(53 days)
Disposable cement spacer molds with stainless steel reinforcements are intended to be used to mold a hemi-hip femoral prosthesis, indicated for temporary use (maximum 180 days) in skeletally mature patients undergoing a two-stage procedure due to septic process.
The temporary prosthesis is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The temporary prosthesis is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The hemi-hip femoral prosthesis is not intended for use 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 inherent mechanical limitations of the material (polymethylmethacrylate/gentamicin), the molded temporary prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.
The device consists of a sterile, assembled cement spacer mold made of medical grade silicone with a stainless steel reinforcement stem located inside the silicone mold, designed to construct a temporary cement hemihip femoral spacer. The silicone component of the spacer mold is designed to shape the temporary spacer but is not implanted, and is to be discarded after a single use. The stainless steel reinforcement stem serves as the load-bearing endoskeleton of the hemi-hip prosthetic implant and is incorporated into the prosthesis by being coated over by bone cement.
Polymethylmethacrylate/gentamicin bone cement is filled into the silicone mold containing the stainless steel reinforcement stem. The temporary hip prosthesis is removed from the silicone mold after the cement hardens and is placed into the patient's hip joint space.
The femoral cement spacer molds are offered in four sizes (9 mm x 125 mm/ 43mm head, 9 mm x 125 mm/ 51mm head, 13 mm x 145 mm/ 57 mm head & 17 mm x 165 mm/ 64 mm head).
The provided document is a 510(k) summary for the StageOne™ Disposable Cement Spacer Mold. It details the device's description, intended use, and indications for use, as well as non-clinical testing performed. However, it does not contain any information about acceptance criteria or specific study results that delineate device performance against such criteria in a quantitative manner.
Here's a breakdown of the available information based on your request, highlighting what is present and what is absent:
-
A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in quantitative terms within the provided text. The document focuses on demonstrating "substantial equivalence" to a predicate device.
- Reported Device Performance: The non-clinical testing section reports qualitative findings:
- "The temporary hip prostheses were found to be substantially equivalent in fatigue characteristics."
- "The percentage of total gentamicin eluted from the spacer made from a Biomet mold and antibiotic-loaded G bone cement was substantially equivalent to the percentage of gentamicin eluted from the Tecres Spacer-G."
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the non-clinical testing.
- Data Provenance: Not specified.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable as there was no clinical testing involving expert review of patient data to establish ground truth. The testing was non-clinical (mechanical and elution).
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable as there was no clinical testing involving human adjudication of results.
-
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
- No MRMC study was done, nor were there any clinical studies involving human readers or AI.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No standalone algorithm performance study was done, as this device is a physical medical device (cement spacer mold), not a software algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical testing, the "ground truth" was established by comparative mechanical and antibiotic elution testing against a legally marketed predicate device. This involved standardized laboratory testing methods, not a clinical ground truth like pathology or outcomes data.
-
The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
-
How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.