(102 days)
The Excia Hip System is intended to replace a hip joint. The device is intended for: 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 ephiphysis. Patients suffering from disability due to previous fusion. Patients with acute femoral neck fractures. The Excia Hip System is available with two (2) femoral stems. One is manufactured for cemented fixation. The other femoral stem is for uncemented from Ti with Plasmapore with or with or without yCaP®.
Excia T femoral stem is manufactured from Titanium (Ti) with a Plasmapore coating. The femoral stem will be offered in a 12/14 taper in stem sizes 8 to 20. The stems are designed without a trochanter wing and features a shorter stem length with an asymmetrical distal tip. Excia T femoral stem is intended for uncemented use.
The provided text describes a 510(k) premarket notification for the Excia T femoral stem, a component of the Aesculap Implant Systems Excia Total Hip System. This submission aims to demonstrate substantial equivalence to previously cleared predicate devices, not to establish novel performance criteria for a new device type through extensive clinical trials or complex AI model validation. Therefore, many of the requested categories for acceptance criteria and study details are not fully applicable or explicitly stated in the context of a Class II medical device 510(k) submission focused on a line extension.
Here's an attempt to extract and interpret the information based on the provided text, acknowledging the limitations inherent in a 510(k) for a hip implant component:
The acceptance criteria and study that proves the device meets the acceptance criteria are as follows:
The core acceptance criterion for a 510(k) submission, especially for a line extension like the Excia T femoral stem, is demonstrating substantial equivalence to existing, legally marketed predicate devices. This means the new device must be as safe and effective as the predicate device(s) and does not raise different questions of safety and effectiveness.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence: The device must be as safe and effective as the predicate devices and not raise different questions of safety and effectiveness. This is assessed by comparing: |
- Indications for Use
- Design
- Materials of Construction
- Manufacturing Process
- Range of Sizes Offered | The Excia T femoral stem was found to be "substantially equivalent" to the predicate devices (Aesculap Implant Systems Excia Total Hip System (K092143 and K060918) and Smith & Nephew Synergy Hip System) based on:
- Indications for Use
- Design
- Materials of Construction
- Manufacturing Process
- Range of Sizes Offered |
| Mechanical/Endurance Properties: The device's mechanical performance (e.g., fatigue strength) must meet established standards for femoral prostheses to demonstrate safety and integrity under physiological loading. | Testing demonstrated that the subject device is "substantially equivalent" to the predicate devices. Specific standards followed include: - Guidance for Industry and FDA Staff Non-clinical Information for Femoral Prostheses, September 17, 2007
- ASTM F2068-09
- ISO 7206-4
- ISO 7206-6 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated as a number of devices. Non-clinical testing typically involves a set number of test articles (e.g., typically 6-12 samples per test condition for fatigue testing), but the exact count is not provided. The data would be generated from new test articles manufactured for the purpose of this submission.
- Data Provenance: The data is likely prospective, generated specifically for this 510(k) submission through laboratory testing performed by or for the manufacturer (Aesculap Implant Systems, LLC, located in Center Valley, PA). The country of origin for the data generation would be the USA (or wherever the testing laboratory is located).
3. 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 in the context of this 510(k) submission. "Ground truth" as applied to clinical data or AI systems with human expert consensus is not part of a non-clinical, mechanical testing report for a hip implant component. The "ground truth" here is adherence to engineering standards and comparison to predicate device specifications. The "experts" involved are likely biomechanical engineers and material scientists conducting and interpreting the tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of images or symptoms. For mechanical testing, the results are quantitative measures against established standards or predicate device performance. There is no "adjudication" in this sense. The test results are typically reviewed and approved by internal engineering and regulatory teams along with notified bodies/FDA.
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 question is not applicable. MRMC studies are used for evaluating diagnostic devices, particularly those involving medical imaging interpreted by human readers, often comparing AI-assisted performance to unassisted human performance. The Excia T femoral stem is a surgical implant, not a diagnostic device or an AI system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The Excia T femoral stem is a physical medical device, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is established by:
- Engineering Standards: Adherence to recognized national and international standards for hip prostheses (e.g., ASTM F2068-09, ISO 7206-4, ISO 7206-6). These standards specify test methods and acceptance criteria for mechanical properties.
- Predicate Device Performance: The established safety and effectiveness profile of the legally marketed predicate devices, against which the new device's technological characteristics and performance are compared to demonstrate substantial equivalence.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of a 510(k) for a mechanical implant. This concept is relevant for machine learning algorithms.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
§ 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.