(59 days)
The Axiom Orthopaedics Shoulder Resurfacing System is intended as a hemi shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device will increase shoulder mobility by reducing pain, restoring alignment, restoring flexion and extension movement, and resisting dislocation.
The Axiom Orthopaedics Shoulder Resurfacing System is indicated for use as a replacement of shoulder joints disabled by
- Rheumatoid arthritis with pain 1.
-
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
-
- Correction of functional deformity
-
- Fractures of the humeral head
-
- Traumatic arthritis.
These components are single use only and are intended for cementless use.
The Axiom Orthopaedics Shoulder Resurfacing System is a series of humeral heads that are designed to articulate with a resurfaced or non-resurfaced Glenoid fossa. The proposed humeral heads are manufactured from cobalt chromium alloy (ASTM F-75) and can be used as either a left or right configuration. The interior surface of the proposed Axiom components contains a pattern of buttressed protrusions that help restrict rotation of the device. In addition to the buttressed protrusion pattern, the interior surface is coated with a plasma spray titanium substrate and a calcium phosphate coating (ASTM 1044 and ASTM 1147, respectively). The proposed humeral heads have been designed to mimic the normal humeral head geometry by employing a non-spherical accurate shape. The shape of the humeral heads does not exceed the radius of curvature of the reamed Glenoid fossa. This helps to maintain contact between the humeral head and the Glenoid fossa throughout the range of motion. The humeral heads are available in 14 sizes.
The provided text describes a 510(k) summary for the "Axiom Orthopaedics Shoulder Resurfacing System," which is a medical device for hemi shoulder replacement. The "study" mentioned here is essentially a performance testing in the form of a Finite Element Analysis (FEA). This is not equivalent to a clinical study with human or animal subjects, but rather an engineering simulation.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Strength (Minimum Factor of Safety) | Factor of Safety: Ranges from 2.6 to 2.1 (for a material strength of 450 MPa). |
| Maximum Tensile Von-Mises Keel Stress | Ranges from 170 to 219 MPa. |
| Compliance with Standards | Complies with ASTM F-75 (cobalt-chromium alloy), F 1044-95, F 1147-99, and F 1160 05. |
| Biocompatibility | Stated that the device is made of biocompatible materials. |
| Functional Similarity | Designed to mimic normal humeral head geometry; fixation features to resist rotation are similar in principle to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The "test set" for the Finite Element Analysis (FEA) involved analyzing three sizes of the humeral head system: the smallest, the middle, and the largest.
- Data Provenance: The data is simulated data generated from a Finite Element Analysis, not from human or animal subjects. Therefore, there is no country of origin or retrospective/prospective nature in the traditional sense. It's a computational study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For a Finite Element Analysis, the "ground truth" is derived from engineering principles, material properties (e.g., ASTM F-75 material strength of 450 MPa), and simulated load conditions (752 N). There's no mention of human experts establishing a ground truth for the results of this specific engineering analysis in the provided text.
4. Adjudication Method for the Test Set
Not applicable. Since this is an engineering simulation, there is no adjudication method in the context of expert review of clinical cases. The results are based on the FEA model and calculations, which are then compared against predefined engineering acceptance criteria (e.g., factor of safety, stress limits).
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 device is a physical orthopedic implant. The provided document describes engineering performance testing (FEA) and regulatory substantial equivalence, not a study evaluating human reader performance with or without AI assistance. This type of study is relevant for diagnostic imaging AI, not for orthopedic implants.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a way. The Finite Element Analysis (FEA) is a standalone simulation of the device's mechanical performance under specific load conditions. It does not involve human interaction or "human-in-the-loop" performance in the context of the device's function or evaluation during the simulation itself. The simulation is a computational assessment of the device's mechanical integrity.
7. The Type of Ground Truth Used
The "ground truth" for the FEA is based on:
- Engineering Principles and Material Properties: The stress and factor of safety calculations are derived from fundamental physics, mechanics of materials, and the specified properties of the cobalt-chromium alloy (ASTM F-75, with a material strength of 450 MPa).
- Simulated Load Conditions: A simulated 752 N load was applied, representing a defined biomechanical scenario.
8. The Sample Size for the Training Set
Not applicable. A Finite Element Analysis (FEA) is a simulation method that does not involve a "training set" in the machine learning sense. The model is built based on the device's design, material properties, and simulated boundary conditions, not "trained" on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in this context. The "ground truth" for the model itself (i.e., the accuracy of the FEA simulation) would generally be established by validation against physical testing of similar designs or theoretical derivations, though no such validation against "ground truth" for the FEA model is explicitly mentioned in the provided text (only the results of the FEA are reported and compared to material strength).
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K06186+ page 144
510(k) Summary for
AUG 2 8 2006
Axiom Orthopaedics Shoulder Resurfacing System
- SPONSOR 1.
Axiom Orthopaedics, Inc. 285 West Side Avenue Suite 251 Jersey City, NJ 07305
| Contact Person: | Peter Verrillo |
|---|---|
| Telephone: | 201-377-9129 |
Date Prepared: June 29, 2006
2. DEVICE NAME
| Proprietary Name: | Axiom Orthopaedics Shoulder Resurfacing System |
|---|---|
| Common/Usual Name: | Shoulder Resurfacing System |
| Classification Name: | Shoulder joint, humeral (hemi-shoulder), metallic uncemented prosthesis |
3. PREDICATE DEVICES
| Depuy Global CAP Resurfacing Replacement Shoulder | K033516 |
|---|---|
| Biomet Copeland Resurfacing Humeral Heads | K010657 |
4. DEVICE DESCRIPTION
The Axiom Orthopaedics Shoulder Resurfacing System is a series of humeral heads that are designed to articulate with a resurfaced or non-resurfaced Glenoid fossa. The proposed humeral heads are manufactured from cobalt chromium alloy (ASTM F-75) and can be used as either a left or right configuration. The interior surface of the proposed Axiom components contains a pattern of buttressed protrusions that help restrict rotation of the device. In addition to the buttressed protrusion pattern, the interior surface is coated with a plasma spray titanium substrate and a calcium phosphate coating (ASTM 1044 and ASTM 1147, respectively).
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The proposed humeral heads have been designed to mimic the normal humeral head geometry by employing a non-spherical accurate shape. The shape of the humeral heads does not exceed the radius of curvature of the reamed Glenoid fossa. This helps to maintain contact between the humeral head and the Glenoid fossa throughout the range of motion. The humeral heads are available in 14 sizes.
INTENDED USE 5.
The Axiom Orthopaedics Shoulder Resurfacing System is intended as a hemi shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device will increase shoulder mobility by: reducing pain; restoring alignment; restoring flexion and extension movement; and resisting dislocation.
The Axiom Shoulder Resurfacing System is indicated for use as a replacement of shoulder joints disabled by
- . Rheumatoid arthritis with pa 1
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular . necrosis)
- Correction of functional defermity .
- Fractures of the humeral head .
- . Traumatic arthritis.
These components are single use only and are intended for cementless use.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The proposed Axiom Orthopaedics Shoulder Resurfacing System, the Depuy Global CAP Resurfacing Replacement Shoulder and the Biomet Copeland Resurfacing Humeral Heads are all identical in that they all consist of humeral heads manufactured from cobalt-chromium-molybdenum alloy that are indicated for uncemented use only. Both the proposed product and the predicate devices are manufactured from cobalt chromium alloy that comply with ASTM F75. The interior surface of both the proposed and predicate device components contain a calcium phosphate coating for cementless use. Both the proposed and predicate devices are cementless humeral replacement systems that require minimal bone resection.
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Both the proposed product and the predicate devices have been designed to mimic the normal humeral head geometry. The Depuy predicate devices are available in diameters of 40, 44, 48, 52 and 56mm, all available with head heights of 15mm (short), 18mm (medium) or 2 1mm (large), and the proposed Axiom product will be available in diameters of 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, and 62 mm with varying thicknesses from 14mm - 24mm.
The only differences between the Axiom device and the predicate devices are that the predicate device includes grooves in the stemmed part of the prosthesis to resist rotation whereas the Axiom device in:ludes fixation features on the inner surface as well as the stemmed part of the head to resist rotation. Additionally, the Depuy predicate device uses a standard spherical method for their articulating surface whereas the proposed device incorporates an elliptical method. These differences do not affect safety or effectiveness of the device since the Axiom device is made of biocompatible materials and is designed similarly to the predicate devices to resist rotation.
7. PERFORMANCE TESTING
A finite element analysis of humeral head loading under a simulated 752 N load was performed to determine the acceptability of the proposed product. The analysis was performed to ensure an acceptable factor of safety with respect to the component material properties, as specified by A.STM F-75. The sizes analyzed represented the smallest, the middle and the largest stzes of the system. The results of this analysis showed that the maximum tensile Von-Mises Keel stress for all of the sizes studied ranges from 170 to 219 MPa. For the given stresses, the factor of safety with respect to the material strength (450 Mpa) ranges from 2.6 to 2.1. The result of this load distribution will be much lower stresses resulting in a higher factor of safety for the Axiom Orthopaedics Shoulder Resurfacing System. The Axiom Orthopaedics Shoulder Resurfacing System components comply with the applicable requirements of the following standards
- F 1044-95, "Standard Test Method for Shear Testing of Porous Metal . Coatings"
- F 1147-99, "Standard Test Method for Tension Testing of Calcium Phosphate . and Metallic Coatings"
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- F 1 160 05 Standard Test Method for Shear and Bending Fatigue Testing of . Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
Additionally, this 510(k) premarket notification was written in consideration of the "Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis''.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2006
Axiom Orthopaedics, Inc. % Ms. Mary McNamara-Cullinane, RAC Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
Re: K061862
Trade/Device Name: Axiom Orthopaedics Shoulder Resurfacing System Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD Dated: June 29, 2006 Received: July 6, 2006
Dear Ms. McNamara-Cullinane:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Mary McNamara-Cullinane, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Soubace Buelus
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Axiom Orthopaedics Shoulder Resurfacing System
Indications For Use:
The Axiom Orthopaedics Shoulder Resurfacing System is intended as a hemi shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device will increase shoulder mobility by reducing pain, restoring alignment, restoring flexion and extension movement, and resisting dislocation.
The Axiom Orthopaedics Shoulder Resurfacing System is indicated for use as a replacement of shoulder joints disabled by
- Rheumatoid arthritis with pain 1.
-
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
-
- Correction of functional deformity
-
- Fractures of the humeral head
-
- Traumatic arthritis.
These components are single use only and are intended for cementless use.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use__No (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buckner
Division Sign Off
Division of General, Restorative and Neurological Devices
510(k) Number K06/862
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.