(220 days)
Spacer-G is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in 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 femoral and acetabular implants and 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.).
The Spacer-G is a "hemi-hip" style device. The one-piece design incorporates a load bearing endoskeleton of AISI 316L stainless steel and an outer coating of fully formed gentamicin/polymethylmethacrylate (PMMA) bone cement. The implants are supplied sterile to an assurance level (SAL) of 10-6.
This document is a 510(k) premarket notification for the "Tecres Spacer-G" medical device. It describes the device, its indications for use, contraindications, and a summary of performance data. However, it does not provide a detailed "acceptance criteria and the study that proves the device meets the acceptance criteria" in the format requested.
The document states:
"PERFORMANCE DATA
Performance testing was conducted to verify that the implant performance would be adequate for anticipated in vivo load applications under the temporary conditions of use. The fatigue strength, static strength, wear characteristics and antibiotic release rate were evaluated and found to support the safety and effectiveness of the device."
This is a very high-level summary and does not contain the specific information required to complete the table or answer the detailed questions about the study design, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot extract the requested information from the provided text. The document confirms that performance testing was conducted and found to support safety and effectiveness, but it does not detail:
- A table of acceptance criteria and the reported device performance: No specific criteria or performance values are listed.
- Sample sizes used for the test set and the data provenance: Not mentioned for any of the performance tests (fatigue, static strength, wear, antibiotic release).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as the performance tests described are mechanical/material characteristic tests, not clinical studies involving expert interpretation of data like images or patient outcomes.
- Adjudication method: Not applicable.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, this is not a study type described.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a medical implant, not an algorithm.
- The type of ground truth used: For mechanical and material tests, the ground truth would be the measured physical properties against established standards. The document does not specify these standards or the measured values. For the antibiotic release, it would likely be laboratory measurements of gentamicin concentration over time.
- The sample size for the training set: Not applicable as there is no "training set" for physical performance testing of an implant in this context.
- 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.