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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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Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemishoulder 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 humeral medullary canal and glenoid cavity of the shoulder following removal of the existing humeral and glenoideal cavity implants and debridement. SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.

The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).

The hemi-shoulder prosthesis made from the SpaceFlex Shoulder 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 treatment performed (e.g. resection arthroplasty, fusion, etc.).

Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (low viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated for patiently follow activity limitation throughout the implant period.

The device can exclusively be used by competent healthcare personnel who has complete scientific and anatomical knowledge.

For what concerns the modes of the bone cement potentially loaded with antibiotics, see the instructions for use of the selected bone cement.

Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder 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 humeral medullary canal and glenoid cavity of the shoulder following removal of the existing humeral and glenoideal cavity implants and debridement. SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.

The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).

The hemi-shoulder prosthesis made from the SpaceFlex Shoulder 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 treatment performed (e.g. resection arthroplasty, tusion, etc.).

Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (low viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitation throughout the implant period.

The device can exclusively be used by competent healthcare personnel who has complete scientific and anatomical knowledge.

For what concerns the modes of usage of the bone cement potentially loaded with antibiotics, see the instructions for use of the selected bone cement.

This document is a 510(k) Premarket Notification from the FDA regarding the SpaceFlex Shoulder device. It contains information about the device's intended use, comparison to predicate devices, and performance data. However, it does not describe an AI/ML-driven medical device or a study involving human readers and AI assistance for diagnostic purposes.

Therefore, I cannot extract the information required to populate the tables and answer the questions about acceptance criteria, study details, human reader performance, or ground truth establishment as it pertains to an AI/ML device.

The document discusses:

• A physical medical device: SpaceFlex Shoulder, which is a disposable cement spacer mold for temporary hemi-shoulder replacement.
• Its intended use in a two-stage revision procedure due to a septic process, where it's molded with bone cement to create a temporary prosthesis.
• Performance testing for mechanical properties (Fatigue, Visual Inspection, Usability, Gentamicin Elution), demonstrating equivalence to predicate devices. This testing is for the physical product, not an AI algorithm.

In summary, there is no information in the provided text to fulfill the request concerning acceptance criteria for an AI/ML device, study design, expert involvement, or MRMC studies.

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