, as no machine learning "training set" is described for this device. The studies are evaluating the biological and material properties of the bone void filler.

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For orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. Connexus is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender and as a bone void filler of the extremities and pelvis. These defects may be surgically created or the result of traumatic injury to the bone.

IsoTis OrthoBiologics is expanding the range of sizes previously cleared in 510(k) K050690 to include Connexus, 0.5cc. The intended use of this additional size does not change from that previously cleared.

Connexus is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with an inert reverse phase carrier and formulated to a putty-like consistency.

The carrier is a solution of polyethylene oxide polypropylene oxide block copolymer dissolved in water exhibiting reverse phase characteristics (i.e., an increase in viscosity as temperature increases).

Here's a breakdown of the acceptance criteria and the study information for the Connexus, 0.5cc device, based on the provided text:

Acceptance Criteria and Device Performance

The provided document, a 510(k) Summary for Connexus, 0.5cc, does not explicitly state quantitative acceptance criteria for its performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Connexus, K050690) and adherence to various standards and validated processes.

The "reported device performance" is described in terms of the results of these tests and validations, rather than specific numerical targets met.

Table of Acceptance Criteria and Reported Device Performance

Study Details

This document describes a pre-market notification (510(k)) for a medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting large-scale clinical trials. The "studies" mentioned are primarily pre-clinical or in-vitro validations.

Here's a breakdown of the specific points requested:

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

   • Viral Inactivation Validation: "A select panel of viruses representing various virus types, sizes, shapes, and genomes were evaluated." (Specific number not provided). Data provenance is from in vitro laboratory validation.
   • Osteoinductivity Potential (DBM component):
     • In vitro assay: Not specified, but each lot of DBM is tested.
     • In vivo athymic rat model validation: "67 out of 67 test lots" that passed the in vitro assay were confirmed in the in vivo model. This indicates a sample size of 67 athymic rat tests. Data provenance is from in vivo animal testing.
   • Overall Product Performance: Evaluated in "rabbit and sheep models." (Specific sample sizes not provided). Data provenance is from in vivo animal testing.

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

   • The document does not mention human experts establishing ground truth for the presented studies.
   • For the osteoinductivity study, the "ground truth" (or validation reference) for the in vitro assay was the in vivo athymic rat model (confirmation of intramuscular bone formation).
   • For animal performance studies, ground truth was established by "radiographic and histological methods" which would typically involve qualified veterinary pathologists or radiologists, but no specific number or qualifications are mentioned.

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

   • Not applicable/Not mentioned. The studies described are lab validations and animal studies, not human reader assessments requiring adjudication.

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 studies are mentioned. This device is a bone void filler, not an AI-powered diagnostic tool.

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

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

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

   • Viral Inactivation: Laboratory validation of viral reduction efficacy (presumably based on standard laboratory assays and controls).
   • Osteoinductivity Potential:
     • In vitro: Alkaline phosphatase activity assay (biochemical marker).
     • In vivo (for validation of in vitro assay): Histological confirmation of intramuscular bone formation in athymic rats (pathology).
   • Overall Product Performance (animal models): Radiographic and histological methods (imaging and pathology).

7. The sample size for the training set:

   • Not applicable as this is not an AI/machine learning product requiring a training set in the conventional sense. The "training" for the DBM osteoinductivity assay involved validating it against 67 athymic rat cases.

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

   • If we consider the validation of the in vitro osteoinductivity assay as a "training" of the assay to predict in vivo performance, then the ground truth for its validation was established by histological confirmation of intramuscular bone formation in athymic rats.

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DynaGraft II Dental is a bone filling material indicated for augmentation or reconstructive treatment of alveolar ridge. This includes:

• Filling of defects after root resection, apicoectomy and cystectomy -
• Filling of extraction sockets to enhance preservation of the alveolar ridge -
• Elevation of maxillary sinus floor -
• Treatment of periodontal defects -

DynaGraft® II Dental is derived from selected donated human borne tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier and formulated to a gel or putty-like consistency.

The provided text is a 510(k) summary for the DynaGraft® II Dental device. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain acceptance criteria or study data demonstrating performance against specific metrics.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The document notes "Pre-clinical animal data and clinical data demonstrate that DynaGraft® II support bone ingrowth and stimulates active bone formation in a variety of bony defects," but it does not provide specific performance metrics or acceptance criteria for these outcomes.
2. Sample size used for the test set and the data provenance: This information is not explicitly stated. The document mentions "clinical case studies" but does not specify their size or origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method for the test set: This information is not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: This information is not present.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: The device is a "human bone graft material," not an AI algorithm, so this question is not applicable.
7. The type of ground truth used: The document refers to "bone ingrowth and stimulates active bone formation" and "bone repair," which would likely be assessed through histological examination or imaging in pre-clinical and clinical studies. However, the specific methodology for establishing
   "ground truth" (e.g., pathology, expert consensus) is not detailed.
8. The sample size for the training set: This information is not applicable as the device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: This information is not applicable.

Summary of what is available from the document:

• Device Name: DynaGraft® II Dental
• Intended Use: Bone filling material for augmentation or reconstructive treatment of the alveolar ridge, including filling defects after root resection, apicoectomy, and cystectomy; filling extraction sockets; elevation of the maxillary sinus floor; and treatment of periodontal defects.
• Predicating Device: Tissue Bone Matrix Sponge (K960267) and autograft.
• Basis for Substantial Equivalence: Similar design, construction, and function to predicate devices, with the main human component (donor DBM) being the same. Both are osteoconductive and have osteoinductive potential, providing a scaffold for bone ingrowth and stimulating bone growth. Differences in carriers (collagen for TBM vs. reverse phase carrier for DynaGraft II) were deemed not to affect safety or effectiveness as they are all resorbable and perform the same function.
• Testing Mentioned: Pre-clinical animal data and clinical data, biocompatibility, extensive bench and animal testing, and clinical case studies to confirm device resorption and bone healing. It also states that "Demineralized bone has been used in clinical practice for more than 25 years with no remarkable safety issues."

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For orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. Connexus is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender and as a bone void filler of the extremities and pelvis. These defects may be surgically created or the result of traumatic injury to the bone.

Connexus is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with an inert reverse phase carrier and formulated to a putty-like consistency. The carrier is a solution of polyethylene oxide polypropylene oxide block copolymer dissolved in water exhibiting reverse phase characteristics (i.e., an increase in viscosity as temperature increases).

The provided text describes the 510(k) summary for the Connexus Putty, a bone void filler. It details the device, its intended use, and substantial equivalence to predicate devices, but it does not contain specific acceptance criteria or a dedicated study demonstrating how the device meets such criteria through quantitative performance metrics.

Instead, the document focuses on demonstrating substantial equivalence primarily through:

• Technological Characteristics: Stating similarities in design, materials, and function with predicate devices, and that both are osteoconductive and osteoinductive.
• Viral Inactivation Validation: Describing a study that evaluated the viral inactivation potential of the DBM processing methods.
• Osteoinductivity Potential: Explaining an in vitro assay for osteoinductive potential of the DBM, validated against an in vivo athymic rat model.
• Product Performance Testing: Mentioning evaluations in rabbit and sheep models for safety and effectiveness, but without presenting specific performance data or acceptance criteria.

Therefore, many of the requested details cannot be extracted directly from this document because it is a 510(k) summary focused on substantial equivalence rather than a full study report with detailed acceptance criteria and performance data.

Here's an attempt to answer based on the available information:

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

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

• Viral Inactivation Validation: No specific sample size mentioned for viruses, just "a select panel of viruses." No data provenance specified.
• Osteoinductivity Potential (Test Set):
  • In vivo athymic rat model: 67 test lots were evaluated.
  • Data Provenance: Not specified, but likely laboratory-based. The study appears to be prospective in nature for validation, and then individual lots are tested prospectively.
• Product Performance Testing (Animal Models): Samples for "rabbit and sheep models" were used, but specific numbers are not provided. The data is likely prospective experimental data from these animal studies.

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 ground truth for viral inactivation is laboratory-based (viral assays). For osteoinductivity, it's based on biochemical markers (alkaline phosphatase) and histological confirmation of bone formation in rats, not expert review of images or clinical outcomes. For the animal performance studies, evaluation by "radiographic and histological methods" likely implies expert interpretation (e.g., veterinary pathologists, radiologists) but the number or qualifications are not stated.

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

Not applicable. This type of adjudication is typically for image-based diagnostic studies or clinical outcomes, which are not the primary focus of the performance data presented 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

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

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

Not applicable. This device is a physical medical device.

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

• Viral Inactivation: Direct viral load measurements and inactivation assays.
• Osteoinductivity:
  • In vitro: Alkaline phosphatase activity (biochemical marker).
  • In vivo (rat model): Histological confirmation of intramuscular bone formation (pathology/histology).
• Product Performance: Radiographic and histological findings in animal models (pathology/histology, imaging interpretation).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI or machine learning algorithm requiring a "training set" in the conventional sense. The "validation" of the in vitro osteoinductivity assay against the in vivo model could be considered a form of training/validation, where the 67 test lots served to establish the correlation.

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

Not applicable in the typical AI sense. For the osteoinductivity assay validation, the ground truth for the in-vitro assay was established by correlating its results with the in-vivo osteoinductivity confirmed via histological analysis of intramuscular bone formation in athymic rats.

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DynaGraft® II is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. DynaGraft® II is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender (extremities, spine, and pelvis) and as bony void filler of the extremities and pelvis. These defects may be surgically created or the result of traumatic injury to the bone.

DynaGraft II is derived from selected donated human bone tissue that has been processed into particles. The demineralized bone matrix (DBM) is combined with a hydrogel carrier and formulated to a gel or putty-like consistency. The carrier is a solution of polyethylene oxide polypropylene oxide block copolymer exhibiting reverse phase characteristics (i.e., an increase in viscosity as temperature increases).

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the DynaGraft II device:

Important Note: The provided document is a 510(k) Summary, which is a premarket notification to the FDA demonstrating substantial equivalence to a legally marketed predicate device. This type of document focuses on demonstrating equivalence rather than providing exhaustive details of standalone clinical trials for novel devices. As such, some of the information requested in your prompt (e.g., specific acceptance criteria for performance metrics, detailed statistical findings from a comparative effectiveness study, or precise sample sizes for human readers in an MRMC study) is not explicitly present in this summary.

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Viral Inactivation (Test Set): A "select panel of viruses" was used, representing "various virus types, sizes, shapes, and genomes." The exact number of viruses is not specified.
  • Data Provenance: Not explicitly stated, but implies laboratory testing performed by the manufacturer.
• Osteoinductivity (In Vivo Correlation Test Set): 67 test lots of DBM were assessed.
  • Data Provenance: Not explicitly stated, but implies laboratory and animal (athymic rat) testing.
• Product Performance (Animal Models): Conducted in "rabbit and sheep models." The specific number of animals or cases is not provided.
  • Data Provenance: Animal studies.
• Product Performance (Clinical Studies): "Clinical studies using DynaGraft II DBM Putty and Gel have been performed." The number of patients/cases is not specified.
  • Data Provenance: "Clinical studies" implies human data, but details like country of origin or prospective/retrospective nature are not given.

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

This information is not provided in the 510(k) summary. Given the nature of the studies (viral inactivation, in vitro osteoinductivity, animal models, and general "clinical studies" for "acceptable outcomes"), it's unlikely that "experts to establish ground truth" (in the sense of independent clinical review of images/data) would be explicitly detailed in this type of submission. The ground truth for the non-clinical studies would typically be based on established biological assays, histological analysis, and radiographic interpretation by trained personnel. For "clinical studies," the "acceptable outcomes" would likely have been determined by primary investigators.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the studies, formal adjudication methods (like 2+1 or 3+1 for imaging studies) are not described. For the osteoinductivity assay, the "correlation" against a positive and negative DBM control suggests a comparative methodology rather than expert adjudication of individual samples.

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

No, an MRMC comparative effectiveness study is not explicitly mentioned or described. The document refers to "clinical studies" demonstrating "acceptable outcomes," but these are not detailed as MRMC studies comparing human readers with and without AI assistance. The device is a bone void filler, not an AI-powered diagnostic tool, so such a study would not typically be applicable.

• Effect Size: Not applicable, as no such study was described.

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

Not applicable. DynaGraft II is a medical device (bone void filler), not an algorithm or AI system. Its performance is inherent to the material properties and biological activity, not an algorithmic output.

7. The Type of Ground Truth Used

• Viral Inactivation: Based on standard virological assays to detect viral clearance/inactivation levels.
• Osteoinductivity (In Vitro): Alkaline phosphatase activity in myoblast cells, with positive and negative DBM controls. This assay was then validated against an in vivo athymic rat muscle pouch model (a biological standard for osteoinductivity, where bone formation in the muscle pouch is the ground truth).
• Product Performance (Animal Models): Radiographic and histological methods for assessing new bone formation, integration, and other healing parameters.
• Product Performance (Clinical Studies): "Acceptable outcomes," which can refer to a variety of clinical endpoints such as fusion rates, pain reduction, functional improvement, lack of complications, etc. The specific outcome data is not provided in detail.
• Substantial Equivalence: Comparison to legally marketed predicate devices based on design, materials, function, and regulatory compliance.

8. The Sample Size for the Training Set

Not applicable. DynaGraft II is a manufactured device, not an AI model that requires a training set. The "training" for the device's development involves material science, biological research, process optimization, and manufacturing controls.

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

Not applicable, as there is no "training set" in the context of an AI algorithm.
For the development and optimization of the device itself, the "ground truth" during R&D would be established through a variety of methods:

• Material characterization: Chemical and physical tests to confirm composition and properties.
• Biocompatibility testing: In vitro and in vivo tests to ensure the material is not toxic or harmful.
• Process validation: Ensuring manufacturing processes consistently produce DBM with desired properties, including osteoinductivity. This relies on established biological assays (like the in vitro osteoinductivity assay validated against the athymic rat model) as a "ground truth" for material efficacy.

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OsSatura™ Dental is a bone filling augmentation material for used for augmentation or reconstructive treatment of alveolar ridge. This includes, filling of defects after root resection, apicoectomy and cystectomy, filling of extraction sockets to enhance preservation of the alveolar ridge, elevation of maxillary sinus floor and treatment of periodontal defects.

OsSatura™ Dental is a synthetic, osteoconductive bone void filler, which consists of a biphasic ceramic (e.g. hydroxyapatite/tri-calcium phosphate) scaffold. The open porous structure of OsSatura™ Dental is similar in structure to human cancellous bone. OsSatura™ Dental is available as irregular shaped chips of size 200μm -2000um.

This document, a 510(k) Summary for IsoTis NV OsSatura™ Dental, relies on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study proving those criteria are met for the device itself.

Therefore, many of the requested categories (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, training set details) are not applicable (N/A) in the context of this 510(k) submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• N/A. This submission is a 510(k) for substantial equivalence. It refers to "pre-clinical animal data" and "extensive bench and animal testing" but does not specify sample sizes for these tests in a way that aligns with a traditional "test set" for performance evaluation in the context of AI/software. The primary "data provenance" is the long history of safe clinical use of the material class and the predicate devices.

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

• N/A. Ground truth in the context of expert consensus is not relevant to this submission. The "ground truth" for the safety and effectiveness claims is derived from the established safety profile of the material class (calcium phosphates) and the safe use of predicate devices, as well as general biological principles verified in animal models.

4. Adjudication method for the test set:

• N/A. No formal adjudication method is mentioned as this is not a study requiring expert consensus on specific cases.

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:

• N/A. This device is a bone graft material, not an AI or diagnostic imaging device. Therefore, MRMC studies and "human readers" are irrelevant.

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

• N/A. This is a physical medical device (bone graft material), not an algorithm or software. "Standalone performance" in this context refers to the device's inherent material properties and biological performance, which were assessed through bench and animal testing.

7. The type of ground truth used:

• The "ground truth" for this submission is based on:
  • Established Material Standards: Compliance with ASTM F1185-88 and F1088-87 for hydroxyapatite and tricalcium phosphate.
  • Biological/Physiological Response: Demonstrated bone ingrowth, degradation, and resorption through pre-clinical animal data and extensive bench and animal testing.
  • Historical Clinical Data: Over 25 years of safe clinical use for calcium-based ceramic materials (hydroxyapatite and tri-calcium phosphate) and safe use of predicate devices.
  • Regulatory Guidance: Compliance with applicable FDA guidance documents on bone void fillers.

8. The sample size for the training set:

• N/A. This is not an AI/machine learning device. The concept of a "training set" is not applicable.

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

• N/A. As above, this is not an AI/machine learning device.

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Aspirex" - Bone Marrow Aspirate Kit is for the aspiration of bone marrow, autologous blood, plasma or other blood components with or without prefilling with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). The kit provides a convenient way to mix autologous blood or bone marrow with bone marrow with bone void filler and deliver to the orthopedic surgical site.

The Aspirex™ - Bone Marrow Aspirate Kit contains two piston syringes: Aspirating Syringe and Infusion Chamber Syringe. These piston syringes along with a single lumen Aspirating Needle, Stylet, Luer-lock Adaptor, Cleaning Rod, Mixing Bowl and Spatula make up the components of the Aspirex™ Kit (will be packaged in various configurations, sizes, and quantities of these components).

The provided document is a 510(k) summary for the IsoTis OrthoBiologics Aspirex™ - Bone Marrow Aspirate Kit. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or MRMC studies.

This type of submission primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed device (predicate) and does not typically require extensive clinical trials or performance studies if substantial equivalence can be established through design, materials, and intended use comparison.

Therefore, for your request, the following information cannot be extracted from the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not available.
• 2. Sample sized used for the test set and the data provenance: Not available.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
• 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 not an AI-assisted diagnostic tool).
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (this device is not an algorithm).
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available.
• 8. The sample size for the training set: Not applicable (this device is not a machine learning model).
• 9. How the ground truth for the training set was established: Not applicable (this device is not a machine learning model).

The document states that the Aspirex™ Kit is considered substantially equivalent to predicate devices based on "intended use, materials and design features." This type of submission does not detail performance testing against specific acceptance criteria in the way a diagnostic or AI device would.

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