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Disposable cement spacer molds with stainless steel reinforcement stems, adapters 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 molded using PALACOS® R+G Bone Cement or Refobacin® Bone Cement R. 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 hemi-hip prosthesis made from the StageOne™ Select 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-hip prosthesis material (PALACOS® R+G Bone and Refobacin® Bone Cement R), 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.

The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. They are intended to be filled with PALACOS® R+G Bone Cement or Refobacin® Bone Cement R* by injecting with a dispenser/gun into the mold. After the cement cures, the hemi-hip prosthesis is to be removed from the molds with the reinforcement remaining as the core of the hemi-hip prosthesis, assembled using the neck length adapter and placed into the joint space. The hemi-hip prosthesis remains in place (180 days or less) until the second stage of the two-stage procedure is performed to implant a conventional hip joint prosthesis.

This document is a 510(k) premarket notification for a medical device, the StageOne™ Select Disposable Cement Spacer Molds for Making Temporary Hemi-Hip Prosthesis with Reinforcement Stem. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for a novel device.

The "acceptance criteria" discussed in this document revolve around the concept of "substantial equivalence" to a legally marketed predicate device (K080979 - StageOne™ Select Cement Spacer Molds for Temporary Hip Replacement). The study described is a non-clinical performance comparison to demonstrate this equivalence.

Here's the information broken down based on your request, as much as can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for the mechanical performance testing, gentamicin elution testing, or bacterial endotoxin testing. It only states that these tests were performed and demonstrated equivalence.

The data provenance is not explicitly detailed beyond being "Non-Clinical Tests" presented by Biomet Inc. It is retrospective in the sense that it's a comparison to existing, defined characteristics of a predicate device. The country of origin of the data is not specified.

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

Not applicable. This submission relies on non-clinical comparative testing against a predicate device and established specifications (like pyrogen limits). There is no mention of experts being used to establish ground truth for a test set in the context of diagnostic accuracy or similar applications.

4. Adjudication Method for the Test Set

Not applicable. As described above, there's no diagnostic test set with human interpretation requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. This document does not mention any MRMC study. The device is a physical medical device (spacer molds), not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense, the non-clinical tests performed are "standalone" in that they assess the physical characteristics and performance of the device itself (or the prosthesis molded from it) against predefined specifications and a predicate device, without direct human interaction as part of the "performance" measurement. However, this is not an "algorithm-only" standalone performance as typically discussed for AI devices.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests is based on:

• Predicate Device Performance: The established mechanical and elution characteristics of the legally marketed predicate device (K080979).
• Established Specifications: Pyrogen limit specifications for bacterial endotoxin testing.
• Material Properties: The known properties of PALACOS® R+G Bone Cement and Refobacin® Bone Cement R.

8. The Sample Size for the Training Set

Not applicable. This is a medical device for physical implantation, not an AI model that requires a training set.

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

Not applicable, as there is no training set for an AI model.

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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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