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The REMEDY Stemmed Knee Spacer, which consists of 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 where gentamicin is the most appropriate antibiotic based on the susceptibility of the infecting micro-organism(s).

The REMEDY Stemmed Femoral Component can be used with a PMMA Tibial Component or an All-Poly tibial component. The device is applied on the femoral condyles (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). Stem Extensions may be used with the Femoral and Tibial components. Moreover, if necessary, the Tibial Component could be coupled with the REMEDY Tibial Insert Wedge when a large tibial defect is present.

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

The REMEDY Stemmed 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, 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 OsteoRemedies' REMEDY Stemmed Knee Spacer (K183017, K223650) are legally marketed devices that are used in skeletally mature patients undergoing a two-stage procedure due to a septic process.

The 510(k)-cleared 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 with each other and the optional insert wedge depending on the anatomy of the patient. All components are manufactured from PMMA with gentamicin; the stems are structurally reinforced with a stainless steel core.

The subject REMEDY All-Poly Tibial Component is intended to be a line extension to the REMEDY Stemmed Knee Spacer ( K183017, and K223650). The REMEDY All-Poly Tibial Component may be used in lieu of the currently cleared PMMA tibial component.

The provided text is a 510(k) summary for the REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component. It describes the device, its indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices.

However, the document does NOT contain the specific details required to answer your request regarding acceptance criteria and the study that proves the device meets those criteria.

Here's why and what information is missing:

• No Acceptance Criteria Table: The document does not provide a table outlining specific numerical or qualitative acceptance criteria for the device's performance.
• No Reported Device Performance Data: While it lists categories of performance testing (Fatigue, Wear, Elution, Range of Motion, Interconnection), it does not present the actual results or data points from these tests that would demonstrate how the device performed against any criteria.
• No Details on Study Design for Performance Testing: The summary mentions "Performance Testing" but provides no information on the methodology, sample sizes, data provenance, ground truth establishment, expert involvement, or adjudication methods for these tests. It merely states that "The following performance characteristics of the device have been assessed." These are likely in vitro bench tests, not clinical studies with human subjects or AI algorithm testing.
• No Mention of AI/ML or Software: The entire document refers to a physical medical device (knee spacer system) and its components, made of materials like PMMA and stainless steel. There is absolutely no mention of any AI algorithm, machine learning, software performance, human-in-the-loop studies (MRMC), or standalone AI performance.

Therefore, since the provided text relates to a physical orthopedic implant and not an AI/ML-driven device, the questions about acceptance criteria for AI algorithms, sample sizes for AI test sets, expert involvement in ground truth for AI, MRMC studies, or standalone AI performance are not applicable to this document.

In summary, the provided document does not contain the information requested in your prompt as it pertains to a traditional physical medical device, not an AI/ML powered one.

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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 condyles (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 antimicrobial antibiotic therapy (standard treatment approach to an infection).

The REMEDY Stemmed 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, allowing basic joint mobility.

The REMEDY Stemmed Knee Spacer System is a temporary knee spacer system consisting of femoral, tibial, and tibial wedge components, and stem extensions which can be combined to address dead space management following explantation of an infected total knee arthroplasty device. These components are available in different sizes to generally match the sizes of the explanted components and to accommodate variations in patient anatomy.

The stem extension components can be coupled with the femoral and tibial implant components to address dead space management in the femoral and tibial intramedullary canals following removal of infected stemmed prostheses.

The components of the REMEDY Stemmed Knee Spacer System are sterile, single-use devices intended for temporary use (maximum 180 days) as joint replacement. The components are made of fully formed polymethylmethacrylate (PMMA), which is radiopaque and contains gentamicin. The stem components have a stainless steel core.

The REMEDY Stemmed Knee Spacer System provides patients a temporary complete knee implant that allows for a natural range of motion and partial weight-bearing 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 components of the REMEDY Stemmed Knee Spacer System are protected from bacterial adhesion due to the presence of gentamicin.

The provided text describes a medical device, the REMEDY Stemmed Knee Spacer, and its FDA 510(k) clearance. This type of clearance is based on demonstrating "substantial equivalence" to a predicate device, rather than a full pre-market approval (PMA) which would require extensive clinical efficacy and safety studies.

Therefore, the information you've requested regarding acceptance criteria for an AI/algorithm-based device and the study that proves it meets those criteria is not applicable to this document. This document pertains to a physical medical device (a knee spacer) and its mechanical, material, and biological properties, not a software-based AI device.

The "Performance Data" section describes:

• Sterilization and Shelf Life: Validation of sterilization cycles and stability studies for shelf life.
• Biocompatibility: Evaluation conforming to ISO 10993 and FDA guidance.
• Performance Testing of Subject REMEDY Stemmed Knee Spacer: This specifically mentions "Antibiotic elution testing," "Fatigue behavior of the stem extensions," and "Interconnection strength." These are all physical and chemical performance characteristics of the knee spacer itself.

Since the request asks for details related to AI/algorithm performance and ground truth, which are not relevant to this physical device's clearance, I cannot fill out the requested table or answer the specific questions about AI/algorithm study design using the provided text.

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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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