(299 days)
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.
| Acceptance Criteria (Test/Standard) | Reported Device Performance (Met/Compared To) |
|---|---|
| InterSpace Knee (XL size): | |
| Static performances of the resin (ISO 5833) | Resin was tested and shown to meet the minimum requirements of ISO 5833. |
| Fatigue performances of the resin (ASTM F2118) | Resin was tested and shown to meet the acceptance criteria according to ASTM F2118. |
| Fatigue test (comparison with other sizes) | The bigger size (XL) has been demonstrated to be a better case compared to the other InterSpace Knee sizes (S-M-L). (This implies it performed as well or better, serving as a worst-case scenario validation for the existing predicate's fatigue performance). |
| Wear test (debris evaluation) | An evaluation of the debris has been compared with another temporary spacer already cleared by FDA. (Implies comparable wear characteristics). |
| Surface Roughness (comparison with other sizes) | Surface roughness is the same of the other sizes already approved. |
| Antibiotic (gentamicin) elution testing (comparison) | The gentamicin elution profile demonstrated substantial equivalence with gentamicin elution of another temporary spacer already cleared by FDA. |
| Sterilization validation (e.g., UNI EN ISO 11135:2014) | Complies with UNI EN ISO 11135:2014; EC 1-2011 UNI EN ISO 11737-1:2006, UNI EN ISO 11737-2:2010, UNI EN ISO 10993-7:2009, UNI EN 556-1:2002, EP current Edition. Validated to a sterility assurance level of 10-6. |
| Shelf Life (e.g., real-time and accelerated aging) | Established through real-time and accelerated aging studies. All demonstrate a shelf life of 5 years. |
| Biocompatibility (ISO 10993 and FDA Draft Guidance) | Evaluation performed to show device materials are safe, biocompatible, and suitable for intended use. Both ISO 10993 and FDA Draft Guidance "Use of International Standard ISO 10993. Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process" have been taken into account. (Implies compliance/satisfaction of these guidelines). |
| InterSpace Knee ATS (additional criteria where applicable): | |
| Static performances of the resin (ISO 5833) | Resin was tested and shown to meet the minimum requirements of ISO 5833. |
| Fatigue performances of the resin (ASTM F2118) | Resin was tested and shown to meet the acceptance criteria according to ASTM F2118. |
| Fatigue test on the device (ASTM F1800) | Has been performed according to ASTM F1800. (Presumably, it passed, or the comparison results were favorable for substantial equivalence). |
| Antibiotic (gentamicin) elution testing (comparison) | The gentamicin elution profile demonstrated substantial equivalence with gentamicin elution of another temporary spacer already cleared by FDA. |
| Sterilization validation & Shelf Life & Biocompatibility (same as XL) | Met the same criteria as the XL size, given the shared materials and manufacturing processes. |
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:
- 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.
- 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.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 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.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.