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Spacer-K is indicated for use as a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. Spacer-K is only indicated for an implantation period of 180 days or less. Because of the inherent mechanical limitations of the device material (gentamicin/polymethylmethacrylate), Spacer-K is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

The Spacer-K is a temporary device that mimics a "total knee prosthesis". The twocomponent unconstrained design incorporates a femoral and a tibial component. The device is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) bone cement. The device is supplied sterile to an assurance level (SAL) of 10-6

The provided text does not contain information about acceptance criteria or a study proving the device meets them. Instead, it is a 510(k) premarket notification for a medical device (Tecres Spacer-K, a temporary knee prosthesis).

The document mainly focuses on:

• Administrative Information: Applicant/Consultant, Manufacturer, Date, Contact Person.
• Classification Information: Classification name, product code, CFR section, device class, classification panel, trade/proprietary names.
• Substantial Equivalence: Comparison to a legally marketed predicate device ("Natural Knee" - K936159).
• Device Description: Two-component unconstrained design (femoral and tibial), made of gentamicin/PMMA bone cement, supplied sterile.
• Indications for Use: Temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process, for an implantation period of 180 days or less, with consistent use of mobility assist devices due to mechanical limitations.
• Contraindications: A comprehensive list of conditions under which the device should not be used.
• FDA Clearance Letter: Confirmation of substantial equivalence and permission to market.

Therefore, I cannot provide a table of acceptance criteria and device performance, nor details about a study evaluating these criteria, as this information is not present in the provided text.

The document is a regulatory submission for premarket clearance, which typically establishes substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria.

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