(29 days)
COPAL® exchange G hip spacer (polymethylmethacrylate / gentamicin) 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 assigned to be used in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). COPAL® exchange G hip spacer 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.). COPAL® exchange G hip spacer is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, canes) throughout the implantation period.
COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile.
COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. The mass used in the filling of the molds (the PMMA unformed resin) is prepared from a powder component and a liguid component. It contains the X-ray contrast medium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
COPAL® exchange G hip spacer will be used with COPAL® exchange G hip trials (510(k) exempt devices).
This response analyzes FDA K220492 for "COPAL® exchange G hip spacer." It is important to note that this device is a physical medical implant, not an AI/ML powered software device. Therefore, many of the requested criteria related to AI/ML device testing (e.g., ground truth establishment, expert adjudication, MRMC studies) are not applicable to this submission.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a physical medical device (hip spacer) and not an AI/ML powered device, the "acceptance criteria" are not based on metrics like accuracy, sensitivity, or specificity. Instead, they relate to mechanical performance, material properties, and biocompatibility. The provided document indicates that the acceptance criteria for the modified device were the same as those for the original predicate device (K191016).
| Criterion | Original Device Standard | Reported Device Performance (K220492) |
|---|---|---|
| Fatigue Performance | ISO 7206-6 (same protocol as K191016) | Meets acceptance criteria (same as original device) |
| Endotoxin Limits | Not explicitly stated, but implied to be standard limits. | Meets endotoxin limits |
| Risk Analysis | DIN EN ISO 14971 | Demonstrated no new worst-case scenario compared to predicate; deemed as safe and effective. |
| Material Composition | Polymethylmethacrylate (radiopaque PMMA with gentamicin) and inner stainless steel (AISI 316L) reinforcing structure | Unchanged from predicate, except for modified dimension |
| Biocompatibility | Not explicitly detailed but implied by material unchanged from predicate | Implied to be acceptable as materials are retained from predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of an AI/ML test set. For physical device testing, the sample size would refer to the number of devices or components tested. The document does not specify the exact number of spacers tested for fatigue or endotoxin, but states that "COPAL® exchange G hip spacer meets endotoxin limits" and "The fatigue performance testing as per ISO 7206-6 was performed... The acceptance criteria were not altered...". This implies that standard testing was conducted on an appropriate number of samples to demonstrate compliance.
- Data Provenance: Not applicable in the context of clinical data for AI/ML. The performance data is generated from laboratory mechanical and material testing. The document states the manufacturer is Heraeus Medical GmbH, located in Germany, implying the testing was conducted under their control.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. For a physical device, "ground truth" is established by engineering specifications, material standards, and validated testing methodologies, not by expert consensus on clinical images or patient data.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical data for AI/ML models.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a physical implant, not a diagnostic AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical device, so there is no "algorithm only" performance to evaluate.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on engineering specifications, international standards (e.g., ISO 7206-6, DIN EN ISO 14971), and validated laboratory testing results for mechanical properties (fatigue), material composition, and biological safety (endotoxin).
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML model, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there's no AI/ML model, there's no training set or ground truth establishment for it.
§ 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.