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Disposable cement spacer molds with stainless steel reinforcement stems, adaptors and inserts are indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is assembled and inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The StageOne" Select hemi-hip prosthesis 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-hip prosthesis material (polymethylmethacrylate/gentamicin), the temporary hemi-hip prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

Cement Spacer Molds are designed to mold a temporary "spacer" hip implant made of antibiotic impregnated bone cement. The spacers are intended for short-term duration use only, not to exceed 6 months.

The StageOne" Select Cement Spacer Molds are a series of Cement Spacer Molds designed to provide modularity of sizing between the femoral stem and the femoral head connponents. The molds provide various stem sizes and various head sizes that can be mated to provide the best fit for each patient. The cement spacer molds are made of biomedical grade silicone. The metal reinforcements within the cement spacer molds are made of implant grade stainless steel.

The provided document is a 510(k) summary for the StageOne™ Select Cement Spacer Molds for Temporary Hip Replacement. It describes the device, its indications for use, and claims substantial equivalence to legally marketed predicate devices.

However, the document does not contain information regarding clinical studies, acceptance criteria, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies because no clinical testing was performed or provided as a basis for substantial equivalence for this device.

The relevant section states:

• "Non-Clinical Testing: Cyclic fatigue testing was conducted on the StageOne™ Select components and the predicate StageOne™ components to provide a direct comparison of the subject and predicate components."
• "Clinical Testing: None provided as a basis for substantial equivalence."

Therefore, I cannot provide the requested information in the format of a table or answer the specific questions related to clinical trials, as such details are explicitly stated as not being part of the submission for this particular device. The FDA's determination of substantial equivalence was based on non-clinical testing (cyclic fatigue) and comparison to predicate devices, not on human-in-the-loop performance or standalone algorithm performance.

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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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Spacer-G is indicated for temporary use (maximum 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and radical debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). Spacer-G is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).

Spacer-G is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) bone cement. The one piece design mimics a hemi-hip prosthesis.

This 510(k) summary for the Spacer-G device primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study with specific acceptance criteria and performance data for the device itself.

Therefore, many of the requested sections about acceptance criteria, study design, and performance metrics are not explicitly detailed in this document. The core of this submission is to show that the modified Spacer-G is just as safe and effective as already approved devices by having similar design, materials, performance characteristics, and gentamicin release profile.

Here is an attempt to address your requests based on the provided text, highlighting where information is absent:

Acceptance Criteria and Study to Prove Device Meets Criteria: Spacer-G Modification

The provided 510(k) summary for the Spacer-G device demonstrates substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria directly linked to a novel performance claim for the modified device. The "acceptance criteria" can be inferred as the standard for substantial equivalence, meaning the device must perform comparably to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the 510(k) summary. Given the nature of a substantial equivalence submission relying on comparison to existing devices, it is unlikely a large "test set" in the sense of a clinical trial was used for this specific modification. The "performance" assessment appears to be based on engineering principles and potentially laboratory testing rather than human clinical outcomes data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable/provided. The submission focuses on substantial equivalence based on technical and material characteristics, not on a clinical ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable/provided. There is no mention of a clinical test set requiring adjudication in this 510(k) summary.

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

This information is not applicable. This device is a temporary hip prosthesis, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

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

This information is not applicable. This device is a medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the performance characteristics of the legally marketed predicate devices. The modified Spacer-G is evaluated against these established benchmarks. No pathology, outcomes data, or expert consensus specific to the modified device's novel performance is referenced as a "ground truth" to meet new performance criteria.

8. The Sample Size for the Training Set

This information is not applicable. This device is not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable. This device is not an AI algorithm.

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