(494 days)
Spacer-K 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.
Spacer-K 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 antimicrobial antibiotic therapy (standard treatment approach to an infection).
Spacer-K is not intended for use for more than 180 days, at which time it must be explanted and 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), Spacer-K is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.
Spacer-G is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.
The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
Spacer-G 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.).
Spacers are temporary joint prostheses. Spacer-G is a single piece device that mimics a hemi-hip prosthesis, and is available in six sizes. Spacer-K includes a femoral and tibial component, and is available in three sizes. Spacer-G and Spacer-K are made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin). Spacer-G contains an inner stainless steel (AISI 316L stainless steel) reinforcing structure. The mass used in the filling of the molds (the PMMA unformed resin) is prepared from a powder component and a liquid component. The liquid component consists of methylmethacrylate, N,N-dimethyl-p-toluidine, hydroquinone; the powder component consists of polymethymethacrylate, barium sulphate, benzovl peroxide, and gentamicin sulphate.
The Spacer devices provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to 1) allow for partial weight bearing and 2) provide a natural range of motion. The devices also maintain a patient's soft tissue and joint space, preventing further complications such as muscular contraction. The gentamicin protects the device from bacterial colonization.
Here's a breakdown of the acceptance criteria and study information for the Tecres Spacer-G and Spacer-K, based on the provided documents:
Acceptance Criteria and Device Performance
The provided 510(k) summary (K101356) does not explicitly state specific quantitative acceptance criteria or detailed performance data in a table format. Instead, it relies on substantiating that the modified devices (Spacer-G and Spacer-K) are substantially equivalent to their previously cleared versions (K062274 for Spacer-K and K062273 for Spacer-G).
The core acceptance criterion implicitly stated is:
- The modified Spacer devices must perform equivalently to their previously cleared versions, ensuring continued safety and effectiveness for their intended temporary use.
The reported device performance is described as:
- "Performance testing was conducted to verify that implant performance continues to meet the production specifications and be adequate for in vivo applications under the temporary conditions of use."
- "Mechanical properties, gentamicin release and stability data were evaluated and found to support the substantial equivalence of the devices."
Without quantitative metrics provided in these documents, a table cannot be fully populated. However, we can infer the categories of assessment:
| Acceptance Criteria Category | Reported Device Performance (Qualitative) |
|---|---|
| Mechanical Properties | Evaluated and found to support substantial equivalence to previously cleared devices. |
| Gentamicin Release | Evaluated and found to support substantial equivalence to previously cleared devices (for antibacterial function). |
| Stability | Evaluated and found to support substantial equivalence to previously cleared devices. |
| Production Specifications | Implant performance continues to meet production specifications. |
| In Vivo Adequacy | Adequate for in vivo applications under temporary conditions of use. |
Study Information
The 510(k) summary for K101356 describes an evaluation for "substantial equivalence" rather than a de novo clinical study with patients. The study primarily involves performance testing to compare a modified device (minor material change) to an established, previously cleared device.
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Sample size used for the test set and the data provenance:
- The document does not specify the sample size for any test set in terms of clinical data or patient cohorts. The performance testing appears to be conducted on the devices themselves (e.g., in vitro mechanical testing, elution studies).
- Data provenance: Not explicitly stated as retrospective or prospective clinical data. Given the nature of a 510(k) for a minor material change to a previously cleared device, the testing would likely be bench testing and possibly some in vitro or ex vivo studies. No specific country of origin for clinical data is mentioned as such data doesn't appear to be the primary basis for this particular submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) submission. The evaluation is based on engineering and material science performance testing, not on interpretation of patient data by medical experts. "Ground truth" here refers to established material properties and performance benchmarks.
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Adjudication method for the test set:
- Not applicable as there is no mention of a human expert review or adjudication process for a test set of clinical cases. The evaluation is against engineering specifications and pre-established performance of the predicate device.
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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 device is a temporary orthopedic implant, not an AI-powered diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device.
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The type of ground truth used:
- Engineering specifications and performance characteristics of the previously cleared predicate devices (K062274 and K062273). The "ground truth" for the modified device's performance is that it matches or exceeds the established performance of its predecessors, as demonstrated through mechanical, gentamicin release, and stability testing.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning study, so there is no concept of a "training set."
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How the ground truth for the training set was established:
- Not applicable.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.