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The Remedy Knee Spacer, which consists of a Femoral Component and a Tibial Insert, is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) 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 device is applied on the femoral component) and on the tibial plate (tibial component) following removal of the existing implant and radical debridement. The use of the Tibial Insert is optional, when a large tibial defect is present.

The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).

The Remedy Knee Spacer 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.). Because of the inherent mechanical limitations of the device materials (gentamicin/polymethylmethacrylate), the device is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers, canes) throughout the implantation period.

The Remedy Stemmed Knee Spacer, which consists of a modular femoral, tibial and stem extension components, is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) 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 device is applied on the femoral component) and on the tibial plate (tibial component) following removal of the existing implant and radical debridement. The use of the stem extension component is optional to replace the space occupied by the previous femoral and/or tibial stem (dead space management). Moreover, if necessary, the tibial component could be coupled with the Osteoremedies Remedy Tibial Insert Wedge when a large tibial defect is present.

The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).

The Remedy Stemmed Knee Spacer is not intended for use tor 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.). Because of the inherent mechanical limitations of the device materials (gentamicin/polymethylmethacrylate), the device is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers, canes) throughout the implantation period, allowing basic joint mobility.

The Remedy® Knee Spacer, cleared via K112470, is a temporary knee spacer device consisting of independent components (femoral component, tibial component and insert wedge) that can be combined one with each other depending on the anatomy of the patient. The cleared femoral components are available in three sizes (54mm, 64mm and 74mm). With this 510(k) submission. OsteoRemedies is adding the additional 84mm size (extra-large) to the FDA cleared range of Remedy Femoral Component.

The Remedy® Stemmed Knee Spacer is a temporary knee spacer device consisting of independent components (femoral component, tibial component and stem extension components) that can be combined one with each other depending on the anatomy of the patient. These components are available in different sizes to further accommodate variations in patient anatomy.

The Stem Extension Implant components can be coupled with both the femoral and the tibial components, as they are intended to be used, if necessary, to replace the space occupied by the previous femoral and/or tibial stem. The Remedy Stemmed Tibial component could also be coupled, if necessary, with the commercially marketed Remedy Tibial Insert Wedge (K112470), when a large tibial defect is present.

The Remedy Femoral Component 84mm and the Remedy Stemmed Knee Spacer are sterile, single-use devices intended for temporary use (maximum 180 days) as joint replacement. The devices are 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 liquid components. The liquid component consists of methylmethacrylate (MMA), N. N dimethyl-p-toluidine and hydroguinone; the powder component consists of PMMA, barium sulphate, benzovl peroxide and gentamicin sulphate. The stem components also present an inner core of Stainless Steel (AISI 316 ESR).

The devices (which consists of the combination of single components) provide patients a temporary complete knee implant that allows for a natural range of motion and partial weightbearing during treatment of the infection, and preserves the soft tissue to prevent further complications, such as muscular contraction, to facilitate the subsequent joint replacement procedure after systemic treatment of the underlying infection. The devices are protected from bacterial adhesion due to the presence of gentamicin, similar to other spacers devices made with PMMA with antibiotics currently on the US market.

The provided text describes the 510(k) premarket notification for the "Remedy® Femoral Component 84mm" and the "Remedy® Stemmed Knee Spacer". This documentation focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study where a device's performance is measured against predefined acceptance criteria in the context of diagnostic accuracy or clinical outcomes.

Therefore, many of the requested elements (e.g., acceptance criteria for diagnostic performance, sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set sample size) are not applicable or mentioned in this type of regulatory submission.

However, I can extract the relevant information regarding performance testing that was conducted to support their claim of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in a table format for each test, but it states that the performance data demonstrates substantial equivalence to the predicate device. The performance tests are primarily engineering and material science tests.

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

The document does not specify sample sizes (e.g., number of units tested) for the engineering and material performance tests. The tests are benchtop, in-vitro experiments, so data provenance in terms of country of origin or retrospective/prospective clinical data is not applicable.

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

Not applicable. Ground truth for these types of mechanical and material tests is established by adherence to documented international and national standards (ISO, ASTM) and the results obtained from those tests, not by expert human interpretation.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically associated with clinical studies or diagnostic accuracy assessments, not with the type of engineering performance tests described.

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

Not applicable. This is not an AI/diagnostic device, and no MRMC study or assessment of human reader improvement is mentioned.

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

Not applicable. This device is a temporary knee spacer, a physical implant, not an algorithm.

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

The "ground truth" for the performance data in this context is based on established engineering and material science standards (e.g., ISO, ASTM) and the objective measurements derived from testing the device against those standards. For biocompatibility, it relied on ISO 10993 and FDA guidance.

8. The sample size for the training set

Not applicable. The device is a physical implant, not an AI or machine learning 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 this type of device.

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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 <20 EU/device.
• Biocompatibility: Evaluated based on ISO 10993 and FDA Draft Guidance, finding materials safe and biocompatible.
• Performance Testing (Mechanical/Material): Included evaluation of static and fatigue performances, surface roughness, device wear, and antibiotic (gentamicin) elution testing. The document states these "demonstrate that the new device is substantially equivalent to the predicate device."

This 510(k) submission is for a physical medical device (an implant), not a software or AI-driven diagnostic or therapeutic device. Therefore, the types of studies and acceptance criteria you're asking about (which are standard for AI/ML medical devices) are not relevant to this specific document.

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The Remedy® Shoulder Spacer, which consists of a modular head and stem, is indicated for temporary use (maximum 180 days) as an adjunct to total or hemi-shoulder replacement 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-organisms.

The head and stem components are inserted into the glenoidal cavity and humeral medullary canal, respectively, following removal of the existing prosthetic components and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The Remedy® Shoulder Spacer 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.).

The Remedy® Shoulder Spacer is a sterile, single-use device intended for temporary use (maximum 180 days) as shoulder replacement.

The Remedy® Shoulder Spacer is composed of two components (a head and a stem) that are intended to be used together to form a temporary shoulder spacer; the components are available in a range of sizes.

The device is made of fully formed polymethylmethacrylate (PMMA), which is radioopaque and contains gentamicin. The stem component has also an inner stainless steel reinforcing structure.

The Remedy® Shoulder Spacer provides a functional-mechanical mode of action; it provides patients a temporary implant allowing for a natural range of motion and partial weight-bearing during treatment. It is designed to preserve soft tissue to prevent further complications, such as muscular contraction, and to facilitate the subsequent joint replacement procedure.

This document appears to be a 510(k) Summary for a medical device called the "Remedy® Shoulder Spacer." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study designed to meet specific acceptance criteria in the way one would for an AI/ML powered device.

Therefore, many of the requested categories for AI/ML device studies (like sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document as it describes a physical orthopedic implant, not a software algorithm.

Below is an attempt to map the available information to the closest relevant categories, with explanations for why certain sections are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

As this is not an AI/ML device, the concept of "acceptance criteria" for diagnostic performance metrics (e.g., sensitivity, specificity, AUC) is not present. Instead, the document discusses performance testing designed to demonstrate safe and effective mechanical function and material properties, and equivalence to a predicate device. The "acceptance criteria" would be compliance with relevant standards and demonstration of properties comparable to the predicate.

2. Sample size used for the test set and the data provenance

This is not applicable for a physical device 510(k) submission in the context of diagnostic "test sets." The performance data is based on laboratory testing of the device itself and its components, according to established engineering and material science protocols. There is no biological "data" in the sense of patient images or clinical outcomes that would have "provenance."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. "Ground truth" in this context refers to a standard of truth for diagnostic or clinical outcome data, which is not evaluated here. The "truth" for device performance is established through physical and chemical testing against engineering standards and comparison to a predicate device.

4. Adjudication method for the test set

This is not applicable. There is no clinical "test set" requiring adjudication by experts.

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 is not applicable as this is not an AI/ML device or a diagnostic device involving "human readers."

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

This is not applicable as this is not an AI/ML device.

7. The type of ground truth used

This is not applicable in the AI/ML sense. The "ground truth" for the device's acceptable performance is defined by:

• Compliance with recognized standards: e.g., ISO for biocompatibility, sterilization standards.
• Engineering and material science principles: for mechanical strength, fatigue, material composition.
• Comparative data to a legally marketed predicate device: demonstrating that the new device is "substantially equivalent" in terms of safety and effectiveness.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device. There is no concept of a "training set" for a physical orthopedic implant.

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

This is not applicable as this is not an AI/ML device.

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