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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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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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