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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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