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

InterSpace Knee is applied on the femoral condyles and on the tibial plate following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).

InterSpace Knee 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 material (gentamicin/polymethylmethacrylate), the is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period

InterSpace Knee ATS 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 a large tibial defect is present.

InterSpace Knee ATS is applied on the tibial plate following removal of the existing implant and radical debridement. The device must be combined with the tibial component of InterSpace Knee. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

InterSpace Knee ATS 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 material (gentamicin/polymethacrylate), the Interspace Knee ATS is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

The InterSpace Knee, cleared by FDA via K101356 and K062274, is a temporary spacer device available in three sizes (S-M-L). With this 510(k) submission, Tecres is adding the additional XL size to the FDA cleared range of InterSpace Knee sizes.

The InterSpace Knee ATS is a temporary spacer device available in four sizes, intended to be combined with the tibial component of InterSpace Knee. Specific sizes of the InterSpace Knee ATS are compatible with certain InterSpace Knee sizes.

The devices, as single device (InterSpace Knee, K101356 and K062274) or once InterSpace Knee is combined with the InterSpace Knee ATS, provide patients with 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 InterSpace Knee XL size and InterSpace Knee ATS components are sterile, single-use device intended for temporary use (maximum 180 days) as a partial 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 hydroquinone; the powder component consists of PMMA, barium sulphate, benzoyl peroxide and gentamicin sulphate.

The provided document is a 510(k) Premarket Notification from the FDA, and it describes a medical device called "InterSpace Knee Extra-Large Size" and "InterSpace Knee ATS." This document details the device's indications for use, its characteristics, and how it compares to predicate devices to establish substantial equivalence.

Crucially, this document focuses on establishing the substantial equivalence of new sizes/components of an existing knee spacer device based on engineering and material performance criteria, NOT on clinical diagnostic performance criteria for an AI/ML-driven device.

Therefore, most of the requested information regarding acceptance criteria and studies for AI/ML device performance (e.g., sample sizes for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable to this document. This submission is for a physical medical implant, not a diagnostic or AI-powered device.

However, I can extract the relevant "acceptance criteria" (in the context of engineering performance) and reported performance from the document.

Acceptance Criteria and Reported Device Performance (Engineering/Material Focus):

The "acceptance criteria" in this context refer to passing various engineering and material tests, often by meeting the requirements of recognized standards (ISO, ASTM) or by demonstrating equivalence to a predicate device that has previously met these standards. The "reported device performance" indicates that the device did meet these criteria.

Since this document is for a physical orthopedic implant and not an AI/ML diagnostic tool, the following points are not applicable and cannot be answered from the provided text:

2. Sample sized used for the test set and the data provenance: Not applicable to a physical device performance study of this nature. Performance tests are typically conducted on a minimal number of samples to demonstrate compliance with standards.
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 an AI/ML diagnostic is typically based on clinical expert consensus or pathology; for this device, "ground truth" refers to physical and chemical properties confirmed by laboratory testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
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 (expert concensus, pathology, outcomes data, etc): Not applicable in the context of diagnostic performance. "Ground truth" here is the adherence to material and mechanical specifications.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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