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This product is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.

This product 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.). During the implantation period, patients have to use traditional mobility assist devices (e.g. crutches, walkers, canes) for daily activities.
With pre-clinical validations of antibiotic elution, tibial spacer fatigue test, and knee spacer wear test, only Palacos MV+G bone cement may be used for preparing the spacers.

Cellbrick Knee Spacer is a temporary knee spacer product, it's suitable for the patients with mature skeleton and required to perform two-stage knee joint prosthesis procedure for infection control. It consists of three components, which are (1) Femoral Spacer, (2) Tibial Spacer, and (3) Canal Rod. The Femoral Spacers and the Tibial Spacers are designed with multiaperture features, which can act as carrier of antibiotic-loaded bone cement to release antibiotic at infection site. The Canal Rod is optional.

• Femoral Spacer
  The Femoral Spacer is made of UHMWPE (ASTM F648/ISO5834-2). The geometrical appearance of Femoral Spacer is designed and modified based on the 510(k) cleared cruciate-retaining femoral component (K140073). Their articular surface geometry and curvature is identical. In addition, the Femoral Spacer is designed with multiaperture feature. Such scaffold-like features can use as a carrier of antibiotic-loaded cement to release antibiotic at the infection site for infection control.
  The Femoral Spacer can be used for both of left and right knee because of the symmetric condyle design. Five femoral spacer sizes have been prepared for different anatomical demands with anteroposterior (AP) and mediolateral (ML) dimensions. The Femoral Spacer is designed “same/ one up" sizing options with the tibial spacers.
• Tibial Spacer
  The Tibial Spacer is made of UHMWPE (ASTM F648/ISO5834-2). The bearing surface's curvature and geometrical design of the tibial spacer is the same as the 510(k) cleared ultra-congruent tibial insert (K132752, K150829, and K222700). The Tibial Spacer is designed with multiaperture feature as well. This scaffold-like feature is used as a carrier of antibiotic-loaded cement to release antibiotic at the infection site for infection control.
  Five Tibial Spacer sizes have been prepared for different anatomical demands with anteroposterior (AP) and mediolateral (ML) dimensions.
• Canal Rod
  The canal rod is made of Ti-6Al-4V alloy (ASTM F136/ISO 5832-3). As a carrier, the rod provides the area for cement to attach so that to increase the surface area of cement. The canal rod is an optional device, it could be applied to patient with deeper infection problem, applying Canal Rod can make surgeon placing antibiotic-loaded cement into the deeper infection site. The Canal Rod is provided with one dimension: Ø 4(diameter) ×80mm (length).

The provided text is a 510(k) summary for the "Cellbrick Knee Spacer". It describes the device, its intended use, and compares it to predicate devices. However, the document does not contain any information about acceptance criteria or a study proving that an AI/ML device meets acceptance criteria.

The requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is all highly relevant to the evaluation of AI/ML-driven medical devices. Since the Cellbrick Knee Spacer is described as a physical implant (femoral spacer, tibial spacer, canal rod made of UHMWPE and Ti-6Al-4V alloy) and not a software or AI/ML product, the submission details focus on pre-clinical validations for physical properties like antibiotic elution, wear tests, fatigue tests, range of motion, constraint performance, and endotoxin testing.

Therefore, I cannot provide the requested information as it is not present in the provided document. The document describes a physical medical device clearance, not an AI/ML device validation.

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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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