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The REMEDY Acetabular Cup 46mm ID/54mm OD consists of an acetabular cup that is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.

The REMEDY Acetabular Cup 46mm ID/54mm OD is positioned into the acetabular cavity following removal of the existing acetabular and femoral components and radical debridement. The device must be combined with the REMEDY Hip Spacer using the REMEDY 46mm Modular Head when gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s), or the REMEDY SPECTRUM GV Hip Spacer using the REMEDY SPECTRUM GV 46mm Modular Head when gentamicin and vancomycin are the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s). The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The REMEDY Acetabular Cup 46mm ID/54mm OD 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, etc.).

The REMEDY Acetabular Cup is a temporary spacer device available in a single size, intended to be combined with either the REMEDY Hip Spacer with 46mm Modular Head or the REMEDY SPECTRUM GV Hip Spacer using its 46 mm Modular Head.

The REMEDY Acetabular Cup is a sterile, single-use device intended for temporary use (maximum 180 days) as joint replacement. The device is made of fully formed polymethylmethacrylate (PMMA), which is radio-opaque and contains gentamicin.

The REMEDY Acetabular Cup and REMEDY or REMEDY SPECTRUM GV Hip Spacers provide a functional-mechanical mode of action; the system provides patients a temporary implant allowing for a natural range of motion and partial weight-bearing during treatment. The system is designed to preserve soft tissue to prevent further complications, such as muscular contraction, and to facilitate the subsequent joint replacement procedure. The REMEDY Acetabular Cup is protected from bacterial adhesion due to the presence of gentamicin.

This is a 510(k) premarket notification for a medical device called the "REMEDY Acetabular Cup." This document does not describe a study that validates an AI/ML powered medical device. It instead details the equivalency of the REMEDY Acetabular Cup to predicate devices through physical performance testing and engineering analysis, not through a clinical or algorithmic performance study involving a test set, ground truth, or expert readers.

Therefore, I cannot provide the information requested in the format of acceptance criteria and study proving device meets the criteria, as this document does not contain that type of information for a device that relies on algorithmic performance.

The document discusses:

• Device Name: REMEDY Acetabular Cup
• Regulation: 21 CFR 888.3360 (Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis)
• Product Codes: KWL, KWY
• Indications for Use: Temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. It requires combination with specific Hip Spacers (REMEDY Hip Spacer or REMEDY SPECTRUM GV Hip Spacer) depending on the appropriate antibiotic (gentamicin or gentamicin and vancomycin).
• Device Description: Sterile, single-use, made of polymethylmethacrylate (PMMA), radio-opaque, contains gentamicin. Provides functional-mechanical mode of action, allows natural range of motion and partial weight-bearing.
• Predicate Devices: REMEDY Acetabular Cup (K173967) and REMEDY SPECTRUM GV Hip Spacer (K172906).
• Substantial Equivalence: Demonstrated through performance testing (static and fatigue strength of resin, range of motion, surface roughness, antibiotic release kinetics) and engineering analysis of wear. Endotoxin testing also performed.

The relevant section regarding acceptance criteria and performance would be "Performance testing... to support its substantial equivalence" on page 5. However, this refers to mechanical and material performance, not the performance of an AI/ML algorithm.

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The REMEDY® Acetabular Cup 46mm ID/54mm OD consists of an acetabular cup that is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process, and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s).

The REMEDY® Acetabular Cup 46mm ID/54mm OD is positioned into the acetabular cavity following removal of the existing acetabular and femoral components and radical debridement. The device must be combined with REMEDY® Hip Spacer using REMEDY® Modular Head 46 mm. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The REMEDY® Acetabular Cup 46mm ID/54mm OD 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, etc.).

The Remedy® Acetabular Cup is a temporary spacer device available in a single size, intended to be combined with Remedy Hip Spacer using Remedy® Modular Head 46 mm.

The Remedy® Acetabular Cup is sterile, single-use device intended for temporary use (maximum 180 days) as joint replacement. The device is made of fully formed polymethylmethacrylate (PMMA), which is radio-opaque and contains gentamicin. The mass used to fill the molds (the unformed PMMA resin) is prepared from powder and liguid components. The liquid component consists of methylmethacrylate (MMA), N, N dimethylp-toluidine and hydroquinone; the powder component consists of PMMA, barium sulphate, benzoyl peroxide and gentamicin sulphate.

The Remedy® Hip Spacer and Acetabular Cup provide a functional-mechanical mode of action; the system provides patients a temporary implant allowing for a natural range of motion and partial weight-bearing during treatment. The system is designed to preserve soft tissue to prevent further complications, such as muscular contraction, and to facilitate the subsequent joint replacement procedure. The Remedy® Acetabular Cup is protected from bacterial adhesion due to the presence of gentamicin, similar to other spacers devices made from antibiotic loaded PMMA currently on the US market.

The provided text describes a 510(k) premarket notification for a medical device called the "Remedy® Acetabular Cup." This documentation is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, not on proving clinical efficacy or diagnostic performance as one might for an AI/ML medical device.

Therefore, the information required to answer your questions about acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and training sets for an AI/ML device is not present in the provided document. The document primarily details:

• Device Description: What the Remedy® Acetabular Cup is (a temporary acetabular cup spacer with gentamicin).
• Intended Use: Its temporary use (max 180 days) as an adjunct to total hip replacement in a two-stage procedure due to a septic process.
• Comparison to Predicate Device: How it is similar and different from its predicate (Remedy® Hip Spacer) in terms of materials, design, and performance characteristics.
• Performance Data (Non-Clinical): Summaries of sterilization, shelf life, biocompatibility, and mechanical performance testing (static, fatigue, surface roughness, wear, antibiotic elution).

In the context of the provided text, there are no "acceptance criteria" or "study" described that would prove an AI/ML device meets certain performance metrics. The "performance data" referred to in section 8 are bench and lab tests demonstrating the physical and material properties of the implant, not clinical or diagnostic performance evaluated against a ground truth dataset in the way an AI/ML model would be.

To directly answer your request based on the absence of this information in the provided text:

1. A table of acceptance criteria and the reported device performance:
   • No such table exists for an AI/ML device's performance metrics (e.g., sensitivity, specificity, AUC). The document lists mechanical and material performance attributes, but not against quantitative "acceptance criteria" in a table format relatable to AI.
2. Sample sized used for the test set and the data provenance:
   • Not applicable/Not provided. There is no test set of patient data for AI model evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   • Not applicable/Not provided. Ground truth establishment for an AI/ML model is not mentioned.
4. Adjudication method for the test set:
   • Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
   • No. This is a physical implant, not a diagnostic AI tool requiring MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   • Not applicable.
7. The type of ground truth used:
   • Not applicable.
8. The sample size for the training set:
   • Not applicable.
9. How the ground truth for the training set was established:
   • Not applicable.

Summary of what is provided about "performance data" (non-AI related):

The document states in section 8, "PERFORMANCE DATA":

• Sterilization and Shelf Life: Validated using international standards. Endotoxins tested via LAL test, meeting

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