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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 device is indicated for use in total knee arthroplasty in skeletally mature patients with the following conditions:

1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
2. Collagen disorders, and/or avascular necrosis of the femoral condyle.
3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
4. Moderate valgus, varus, or flexion deformities.
5. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

The device includes Cruciate Retained (CR) type, Posterior Stabilized (PS) type and Ultracongruent (UC) type. CR and UC types are designed to collocate with CR femoral component, while PS type is designed to collocate with PS femoral component.

This device is a single use implant and intended for cemented use only.

All Poly Tibial Components are made of Ultra High Molecular Weight Polyethylene (UHMWPE), including Cruciate Retained (CR) type, Posterior Stabilized (PS) type and Ultracruent (UC) type. All types are available in sizes #0~#7 (ranging from 39.5mm/60mm AP/ML to 58mm/84mm AP/ML) with ten thickness options (9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm and 18mm). The CR type of All Poly Tibial Component is intended to accommodate the posterior cruciate ligament (PCL) if it is present. The PS type and UC type are intended to be used in situation where the posterior cruciate ligament is absent or cannot be preserved. All Poly Tibial Components can be used with femoral components of U2 Total Knee System and patella (K021657, K103733, K051640 and K082469) in primary or revision total knee arthroplasty. CR and UC types are designed to collocate with CR femoral component (K140073, K150829, K140075 and K150832) while PS type is designed to collocate with PS femoral component (K051640, K120507 and K150829). The X-ray marking wire which is made of Co-20Cr-15W-10Ni alloy is embedded in the All Poly Tibial Component for X-ray image identification purpose.

I am sorry, but based on the provided text, there is no information about acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment for a device that uses AI or machine learning.

The document describes a medical device called "All Poly Tibial Component," which is a knee implant. The "Performance Data" section explicitly states "Non-clinical Performance" and lists mechanical tests like Range of Motion, Contact Area and Contact Pressure, Constraint Test, Wear Simulation Test, and Fatigue Test. It also explicitly states "Clinical Performance Data/Information: None provided as a basis for substantial equivalence."

Therefore, I cannot provide the requested information.

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Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or posttraumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

The devices covered by this 510(k) are intended to be used with a Repicci Femoral component.

The device is a single use implant intended for implantation with bone cement.

The Repicci II Unicondylar Knee system consists of a femoral and tibial component. The femoral components have been cleared through a previous 510(k) as have thicker sizes of the all poly tibial component.

The all polvethylene tibial component is universal in geometry so separate components are not necessary for left and right knees. A waffle pattern and recessed holes on the under surface assists in fixation with bone cement. Due to the radiolucency of polyethylene, a wire is molded within the component.

The provided text is a Summary of Safety and Effectiveness for the Biomet Repicci II Unicondylar Knee All Poly Tibial Components, along with an FDA clearance letter. This type of document is a pre-market notification (510(k)) and primarily focuses on demonstrating substantial equivalence to a previously legally marketed device, rather than proving a device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, and standalone performance is not present in the provided text, as these are typically part of a clinical trial or performance study, which is not the primary purpose of a 510(k) submission for this type of device.

The document states that "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This means the FDA found it equivalent to similar devices already on the market based on its intended use, design principles, and materials, without requiring new, independent performance data against specific acceptance criteria like you would find for a novel diagnostic AI algorithm.

However, I can extract information related to the device and its intended use, which are implicitly part of the "acceptance" for market clearance:

1. A table of acceptance criteria and the reported device performance:

Since specific quantitative acceptance criteria and performance data from a dedicated study are not presented, I cannot create this table as requested. The "performance" demonstrated for a 510(k) is typically by demonstrating equivalence to a predicate device in terms of materials, design, and intended use, rather than achieving specific numerical performance thresholds in a clinical study for this type of implant.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. The document does not describe a "test set" or a study designed to evaluate performance metrics. It's a 510(k) submission for substantial equivalence.

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):

Not applicable. No "test set" and no related ground truth establishment by experts are described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No "test set" or adjudication method are 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 comparative effectiveness study is mentioned.

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

Not applicable. This is a physical implant, not an algorithm.

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

Not applicable. No study requiring ground truth is described.

8. The sample size for the training set:

Not applicable. This is a physical implant, not a machine learning model, so there's no concept of a "training set" in the context of the provided document.

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

Not applicable. There is no training set involved.

Summary of what IS available in the document regarding "acceptance" for market clearance:

• Intended Use (Implicit Acceptance Criteria for Market Clearance): The device is intended for "Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty."
• Design and Materials (Implicit Acceptance Criteria for Market Clearance): The device is an all-polyethylene tibial component, universal in geometry, with a waffle pattern and recessed holes for cement fixation, and a molded wire for radiolucency. It is intended for use with a Repicci Femoral component.
• Safety (Implicit Acceptance Criteria for Market Clearance): The potential risks are acknowledged to be "the same as with any joint replacement device."
• Clinical Performance (Implicit Acceptance Criteria for Market Clearance): The FDA clearance is based on the device being "substantially equivalent" to predicate devices already on the market, implying that its performance is expected to be comparable and acceptable based on the history of those predicate devices. No new clinical performance study is detailed in this document.
• Specific Limitations/Conditions for Market Clearance from the FDA:
  • Thinnest tibial component is nominal 6.5mm, with a minimum polyethylene thickness of 6.5mm.
  • May not be labeled or promoted for non-cemented use.
  • All labeling must prominently state that it is for cemented use only.
  • Non-cemented fixation is considered investigational and requires IDE regulations (21 CFR, Part 812) and IRB/FDA approval.

In conclusion, the document is a 510(k) pre-market notification that demonstrates substantial equivalence, not a clinical study report with detailed performance metrics against specific acceptance criteria.

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