(198 days)
COPAL® exchange G knee (polymethylmethacrylate/gentamicin) 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. COPAL® exchange G 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 antimicrobial antibiotic therapy (standard treatment approach to an infection).
COPAL® exchange G 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.). COPAL® exchange G knee is only indicated for patientswho will consistently use traditional mobility assist devices e.g. crutches, walkers, canes) throughout the implantation period.
COPAL® exchange G hip (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 antimicrobial antibiotic therapy (standard treatment approach to an infection). COPAL® exchange G hip 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, perm etc.). COPAL®exchange G hip is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.
The COPAL® exchange G Hip and Knee Spacers are combination products that 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 an approximate 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.
The COPAL® exchange G Hip and Knee Spacers are placed into the joint to maintain normal joint space and alignment. They provide patient comfort and limited mobility while the infection is being treated. The COPAL® exchange G Hip and Knee Spacers are made with bone cement that are loaded with gentamicin antibiotics. The COPAL® exchange G Hip and Knee Spacers are temporary joint prostheses designed to temporarily replace an infected implant during a total hip or knee arthroplasty and provide the patient with limited mobility and predictable, consistent local antibiotic release
COPAL® exchange G Hip Spacer is a single use device that mimics a hemi-hip prosthesis and is available in 8 sizes and usable for both left and right hips.
The COPAL® exchange G Hip Spacers are combination products made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin). The COPAL® exchange G Hip Spacers contain 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 methyl methacrylate, N, N-dimethyl-p-toluidine, hydroquinone. The powder component consists of polymethymethacrylate, calcium carbonite, benzoyl peroxide, and gentamicin sulphate. The raw materials and a summary of the manufacturing process are found below.
COPAL® exchange G Knee Spacer is a single use device that is comprised of a tibia and femur component and is available in 3 sizes to form one knee spacer that is usable for left and right knee.
The provided text describes a 510(k) premarket notification for Heraeus Medical GmbH's COPAL® exchange G Hip and Knee Spacers. The document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo clinical performance with specific acceptance criteria that an AI/ML device would typically face.
Due to the nature of this submission (510(k) for a physical medical device, not an AI/ML algorithm), the information required for filling out the requested table regarding acceptance criteria and performance of an "AI/ML device" is largely not applicable or not present in the document. The performance testing section refers to physical and biological tests, not AI model metrics.
However, I will extract what is available and clearly state what information is missing based on your request.
Here's an attempt to address your request based solely on the provided text, while making the critical distinction that this document does not pertain to an AI/ML device:
Acceptance Criteria and Study for COPAL® exchange G Hip and Knee Spacers (as described in K191016)
Note: The provided document describes the 510(k) clearance for physical medical devices (hip and knee spacers) and not an Artificial Intelligence/Machine Learning (AI/ML) device. Therefore, the typical acceptance criteria and study design elements requested for an AI/ML device (e.g., sensitivity, specificity, expert ground truth, MRMC studies, training/test sets) are not relevant or present in this submission. The "acceptance criteria" for this device are demonstrated through equivalence to predicate devices via various physical, chemical, and biological performance testing, not through AI/ML performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Reinterpreted for a physical device) | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Biocompatibility | Adherence to ISO 10993-1, -3, -5, -6, -10, -11, -12 for various tests (cytotoxicity, irritation, hypersensitivity, acute/subchronic systemic toxicity, mutation assays, femoral bone implantation). | - In vitro cytotoxicity: No leachable substances dissolved in cytotoxic amounts. |
- Irritation: No signs of irritation; classified as not irritant.
- Delayed-type hypersensitivity: No reactions identified as sensitization.
- Acute systemic toxicity: No acute systemic toxic characteristics.
- Reverse mutation assay: Non-mutagenic.
- In vitro mammalian cell gene mutation assay: Non-mutagenic.
- Femoral bone implantation/subchronic systemic toxicity: No inflammatory or degenerative findings at implantation sites.
- Summary: COPAL® exchange G spacers are biocompatible according to ISO10993-2016. |
| Sterilization Validation | Sterility Assurance Level (SAL) of 10-6 according to ISO 11135 and AAMI TIR 28. | Chosen sterilization process (ethylene oxide gassing) is valid; sterile units achieved with defined bioburden and SAL of 10-6. |
| Shelf Life | Maintain sterility (DIN EN ISO 11737. Part 2), compressive strength (ISO 7206-6 and ISO 14879-1), gentamicin content, and gentamicin impurities over 36 months at 25 ± 2 °C. | All hip/knee spacers sterile throughout 36-month storage. Compressive strength within specified range. Gentamicin content and impurities remained within specified range.
Summary: Stable at 25 ± 2 °C and 50% humidity for 36 months. |
| Sterile Barrier Integrity | Adherence to ISO 11607-1 and ISO 11607-2, including maintenance over 5 years of transport and shelf life. | Integrity of the system shown; maintenance of sterile barrier system demonstrated over 5 years. |
| Mechanical Performance | Compressive strength (ISO 14879-1, ISO 7206-4, ISO 7206-6), cyclic fatigue (ISO 14879-1, ISO 14242-1:2012), abrasion (ISO 14243-1:2009, ISO 14242-1:2012) demonstrating equivalence to predicate devices. | - Compressive strength: Equivalent to predicate devices. - Cyclic fatigue: Equivalent to predicate devices.
- Abrasion: Equivalent to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
Due to the nature of the device (physical implant, not software/AI):
- Sample Size for Test Set: This concept doesn't directly apply in the "AI/ML" sense of a data test set. The document refers to "tests performed" and "results obtained" for various physical and biological properties. Specific quantitative sample sizes for each test (e.g., number of hip spacers tested for compressive strength) are not provided in this summary.
- Data Provenance: Not applicable in the context of an AI/ML algorithm (e.g., country of origin of patient data). The testing data is generated in a lab setting through physical and chemical tests on the manufactured devices. The document implies these tests were conducted by the manufacturer (Heraeus Medical GmbH, Germany).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This is not applicable for this type of device submission. Ground truth, in the AI/ML context, refers to expert labeling of data (e.g., images). For this physical device, "ground truth" is established by adherence to recognized international standards and laboratory testing protocols performed by qualified professionals in those fields (e.g., materials science, microbiology, mechanical engineering). The specific number or qualifications of these testing personnel are not detailed in the summary.
4. Adjudication Method for the Test Set
- This is not applicable for this type of device submission. Adjudication, in the AI/ML context, is typically used for resolving disagreements among multiple human annotators during ground truth establishment. For a physical device, passing/failing criteria are set by the established standards and internal quality control.
5. 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
- This is not applicable as the device is not an AI/ML algorithm intended to assist human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable as the device is not an AI/ML algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for these physical devices is established by compliance with recognized international standards (e.g., ISO, ASTM) for material properties (e.g., mechanical strength, chemical composition), biological interactions (biocompatibility), and manufacturing processes (sterilization, shelf life). The "outcome data" is whether the device meets these pre-defined physical and biological performance specifications and demonstrates equivalence to the predicate device.
8. The Sample Size for the Training Set
- This is not applicable as the device is not an AI/ML algorithm. There is no concept of a "training set" in this context. The product is manufactured based on design specifications and then tested for performance.
9. How the Ground Truth for the Training Set was Established
- This is not applicable as the device is not an AI/ML algorithm.
In conclusion, the provided FDA 510(k) submission is for a physical medical device (hip and knee spacers) and not for an AI/ML-based device. Therefore, the requested information regarding AI/ML-specific acceptance criteria, study methodologies (e.g., human-in-the-loop, standalone, MRMC), and data sets (training, test, ground truth establishment) is largely irrelevant to this document. The document primarily focuses on demonstrating substantial equivalence through various physical, chemical, and biological performances tests against established standards and predicate devices.
§ 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.