(44 days)
The Excia Hip System is intended to replace a hip joint. The device is intended for: Patients suffering from severe hip and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis Patients suffering from disability due previous fusion Patients with acute femoral neck fractures. The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without u-CaP®. The Metha® Hip System (uncemented, press-fit fixation) is intended to replace a hip joint. The device is intended for: skeletally mature individuals undergoing primary surgery for total hip replacement patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur. patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis patients suffering from disability due to previous fusion patients with acute femoral neck fractures.
The Aesculap Implant Systems BIOLOX® delta Ceramic Femoral Heads are manufactured from an alumina matrix composite. The ceramic femoral head is offered in thee diameters of 28, 32, and 36 mm with a range of neck lengths. The BIOLOX® delta Ceramic head provides the surgeon another option to both the metal and alumina ceramic femoral heads for use in total hip arthroplasty.
The provided text describes a 510(k) submission for a ceramic femoral head (BIOLOX® delta Ceramic Femoral Head), which is a medical device used in hip replacement surgery. The documentation focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove the device meets specific acceptance criteria in the context of AI/algorithm performance.
Therefore, many of the requested categories in your prompt a.are not applicable or cannot be answered from the provided text, as the submission is for a physical orthopedic implant, not an AI or software-as-a-medical-device (SaMD) product.
Here's an analysis based on the provided text, highlighting what is applicable and what is not:
1. Table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence through material and technological characteristics comparisons, and references general performance testing guidance for orthopedic implants, rather than specific acceptance criteria for a new performance claim or a new algorithm.
2. Sample size used for the test set and the data provenance
Not applicable. This is a physical device, and the "test set" concept as used for AI/algorithm validation (e.g., images for classification) does not apply. The document mentions "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable," along with other specific guidance documents for orthopedic implants (e.g., testing orthopedic implants with modified metallic surfaces, testing metallic plasma sprayed coatings, testing non-articulating modular implant components, acetabular cup prostheses, femoral stem prostheses, ceramic ball hip systems, UHMWPE). These guidances typically entail mechanical, fatigue, wear, and biocompatibility testing of the physical implant components, not data-driven performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of expert consensus for AI/algorithm training or validation, is not relevant for this physical device submission.
4. Adjudication method for the test set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements in expert labeling for AI/algorithm ground truth, which is not relevant here.
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
Not applicable. This is not an AI/SaMD product.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/SaMD product.
7. The type of ground truth used
Not applicable. Ground truth for AI/algorithm validation is not relevant. The "ground truth" for this device's performance would be established through physical testing and material characterization against established standards and predicate device performance.
8. The sample size for the training set
Not applicable. This is not an AI/SaMD product.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/SaMD product.
Summary of Device and Performance Information Provided:
- Device Name: BIOLOX® delta Ceramic Femoral Head
- Manufacturer: Aesculap Implant Systems, Inc.
- Device Description: An alumina matrix composite ceramic femoral head, offered in 28, 32, and 36 mm diameters with a range of neck lengths for use in total hip arthroplasty.
- Intended Use: To replace a hip joint for patients suffering from severe hip issues due to various conditions (rheumatoid arthritis, traumatic arthritis, avascular necrosis, fractures, congenital hip dysplasia, etc.)
- Substantial Equivalence Claim: The device is claimed to be a line extension to previously cleared Aesculap Implant Systems Excia and Metha Hip Systems and substantially equivalent to the Zimmer BIOLOX® delta Ceramic Femoral Head (K071535).
- Performance Data (General): The document states that all required testing per various guidance documents for orthopedic devices was completed where applicable. These guidances typically cover mechanical, material, and biocompatibility aspects relevant to physical implants. There are no specific performance metrics or acceptance criteria explicitly listed in this summary, as the focus is on compliance with general testing standards for similar orthopedic devices to demonstrate substantial equivalence.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.