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The SpaceFlex Acetabular Cup consists of disposable cement spacer molds indicated for use to mold a temporary Acetabular cup replacement for skeletally mature patients undergoing a two-stage procedure due to a septic process.

The temporary prosthesis is molded using low viscosity antibiotic polymethylmethacrylate bone cement (G3A 40 bone cement) and positioned into the acetabular cavity following removal of the existing acetabular and femoral components and radical debridement.

The molded acetabular cup is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The molded temporary Acetabular cup prosthesis is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (Bone Cement), the molded temporary prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers) throughout the implant period.

The SpaceFlex Acetabular Cup consists of disposable cement spacer molds. The molds are comprised of a lower mold, an upper mold, an injector, and tightening clips. The lower mold has a fixed diameter and couples with one of three upper molds. The upper mold has five channels for air flow and four holes for clips. The injector connects to the upper mold for bone cement injection. Tightening clips secure the upper and lower molds. The system is filled with low viscosity antibiotic polymethylmethacrylate bone cement. After curing, the temporary spacer is removed and placed into the joint space for up to 180 days.

The SpaceFlex Acetabular Cup is a device that consists of disposable cement spacer molds used to create a temporary acetabular cup replacement for patients undergoing a two-stage procedure due to a septic process. The temporary prosthesis is molded using low viscosity antibiotic polymethylmethacrylate bone cement (G3A 40 bone cement).

Here's an analysis of its acceptance criteria and the study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes bench testing for performance evaluation. Specific sample sizes for each test are not explicitly detailed in the provided text. However, for the Gentamicin Elution Test, it mentions "different sizes (52 and 60 mm)" were tested. The data provenance is from bench testing conducted by G21, S.r.l. and is prospective in nature, as it involves testing the manufactured device components. This is not clinical data, but rather engineering and material property testing.

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

This information is not applicable as the described studies are bench tests (mechanical and material property assessments) rather than studies requiring expert interpretation of clinical data or images. The "ground truth" for these tests is established by industry standards (e.g., ASTM, ISO) and the device's design specifications.

4. Adjudication Method for the Test Set:

This information is not applicable for the bench tests described. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The provided text describes only bench testing of the device's mechanical properties and material interactions, not a study involving human readers or clinical effectiveness compared to an alternative.

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

This information is not applicable. The SpaceFlex Acetabular Cup is a physical medical device (molds for a temporary prosthesis), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

The ground truth for the performance tests is based on engineering and material science standards (e.g., ASTM 3090-20:2020, ISO 14242-1-2014) and the device's defined specifications (e.g., 400 N compression strength, 500,000 cycles for fatigue and wear, 120°C temperature limit, comparable elution profiles, no chemical modification).

8. The Sample Size for the Training Set:

This information is not applicable. As this is a physical medical device undergoing bench testing, there is no "training set" in the context of machine learning or AI.

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

This information is not applicable for the same reason as point 8.

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SpaceFlex Knee disposable cement spacer molds are indicated for use to mold a temporary Total Knee Replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. The molded temporary knee prosthesis is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (G3A Bone Cement), the molded temporary prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

G21 SpaceFlex Knee system are disposable cement spacer molds made of polypropylene (PP) intended to be filled with low-viscosity polymethyl methacrylate bone cement directly in the operating room. Once the bone cement has hardened, the SpaceFlex Knee system creates a polymethyl methacrylate based bone cement spacer for patients undergoing a two-stage procedure following a periprosthetic joint infection. The device can be used in either the left or right knee joint. The SpaceFlex Knee molds are single-use and cannot be re-used or re-sterilized.

This document is a 510(k) summary for a medical device called "SpaceFlex Knee - 80mm Size." It aims to demonstrate that this new device is substantially equivalent to existing predicate devices.

1. Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size for the test set. It mentions "The mechanical properties of the SpaceFlex knee System 80mm size were tested in accordance with applicable international standards," implying that a sufficient number of samples were tested to meet the requirements of those standards.

The provenance of the data is directly from the manufacturer, G21 S.r.l., whose address is in Italy. The testing described appears to be prospective performance testing conducted on the device itself, rather than retrospective analysis of patient data.

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

This type of study does not involve establishing ground truth through expert review in the way a diagnostic AI study would. The performance data presented here relates to mechanical and material properties of the device, not clinical diagnostic accuracy. Therefore, the concept of "experts" establishing ground truth in this context is not applicable. The "ground truth" for these tests would be the established international standards and engineering specifications.

4. Adjudication Method for the Test Set:

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, where there might be disagreements among expert reviewers. This document describes laboratory-based mechanical and material performance testing of a physical device. Therefore, adjudication methods are not applicable here. The results of these tests are objective measurements against predefined standards.

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

No, an MRMC comparative effectiveness study was not done. This study is focused on the mechanical and material performance of a physical medical device (a cement spacer mold for knee replacement), not on the diagnostic accuracy or effectiveness of an AI algorithm interpreted by human readers.

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

No, a standalone (algorithm only) performance study was not done. This document is about the physical characteristics and performance of a medical device, not an AI algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this study is based on predefined international standards and engineering specifications for the mechanical properties and material characteristics of medical devices, specifically those for knee joint prostheses and bone cement. The tests (Dimensional and Visual Characterization, Rupture Test, Fatigue Test, Elution Test) verify that the device meets these established physical and material requirements.

8. The Sample Size for the Training Set:

This document describes the performance testing of a physical medical device, not the development or training of an AI algorithm. Therefore, the concept of a "training set" and its sample size is not applicable.

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

As this study does not involve an AI algorithm with a training set, the question of how ground truth for a training set was established is not applicable.

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G1 40 Radiopaque Bone Cement is intended for use in arthroplasty procedures of the hip, knee, ankle, shoulder and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

G1 40 Radiopaque Bone Cement is a polymethylmethacrylate (PMMA) bone cement that provides two separate, premeasured sterilized components which, when mixed, form a radiopaque rapidly setting bone cement. The packaging configuration (powder pouches, amber glass ampoule) for the subject device is identical to the predicate device.

The provided text describes the G1 40 Radiopaque Bone Cement, a medical device intended for use in arthroplasty procedures. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore,
No information is available regarding acceptance criteria and a study proving a device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.

Instead, the document details performance testing conducted to show that the G1 40 Radiopaque Bone Cement has comparable characteristics and performs similarly to its predicate devices. This type of testing is common for demonstrating substantial equivalence for Class II devices.

Here's a breakdown of the available information regarding the performance comparison, addressing the relevant parts of your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative "acceptance criteria" for clinical performance (e.g., a certain percentage of successful fixation). Instead, the "acceptance criteria" are implied by compliance with established international and ASTM standards for bone cement properties. The "reported device performance" is framed as "comparable" to predicate devices and "in compliance" with these standards.

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

• Test Set Sample Size: Not explicitly stated as a number of samples or patients. The testing involved material samples for mechanical and material characterization, and biological samples for biocompatibility. The standards listed (e.g., ASTM F451-08, ISO 5833:2002) would dictate appropriate sample sizes for each specific test, but these are not enumerated in the document.
• Data Provenance: Not specified. Given the nature of material and biological testing, it would be laboratory-generated data, likely from the manufacturer or a contracted testing facility. No information on country of origin or whether it's retrospective/prospective is provided, as these terms are more relevant to clinical studies.

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

• Not Applicable. This document describes laboratory and material testing, not human-read clinical data where expert ground truth would be established. The "ground truth" for these tests is based on objective measurements against established international and industry standards.

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

• Not Applicable. See point 3.

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 cement, not an AI-powered diagnostic or assistive technology.

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

• Not Applicable. This is not an algorithm or AI device. The "standalone" performance refers to the device's material properties and biological effects, which were indeed tested directly.

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

• The "ground truth" for these material and biological performance tests is objective physical and chemical measurement against established international and industry standards. For example, compressive strength is objectively measured and compared to the acceptable range defined in ASTM F451. Biocompatibility is assessed through standardized in-vitro and in-vivo tests according to ISO 10993.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device that requires a training set.

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

• Not Applicable. See point 8.

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G3 40 Radiopaque Bone Cement is intended for use in arthroplasty procedures of the hip, knee, ankle, shoulder and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

G3 40 Radiopaque Bone Cement is a polymethylmethacrylate (PMMA) bone cement that provides two separate, premeasured sterilized components which, when mixed, form a radiopaque rapidly setting bone cement. The packaging configuration (powder pouches, amber glass ampoule) for the subject device is identical to the predicate device.

The provided text describes the 510(k) summary for the G3 40 Radiopaque Bone Cement, which is a polymethylmethacrylate (PMMA) bone cement. It details the substantial equivalence to predicate devices rather than providing a study proving the device meets specific performance acceptance criteria for an AI/ML device.

Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth used, sample size for training set, and how training set ground truth was established) are not applicable as this document pertains to a traditional medical device (bone cement) and not an AI/ML powered device.

However, I can extract the information relevant to the performance of the bone cement for the applicable categories.

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

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. This is a physical medical device (bone cement), and the testing described is primarily in-vitro and mechanical characterization, not a clinical study with patients or data requiring test sets in the context of AI/ML.

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 an AI/ML algorithm is not relevant for this traditional medical device.

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

• Not Applicable. Adjudication methods are not relevant for the performance testing of this physical medical device.

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

• Not Applicable. This is not an AI/ML device, so an MRMC study is not relevant.

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

• Not Applicable. This is a physical bone cement, not an algorithm.

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

• Physical Properties/Standardized Tests: The "ground truth" for this device's performance is established by adherence to recognized international and ASTM standards (e.g., ISO 10993 for biocompatibility, ISO/ASTM standards for mechanical properties like compressive strength, bending modulus, cyclic fatigue, tensile properties, creep, fracture toughness, and shrinkage). The results of these tests define its performance against established benchmarks for PMMA bone cements.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device.

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

• Not Applicable. This is not an AI/ML device.

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Disposable cement spacer molds with titanium reinforcement stem and prolongation are indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone cement and inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement.

The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The hemi-hip prosthesis made from the SpaceFlex Hip disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatmy performed (e.g. resection arthroplasty, fusion, etc.).

Due to the inherent mechanical limitations of the hemi-hip prosthesis material (low viscosity polymethylmethacrylate), the temporary hemi-hip prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

Disposable cement spacer molds with titanium reinforcement stem and prolongation are indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone cement and inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement.

This document describes the G21 SpaceFlex Hip, a medical device for temporary hemi-hip replacement, and provides information regarding its FDA clearance.

Here's an analysis of the provided text with respect to your questions:

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

The document mentions that the device was tested against "applicable international standards" and that "all results were satisfactory and met all performance specifications." However, it does not provide a specific table of acceptance criteria with corresponding performance outcomes. It lists the types of tests performed:

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

The document mentions "performance testing - mechanical/bench testing," but it does not specify the sample size for any of these tests. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective. These were likely benchtop (laboratory) studies, not human or animal studies.

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

This question is not applicable to the information provided. The document describes mechanical/bench testing, which typically does not involve human experts establishing ground truth in the same way clinical studies do. The "ground truth" here would be the physical properties and performance characteristics measured by engineering and scientific methods against established standards.

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

This question is not applicable for the same reasons as point 3. Adjudication methods are relevant for interpretation of clinical data or images, not for objective measurements in bench testing.

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

This question is not applicable. The G21 SpaceFlex Hip is a physical medical device (cement molds for temporary hip replacement), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies or AI assistance are not relevant.

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

This question is not applicable, as the device is a physical medical product, not an algorithm.

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

For the performance testing mentioned, the "ground truth" would be established by engineering and scientific standards (e.g., ISO, ASTM, USP) for mechanical properties, material properties, and biocompatibility. For instance, the pyrogen testing refers to USP 38: NF33 , which defines the method and acceptance criteria for pyrogenicity.

8. The sample size for the training set

This question is not applicable as the device is a physical product and not an AI algorithm that requires a training set.

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

This question is not applicable for the same reason as point 8.

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SpaceFlex Knee disposable cement spacer molds are indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. The molded temporary knee prosthesis is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (G3A Bone Cement), the molded temporary prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

G21 SpaceFlex Knee system are disposable cement spacer molds made of polypropylene (PP) intended to be filled with low-viscosity polymethyl methacrylate bone cement directly in the operating room. Once the bone cement has hardened, the SpaceFlex Knee system creates a polymethyl methacrylate based bone cement spacer for patients undergoing a two-stage procedure following a periprosthetic joint infection. The device can be used in either the left or right knee joint. The SpaceFlex Knee molds are single-use and cannot be re-sterilized.

The provided text describes the regulatory clearance of the G21 s.r.l SpaceFlex Knee, a disposable cement spacer mold. This device is classified as Class II and is indicated for use in molding a temporary total knee replacement for skeletally mature patients undergoing a two-stage procedure due to a septic process.

However, the provided document does not contain information about an AI/ML-based medical device study. Instead, it focuses on the substantial equivalence of a physical medical device (a knee spacer mold) to existing predicate devices, based on typical mechanical and material performance testing.

Therefore, I cannot extract the information required by your request about acceptance criteria and a study proving an AI/ML device meets those criteria, as the document details a different type of medical device and a different type of clearance process.

To answer your request, I would need a document describing the study and acceptance criteria for an AI/ML-driven medical device, not a physical orthopedic device.

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The provided text is an FDA 510(k) clearance letter for a bone cement device (G3A 40 Bone Cement). It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These types of details are typically found in the 510(k) summary or the full submission, not in the clearance letter itself.

Therefore, I cannot provide the requested information based on the text provided.

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OrthoSteady G Bone Cement is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.

The OrthoSteady G Bone Cement consists of Gentamicin sulphate antibiotic and a two component system consisting of separate, sterile and liquid powder components.

This document is a 510(k) summary for the OrthoSteady G Bone Cement, a polymethylmethacrylate (PMMA) bone cement. It addresses the substantial equivalence of the device to existing predicate devices. The information provided heavily focuses on the physical and chemical properties of the bone cement and its manufacturing processes rather than an AI/ML powered device. Therefore, many of the requested elements for an AI/ML powered device study cannot be answered from the provided text.

Here is the information that can be extracted or deduced from the document:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a numerical or categorical format for device performance. Instead, it states that the performance testing results showed "comparable performances to the predicate devices" and were "in compliance with" various ASTM and ISO standards. The specific quantitative results are not provided 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)

The document does not provide information about sample sizes for testing or data provenance (country of origin, retrospective/prospective). The performance data cited refers to mechanical and material property testing, not clinical studies involving human or patient data in the way an AI/ML device would.

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

Not applicable. The "ground truth" for bone cement performance is established through standardized laboratory testing against international and national standards (e.g., ISO, ASTM), not through expert consensus on medical images or clinical outcomes.

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

Not applicable. This concept is relevant for clinical or image-based studies where expert opinions might differ; for material science testing, the results are typically objectively measured by instruments and methods defined in the standards.

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

Not applicable. This is not an AI-powered device.

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

Not applicable. This is not an AI-powered device.

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

The "ground truth" for this device's performance is based on standardized mechanical and material property testing against established ASTM and ISO standards for bone cements.

8. The sample size for the training set

Not applicable. This is not an AI-powered device.

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

Not applicable. This is not an AI-powered device.

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The Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters are intended to be used for the reduction and fixation of fractures and or creation of a void in cancellous bone in the spine. This includes use during percutancous vertebral augmentation. This system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty.

Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon catheters are designed for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty in association with cleared spinal polymethylmethacrylate (PMMA) bone cements.

The inflation of the balloon serves to create a cavity in the vertebral body, compressing the cancellous bone and/or move cortical bone, thereby reducing the fracture and preventing cement leakage, while still allowing for cement interdigitation. Winch Kyphoplasty (15 and 20 mm) 11 Gauge balloon catheters fit through a 10 Gauge cannula allowing a minimally invasive kyphoplasty procedure.

The low preinflation profile (low wrapping profile of folded balloon) enables their insertion into these small working cannulas. The stiff distal end of the balloon catheter provides rigidity for smooth insertion while flexible proximal catheter allows for easy maneuverability.

I am sorry, but the provided text does not contain information about acceptance criteria and a study proving a device meets them. The document is an FDA 510(k) clearance letter for the "Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters."

This document focuses on:

• FDA's substantial equivalence determination: Stating that the device is substantially equivalent to legally marketed predicate devices.
• Device description and indications for use: Explaining what the device is and what it's intended to do.
• Comparison to predicate devices: Highlighting similarities in technological characteristics.
• Biocompatibility testing: Listing the types of tests performed to ensure the device is biocompatible.
• Performance data (general statement): A general statement that the device "met specifications and performance characteristics" and that "The testing included functional testing" (e.g., dimensional characterization, inflation/deflation time, burst characteristics) and "mechanical testing according to ISO 10555-1:2013".

However, the document does NOT provide:

• A specific table of acceptance criteria.
• Reported device performance against those criteria.
• Details about a formal study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance details, training set information) that would typically prove a medical device meets specific performance acceptance criteria. The performance data mentioned are general functional and mechanical tests to demonstrate equivalence, not a clinical or performance study with detailed statistical outcomes.

Therefore, I cannot fulfill your request based on the provided text.

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V-STEADY and V-FAST bone cements are indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.

V-STEADY and V-FAST are polymethylmethacrylate (PMMA) based bone cements formulated to perform percutaneous vertebral augmentation procedures, such as vertebroplasty . Bone cements are self-curing systems consisting of liquid and powder components:

• the powder component is constituted of PMMA beads shaped particles containing the initiator benzoyl peroxide required for starting initiating the cement curing. The radiopacifier agent, zirconium dioxide, is necessary for the cement visibility under radiographs but it does not take part of the curing process (radical polymerization).
• The liquid component comprises the monomer, methylmethacrylate (MMA); dimethyl-para-toluidine (DMPT) as polymerization accelerator and hydroquinone (HQ) as stabilizer to prevent polymerization of the liquid during storage.
  The specific content of PMMA and benzoyl peroxide is slightly different between the two cements conferring upon them specific properties. V-STEADY bone cement has an immediate development of viscosity and thus it is a high viscosity cement that maintains its properties throughout the useful working time. The V-FAST has a low initial viscosity and a long working time allowing to work extremely carefully when a good time margin before polymerization is required. Both the liquid and powder components are supplied sterile-filtered monomer component is supplied in an amber glass ampoule (10 ml) and comes in a blister pack sterilized by ethylene oxide. The polymer powder component is supplied in a double sterile packaging.

The provided document is a 510(k) Premarket Notification for medical devices, specifically bone cements (V-STEADY and V-FAST). It describes the chemical composition, intended use, and comparison to a predicate device. However, this document does not contain information about the performance of a device that relies on artificial intelligence (AI) or machine learning (ML), nor does it detail a study that would involve acceptance criteria, human reader performance, ground truth establishment for AI/ML models, or sample sizes related to such studies.

The "Performance Data" section (Page 6) focuses on:

• Biocompatibility: Compliance with ISO-10993.
• Sterilization: Validation of the sterilization process according to various ISO standards.
• Material, Mechanical and Performance Characterization: Comparison of V-STEADY and V-FAST bone cements to the predicate device and reference devices based on mechanical properties (e.g., viscosity, setting time, strength) as per ASTM and ISO standards for bone cements.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets those criteria based on this document. The document describes a traditional medical device (bone cement), not an AI/ML powered device.

To answer your specific questions, if this were an AI/ML driven device submission, one would look for:

1. A table of acceptance criteria and the reported device performance: This would typically involve metrics like sensitivity, specificity, AUC, recall, precision, etc., for an AI algorithm against a defined ground truth, with specific thresholds for acceptance.
2. Sample sizes used for the test set and the data provenance: Details on the number of cases/patients in the test set, where the data came from (e.g., specific hospitals, regions), and whether it was collected retrospectively or prospectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Information on how many clinical experts (e.g., radiologists, pathologists) independently reviewed the test cases to establish the correct diagnosis or finding, and their experience levels.
4. Adjudication method for the test set: How disagreements among experts were resolved (e.g., majority vote, senior expert arbitration, additional review).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: A study setting where human readers interpret cases both with and without AI assistance to measure the improvement AI brings. The effect size would quantify this improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The performance of the AI algorithm by itself, without human input or review.
7. The type of ground truth used: Whether the ground truth was established by expert consensus, confirmed by pathology reports, based on long-term patient outcomes, or other methods.
8. The sample size for the training set: The number of cases/patients used to train the AI model.
9. How the ground truth for the training set was established: Similar to the test set, but for the data used during the development phase of the AI model.

None of this information is present in the provided 510(k) filing because the device in question is PMMA bone cement, not an AI-powered diagnostic or therapeutic device.

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