(27 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 from CoCr and intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without uCaP®.
Excia T cemented femoral stem is manufactured from CoCrMo. The femoral stem will be offered in a 12/14 taper in stem sizes 10 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 cemented use.
The provided document is a 510(k) premarket notification for a medical device, specifically the Excia Total Hip System. This type of document is a regulatory submission to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, not a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study would for an AI/CADe device.
Therefore, many of the requested categories are not applicable or cannot be extracted from this type of document. The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and pre-clinical performance data (e.g., endurance testing), rather than clinical performance measured against acceptance criteria with patient outcomes.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Applicable / Not Provided in this format. This document is a 510(k) for a medical implant (total hip system), not an AI/CADe device. The "acceptance criteria" here relate to demonstrating substantial equivalence to a predicate device through material, design, and mechanical testing, rather than clinical performance metrics (like sensitivity, specificity, AUC) for an AI algorithm.
- The performance data mentioned are related to mechanical endurance properties, not clinical outcomes or diagnostic accuracy.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. No "test set" in the context of an AI algorithm is mentioned. The testing described is mechanical (endurance properties) on physical device samples, not on patient data.
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)
- Not Applicable / Not Provided. There is no mention of experts establishing a "ground truth" related to patient data, as this is a hip implant, not a diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. No adjudication method is mentioned for any "test set."
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 / Not Provided. This is not an AI-assisted device. No MRMC study was done, nor is there any mention of human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. The "performance data" refers to "Endurance properties" of the medical device itself, evaluated against mechanical standards (ASTM, ISO). The "ground truth" for these tests would be the physical properties predicted by the standards, not clinical outcomes or expert consensus.
8. The sample size for the training set
- Not Applicable / Not Provided. There is no "training set" for an AI algorithm mentioned.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. There is no "training set" for an AI algorithm mentioned.
Summary regarding the provided document:
The provided document is a 510(k) premarket notification for a hip implant system. It focuses on demonstrating substantial equivalence to previously cleared devices based on:
- Technological Characteristics: Indications for Use, design, materials of construction, manufacturing process, and range of sizes.
- Performance Data (Pre-clinical): Endurance properties of the stem, head, and neck evaluated according to industry standards (ASTM F2068-09; ISO 7206-4 and ISO 7206-6). The document states: "Testing demonstrated that the subject device is substantially equivalent to the predicate devices."
This document does not contain information about acceptance criteria or studies related to AI/CADe device performance, clinical trials with patient outcomes, or expert reviews for establishing ground truth, as it is a regulatory filing for a different type of medical device (a mechanical implant).
§ 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.