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Spacer-K is indicated for temporary use (maximum 180 days) as an adjunct in total knee replacement (TKR) in 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/polymethilmethacrylate), 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 two-component unconstrained design incorporates a femur and tibial component, it's fully formed by gentamicin/polymethyImethacrylate (PMMA) bone cement.

This 510(k) summary for the Spacer-K knee prosthesis modification does not include the detailed information required to describe acceptance criteria and a study proving device performance in the way you've outlined. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study with acceptance criteria.

However, I can extract information related to the device's characteristics and the basis for its clearance:

Here's what can be gathered, and what is explicitly missing from the provided text:

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

• Missing from the document. The 510(k) summary states that the modified Spacer-K has "equivalent performance and mechanical characteristics" to the predicate Spacer-K (K032522) and a "similar gentamicin release profile" to another predicate (K050210). However, it does not provide specific acceptance criteria (e.g., minimum tensile strength, specific drug release rates) or reported numerical performance data from a study.

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

• Missing from the document. There is no description of a specific test set or clinical study with patient data. The equivalence is based on design, materials, and mechanical characteristics (likely bench testing or literature review, but details are not provided).

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)

• Missing from the document. This type of information is relevant for studies involving subjective assessment (e.g., image interpretation), which is not the primary focus of this 510(k) application.

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

• Missing from the document. Not applicable given the type of submission.

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

• Missing from the document. Not applicable. The Spacer-K is a physical medical device (a temporary knee prosthesis), not an AI-assisted diagnostic tool.

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

• Missing from the document. Not applicable.

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

• Missing from the document. For a device like this, "ground truth" would typically refer to established engineering standards for materials and mechanical properties, or validated methods for drug release testing. The document refers to "equivalent performance and mechanical characteristics" and "similar gentamicin release profile," implying that these aspects were compared to predicate devices, but the specific methodologies for determining this "truth" are not detailed.

8. The sample size for the training set

• Missing from the document. Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Missing from the document. Not applicable.

Summary of what the document DOES provide regarding clearance:

The device (Spacer-K Modification) received 510(k) clearance (K062274) based on a demonstration of substantial equivalence to legally marketed predicate devices.

• Predicate Devices:
  • Spacer-K device (K032522): The modified Spacer-K has the "same design, incorporates the same materials, has equivalent performance and mechanical characteristics, and has the same shelf and packaging" as this predicate.
  • Biomet Stage One Disposable Cement Spacer Mold for Temporary Knee Prosthesis with Reinforcement Stem (K050210): The modified Spacer-K has a "similar gentamicin release profile" when used with Biomet Cobalt G HV Bone Cement (K051532).

Key Takeaway: This 510(k) summary is typical for a device modification, where the primary goal is to show that the new version is as safe and effective as a previously cleared device. It does not contain the kind of detailed performance study and acceptance criteria you would expect from a de novo submission or a product requiring extensive clinical trials. The "study" here is essentially the comparison against the predicate devices across defined parameters (design, materials, mechanical characteristics, drug release).

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