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ArTT Augments and Buttresses are indicated to be used, in combination with EMPOWR Acetabular Cup System, as an alternative to structural allograft in skeletally mature patients in cases of segmental acetabular deficiencies.

ArTT Augments and Buttresses are indicated for cementless use to the bone interface; and are affixed to the mating acetabular cup using bone cement.

This 510(k) submission aims at introducing new device components, the ArTT Augments and Buttresses and Bone Screws (Revision Bone Screws (Dia. 6.5mm), Locking Bone Screws (Dia. 6.5mm), Locking Bone Screws (Dia. 4mm), Bone Screws (Dia. 4mm)) to be used in combination with the EMPOWR Acetabular Cup System (K190057) manufactured by Encore Medical, L.P.

ArTT Augments and Buttresses are manufactured from Ti6Al4V 3D printed (ISO 5832-3) and are indicated for cementless use to the bone interface; they are affixed to the mating acetabular cup using bone cement. ArTT Augments are available in 9 diameters (Dia. 50mm to 66mm) and 3 eccentricities (Ecc. 10mm, Ecc. 15mm, Ecc. 20mm), while ArTT Buttresses are available in 3 diameters (Dia.50mm, Dia.56mm, Dia.62mm), 3 heights (H. 15mm, H. 30mm, H. 60mm) and 3 configurations (Neutral, Left, Right).

Bone Screws are manufactured from Ti6Al4V (ISO 5832-3 - ASTM F1472); they are intended for cancellous or cortical bone and are available in several lengths.

This FDA 510(k) clearance letter pertains to
"ArTT Augments and Buttresses and Bone Screws" for orthopedic use. It's important to note that this document is a clearance letter, not a detailed scientific study publication. As such, it provides summary information about the device and the types of testing performed to demonstrate substantial equivalence, rather than a deep dive into specific study methodologies or acceptance criteria with detailed performance metrics.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum wear rate, specific pull-out force thresholds) or precise numerical performance results for the ArTT Augments and Buttresses and Bone Screws.

Instead, it states:

• "Mechanical tests demonstrated that the device performance fulfilled the intended use, and that the device is substantially equivalent to the predicate device."
• "Other performance requirements were fulfilled through rationales and comparisons with previously cleared components (K210717, latest 510(k) approval)."

This implies that the acceptance criteria were based on:

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

• Sample Size for Test Set: The document states that mechanical testing was performed on "worst case components or constructs." However, it does not specify the exact number of samples or specimens used for each test (e.g., how many augments, how many screws of each type).
• Data Provenance: The studies were "Non-clinical testing" conducted by the manufacturer, Limacorporate S.p.A. The location of the testing laboratories or specific origin of data (e.g., retrospective/prospective in a clinical sense) is not described, as these are non-clinical (mechanical) tests.

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

This section is not applicable as the studies described are non-clinical (mechanical) tests. The "ground truth" for mechanical testing is typically established by engineering standards (e.g., ASTM F543) and internal protocols, not by expert consensus from medical professionals.

4. Adjudication Method for the Test Set:

This section is not applicable for non-clinical mechanical testing, where adjudication methods like 2+1 or 3+1 by human experts are not used. Performance is measured against engineering specifications and standards.

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

No, an MRMC comparative effectiveness study was not done. The clearance is for a physical orthopedic implant system, not an AI software/diagnostic device that would involve human readers interpreting cases.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical implant system, not an algorithm or AI.

7. The Type of Ground Truth Used:

For the mechanical tests conducted, the "ground truth" implicitly refers to:

• Engineering Standards: Specifically mentioned is ASTM F543 for torsional properties, driving torque, and pull-out load of bone screws.
• Internal Protocols: Used for fretting fatigue testing.
• Performance of Predicate Devices: The measured performance of the ArTT Augments and Buttresses was deemed "substantially equivalent" to that of the predicate devices. This means the performance of the predicate likely served as a benchmark or reference point for establishing acceptable performance.

8. The Sample Size for the Training Set:

This section is not applicable as this is a physical medical device, not an AI/machine learning model that requires a training set.

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

This section is not applicable for the same reason as above (physical medical device, no training set).

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FG Bone Graft B is recommended for:

• Augmentation or reconstructive treatment of the alveolar ridge.
• Filling of infrabony periodontal defects.
• Filling of defects after root resection, apicoectomy, and cystectomy.
• Filling of extraction sockets to enhance preservation of the alveolar ridge.
• Elevation of the maxillary sinus floor.
• Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
• Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

FG Bone Graft B is a sterile, synthetic, multi-porous biocompatible ceramic matrix in granular form for filling bone defects. The material with microporous structure supports rapid ossification with local bone. With its phase purity of >= 99%, the ceramic material complies with US standard specification ASTM F 1088-04. The validated manufacturing process guarantees batch conformity and reproducibility.

The FDA 510(k) clearance letter for FG Bone Graft B indicates that the device is substantially equivalent to a predicate device (CERASORB M DENTAL). The clearance letter references non-clinical tests performed to demonstrate this equivalence, focusing on chemical composition, physical properties, and performance in vivo.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, 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

• Sample size for the test set: The document states that the in vivo study used a "Beagle dog" model, and the animals were "divided into groups: test group (FG Bone Graft B), positive control group (Cerasorb, a commercial β-TCP), and a negative control (empty defect)." However, the exact number of animals in each group or total animal count is not specified in the provided text.
• Data provenance: The study was a prospective in vivo animal study performed on Beagle dogs. The location/country of origin of the study is not explicitly stated in the provided text, but the submitter "Full Golden Biotech Co., Ltd." is located in Taiwan.

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

• Number of experts: Not explicitly stated. The histological and radiographic analyses were likely performed by trained professionals (e.g., veterinary pathologists, radiologists), but the number of reviewers or their specific qualifications are not detailed in the provided text.
• Qualifications of experts: Not specified beyond the implied expertise in conducting and analyzing in vivo studies (e.g., histology, micro-CT).

4. Adjudication Method for the Test Set

• Adjudication method: Not explicitly stated. For animal studies, consistency and blinding are typically employed, but a formal "adjudication method" in the sense of multiple human readers for consensus is not described for this non-AI bone graft device. The results are presented as quantitative measurements and observations (e.g., "new bone formation increased," "minimal to mild inflammatory response").

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

• MRMC study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI/image analysis devices where the AI's impact on human reader performance is being assessed. This document describes a traditional preclinical performance study for a bone graft material.

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

• Standalone performance: N/A. This is a bone graft material, not an algorithm or AI device. The "performance" refers to the biological and physical properties of the material itself, not the output of a software algorithm.

7. The Type of Ground Truth Used

• Type of ground truth: The ground truth for the in vivo study (which is the primary performance study) was established through direct anatomical, histological, and radiographic assessments of the bone defects in the animal model.
  • Histological analysis: Quantified new bone formation, material degradation, and inflammatory response. This involves microscopic examination of stained tissue sections, which is considered a gold standard for assessing tissue regeneration and integration.
  • Radiographic analysis: Used micro-CT to assess bone density and bone volume, providing quantitative structural data.
  • Comparison to predicate: The "ground truth" for showing substantial equivalence was the performance of the established predicate device (Cerasorb) under the same study conditions.

8. The Sample Size for the Training Set

• Sample size for training set: N/A. This device is a bone graft material, not an AI or machine learning algorithm. Therefore, there is no "training set."

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

• Ground truth for training set: N/A. As there is no AI component, there is no training set and no ground truth establishment for such a set.

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Bone Screw is used to stabilize and fixate bone grafts, bone filling material, and/or barrier membranes used for regeneration of bone in the oral cavity.

Bone Screw is using as anchor to fix the bone plate, membrane that cover bone material or block bone for bone regeneration or remodeling. Ø1.2 diameter screw is for fixing non-resorbable membrane or non-resorbable titanium membrane (Osstem OssBuilder OB2 and OB3), cleared in K172354.

The specifications of the proposed device are as follow;

• Bone Screw
• Diameter (mm): Ø1.2
• Length (mm): 3.0, 4.0, 5.0

This document is a 510(k) clearance letter for a bone screw, not a study evaluating an AI/software as a medical device (SaMD). Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria and studies proving device performance for an AI/SaMD.

The 510(k) summary focuses on demonstrating "substantial equivalence" of the new Bone Screw device to existing predicate devices based on:

• Indications for Use: The new device has the same intended use as the predicate.
• Technological Characteristics: Similarities in material (Titanium Alloy), manufacturing process (machined), design, and sterilization method (Gamma Irradiation).
• Performance Testing: Non-clinical tests (Driving Torque, Axial Pullout Strength, Torsional Strength) were conducted to show the new device performs comparably to the predicate, especially regarding a new smaller thread diameter.
• Biocompatibility and Shelf-life: Leveraged data from the predicate device due to material and packaging similarities.
• MR Compatibility: Assessed using scientific rationale and published literature, not a study with acceptance criteria.

Therefore, I cannot extract the requested information as it pertains to an AI/SaMD from this document.

If you have a document describing the performance study of an AI/SaMD, I would be happy to help you extract that information.

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The External Fixation Bone Distractor is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities.
The External Fixation Bone Distractor is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.

The Paragon 28 External fixation Bone Distractor is a transverse bone transport system designed to assist in the controlled movement of a bone segment across a defect. The device can be used independently or in conjunction with the Monkey Rings External Fixation System (K232838) or Monkey Bars Pin to Bar External Fixation System (K242452) to form hybrid frames.

The provided FDA 510(k) clearance letter for the "External Fixation Bone Distractor" does NOT include information about acceptance criteria or a study that proves the device meets specific performance criteria through clinical data, especially not in the context of an AI/ML-driven medical device.

This document describes a traditional medical device (an external fixation system) and its clearance is based on substantial equivalence to existing predicate devices, rather than on meeting specific performance metrics derived from a study like an MRMC or standalone AI performance evaluation. The "Performance Testing" section explicitly states: "No additional bench testing was performed for the subject device. Instead, a worst-case analysis was conducted using existing data from other components within the device system." This means the clearance is based on engineering design analysis and comparison to mechanically similar, already cleared components, not on a study with clinical performance acceptance criteria.

Therefore, I cannot extract the requested information from the provided text. The questions posed relate to the evaluation of AI/ML-driven medical devices, which operate under different regulatory and performance evaluation paradigms.

To answer your request thoroughly, I will indicate that the information is not present in the provided document for each point.

Here's the breakdown, indicating the information is not present based on the provided FDA 510(k) letter:

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

• Information Not Present: The document does not specify quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) nor does it report performance metrics from a clinical study. The clearance is based on substantial equivalence and mechanical properties derived from "worst-case analysis" using existing data, not a specific performance study against defined clinical criteria.

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

• Information Not Present: No test set is mentioned, as there was no clinical performance study conducted or reported for this 510(k) submission. The document relies on existing data from other components and worst-case analysis for mechanical performance.

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)

• Information Not Present: This is not applicable. There was no test set with clinical ground truth established by experts.

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

• Information Not Present: This is not applicable. No test set involving human expert adjudication was used.

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

• Information Not Present: An MRMC study was not done. The device is a mechanical medical device, not an AI/ML-driven diagnostic or assistive tool.

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

• Information Not Present: A standalone performance study was not done. The device is a mechanical bone distractor, not an algorithm.

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

• Information Not Present: Ground truth, in the context of clinical performance evaluation for AI/ML devices, is not relevant here as it's a mechanical device. The "ground truth" for this device's clearance relates to its mechanical integrity and biocompatibility, established through engineering standards (ASTM F1541-17) and material properties.

8. The sample size for the training set

• Information Not Present: A training set is not applicable. This is a mechanical device, not an AI/ML system.

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

• Information Not Present: This is not applicable. No training set or associated ground truth establishment method is mentioned.

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USTOMED Bone Fixation/Bone Augmentation Systems – PIN is intended for fastening membranes during bone regenerative treatment.

USTOMED Bone Fixation/Bone Augmentation Systems – PIN consists of a titanium pin. The Pin can be used to fasten third-party non-absorbable PTFE and titanium-reinforced membranes up to a thickness of 1.0mm cleared by FDA for stabilization and support of bone grafts in dento-alveolar bony defect sites (product code JEY). After fulfilling its supportive function, which is typically achieved within three to nine months, the Pin must be removed, as it is not intended to remain in the body permanently.

The Pin are intended for single use and provided non-sterile for cleaning and sterilization by the user before use.

This 510(k) clearance letter pertains to a Class II medical device, the USTOMED Bone Fixation/Bone Augmentation Systems - PIN. The letter states that the device has been found substantially equivalent to a predicate device (NEOSS Ltd.'s Membrane Tack, K201561).

The information provided in this 510(k) summary focuses primarily on demonstrating substantial equivalence through a comparison of technological characteristics and performance testing to ensure the device meets established safety and performance standards. It does not describe a clinical study of diagnostic performance, but rather engineering and material tests typical for an implantable device with a mechanical function.

However, based on the provided text, we can describe the acceptance criteria and study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes for each test mentioned (dimensional verification, reprocessing validation, mechanical testing, biocompatibility, cytotoxicity, materials chemical analysis). These are likely engineering and laboratory tests, not clinical trials with patient data. Therefore, "data provenance" in terms of country of origin of patient data or retrospective/prospective is not applicable to these types of tests. The data provenance would be laboratory testing conducted by the manufacturer or a contracted lab.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable to the types of tests described. These are not diagnostic accuracy studies requiring expert reads of images or clinical assessments to establish ground truth. The "ground truth" for these tests is established by the specifications and standards (e.g., ASTM F543-17, ISO 10993).

4. Adjudication Method for the Test Set

Not applicable. The tests described are laboratory and engineering tests with objective pass/fail criteria based on established standards, not subjective assessments requiring expert adjudication.

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

No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data, often with and without AI assistance, to assess changes in diagnostic performance. This device is a bone fixation pin and therefore, this type of study is not relevant for its clearance.

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

Yes, in a sense. The "performance testing" described (dimensional verification, mechanical testing, biocompatibility, etc.) are all standalone tests of the device's physical and material properties, independent of human interaction during testing, beyond setting up the experiment. This device is not an AI algorithm, so the term "algorithm only" is not directly applicable.

7. The Type of Ground Truth Used

The ground truth for these performance tests is based on engineering specifications, material science standards (e.g., ISO 10993, ASTM F543-17), and documented reprocessing protocols. For example, for dimensional verification, the ground truth is the specified dimensions from the device design. For mechanical testing, the ground truth is the expected mechanical properties as defined by the ASTM standard for a similar device. For biocompatibility, the ground truth is the absence of adverse biological reactions as defined by ISO standards.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.

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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Grafton™ DBM and Grafton Plus ™ DBM Paste are intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space (excluding Flex or Crunch), pelvis and extremities) 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. When used in intervertebral body fusion procedures, Graft™ DBM (excluding Flex or Crunch) and Grafton Plus ™ DBM Paste must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Grafton™ DBM and Grafton Plus™ DBM Paste are absorbed/remodeled and replaced by host bone during the healing process.

Magnifuse™ Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, pelvis and extremities) not intrinsic to the stability of the bony structure. Voids or gaps may be surgically created defects or defects created by traumatic injury to the bone.
Magnifuse™ Bone Graft may be used in a manner comparable to autogenous bone or allograft bone. Magnifuse™ Bone Graft may be mixed with fluid such as bone marrow aspirate, blood, sterile water, or sterile water in order to adjust consistency and handling of bone graft material.
When used in intervertebral body fusion procedures, Magnifuse™ Bone Graft must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Magnifuse™ Bone Graft is resorbed/remodeled and is replaced by host bone during the healing process.

The Grafton™ DBM, Grafton Plus™ DBM Paste, and Magnifuse™ Bone Graft devices in this submission are human bone products containing human demineralized bone matrix (DBM).

Grafton™ DBM is a human bone product that contains human DBM with an inert additive. Grafton™ DBM is produced in particular physical forms (Grafton™ DBM Gel, Grafton™ DBM Putty, Grafton™ DBM Matrix, Grafton™ DBM Orthoblend) and/or handling property. Grafton™ DBM is provided in ready-to-use form and is intended in single patient, single use containers. Grafton™ DBM is identical to the device cleared in K051195.

Grafton Plus™ DBM Paste is human demineralized bone matrix combined with an inert additive to yield a product having a particular physical form and/or handling property. Grafton Plus™ DBM Paste is identical to the device cleared in K043048.

Magnifuse™ Bone Graft is a human bone allograft product containing human DBM and surface demineralized cortical bone chips sealed in an absorbable mesh pouch for intraoperative handling. It is intended for use in filling bony voids or gaps or the skeletal system not intrinsic to the stability of the bony structure. Magnifuse™ Bone Graft is provided ready-to-use in various package sizes by volume or dimension and is intended for single patient use. Magnifuse™ Bone Graft is identical to the device cleared in K082615.

This FDA 510(k) clearance letter (K251193) is for bone graft materials (Grafton™ DBM, Grafton Plus™ DBM Paste, Magnifuse™ Bone Graft) and does not describe an AI/software device or a study with "acceptance criteria" based on AI performance metrics like sensitivity, specificity, or reader studies.

The document details the substantial equivalence of new product formulations/expanded indications for use to previously cleared predicate and reference devices. The "performance" section refers to pre-clinical testing and leveraging prior clearances for bone graft characteristics (e.g., DBM properties, viral inactivation, shelf-life, biocompatibility in animal models, etc.), not a clinical study involving human readers or AI algorithm performance.

Therefore, I cannot provide the information requested in your prompt as it pertains to AI device acceptance criteria and performance studies. The document does not contain:

• A table of acceptance criteria and reported device performance for an AI system.
• Sample sizes for a test set, data provenance, or expert ground truth establishment for an AI study.
• Details on MRMC studies or human reader improvement with AI assistance.
• Standalone algorithm performance.
• Description of ground truth type for an AI system.
• Training set sample size or how ground truth for training was established for an AI system.

The "Performance" section explicitly states: "The devices' performance in the intervertebral body space was supported by a robust analysis of bone grafting materials in the prior posterolateral spine fusion studies." This refers to biological and mechanical performance of the bone graft materials themselves, not an AI software.

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The XeliteMed VertehighFix High Viscosity Spinal Bone Cement System is intended for delivery of the XeliteMed VertehighFix High Viscosity Spinal Bone Cement, which is indicated for the treatment of pathological fracture of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may be caused by osteoporosis, benign tumors (e.g., hemangioma), or malignancy (e.g., metastatic cancer, myeloma).

XeliteMed VertehighFix High Viscosity Spinal Bone Cement System is divided into two parts, bone cement and a delivery system.

Bone cement is provided as a two-component system. The powder component consists of a PMMA-styrene copolymer with barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methyl methacrylate monomer with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as promoter. The powder and liquid components are mixed prior to use.

The delivery system consists of a bone cement mixing device and a hydraulic pump. The Bone Cement Mixing Device can mix and stir the powder and liquid and transfer it to the injection barrel. Then, the bone cement is extruded and injected into the vertebral body by the hydraulic pump.

This FDA clearance letter pertains to a bone cement system and its delivery system, not an AI/ML powered device. As such, the typical acceptance criteria and study descriptions relevant to AI/ML devices (e.g., sensitivity, specificity, MRMC studies, expert adjudication) are not present in this document.

The provided text focuses on the substantial equivalence of the XeliteMed VertehighFix High Viscosity Spinal Bone Cement System to a predicate device, primarily based on its materials, indications for use, and pre-clinical testing for the delivery system.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML device from this document. The information presented is for a traditional medical device (bone cement and its delivery system).

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SPECTRUM® GV Bone Cement is indicated for the fixation of the REMEDY® & REMEDY SPECTRUM® GV Spacers, and for the fixation of prostheses to living bone in the second stage of a two-stage revision of a total joint arthroplasty after the initial infection has been cleared.

SPECTRUM® GV Bone Cement is a radiopaque, PMMA bone cement with gentamicin and vancomycin. The bone cement is single-use and provided sterile. SPECTRUM® GV Bone Cement is a traditional bone cement in that the liquid is contained in a vial and the powder in a sachet. The two components are mixed manually immediately before use. The device is protected from bacterial adhesion due to the presence of gentamicin and vancomycin.

This FDA 510(k) clearance letter is for a bone cement, not a medical device that utilizes AI or requires complex studies to demonstrate performance through acceptance criteria in the way you've described.

The document indicates that SPECTRUM® GV Bone Cement is substantially equivalent to a previously cleared predicate device (K231556), and therefore, extensive new studies to prove acceptance criteria in the context of device performance metrics (like sensitivity, specificity, or reader improvement with AI) were not required.

Here's why and what information is provided:

• Device Type: This is a Polymethylmethacrylate (PMMA) bone cement, a physical material used for fixation. It's not a diagnostic imaging device, a software as a medical device (SaMD), or an AI algorithm.
• Substantial Equivalence: The clearance is based on the device being "substantially equivalent" to a legally marketed predicate device. This means the FDA has determined it is as safe and effective as the predicate, often due to identical or very similar technological characteristics and intended use.
• No New Performance Data (for the requested criteria): The document explicitly states: "Non-clinical testing was not required as the subject device is identical to that of the predicate." This confirms that specific performance metrics, sample sizes for test sets, expert adjudication, or AI-related studies were not performed for this specific submission because the device itself hasn't changed.

Therefore, I cannot provide the detailed information requested in your prompt because the provided 510(k) letter does not contain the type of acceptance criteria and study analysis that would be relevant for an AI-powered diagnostic device. The questions about sensitivity, specificity, MRMC studies, ground truth establishment, and training/test set sizes are pertinent to AI/software device clearances, not to the material science and manufacturing consistency demonstrated for a bone cement via substantial equivalence.

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The OsteoCentric Bone Plate and Screw is intended for fixation of fractures, osteotomies, and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, but not limited to periarticular, and intraarticular fractures

The subject system is a line extension that includes clavices (superior lateral, anterior mideral, and anterior midshaft) and additional locking and non-locking screws (2.1mm, and 2.7mm diameter). The plates and screws are fabricated from either medical grade stainless steel per ASTM F138 or Titanium per ASTM F136. Plates and screws are provided non-sterile. Instruments are provided non-sterile with instructions for sterilization.

This FDA 510(k) clearance letter is for a physical medical device (The OsteoCentric Bone Plate and Screw System), not an AI/Software as a Medical Device (SaMD). Therefore, the specific information requested in your prompt regarding AI/SaMD performance criteria, such as acceptance criteria based on accuracy, sensitivity, specificity, MRMC studies, training/test sets, and ground truth establishment, is not applicable to this document.

For traditional medical devices like the OsteoCentric Bone Plate and Screw System, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically addressed through non-clinical performance testing (e.g., mechanical testing, biocompatibility, sterilization validation) and comparison to predicate devices, rather than clinical studies involving human readers or AI algorithms.

However, I can extract the relevant information regarding the non-clinical testing and conclusions provided in the document:

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

The document doesn't present a formal table of acceptance criteria with numerical targets and reported performance in the way an AI/SaMD submission would. Instead, it states:

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

• Sample Size: Not applicable. For mechanical testing of physical devices, "sample size" refers to the number of test articles (plates, screws) subjected to the engineering analyses. This specific number is not disclosed in the clearance letter but is part of the detailed test reports provided to the FDA.
• Data Provenance: Not applicable. The data comes from "Engineering analysis," which means laboratory testing and simulations performed on the device components themselves, not clinical data from patients or a specific country. This is in vitro data.

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 mechanical performance is established through objective, quantifiable engineering measurements against predefined standards or predicate device performance, not expert consensus interpretation.

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

Not applicable. Adjudication methods are relevant for subjective interpretations by multiple human readers, not for objective mechanical test results.

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

Not applicable. This device is a bone plate and screw system, not an AI-powered diagnostic tool.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for this type of device's performance is based on objective engineering and mechanical properties (e.g., material strength, fatigue life, torsional rigidity, bending stiffness, screw pull-out strength). These properties are measured and evaluated against established industry standards (e.g., ASTM F138 for stainless steel, ASTM F136 for titanium) and/or comparison to predicate devices, which have a known history of safe and effective use.

8. The sample size for the training set:

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

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

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

In summary, the FDA 510(k) clearance for The OsteoCentric Bone Plate and Screw System relies on non-clinical engineering analysis and comparison to predicate devices to demonstrate substantial equivalence, rather than the types of performance studies typically conducted for AI/SaMD products.

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Synthetic Bone Graft Particulate is intended to be used to augment the alveolar bone in tooth extraction procedures. (i.e., use in extraction sockets only)

Synthetic Bone Graft Particulate is a synthetic absorbable osteoconductive bone graft substitute manufactured from 45S5 bioactive glass. The device is in particulate form with a size range of 0.5 mm to 1 mm.

The device is intended for augmenting alveolar bone in tooth extraction procedures. At time of use, the device is mixed with sterile saline to form a wet sandy paste that is applied to the defect. Synthetic Bone Graft Particulate is progressively resorbed and replaced by new bone tissue during the healing process.

It is supplied sterile, packaged in a rubber stopper-sealed glass bottle within a sterile barrier package (Tyvek-sealed PETG box). The device packages are protected by carboard box.

The provided document is a 510(k) summary for a medical device called "Synthetic Bone Graft Particulate." It focuses on demonstrating substantial equivalence to a predicate device ("PerioGlas - Bioglass Bone Graft Particulate") for regulatory clearance.

This document does not contain acceptance criteria or study details for an AI/ML-driven device's performance. The "performance data" section (Section 7) describes non-clinical tests (sterilization, shelf-life, biocompatibility, chemical/physical properties) and an animal study for the bone graft material itself, not for an AI/ML system.

Therefore, I cannot extract the requested information about acceptance criteria and the study proving the device meets those criteria in the context of an AI/ML device. The device described in the document is a physical medical implant (synthetic bone graft particulate), not an AI/ML software or system.

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