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PliaFX® Flo is indicated for bony voids or gaps that are not intrinsic to the bony structure. It is indicated to be placed into the bony voids or gaps of the skeletal system (e.g., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. This product provides a bone void filler that remodels into the recipient's skeletal system.

PliaFX® Flo Flowable Demineralized Fibers is a sterile, freeze-dried, human bone allograft product consisting of demineralized bone matrix fibers combined with USP grade glycerol/glycerin. The subject device is pre-filled in a 3cc or 14cc delivery syringe based on product volume. The 3cc syringe configuration also includes an optional female luer cap.

This appears to be a 510(k) summary for a medical device called PliaFX Flo, a resorbable calcium salt bone void filler. The document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove performance against specific acceptance criteria.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria in the way typically found for software-based medical devices or diagnostic tools.

Instead, the summary focuses on non-clinical performance testing to demonstrate that the delivery syringe (a change from the predicate device) is capable of storing and delivering the bone void filler and does not raise different questions of safety or effectiveness.

Therefore, I cannot fulfill all parts of your request with the provided input. However, I can extract the relevant information regarding the non-clinical testing performed and the conclusions drawn:

Information available from the provided text:

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

The document doesn't explicitly define acceptance criteria in a table format with corresponding performance results in the context of a clinical or functional performance study for the bone void filler itself. Instead, it describes general non-clinical performance testing for the delivery syringe.

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

This information is not provided in the document. The document refers to "non-clinical performance testing" but does not detail the sample sizes or the origin of any data used for these tests.

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

This information is not applicable and therefore not provided. The document describes non-clinical engineering/mechanical testing of a delivery system, not a study requiring expert-established ground truth for clinical or diagnostic performance.

4. Adjudication method for the test set:

This information is not applicable and therefore not provided. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which is not the case for the described non-clinical testing.

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

This information is not applicable and therefore not provided. This device is a bone void filler and delivery system, not an AI-assisted diagnostic tool.

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

This information is not applicable and therefore not provided. This device is not an algorithm.

7. The type of ground truth used:

This information is not applicable in the usual sense of clinical ground truth (e.g., pathology, expert consensus). The "ground truth" for the described non-clinical tests would be defined by engineering specifications and physical measurements for mechanical properties (e.g., proper extrusion force, no leaks, correct delivered volume).

8. The sample size for the training set:

This information is not applicable and therefore not provided. There is no mention of a training set as this is not an AI/machine learning device.

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

This information is not applicable and therefore not provided. See point 8.

In summary: The provided document is a 510(k) summary focused on demonstrating substantial equivalence. The "study" mentioned is "non-clinical performance testing" of the device's delivery system (the syringe) to ensure it stores and delivers the bone void filler safely and effectively, and does not relate to the performance of the bone void filler itself in a clinical setting against specific acceptance criteria.

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Vivorté Trabexus™ EB" is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). Vivorté Trabexus™ EB™ is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté Trabexus™ EB" may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté Trabexus " EB" is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process.

Vivorté Trabexus™ EB™ is a moldable, self-setting, gradually resorbable, biocompatible, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). The device is provided in kit sizes of 3 cc. 5 cc. and 10 cc. corresponding to the amount of bone void filler produced when the components of the kit are mixed together.

This document describes a 510(k) premarket notification for the Vivorté Trabexus™ EB™ device. The submission primarily focuses on establishing substantial equivalence to a predicate device, the Vivorté BVF™. The core of the submission emphasizes that the only difference in the subject device is the inclusion of an additional accessory (a delivery cannula). As such, the presented information does not detail a study proving the device meets clinical acceptance criteria in the way one might expect for a novel therapeutic or diagnostic device. Instead, the "acceptance criteria" and "study" are primarily focused on non-clinical performance and equivalence to the predicate device.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Extrudability: The "Not applicable" result for extrudability is unusual for a bone void filler that is "applied to the defect through a cannula." This likely implies that the predicate device already demonstrated acceptable extrudability, and since the subject device is essentially the same formulation with just an added cannula, the company may have argued that the existing extrudability data on the formulation itself, or the new testing was not deemed necessary for the new device because it was simply an accessory. However, it is a significant omission if the new cannula itself was not tested for extrudability with the material.

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

The document does not specify sample sizes for the non-clinical tests (Biocompatibility, Bubble leak test, Heat seal strength). It also does not specify dates or countries of origin for these non-clinical tests, nor whether they were retrospective or prospective. This information would typically be detailed in a more comprehensive test report, not necessarily summarized in the 510(k) summary.

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

This question is not applicable to this submission. The "test set" described here relates to non-clinical engineering and material properties, not clinical diagnostic or therapeutic outcomes requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

This question is not applicable to this submission. Adjudication methods are used in clinical studies, typically for establishing ground truth or resolving discrepancies in readings. The tests performed are objective laboratory measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with vs. without AI Assistance

This question is not applicable to this submission. The Vivorté Trabexus™ EB™ is a medical device (bone void filler) and not an AI-powered diagnostic or therapeutic system. Therefore, an MRMC study related to AI assistance is not relevant.

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

This question is not applicable to this submission. As stated above, this is a medical device, not an algorithm.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the non-clinical tests, the "ground truth" is established by the predefined acceptance criteria for each test method (e.g., specific thresholds for biocompatibility, absence of bubbles, minimum seal strength). These are objective physical or chemical standards, not clinical outcomes or expert consensus.

8. Sample Size for the Training Set

This question is not applicable to this submission. There is no mention of a "training set" as this device does not involve machine learning or AI.

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

This question is not applicable to this submission. Since there is no training set, there is no ground truth establishment for it.

Summary of the Study and Acceptance Criteria (from the provided text's perspective):

The "study" described in the 510(k) Summary is primarily a non-clinical performance testing exercise aimed at demonstrating that the Vivorté Trabexus™ EB™ device, particularly with its new cannula accessory, maintains the safety and effectiveness characteristics of its predicate device, Vivorté BVF™.

The acceptance criteria are implied to be the successful completion ("Pass") of standard engineering and biocompatibility tests. The submission hinges on the argument that the subject device is "essentially the same as the predicate device" with only an added cannula accessory. The non-clinical testing was conducted "according to the design verification test methods indicated by the risk analysis." The successful passing of these tests forms the basis for demonstrating substantial equivalence and, by extension, that the device meets its core acceptance criteria for safety and performance in the context of this 510(k) submission. No clinical efficacy or safety studies were presented in this summary section, as substantial equivalence to a legally marketed predicate device often relies heavily on non-clinical data if the changes are minor.

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Vivorté BVF™ is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). Vivorté BVF™ is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté BVF™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process.

Vivorté BVF™ is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). Vivorté BVF™ is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté BVF™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ isothermically hardens in vivo to form a composite of a carbonated apatite (hydroxyapatite) and shaped particles of human bone that contain DBM. Vivorté BVF™ has a compressive and bending strength that is greater than that of human cancellous bone. The carbonated apatite (hydroxyapatite) which closely resembles the mineral phase of bone provides an osteoconductive scaffold and the shaped particles of human bone contain osteoinductive demineralized bone matrix (DBM). The composite device is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process. Vivorté BVF™ is provided in various kit sizes corresponding to the amount of bone void filler produced when the components of the kit are mixed together.

Each lot of allograft human bone in the Vivorté BVF™ is assayed for osteoinductive potential using an athymic mouse or rat model. The results of the osteoinductive potential testing may or may not be indicative of the osteoinductivity of Vivorté BVF™ in humans.

The provided document describes a 510(k) premarket notification for a medical device called Vivorté BVF™. A 510(k) submission generally aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval). Therefore, the concept of "acceptance criteria" as applied to a device's performance in a standalone clinical efficacy study might not directly align with the information typically found in a 510(k) summary.

Based on the provided text, the Vivorté BVF™ device is claiming substantial equivalence to two predicate devices: ETEX EquivaBone® Osteoinductive Bone Graft Substitute (K090855) and Synthes® Norian® SRS® Bone Void Filler (K011897). The "study" demonstrating this substantial equivalence is primarily focused on non-clinical testing.

Here's an analysis of the provided information in response to your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission focused on substantial equivalence, specific "acceptance criteria" for clinical performance are not explicitly detailed in the document in the way one might expect for a PMA or a de novo submission. Instead, the acceptance criteria are implicitly met by demonstrating comparable characteristics to the predicate devices through non-clinical testing.

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

• Test Set Sample Size: Not applicable in the context of a clinical test set for performance. The "test set" here refers to materials and animal models used for non-clinical and animal testing. Specific sample sizes for the chemical, physical, mechanical, biocompatibility, and animal testing are not provided in this summary.
• Data Provenance: The testing was performed by Vivorté, Inc. and its contractors. The country of origin for the data is implicitly the United States, where Vivorté, Inc. is located and operates. The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission.

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

• Number of Experts: Not applicable. Ground truth, in the clinical sense, would be established by medical experts for patient outcomes or diagnoses. No such clinical "ground truth" establishment is mentioned as part of this 510(k) submission. For the non-clinical and animal testing, the "ground truth" is defined by established scientific and regulatory standards (e.g., ISO, ASTM, USP) and laboratory protocols.
• Qualifications of Experts: Not specified. Testers performing the non-clinical and animal studies would be qualified scientists, engineers, and veterinarians/animal technicians relevant to their fields, but their specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical trials to resolve discrepancies in expert judgments for ground truth establishment. Since no clinical trials are described, this is not relevant. The "adjudication" for non-clinical tests typically involves adherence to validated methods and review by internal quality control or regulatory bodies.

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

• MRMC Study Done: No. An MRMC comparative effectiveness study is used to assess the impact of a device (often AI-assisted) on human reader performance in diagnostic tasks. Vivorté BVF™ is a bone void filler, not a diagnostic imaging device, and its 510(k) submission explicitly states: "Clinical testing was not necessary to determine substantial equivalence between Vivorté BVF™ and the predicate devices." Therefore, no MRMC study was conducted or is relevant.
• Effect Size of Human Readers with/without AI assistance: Not applicable.

6. Standalone Performance Study (Algorithm Only)

• Standalone Study Done: Not applicable. This question concerns the performance of an algorithm without human intervention, typically for AI/ML diagnostic devices. Vivorté BVF™ is a physical medical device, and the concept of "standalone performance" for an algorithm is not relevant. The performance of the physical device is established through the non-clinical (chemical, physical, mechanical, biocompatibility) and animal testing to show substantial equivalence.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" here is based on established scientific and regulatory standards and measurement techniques for material properties (chemical composition, physical properties, mechanical strength), biocompatibility, and animal responses (for osteoinductive potential of the DBM component). It is not pathology, expert consensus on patient outcomes, or human-specific clinical outcomes data, as clinical testing was not performed.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. A "training set" refers to data used to train an algorithm, typically in AI/ML applications. Vivorté BVF™ is not an AI/ML device. The non-clinical and animal testing involved samples of the device and biological models for evaluation, but these are not "training sets" in the AI/ML context.

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

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OsteoSelect® DBM Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony strtucture. OsteoSelect® DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect® DBM Putty can be used as follows: - Extremities . - Posterolateral spine - Pelvis

OsteoSelect® DBM Putty is processed human bone that has been demineralized and combined with an absorbable carrier that is biocompatible and biodegradable. The combination of demineralized bone and the absorbable carrier results in a putty-like consistency for ease and flexibility of use during surgical application. The carrier material is a mixture of carboxymethylcellulose (a wax-like material) and phosphate buffered saline (a dispersing agent). OsteoSelect® DBM Putty is virtually odorless, tan in color and can be spread easily with minimal adhesion to surgical gloves. OsteoSelect® DBM Putty is intended for use as a filler for voids or gaps that are not intrinsic to the stability of the bony structure. The putty will be absorbed within a period of 90 days.

The provided text describes a 510(k) summary for a medical device, OsteoSelect® Demineralized Bone Matrix Putty. It primarily focuses on demonstrating substantial equivalence to predicate devices based on manufacturing procedures, physical test results, shelf-life testing, functionality (efficacy testing), and biocompatibility.

However, the provided document DOES NOT contain information regarding:

• Acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy for an AI/algorithm).
• A "study" that proves the device meets these acceptance criteria in the context of an AI/algorithm for image analysis or diagnostics.
• Sample sizes for a test set or training set related to AI model evaluation.
• Details about ground truth establishment by experts, adjudication methods, or MRMC studies.
• Standalone performance (algorithm only) versus human-in-the-loop performance.

The "functionality (efficacy testing) results" mentioned refer to in vitro and in vivo biological tests for bone healing properties typical for a bone void filler, not an AI/ML diagnostic or predictive device. Specifically, it mentions:

• Viral inactivation potential: Evaluated with a panel of model viruses.
• Osteoinductive potential: Tested in an athymic rat model, with every final lot tested. The document explicitly states: "It is unknown how the osteoinductivity potential in the rat model correlates with human clinical performance."
• In vivo study: A report of an in vivo study was conducted to support use in the posterolateral spine. No details on this study's design, sample size, or outcomes are provided beyond its existence.

Therefore, it is not possible to fill out the requested table and answer the questions related to acceptance criteria and study proving device performance for an AI/ML device, as the provided text pertains to a traditional medical device (bone void filler) and not an AI/ML-driven product.

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

MAGNIFUSE® II Bone Graft is assembled by the clinician at the time of the procedure using the supplied human bone allograft tissue matrix mixed 1:1 with autograft tissue. The mixture is packed into a polyglycolic acid (PGA) resorbable mesh bag with the supplied injection molded plastic spatula, funnel, and plunger. This product enables clinicians to generate a construct having a particular physical form and handling property. No additional carrier is added to the allograft material. This MAGNIFUSE® II Bone Graft product was prepared from human bone tissue recovered from a cadaveric donor using aseptic surgical techniques and microbiologically tested during recovery. As a biological material, some variations in the product should be expected in both handling and appearance. The final product in packaged form was tested for sterility according to the procedures in the current U.S. Pharmacopoeia USP standard .

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

Key Takeaway: This submission is for a bone graft substitute, and its acceptance hinges on demonstrating substantial equivalence to a predicate device (GRAFTON® II eDBM) through non-clinical testing. The "acceptance criteria" here are implicitly tied to showing comparable performance to the predicate and established safety profiles. The study primarily focuses on fusion rates and host tolerance in a validated animal model.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a bone graft substitute demonstrating substantial equivalence, the "acceptance criteria" are not explicitly quantitative thresholds like you might find for an AI diagnostic device (e.g., AUC > 0.9). Instead, they are performance characteristics expected to be comparable to the predicate device to establish substantial equivalence.

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

• Sample Size for Non-Clinical Study: The document states "A Rabbit posterlateral lumbar fusion study was conducted..." but does not specify the exact number of rabbits used in the study. It refers to "All animals tolerated the graft material well," implying a group of subjects.
• Data Provenance: The data comes from a prospective animal study (rabbit posterolateral lumbar fusion study). The country of origin is not explicitly stated, but Medtronic Sofamor Danek USA is based in Memphis, Tennessee, suggesting a U.S.-based study.

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

• The non-clinical study involves animal models (rabbits and athymic rats) where "ground truth" would likely be established through histological analysis, radiography evaluation, and macroscopic observation.
• The document does not specify the number of experts or their qualifications (e.g., veterinary pathologists, orthopedic surgeons evaluating radiographs/histology) who assessed the outcomes of the rabbit study or the athymic rat assay. It refers to "scoring bone formation" in the rat assay, implying expert evaluation.

4. Adjudication Method for the Test Set

• The document does not describe an explicit adjudication method (like 2+1 or 3+1 consensus) for assessing the outcomes of the animal studies. Assessments like "comparable fusion rates" and "tolerated the graft material well" suggest evaluation by researchers, but the specific process for resolving discrepancies is not detailed.

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

• No. An MRMC comparative effectiveness study is designed to evaluate human reader performance with and without AI assistance, typically in diagnostic imaging. This submission is for a bone graft substitute and relies on non-clinical (animal) studies to demonstrate substantial equivalence, not human reader performance.

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

• Not applicable. This device is a bone graft substitute, not an algorithm or AI. Therefore, the concept of "standalone performance" for an algorithm doesn't apply. The performance evaluated is the biological performance of the graft material itself.

7. The Type of Ground Truth Used

• Animal Model Outcomes (Histology, Radiography, Macroscopic Observation):
  • For the rabbit posterolateral lumbar fusion study, the ground truth for "fusion rates" would likely be established by a combination of radiographic assessment and histological evaluation of the spinal segments. "Tolerance" would be based on clinical observation and potentially gross pathology.
  • For the athymic rat assay, the ground truth for "osteoinductivity" is established by "scoring bone formation at 28 days post implantation" using a "five-point linear scale (0, 1, 2, 3, 4)." This is a histological assessment.

8. The Sample Size for the Training Set

• The concept of a "training set" is relevant to machine learning algorithms. This submission is for a biological device (bone graft). Therefore, there is no "training set" in the context of AI or algorithms. The "training" for such a device is implicitly in the development and refinement of its manufacturing processes and material composition.

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

• As there is no "training set" in the AI/algorithm sense, this question is not applicable. The "ground truth" for the device's design and manufacturing is established through extensive material science, biological compatibility testing, and historical performance of similar predicate devices, which are all part of the product development and regulatory submission process.

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The SurFuse™ Gel, SurFuse™ Putty, ExFuse™ Gel, and ExFuse™ Putty products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are intended to be gently packed into bony voids or gaps of the skeletal system (posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

The SurFuse™ and ExFuse™ family of products are derived from human allograft bone tissue that is processed into a powder and demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a resorbable carrier, carboxymethylcellulose (CMC) and formulated into a putty or gel-like consistency. The ExFuse™ products also contain cancellous bone powder. The products are provided sterile for single patient use.

The provided text is a 510(k) summary for the HansBiomed Corp. SurFuse™ and ExFuse™ devices. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics typically seen for AI/ML-driven software as a medical device.

Therefore, the requested information specifically related to acceptance criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, and ground truth types are not available in the provided document, as these are primarily associated with the validation of AI/ML diagnostic or prognostic algorithms.

The document discusses safety and performance in a more general sense for a bone void filler product, focusing on biocompatibility, osteoinductivity, and osteoconductivity, rather than an AI/ML algorithm's analytical or clinical performance.

Here's a breakdown of what can be extracted and what is missing:

The device is a physical medical device (resorbable bone void filler), not an AI/ML software. Therefore, the parameters typically used to describe AI/ML studies are not relevant or present.

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for quantitative metrics in an AI context. Instead, the acceptance is based on demonstrating safety (biocompatibility, viral inactivation) and performance (osteoinductivity, osteoconductivity) through established biological and in vivo models.
• Reported Device Performance:
  • Safety:
    • Donor bone obtained from AATB-certified tissue banks, screened for infectious viruses.
    • Manufacturing and sterilization processes validated to inactivate HIV-1, Bovine Herpes Virus (BHV), Bovine Viral Diarrhea Virus (BVDV), Hepatitis A Virus (HAV), and Porcine Parvovirus (PPV).
    • Biocompatibility testing (according to ISO 10993) performed, demonstrating devices are safe, nontoxic, and biocompatible.
  • Performance:
    • Osteoconductive ability: Successfully grown bone in the in vivo rabbit spinal model.
    • Osteoinductive potential:
      • Demonstrated new bone growth within muscle tissue in the athymic (nude) rat muscle pouch model.
      • Evaluated with a surrogate, in vitro BMP-2 ELISA assay, with results correlated with successful bone formation in the athymic rat for the same lots.
      • Each lot will be evaluated for osteoinductive potential using the in vitro assay.

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

• Sample Size (Test Set): Not specified for human data. For preclinical studies:
  • Rabbit spinal model: Sample size not specified.
  • Athymic (nude) rat muscle pouch model: Sample size not specified.
• Data Provenance: Preclinical animal models (rabbit and rat). Human data (if any for testing) is not described. Donor bone is sourced from AATB-certified tissue banks in the United States.

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 this type of device relies on biological outcomes in animal models (e.g., bone formation observed histologically) and in vitro assays, not on expert human interpretation of medical images or clinical cases.

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

• Not applicable. This is not an AI/ML diagnostic device requiring adjudication of human expert interpretations.

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

• Not applicable. This is not an AI/ML device that assists human readers.

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

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

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

• Ground Truth (for performance):
  • Observation of bone formation in vivo (rabbit spinal model, athymic rat muscle pouch model).
  • Results of in vitro BMP-2 ELISA assay correlated with in vivo bone formation.
• Ground Truth (for safety/biocompatibility):
  • Viral inactivation validation studies.
  • ISO 10993 biocompatibility testing results.

8. The sample size for the training set

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

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

• Not applicable. There is no training set for this physical device.

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Accell Evo3 is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use as a bone graft extender in the spine, extremities and pelvis. Accell Evo3 may also be used as a bone void filler in the posterolateral spine, extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

Accell Evo3 is a moldable putty that contains ground, cortical de-mineralized bone marrix (DBM) in particulate and solubilized forms as well as a poloxamer reverse phase medium for proper handling. The device is packaged in a prefiled open-bore polycarbonate syringe and terminally sterilized by e-beam radiation. The DBM used to manufacture Accell Evo3 is only obtained from AATB-accredited facilities.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

Acceptance Criteria and Device Performance

The acceptance criteria are implied by the claim of "effective bone formation through fusion" and "equivalence to autograft." The device performance is the demonstration that it met these criteria.

Study Information

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

   • Test Set Sample Size: Not explicitly stated as a number of rabbits, but the study was conducted in a "posterolateral rabbit spine model."
   • Data Provenance: Animal study (rabbit model), likely prospective (an experimental study designed to test the device). Country of origin is not specified.

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

   • Not specified. The assessment involved "Radiographic, histological and biomechanical evidence," suggesting evaluation by relevant experts in these fields (e.g., veterinary radiologists, histopathologists, biomechanical engineers), but their number or specific qualifications are not provided.

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

   • Not specified.

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. This was not an MRMC study comparing human readers or AI assistance. It was an animal study evaluating direct device performance.

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

   • N/A. This device is a bone void filler, not an algorithm.

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

   • The ground truth was established through radiographic, histological, and biomechanical evidence from the animal model. This combines imaging findings, tissue analysis (pathology), and functional/mechanical testing to assess bone formation and fusion.

7. The sample size for the training set:

   • N/A. This is not an AI/machine learning device, so there is no "training set."

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

   • N/A.

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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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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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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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