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Osteo Vation Impact is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranialbone defects and craniotomy cuts with a surface area no larger than 25cm2. OsteoVation Impact may be used in the restoration or augmentation of bony contours of the cranialbone skeleton.

OsteoVation Impact is a self-setting, calcium phosphate bone void filler designed for single use and biocompatible. Osteo Vation Impact is an impactable (moldable) calcium phosphate.

OsteoVation Impact is comprised of two working components: a calcium phosphate, a sodium phosphate (SPMA), carboxymethylcellulose powder, a sodium silicate, sodium phosphate (SPMA) solution, and a mixing system (mixing bowl, pestle and spatula). The two working components are packaged separately and are to be mixed together by the end user prior to implantation.

OsteoVation Impact is offered in 3cc, 5cc, and 10cc sterile convenience kits. Each kit includes the two working components in combination with a mixing bowl, pestle, and spatula. It is sterilized using gamma radiation with a minimum dose of 25 kGy and a maximum dose of 50 kGy with a Sterility Assurance Level of 10-9.

The provided text describes the OsteoVation Impact, a calcium phosphate bone void filler. The submission focuses on demonstrating substantial equivalence to a predicate device (OsteoVation® CMF Bone Void Filler, K051784) rather than establishing novel acceptance criteria for a new type of device. Therefore, the "acceptance criteria" discussed here relate to ensuring the modified device maintains performance comparable to the predicate.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail table format with specific numerical targets for each test, but it describes how results were evaluated against the predicate device. The performance is consistently stated as "comparable to the predicate device" or "PASS," implying that the results fell within acceptable ranges established by the predicate's performance.

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

The document does not explicitly state the sample sizes (number of devices, batches, or specimens) used for each bench test. It mentions "All samples" passed for working and setting time but doesn't quantify "all."

The data provenance is bench testing conducted by Skeletal Kinetics, LLC. There's no mention of country of origin for data as it's mechanical/chemical testing. The tests are prospective for the modified device to demonstrate its performance.

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

N/A. This being a bench test study for a material, there isn't a "ground truth" established by experts in the typical sense (e.g., radiologist consensus for image analysis). The "ground truth" is derived from the objective physical and chemical properties and performance of the device and its comparison to a well-characterized predicate.

4. Adjudication Method for the Test Set:

N/A. This is not applicable to bench testing of material properties. The results are physical measurements and chemical analyses, not subjective assessments requiring adjudication.

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 study is for a medical device (bone void filler material), not an AI diagnostic or assistance tool. Therefore, MRMC studies and AI effect sizes are not relevant.

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

N/A. As above, this is about a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this submission is the established performance characteristics and material composition of the predicate device (OsteoVation® CMF Bone Void Filler, K051784). The goal of the study was to demonstrate that the modified OsteoVation Impact has comparable physical, chemical, and performance characteristics to this predicate, ensuring that the formulation change did not adversely affect its safety and efficacy.

8. The sample size for the training set:

N/A. This is not a machine learning or AI study, so there is no concept of a "training set."

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

N/A. There is no training set in this context.

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SKaffold NMX is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SKaffold NMX is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The device provides a bone void filler that resorbs and is replaced by bone during the healing process.

SKaffold NMX is a pre-mixed moldable and biocompatible putty/paste bone void filler. SKaffold NMX consists of a mixture of calcium phosphate powder in a bioinert polyethylene glycol (PEG) based polymer that resorbs and is replaced with bone during the healing process. The 5 cc and 10 cc SKaffold NMX kits are provided sterile and are for single use only.

The provided document is a 510(k) premarket notification for a medical device called SKaffold NMX, a resorbable calcium salt bone void filler.

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state "acceptance criteria" in a tabulated format with numerical targets. Instead, the approach for demonstrating substantial equivalence is through comparison of critical specifications with a predicate device. The implicit acceptance criteria are that the device's critical specifications (chemistry, crystallinity, physical form, porosity, and solubility) should be "substantially equivalent" or "the same as" those of the predicate device.

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

• Non-clinical tests (material characterization): The document does not specify sample sizes for the analytical tests (FTIR, XRD, SEM, Mercury Intrusion Porosimetry, in vitro dissolution). These are typically laboratory tests on material samples, not patient data. Data provenance (country of origin) is not mentioned.
• Biocompatibility: The ISO 10993-1 tests involve various in vitro and in vivo models, but specific sample sizes for these tests are not provided in the summary. Data provenance is not mentioned.
• In vivo, pre-clinical, large animal studies: The document mentions "large animal studies" and "well-defined rabbit model," but specific sample sizes (number of animals) are not provided. The studies were prospective animal model studies. Data provenance (country of origin) is not mentioned.

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 section is not applicable as the device is a bone void filler and the studies described are non-clinical (material characterization, animal studies). There is no "ground truth" established by human experts in the context of diagnostic performance or interpretation as would be the case for an AI device. The ground truth in animal studies would be histopathological findings and radiographic assessments by veterinary pathologists/radiologists, but specific details on the number or qualifications of these experts are not provided.

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

This is not applicable as there is no human interpretation of results requiring adjudication in the context of this 510(k) summary for a bone void filler.

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 is not applicable. The device is a bone void filler, not an AI-assisted diagnostic tool. No MRMC studies were performed.

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

This is not applicable. The device is a bone void filler, not an algorithm or AI system.

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

For the non-clinical material characterization tests, the "ground truth" is derived from established scientific measurement techniques (e.g., FTIR, XRD, SEM, Porosimetry) that quantify material properties.
For the in vivo pre-clinical animal studies, the ground truth would be established through histological, radiographic, and histopathologic analyses of tissue samples and imaging performed on the animals.

8. The sample size for the training set

This is not applicable. The device is a medical implant, not an AI/ML algorithm that requires a training set.

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

This is not applicable. As no training set exists for this type of device.

In summary, the document describes a substantial equivalence pathway for a bone void filler based on extensive non-clinical laboratory testing and animal studies, rather than clinical trials or AI performance evaluations. The "acceptance criteria" are implicitly met by demonstrating that the critical specifications and performance of SKaffold NMX are substantially equivalent to a legally marketed predicate device (Callos Bone Void Filler K051123), and by meeting biocompatibility and sterilization standards. No AI-specific evaluation metrics or studies were performed.

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Beta TCP Granules Bone Void Filler (BVF) is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Beta TCP Granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Beta TCP Granules BVF will resorb and be replaced with bone during the healing process.

Beta TCP Granules Bone Void Filler is composed of porous, osteoconductive, resorbable beta- tricalcium phosphate (B-TCP) granules for repair of bony defects. The single use Beta TCP Granules sterile kit contains: Calcium Phosphate granules contained in a plastic vial packaged within two industry standard peel pouches that provide a double sterile barrier.

Here's a breakdown of the acceptance criteria and the study information for the Beta TCP Granules device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The primary "test set" for demonstrating substantial equivalence was a comparison of critical specifications between the Beta TCP Granules and the predicate device, Cerasorb M Ortho (K040216). This involves direct laboratory analysis of material properties rather than human patient data.
• Data Provenance: The document does not explicitly state the country of origin for the lab-based material characterization studies. It is implicitly "prospective" in the sense that these tests were conducted on the Beta TCP Granules product for the submission.
• Animal Study: A "large animal, cancellous bone defect model" was used for non-clinical animal data. The document does not specify the exact sample size (number of animals) for this study, nor its country of origin. This would be considered prospective animal data specifically generated for this submission.

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

• This device submission relies on non-clinical testing (material characterization and animal studies), not on human clinical data or expert interpretation of images/diagnoses.
• Therefore, the concept of "experts establishing ground truth for the test set" in the context of human clinical data or diagnostic accuracy studies is not applicable here. The "ground truth" for the material properties was established by validated analytical methods and scientific standards.

4. Adjudication Method for the Test Set

• Not applicable. As noted above, this submission relies on non-clinical laboratory and animal studies, not human clinical data that would require adjudication of findings.

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 resorbable bone void filler and does not involve AI or human image interpretation for diagnosis or treatment planning in a clinical setting.

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

• Not applicable. This device is a material product, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for this submission is based on:
  • Scientific and Analytical Measurements: For chemistry, crystallinity, physical form, porosity, and solubility, the ground truth was established by validated laboratory techniques (FTIR, XRD, SEM, Mercury Intrusion Porosimetry, ICP-AES) according to scientific standards.
  • Biological Standards: For biocompatibility, the ground truth was adherence to ISO 10993-1.
  • Validated Sterilization Protocols: For sterility, adherence to ISO 11137-2006 for SAL 10^-6.
  • Animal Model Outcomes: For resorption and bone ingrowth, the ground truth was the observation of these phenomena in a "large animal, cancellous bone defect model."

8. The Sample Size for the Training Set

• Not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI. The product itself is the subject of characterization.

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

• Not applicable. As there is no training set, there is no ground truth to establish for it.

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Callos® ProModel Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos ProModel is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Callos ProModel Bone Void Filler is a moldable and biocompatible calcium phosphate/calcium sulphate composite bone void filler. The single-use Callos ProModel kit contains the necessary components for mixing of the bone void filler. The Callos ProModel sterile kit contains: Calcium Phosphate/Calcium Sulfate Powder, Dilute Sodium Silicate Liquid, a Mixing System (Mixer and Syringe) and a Cannula.

The provided text describes the device "Callos ProModel Bone Void Filler" and its regulatory clearance process, including summaries of non-clinical tests. However, it does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets those criteria in human patients, as would be expected for a device with a focus on AI performance or clinical efficacy against measured outcomes.

Instead, the document states:

• "Callos ProModel does not meet the criteria to require clinical testing."
• "In vitro and in vivo performance demonstrate that Callos ProModel is substantially equivalent to legally marketed predicate devices."

This indicates that clearance was based on substantial equivalence to existing devices and non-clinical data, not on a clinical effectiveness study with defined acceptance criteria for patient outcomes.

Therefore, I cannot provide the requested table and information as the document does not contain the specific details about acceptance criteria, device performance against those criteria, or a qualifying clinical study.

Based on the provided text, the following points can be addressed, but the core request for acceptance criteria and a study proving their fulfillment cannot be fully met:

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

   • Acceptance Criteria: Not explicitly stated as quantifiable metrics for a clinical effectiveness study in the provided text. The criteria are implied to be "substantial equivalence" to predicate devices based on non-clinical data (biocompatibility, bench testing, animal study).
   • Reported Device Performance:
     • "Callos ProModel met the standards set forth in ISO 10993-1. Biological Evaluation of Medical Devices."
     • "radiation sterilization validation is in compliance to ANSI/A AMI/ISO 11137-2:2006."
     • "Bench testing demonstrated that Callos ProModel is substantially equivalent to the marketed predicate devices. The results indicated that the device met performance criteria outlined for its intended use." (Specific numerical performance metrics are not provided).
     • "The animal study provided data that Callos ProModel elicited similar biologic response in a large animal critical size defect model as compared to predicate devices for its intended use." (Specific outcome data or statistical comparisons are not provided).

2. Sample size used for the test set and the data provenance: Not applicable. No clinical "test set" (human patient data) is described in the context of proving efficacy against acceptance criteria. The non-clinical studies involved bench testing (materials, mechanical properties) and an animal model. The sample size for the animal study is not specified, nor is the provenance of the animals.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human expert review of clinical cases is described for establishing ground truth, as no clinical effectiveness study requiring such review was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical "test set" requiring adjudication by multiple experts is described.

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. The device is a bone void filler, not an AI-powered diagnostic or assistive tool, so an MRMC study is irrelevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a medical implant, not a standalone algorithm.

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

   • For biocompatibility: Adherence to ISO standards.
   • For sterilization: Compliance with ANSI/AAMI/ISO standards.
   • For bench testing: Comparison to predicate device performance (implied physical/mechanical properties). The "ground truth" would be objective measurements of these properties.
   • For animal study: Biologic response compared to predicate devices in a large animal model. "Ground truth" would likely involve histological assessment, imaging, or gross observation of bone healing and integration in the animals, as interpreted by veterinary or pathological experts.

8. The sample size for the training set: Not applicable. This device is not an AI algorithm that requires a training set. The "development" would involve material science and engineering, not machine learning.

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

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CAAP (Calcium Apatite) Bone Wax is indicated to control the bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

The single use CAAP (Calcium Apatite) Bone Wax sterile kit contains: Calcium Phosphate Powder, Dilute Sodium Silicate Liquid, and a Mixing System (Mixing Bowl, Pestle and Spatula). CAAP Bone Wax is to be mixed immediately prior to use.

The provided text describes a 510(k) summary for the CAAP (Calcium Apatite) Bone Wax, asserting its substantial equivalence to predicate devices rather than proving its performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study sizes, ground truth establishment, and MRMC studies is not available in the given document.

The document states: "CAAP Bone Wax does not require clinical test."

However, it does mention non-clinical tests. Here's a breakdown of what information can be extracted and what cannot:

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

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

• Test set sample size: Not specified. The document mentions an "animal study" but does not detail the number of animals or specific experimental setup.
• Data provenance: Not specified beyond "animal study." No information on country of origin or whether it was retrospective/prospective.

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

• Not applicable/Not specified. The document does not describe a human-read test set or expert ground truth establishment for the animal study.

4. Adjudication method for the test set

• Not applicable/Not specified.

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

• No. This is not a study involving AI or human readers. The document states, "CAAP Bone Wax does not require clinical test."

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

• Not applicable. This is not about an algorithm or AI.

7. The type of ground truth used

• For the animal study: The ground truth was based on the observed "adequate hemostasis" in comparison to predicate devices, implying a functional outcome assessment by the researchers conducting the study. No mention of pathology or other objective measures for this comparison.
• For biocompatibility and sterilization: Ground truth is compliance with specified ISO standards.
• For bench testing: Ground truth is remaining within physiological pH and temperature ranges.

8. The sample size for the training set

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

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

• Not applicable.

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Callos Bone Void Filler is indicated to the following indications:
1 . To fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis) not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2. To be used with autograft as a bone graft extender (i.e. extremities, and pelvis only).
Callos resorbs and is replaced by bone during the healing process.

Callos Bone Void Filler is a moldable and biocompatible calcium phosphate bone void filler. The single-use Callos Kit contains the necessary components for mixing of the bone void filler. The Callos sterile kit contains: Calcium Phosphate Powder, Dilute Sodium Silicate Liquid, and a Mixing System (Mixing Bowl, Pestle and Spatula).

The provided text is a 510(k) summary for the Callos® Bone Void Filler. This document describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study that specifically proves the device meets particular numerical performance criteria.

Instead, the summary focuses on demonstrating substantial equivalence to previously approved devices based on:

• Technological characteristics: Callos is composed of a calcium phosphate powder and a sodium silicate solution, which when mixed forms a paste that hardens into hydroxyapatite, similar to the mineral phase of native bone. Its function as a bone graft extender is similar to predicate devices.
• Biocompatibility: In accordance with ISO 10993-1.
• Sterilization validation: Compliant to ANSI/AAMI/ISO 11137-2.2006.
• Physical/mechanical characteristics: Evaluated using setting tests (modified ASTM) and X-ray Diffraction (XRD) phase analysis, and compared with predicate devices.
• Clinical use (for new indication): An "ewe study" (sheep study) demonstrated its use as an orthopedic bone graft extender.

Therefore, most of the specific questions about acceptance criteria, numerical performance, sample sizes, expert ground truth, adjudication, MRMC studies, or standalone algorithm performance cannot be answered from the provided text, as these concepts are typically associated with performance evaluations of diagnostic or AI-based devices, not material equivalence for a bone void filler as presented here.

However, I can extract the specific information that is present regarding the device and its evaluation methods.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not present quantitative acceptance criteria or device performance in the manner typically seen for diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices based on material properties, biocompatibility, and functional similarity.

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

• Sample Size: Not specified in the provided summary.
• Data Provenance: The "ewe study" is mentioned, indicating an animal (sheep) model in a prospective study design for the new indication as a bone graft extender. Other tests (biocompatibility, sterilization, physical/mechanical) are cited as having been performed previously for earlier Callos clearances (K030554 and K051123) and are standard laboratory evaluations. The location/country of origin is not specified.

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

Not applicable/provided. This type of detail is not required or typically included in a 510(k) summary for a bone void filler's substantial equivalence determination. The "ewe study" likely involved veterinary surgeons and pathologists, but specific numbers and qualifications are not listed.

4. Adjudication Method for the Test Set

Not applicable/provided. This is not relevant for the type of device and evaluation described.

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

No MRMC study was done. This type of study is typically for evaluating the performance of diagnostic imaging devices or CAD systems, not for a bone void filler.

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

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

7. The Type of Ground Truth Used

For the "ewe study," the ground truth for evaluating bone graft extension would likely involve histopathology (analysis of tissue samples under a microscope to confirm bone formation, resorption of the material, integration with host bone) and potentially radiographic imaging over time. For the physical/mechanical tests, the "ground truth" is defined by the standardized test methods (e.g., modified ASTM) and the material characteristics of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set. The "ewe study" could be considered a "test set" for the expanded indication.

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

Not applicable. No training set is involved.

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OsteoVation CMF Bone Void Filler is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other craniofacial defects and craniotomy cuts with a surface area no larger than 25cm². OsteoVation CMF Bone Void Filler may be used in the restoration or augmentation of bony contours of the craniofacial skeletaon, including fronto-orbital, malar, and mental areas.

OsteoVation is a calcium phosphate bone void filler which can either be injected or digitally impacted into the targeted void. It is a single use only proudct.

This document is a 510(k) premarket notification for the OsteoVation™ CMF Bone Void Filler. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a new clinical study. Therefore, most of the requested information about acceptance criteria, specific study design, and performance metrics is not present in this document.

Here's an breakdown of what is available and what is not:

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

• Not Applicable/Not Provided: This 510(k) is based on substantial equivalence to predicate devices (Callos Bone Void Filler and Callos CMF Bone Void Filler), not on meeting specific, defined acceptance criteria from a new clinical study for performance. The "performance" being demonstrated here is primarily the equivalence of the modified material to the predicate, ensuring it doesn't negatively impact safety or efficacy. No numerical performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical properties with acceptance thresholds) are listed as they would be for a new device requiring de novo authorization or a PMA.

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

• Not Applicable/Not Provided: No clinical "test set" in the context of an algorithm or diagnostic device performance evaluation is described. The submission focuses on material modification and substantial equivalence.

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/Not Provided: As there is no "test set" and no evaluation of an algorithm's diagnostic performance, there is no mention of experts establishing ground truth.

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

• Not Applicable/Not Provided: There is no "test set" or diagnostic performance evaluation described which would require an adjudication method.

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/Not Provided: This device is a bone void filler, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or is relevant.

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

• Not Applicable/Not Provided: This device is a medical implant, not an algorithm.

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

• Not Applicable/Not Provided: Ground truth in the context of diagnostic accuracy is not relevant to this type of device submission. The "truth" being established is that the modified device is substantially equivalent to existing, cleared devices in terms of its safety and efficacy for its intended use. This is typically established through a combination of bench testing, biocompatibility studies, and comparisons to predicate device characteristics.

8. The sample size for the training set

• Not Applicable/Not Provided: There is no "training set" as this is not an AI/algorithm device.

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

• Not Applicable/Not Provided: This is not relevant to the device.

Summary regarding Acceptance Criteria and Study:

The document describes a Special 510(k) submission (K051784) for the OsteoVation™ CMF Bone Void Filler.

The "study" or justification for clearance is based on demonstrating substantial equivalence to existing predicate devices (Callos Bone Void Filler K051123; Callos CMF Bone Void Filler K042072).

• Acceptance Criteria (Implied): The implied "acceptance criteria" for this 510(k) is that the modified OsteoVation CMF Bone Void Filler is substantially equivalent to its predicate devices in terms of:

  • Indications for use (which remained the same)
  • Technology
  • Principle of operation
  • Packaging
  • Sterilization parameters
  • Safety and effectiveness (despite a material modification, the submission asserts it is not a substantial change and does not significantly affect safety or efficacy).

• The "Study" / Justification: The document states:

  "This Special 510(k) proposes a modification in materials for Osteo Vation, which was previously cleared under K042072 on June 3, 2005. The indications for use, technology, principle of operation, packaging, and sterilization parameters of Osteo Vation remain the same as in the predicate cleared 510(k)s."

  "OsteoVation, as described in this submission, is substantially equivalent to the predicate, unmodified Callos CMF. The proposed modification in materials, is not a substantial change or modification, and does not significantly affect the safety or efficacy of OsteoVation."

This type of submission relies on comparison to a legally marketed predicate, rather than generating new clinical data to meet predefined performance metrics. The FDA's clearance letter confirms this by stating they have "determined the device is substantially equivalent... to legally marketed predicate devices."

In essence, the "study" is a comparison to predicate devices, and the "acceptance criteria" is that the modified device maintains substantial equivalence to those predicates.

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Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Callos is a calcium phosphate bone void filler which can either be injected or digitally impacted into the targeted void. It is a single use only proudct.

The provided document K051123, a 510(k) Pre-Market Notification for the Callos™ Bone Void Filler, does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, this submission is a Special 510(k), which is used for modifications to a legally marketed device where the modification does not significantly affect the safety or effectiveness of the device. In this instance, the modification is described as a "modification in materials" for the Callos Bone Void Filler, which was previously cleared under K030554.

The submission states: "This Special 510(k) proposes a modification in materials for Callos, which was previously cleared under K030554 on May 20, 2003. The indications for use, technology, principle of operation, packaging, and sterilization parameters of Callos remain the same as in the predicate cleared 510(k)s. ... The proposed modification in materials, is not a substantial change or modification, and does not significantly affect the safety or efficacy of Callos."

Therefore, this specific document does not report on a study with acceptance criteria and device performance metrics because it relies on the previous clearance (K030554) for establishing substantial equivalence. The focus of this submission is on demonstrating that the change in material does not alter the fundamental safety and effectiveness profile already established for the predicate device.

To answer your request, one would need to refer to the original 510(k) submission (K030554) for Callos Bone Void Filler, as that is where clinical performance data and acceptance criteria would likely be presented, if required for that initial clearance. This current document (K051123) is an approval for a material modification, not an initial market clearance that would typically include such a study.

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Callos CMF Bone Void Filler is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other craniofacial defects and craniotomy cuts with a surface area no larger than 25cm². Callos CMF Bone Void Filler may be used in the restoration or augmentation of bony contours of the craniofacial skeleton, including fronto-orbital, malar, and mental areas.

Callos CMF Bone Void Filler is an impactable and moldable single use, biocompatible calcium phosphate bone void filler, that remodels and is replaced by bone during the healing process. Callos CMF is packaged in various kit sizes (3cc, 5cc, and 10cc).

This submission is for a medical device (Callos CMF Bone Void Filler), not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific metrics (such as sample sizes for test/training sets, ground truth establishment methods, number of experts, adjudication methods, MRMC studies, standalone performance, and effect sizes of AI assistance) are not applicable and are not present in the provided 510(k) summary.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on indications for use, materials, technology, and product specifications for a bone void filler product. It does not involve any form of AI for image analysis or diagnostic support.

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Callos Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Callos Bone Void Filler is an injectable, moldable and biocompatible bone void filler. Callos Bone Void Filler resorbs and is replaced with bone during the healing process. The 3 cc, 5 cc, and 10 cc Callos Bone Void Filler kits are provided sterile and are for single use only.

The provided text describes the 510(k) summary for the Callos™ Bone Void Filler. This submission is for a medical device and not an AI/ML powered device, so many of the requested fields related to AI/ML specific studies (e.g., test set, ground truth methods, MRMC studies, training set details) are not applicable or extractable from this document. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical and animal testing.

Here's the information that can be extracted and formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study conducted to prove the device meets acceptance criteria is a series of non-clinical and animal tests, along with comparative testing against a predicate device. The primary goal was to demonstrate "substantial equivalence" to the legally marketed predicate device, Norian SRS Bone Void Filler (K011897).

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

• Sample Size for Test Set: Not applicable as this is a materials science and animal study, not an AI/ML study with a distinct "test set" of data samples in the same sense. The "test set" would encompass the various samples of the Callos Bone Void Filler material used for the non-clinical tests and the animals used in the in-vivo study. The exact number of material samples or animals is not specified in this summary.
• Data Provenance: Not explicitly stated, but the studies would have been conducted in a laboratory or animal testing facility context. The data is prospective as it was generated specifically for this submission.

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

Not applicable. Ground truth for material properties, chemical analyses, and biocompatibility is established through standardized laboratory testing methods rather than expert consensus on diagnostic images. For the animal study, "ground truth" would be derived from the histological, chemical, crystallographical, and mechanical analyses performed by qualified scientists/pathologists, but the number and specific qualifications of these individuals are not detailed.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical imaging studies involving human readers and are not relevant for material science or animal studies of this nature.

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 a medical device submission for a bone graft substitute, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers was not performed.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this device's performance was established through:

• Quantitative measurements from non-clinical laboratory tests (e.g., density, pH, setting time).
• Standardized analytical techniques (e.g., XRD, FTIR, elemental analysis) confirming material composition and structure.
• Biocompatibility assays conforming to recognized standards (e.g., for cytotoxicity, irritation).
• Histological, chemical, crystallographical, and mechanical analyses of animal tissues and implants to assess in-vivo resorption, bone ingrowth, and material behavior.

8. The sample size for the training set:

Not applicable. This is not an AI/ML powered device, so there is no training set in the context of machine learning.

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

Not applicable. There is no AI/ML training set.

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