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B-GENIN and R-GENIN are indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed with autogenous blood prior to use at the physician's discretion.

B-GENIN is a bone void filler consisting of resorbable purified fibrillar bovine collagen and demineralized bone matrix (DBM). The device is an implant where new bone can grow.

R-GENIN is a bone void filler consisting of resorbable purified fibrillar bovine collagen, hydroxyapatite, tri-calcium phosphate, and DBM. The device is an implant where new bone can grow.

This regulatory submission (K113791) for B-GENIN and R-GENIN indicates that the device's safety and effectiveness are supported by its substantial equivalence to a previously cleared device (K091912). Therefore, a detailed study proving the device meets specific acceptance criteria in the manner typically seen for novel devices is not present in the provided text.

Instead, the submission relies on demonstrating that the new devices are essentially the same as a device already on the market. The "Acceptance Criteria" in this context are primarily related to the manufacturing and testing of the DBM component, ensuring its osteoconductive potential and viral inactivation.

Here's an breakdown based on the information provided, emphasizing that the "study" is more about process validation and equivalence than a clinical performance trial:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the study and its details:

The primary "study" described here is more of a process validation and comparability assessment rather than an independent clinical trial.

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

• Viral Inactivation: The sample size is not explicitly stated. The "test set" would be the panel of viruses used ("human immunodeficiency virus (HIV-1), hepatitis A virus, hepatitis C virus (bovine viral diarrhea as model), porcine parvovirus, and pseudorabies virus"). Data provenance is not specified, but this would typically be laboratory-generated data from studies conducted by the manufacturer or a contract lab.
• Osteoconductive Potential: The sample size for each batch of DBM is not specified, but involves an athymic nude-mouse model. The reference to "Edwards, J. T., Diegmann M. N., Scarborough, N. L.; Osteoinduction of human deminerslized bone: characterization in a rat model, Clin. Orthopaedies, Vol. 357, pp. 219-28 (1998)" suggests the methodology is based on established scientific literature, likely from a lab setting. The data would be proprietary to the manufacturer or a contracted lab. It's a prospective test for each batch.
• Substantial Equivalence: This is a comparison to a retrospective set of information (K091912) rather than a test set with a specific sample size.

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

• Viral Inactivation & Osteoconductive Potential: The document does not specify the number or qualifications of experts involved in establishing ground truth for these lab tests. These are typically assessed by qualified laboratory personnel following established protocols.
• Substantial Equivalence: The ground truth is the prior FDA clearance of K091912. The experts involved in that initial clearance (FDA reviewers) are not detailed here, and for this submission, the ground truth is the established equivalence to that device.

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

• None explicitly stated. For lab tests like viral inactivation and osteoinduction, internal quality control and peer review within the lab would be assumed, but no formal adjudication method like a "2+1" or "3+1" approach is mentioned.

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 submission is for a bone void filler product, not an AI/software device that would involve human readers or image interpretation. Therefore, an MRMC study and AI-related effect sizes are not relevant here.

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.):

• Viral Inactivation: Laboratory assay results demonstrating a reduction in viral load using established scientific methods.
• Osteoconductive Potential: Histopathological evidence of new bone formation in an animal model, observed and scored by qualified laboratory personnel, based on a reference standard (Edwards, et al. 1998).
• Substantial Equivalence: Prior FDA clearance of the predicate device (K091912) based on its documented safety and effectiveness.

8. The sample size for the training set:

• Not applicable. This submission does not describe an AI/ML device that requires a training set. The "training" for this device would be its manufacturing process and quality controls.

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

• Not applicable. As above, no training set for an algorithm is discussed. The "ground truth" for the overall device's safety and effectiveness relies on its similarity to the predicate device and validation of its manufacturing processes for viral inactivation and osteoinductive potential.

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B-GENIN and R-GENIN are indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

B-GENIN is a bone void filler consisting of resorbable purified fibrillar bovine collagen and demineralized bone matrix (DBM) powder. The device is an implant where new bone can grow.

R-GENIN is a bone void filler consisting of resorbable purified fibrillar bovine collagen, demineralized bone matrix (DBM) and hydroxyapatite-tricalcium phosphate granules. The device is an implant where new bone can grow.

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria in the typical sense of performance metrics (like sensitivity, specificity, accuracy, etc.) for a diagnostic device or a pass/fail threshold for a therapeutic device.

Instead, the document is a 510(k) Summary Statement for two medical devices, B-GENIN and R-GENIN, which are resorbable calcium salt bone void fillers. The "study" mentioned is not a clinical trial with acceptance criteria for device performance, but rather a set of tests to establish substantial equivalence to predicate devices and confirm certain material properties and safety aspects.

Here's a breakdown of the available information based on your requested categories, acknowledging that much of what you asked for is not explicitly present in this type of regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Viral Inactivation: The document mentions "a select panel of viruses." No specific sample size (number of viruses tested, repeats of tests) is provided, nor is the provenance of the viral strains. This is a lab-based, in vitro study.
• Osteoconductive Potential: Uses an "athymic nudemouse model." No specific sample size (number of mice or DBM samples per batch) is provided. This is an in vivo animal model study. Data provenance is implied as being from the manufacturer's internal testing as part of "batch testing."

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

This information is not provided. The tests described are laboratory and animal studies, not human clinical studies requiring expert review of outcomes for "ground truth" establishment in the context of diagnostic or classification tasks. The histopathological evaluation in the nudemouse model would be performed by trained personnel (e.g., veterinary pathologists), but their number and qualifications are not specified.

4. Adjudication Method for the Test Set

Not applicable. The described "tests" are primarily laboratory and animal studies evaluating material properties and biological activity, not clinical studies with outcomes requiring adjudication.

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

No. The document describes a 510(k) submission, which focuses on substantial equivalence to existing predicate devices. It does not include a comparative effectiveness study, especially not one involving human readers and AI for an orthopedic bone void filler.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not a software/AI device. The "device" is a physical bone void filler.

7. Type of Ground Truth Used

• Viral Inactivation: Laboratory assay results demonstrating viral reduction.
• Osteoconductive Potential: Histopathological evidence of new bone formation in a nudemouse model. This is an animal model endpoint/biological readout. The document explicitly states this assay "should not be interpreted to predict clinical performance in human subject."
• Substantial Equivalence: Comparison of material properties, intended use, and general characteristics to legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. The concept of a "training set" for an algorithm does not apply here.

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

Not applicable. As above, there is no training set for an algorithm. The "truth" for this device's safety and effectiveness relies on material characterization, viral inactivation studies, and animal model results, along with the established safety profiles of the predicate devices.

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Bi-Ostetic Foam (or Putty) is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 mL.

The device is a bone void filler consisting of a mineralized collagen matrix. The bovine fibrillar collagen component is biocompatible. The device provides a scaffold around which new bone can grow.

This K092046 document is a 510(k) Summary Statement for the Bi-Ostetic Foam and Putty, indicating that the device is being cleared based on substantial equivalence to predicate devices, rather than a new clinical study demonstrating specific performance metrics against acceptance criteria. Therefore, the document does not contain the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).

The document primarily focuses on:

• Intended Use: Bi-Ostetic Foam (or Putty) is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure, to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). It provides a bone void filler that resorbs and is replaced by the growth of new bone.
• Device Description: A bone void filler consisting of a mineralized collagen matrix (bovine fibrillar collagen component is biocompatible) providing a scaffold for new bone growth.
• Substantial Equivalence: The safety and effectiveness are supported by substantial equivalence to previously cleared predicate devices.

Missing Information:

Since this is a 510(k) substantial equivalence submission, it does not typically involve the type of detailed performance criteria, ground truth studies, or AI-specific evaluations (like MRMC or standalone performance with AI) that would be present for software or AI-driven diagnostic devices. The acceptance criteria here are implicitly met by demonstrating substantial equivalence to pre-existing, legally marketed devices.

Therefore, no table of acceptance criteria and reported device performance from a specific study can be extracted from this document, nor can the other requested details related to such a study.

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Bi-Ostetic Foam is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed with autogenous bone marrow prior to use at the physician's discretion. In weight bearing situations, Bi-Ostetic Foam is to be used in conjunction with internal or external fixation devices. The fracture defect treated with Bi-Ostetic Foam should not exceed 30 mL.

Bi-Ostetic Foam is a bone void filler consisting of resorbable purified fibrillar collagen and resorbable hydroxyapatite/tri-calcium phosphate granules. The bovine fibrillar collagen component is biocompatible. The device provides a scaffold around which new bone can grow.

It appears that the provided text is a 510(k) summary statement for a medical device (Bi-Ostetic Foam) and the associated FDA clearance letter. This document describes a bone void filler and its intended use, but it does not contain the type of study data, acceptance criteria, and performance metrics typically found in AI/algorithm-based device submissions.

The document states: "The safety and effectiveness of Bi-Ostetic Foam are adequately supported by the substantial equivalence information provided within the Premarket Notification." This indicates that the device's clearance was based on its similarity to existing cleared devices (predicate devices), rather than a de novo clinical trial with specific performance acceptance criteria against a ground truth.

Therefore, many of the requested items (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set information) are not applicable or available in this specific document.

However, I can extract the following relevant information from the provided text:

• Device Name: Bi-Ostetic Foam
• Intended Use: For use in bony voids or gaps that are not intrinsic to the stability of the bony structure (e.g., extremities, spine, pelvis). Acts as a bone void filler that resorbs and is replaced by new bone growth. Can be mixed with autogenous bone marrow. In weight-bearing situations, used with internal or external fixation. Fracture defect treated should not exceed 30 mL.
• Mechanism of Action: Provides a scaffold around which new bone can grow. Consists of resorbable purified fibrillar collagen and resorbable hydroxyapatite/tri-calcium phosphate granules.

Since the document focuses on substantial equivalence and does not detail a study proving specific performance metrics against acceptance criteria, I cannot fill out the requested table or answer most of the questions.

If you have a different document that describes an AI/algorithm-based device and its performance study, I would be able to provide a more complete answer.

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GenerOs™ is an osteoconductive bone substitute shaped as granules or blocks that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.

The granules or blocks may be pressed into the void or into the surgical site by hand. The GenerOs™ granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. GenerOs™ is biocompatible and resorbs in the body as bone ingrowth occurs.

GenerOs (60 or 80) is a sterile osteoconductive bone void filler. This synthetic bone graft comes in the shape of granules or blocks. GenerOs (60 or 80) is supplied sterile for single patient use only. It is biocompatible and resorbs in the human body as bone ingrowth occurs when applied according to its indications for use. The implant is bioresorbable and radio-opaque.

The provided text is a 510(k) Summary Statement for a medical device called GenerOs Bone Void Filler. This document does not describe a study involving AI or software, nor does it provide acceptance criteria and detailed performance data in the way you're asking.

Instead, it's a regulatory submission to the FDA to demonstrate substantial equivalence to existing predicate devices. It focuses on the intended use, device description, and materials, asserting that these are substantially equivalent to devices already cleared for market.

Therefore, I cannot extract the information requested regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided document.

The document only states: "The safety and effectiveness of GenerOs are adequately supported by the substantial equivalence information provided within the Premarket Notification." This implies that the device's safety and effectiveness are established by its similarity to already approved devices, rather than through new, independent performance studies against specific acceptance criteria.

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Marrow Plus (M+™) is intended for use as a system for the aspiration of bone marrow, autologous blood, plasma or other blood components. Prior to use, the syringe is either pre-filled or filled with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). This system provides the surgeon with a convenient way to syringe bone graft material and deliver the material to the orthopaedic surgical site.

M+ may be pre-filled with synthetic bone substitute (Bi-Ostetic, Cem-Ostetic, Tri-Ostetic, BioPlus, GenerOs) shaped as granules or blocks (cancellous, cortical or cortico-cancellous) that are intended to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are pressed into the void or into the surgical site by hand. The granules or blocks are not intended to provide structural support. The material is radio-opaque. It is biocompatible and resorbs in the body as bone ingrowth occurs.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Berkeley Advanced Biomaterials, Inc. regarding their device, M+. This document outlines the FDA's determination of substantial equivalence for the device.

However, the furnished text DOES NOT contain the following information:

• Acceptance criteria and reported device performance.
• Details of any study (including sample size for test set, data provenance, number/qualifications of experts for ground truth, adjudication method, MRMC study, standalone performance study, type of ground truth used for test set, training set size, or how its ground truth was established).

The document is purely a regulatory approval letter. It states that the device is substantially equivalent to legally marketed predicate devices, but it does not detail the specific performance metrics or studies used to demonstrate that equivalence.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or describe the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

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GenerOs™ is an osteoconductive bone substitute shaped as granules or blocks (cancellous, cortical or cortico-cancellous) that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.

The granules or blocks may be pressed into the void or into the surgical site by hand. The GenerOs™ granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. GenerOs™ is biocompatible and resorbs in the body as bone ingrowth occurs.

GenerOs™ is a sterile osteoconductive bone void filler composed of ß-TCP. This synthetic bone graft comes in the shape of granules or blocks. GenerOs™ is supplied sterile for single patient use only. GenerOs™ is biocompatible and resorbs in the human body as bone ingrowth occurs when applied according to its indications for use. The implant is bioresorbable and radio-opaque.

This document pertains to a 510(k) premarket notification for a bone void filler and does not contain information about an AI/ML device or its acceptance criteria and study data. Therefore, I cannot provide the requested information.

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BioPlus is an osteoconductive bone substitute shaped as granules or blocks (cancellous, cortical or cortico-cancellous) that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.

The granules or blocks may be pressed into the void or into the surgical site by hand. The BioPlus granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. BioPlus is biocompatible and resorbs in the body as bone ingrowth occurs.

BioPlus is a sterile osteoconductive bone void filler. It consists of a formulation of calcium-based compounds. This synthetic bone graft comes in the shape of granules or blocks. BioPlus is supplied sterile for single patient use only. BioPlus is biocompatible and resorbs in the human body as bone ingrowth occurs when applied according to its indications-for-use. The implant is bioresorbable and radio-opaque.

The provided text is a 510(k) summary for a medical device (BioPlus Bone Void Filler) and related FDA correspondence. It does not include information about specific acceptance criteria or a study that proves the device meets those criteria in the way described in the request (e.g., performance metrics like sensitivity, specificity, or human-AI comparison).

The submission relies on demonstrating substantial equivalence to a predicate device (Bi-Ostetic™ - K023703) rather than proving performance against specific quantitative acceptance criteria through a standalone study with performance metrics.

Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided input. The document focuses on regulatory equivalence rather than a clinical performance study with specific quantifiable results.

Here's a breakdown of why the requested information cannot be extracted:

• Acceptance Criteria & Reported Performance: The document states that "The safety and effectiveness of BioPlus are adequately supported by the substantial equivalence information, materials data, and test results provided in the full document." However, it does not detail specific performance metrics (e.g., regarding bone ingrowth rate, void filling efficacy, or resorption time) or define quantitative acceptance criteria for those metrics. The "test results" mentioned are likely biocompatibility tests, material characterization, and potentially animal studies (though not detailed here), rather than a clinical trial with statistical performance endpoints.
• Study Design Details (Sample Size, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone): These are all elements of a clinical performance study. Since the submission relies on substantial equivalence and mentions "materials data, and test results" without detailing a clinical study with human or animal subjects that establishes specific performance against acceptance criteria, these details are absent.
• Training Set Information: This is relevant for AI/ML devices. BioPlus is a physical bone void filler, not an AI/ML diagnostic or therapeutic device. Thus, there is no training set in the context of machine learning.

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Tri-Ostetic is an osteoconductive putty that is intended to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.

The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The Tri-Ostetic paste set in situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque Tri-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.

Tri-Ostetic is a sterile osteoconductive bone void filler. Tri-Ostetic consists of a pre-measured formulation of distilled water and calcium-based compounds in a container that can be used to prepare a putty. Tri-Ostetic forms a paste when mixed with sterile distilled water. Both powder and water are supplied pre-measured in separate containers. The putty can be shaped into an implant or inserted into a syringe and injected into the surgical site (i.e., bony voids or gaps of skeletal system). Tri-Ostetic powder and the water are supplied sterile for single patient use only. Tri-Ostetic is biocompatible, bioresorbable and radio-opaque. Tri-Ostetic resorbs in the human body as bone ingrowth occurs when applied according to its indications for use.

This document is a 510(k) summary for the Tri-Ostetic Bone Void Filler, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types for specific studies) are not present in the provided text as the nature of a 510(k) submission for a device like this primarily involves demonstrating equivalence through material data and a comparison to an already approved device.

Here's a breakdown of what can be extracted and what information is missing based on the prompt:

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

This information is not provided in the document. 510(k) summaries for simple devices like bone void fillers typically focus on demonstrating substantial equivalence to a predicate device through material composition, intended use, and general safety/biocompatibility, rather than setting and reporting against specific numerical performance acceptance criteria for a new clinical study. The document states: "The safety and effectiveness of Tri-Ostetic are adequately supported by the substantial equivalence information, materials data, and test results provided in the document submitted within the scope of this Pre-Market Notification." However, these specific test results and their acceptance criteria are not detailed in this summary.

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

This information is not provided. As explained above, the submission relies on substantial equivalence and material data, not a clinical trial with a "test set" in the context of diagnostic or AI device evaluation.

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

This information is not provided. There is no mention of a test set requiring expert ground truth establishment.

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

This information is not provided. There is no mention of an adjudication process for a test set.

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

This type of study is not applicable and not mentioned. The device is a bone void filler, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

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

This is not applicable and not mentioned. The device is a physical bone void filler, not an algorithm.

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

As there is no "test set" described for performance evaluation, the concept of "ground truth" as typically applied to diagnostic or AI devices is not relevant or discussed in this 510(k) summary. The "truth" here relates to the inherent properties of the material and its equivalence to a predicate device.

8. The sample size for the training set

This information is not provided. A "training set" is not relevant to this type of device submission.

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

This information is not provided. Not relevant.

Summary of the Study and "Proof" for Substantial Equivalence:

The provided document describes a 510(k) submission for the Tri-Ostetic Bone Void Filler. The "study" that proves the device meets (implicitly, rather than explicitly stated) acceptance criteria is the demonstration of substantial equivalence to a legally marketed predicate device, Cem-Ostetic™.

The evidence for this substantial equivalence is based on:

• Identical Indications-for-Use: Tri-Ostetic is used to fill voids and gaps in bone, in extremities, spine, pelvis, or cranium, augmenting hardware for temporary support, and it is radio-opaque, biocompatible, and bioresorbable. These are stated to be identical to Cem-Ostetic™.
• Identical Contraindications, Warnings, Precautions, and Potential Adverse Events: Again, this indicates a high degree of similarity in safety profile and application to the predicate.
• Very Similar Technical Characteristics: While not detailed, the submission asserts that the technical characteristics are "very similar" to the predicate device. This would typically involve comparisons of material composition (calcium-based compounds), physical properties (forms a paste, sets in situ), biocompatibility, and bioresorbability.
• Materials Data and Test Results: The summary indicates that "materials data, and test results" were provided in the full Pre-Market Notification document to support the safety and effectiveness. These tests would likely include biocompatibility testing (e.g., cytotoxicity, sensitization, irritation, systemic toxicity), mechanical properties (though it's not for structural support), and possibly resorption rates, all compared against acceptable benchmarks or the predicate. The specifics of these tests and their results are not included in this summary.

In essence, the "acceptance criteria" are implicitly defined by the properties and performance of the predicate device, Cem-Ostetic™, and the "study" is the collection of data and analysis demonstrating that Tri-Ostetic™ is sufficiently similar in all relevant aspects.

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Cem-Ostetic™ is an osteoconductive putty that is intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.

The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The Cem-Ostetic™ paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. Cem-Ostetic™ is biocompatible and resorbs in the body as bone ingrowth occurs.

Cem-Ostetic™ Putty Injection Kit consists of a syringe filled with calcium salts. Once mixed with water, the calcium salts can be injected into a bone void or defect with a trocar. Cem-Ostetic is supplied sterile for single patient use only.

The provided text is a 510(k) summary for the Cem-Ostetic™ Injection Kit. This document focuses on establishing substantial equivalence to a legally marketed predicate device (Cem-Ostetic™ Putty) rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for a novel AI/ML device.

Therefore, the requested information elements (acceptance criteria, device performance, sample size for test set, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth type, training set size, and ground truth establishment for training set) are not applicable or not present in the provided document.

The document states:
"The safety and effectiveness of Cem-Ostetic™ Injection Kit are adequately supported by the substantial equivalence information, materials data, and test results provided in the document submitted within the scope of this Premarket Notification."

This implies that the "study" for acceptance involves demonstrating that the new injection kit is substantially equivalent to the existing Cem-Ostetic™ Putty. The "acceptance criteria" are met by showing that:

1. Identical Indications-for-Use: Both devices are intended to fill voids and gaps in bone structures (extremities, spine, pelvis, cranium), can be shaped by hand or injected, provide temporary support, are radio-opaque, biocompatible, and resorbable.
2. Identical Contraindications, Warnings, Precautions, and Potential Adverse Events: The injection kit shares the same safety profiles as the predicate.
3. Very Similar Technical Characteristics: While the injection kit introduces a new delivery method (syringe and trocar), the core material (calcium salts mixed with water forming a paste) is fundamentally the same as the predicate putty.

The document does not detail specific "test results" or "materials data" beyond this declaration of similarity. It is a regulatory submission for substantial equivalence, not a detailed scientific paper on device performance in a clinical or experimental study context.

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