(28 days)
The ESOP® HA Femoral Stem is intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, non-acute femoral neck fracture, revision of previously failed hip arthroplasties, and idiopathic avascular (osteo) necrosis where radiographic evidence shows there is sufficient sound bone to seat the prosthesis. This device is intended for cementless application.
The ESOP® HA Femoral Stem consists of left and right configuration metaphysis parts in various size diameters, and diaphysis parts in various sizes. The ESOP® HA Femoral Stem instrument system is used for proper implantation of the device. The ESOP® HA Femoral Stem design includes: 10 left and right configuration metaphysis parts in various sizes diameters and cone angles, and 7 diaphysis parts of various sizes which are to be screwed into the extremity of the metaphysis part.
The provided text describes a 510(k) premarket notification for the ESOP® HA Femoral Stem, a medical device. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria in the way an AI/ML device would.
Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not present in this document. This is because the regulatory pathway for this device (a femoral stem, a physical implant) relies on demonstrating similarity to existing products, rather than efficacy through clinical trials with specific performance metrics akin to those required for a diagnostic algorithm.
Here's why each of your requested points cannot be answered from the provided text:
- 1. A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on demonstrating substantial equivalence, not specific performance metrics.
- 2. Sample sized used for the test set and the data provenance: Not applicable/not provided. There isn't a "test set" in the context of an algorithm or diagnostic evaluation.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. No ground truth establishment for a test set is mentioned.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not provided. No adjudication method is 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/not provided. This is a physical implant, not an AI-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not provided. This is a physical implant.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/not provided.
- 8. The sample size for the training set: Not applicable/not provided. There is no concept of a training set for this type of device.
- 9. How the ground truth for the training set was established: Not applicable/not provided.
Summary of available information regarding compliance:
The submission states: "Verification/validation and design control activities Performance Data: demonstrate the safety and effectiveness of the ESOP® HA Femoral Stem." and "Conclusion: The ESOP® HA Femoral Stem is substantially equivalent to the claimed predicate devices and other currently marketed femoral stems."
This indicates that the device met the regulatory requirements for a 510(k) by demonstrating substantial equivalence to predicate devices (FHI ESOP® S/C Femoral Stem, K964878 and Landos CORAIL Femoral Stem, K953111) through verification, validation, and design control activities, which would typically involve engineering tests, material compatibility tests, and possibly simulated use, but not clinical studies in the way you've outlined for AI/ML performance. The acceptance criteria for such a device would relate to engineering specifications, material properties, and manufacturing quality, all aligned with the predicate devices. These specific acceptance criteria and the data supporting them are not detailed in the provided summary.
§ 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.