(86 days)
The subject Exeter V40™ Hip System components are intended for use in total hip replacement. They are intended for cemented use only. The subject components are intended for use with any Howmedica Osteonics Corp. acetabular component featuring a polyethylene bearing surface.
Indications:
- Noninflammatory joint disease including osteoarthritis and avascular necrosis,
- Rheumatoid arthritis,
- Correction of functional deformity,
- Revision procedures where other treatments or devices have failed,
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
This Special 510(k) submission is intended to add 36mm Orthinox® V40™ femoral head components in -5mm, +0mm, and +5mm offsets to the Exeter Femoral Bearing Series. The intended use, manufacturing methods, materials, packaging and sterilization of the subject device are identical to those of predicate devices. The Orthinox® V40™ femoral head components are fabricated from Orthinox®, a Stainless Steel Alloy conforming to ASTM F1586 and ISO 5832-9. Like the predicate devices, the subject devices are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.
This document describes a Special 510(k) submission for the addition of 36mm Orthinox® V40™ Femoral Heads to the Exeter Series of femoral head components. The submission asserts that the subject device is substantially equivalent to a predicate device (22mm-32mm V40™ Orthinox® Femoral Head Components cleared under K011623).
Here's an analysis of the provided information concerning acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain explicit performance acceptance criteria or reported device performance data in the way one would typically find for a medical device with an AI/algorithm component requiring performance metrics (e.g., sensitivity, specificity, accuracy).
Instead, the submission is focused on demonstrating substantial equivalence to a predicate device for a physical medical implant. The "performance" in this context is related to the material properties, manufacturing methods, and intended use being identical to the predicate device.
The closest we can come to a "table" based on the provided text is to infer the criteria for substantial equivalence:
| Acceptance Criterion (Inferred from Substantial Equivalence Claim) | Reported Device Performance (as stated in submission) |
|---|---|
| Intended Use (identical to predicate) | Identical to predicate devices: "for use with femoral stems and acetabular components in primary or revision total hip arthroplasty." (Specific indications listed) |
| Manufacturing Methods (identical to predicate) | Identical to predicate devices |
| Materials (identical to predicate or equivalent) | Orthinox® Stainless Steel Alloy conforming to ASTM F1586 and ISO 5832-9 (same as predicate) |
| Packaging (identical to predicate) | Identical to predicate devices |
| Sterilization (identical to predicate) | Identical to predicate devices |
| Design Principles (analogous for new size variant) | 36mm Orthinox® V40™ femoral head components in -5mm, +0mm, and +5mm offsets, an extension of the existing V40™ design. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable and not provided in the document. The submission is not for a software-based AI device that would undergo testing with a "test set" of data in the common sense for AI. It's for a physical implant. The evaluation for substantial equivalence relies on comparing the new device features (size, form, function) and material specifications to those of legally marketed predicate devices, not on a dataset of patient outcomes or imagery.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. There is no "ground truth" establishment in the context of an AI algorithm for this type of medical device submission. The FDA reviews the technical documentation and comparisons to predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. There is no "test set" for adjudication as this is not an AI/algorithm-driven device.
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 information is not applicable and not provided. This submission is for a physical medical implant (a femoral head component), not for an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. This is not an algorithm-only device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable and not provided. For a physical implant like a femoral head, the "ground truth" for its safety and effectiveness is established through adherence to recognized manufacturing standards, material specifications, biocompatibility testing, mechanical testing (e.g., fatigue strength, wear resistance, dimensional accuracy), and clinical performance of predicate devices that have a similar design and use history. The substantial equivalence argument itself acts as the "proof" based on these established standards and predicate performance.
8. The Sample Size for the Training Set
This information is not applicable and not provided. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. There is no "training set" or corresponding ground truth establishment process for this type of medical device submission.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.