(251 days)
The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of:
- · Non- inflammatory deqenerative joint disease including osteoarthritis and avascular necrosis,
- · Post-traumatic osteoarthritis.
- · Fractures,
- · Rheumatoid arthritis.
The main indications for the implantation of an AGILON® hemi shoulder prosthesis are:
- · Multi-fragmental comminuted fractures of the humeral head,
- · 3- and 4-Fragment-fractures of the proximal humerus,
- · Head-splitting fractures,
- · Dislocated head-splitting fractures,
- · Humeral head depression with more than 40% of joint surface depressed,
- · Interlocking chronic dislocation with deep HILL-SACHS lesion,
- · Fracture instability following internal fixation attempt in 3-fragment fractures (secondary dislocation, material loosening),
- · Posttraumatic humeral head necrosis,
- · Omarthrosis.
AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty, to treat a patient after an inverse shoulder has failed. It is not combined with a glenoid implant. It can be used in primary and revision cases.
The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are:
- · Rotator cuff tear arthropathy,
- · Chronic trauma shoulder,
- · Decentering of the humeral head after implantation of a humeral head prosthesis.
Please note, that the patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary.
In case of revision surgery the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system can be performed in revision cases as follows:
- · From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty
- · From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
- · From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
- · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure
- · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure
- From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
- · From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
The device is intended for adults.
The AGILON® XO Shoulder Replacement System Titanium alloy stems are intended for cementless fixation.
The PE-glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation. The qlenoid cementless is intended for cementless use with the addition of screws for fixation.
The AGILON® XO Shoulder Replacement System is a modular shoulder replacement system offering various components that can be combined to replace the shoulder joint with options depending upon the size and anatomical needs of each patient. The subject submission is for new cancellous screws for use in a total reverse shoulder replacement with the previously cleared K231657 components:
- Humeral Head Components ●
- Glenoid and Glenosphere Components ●
- Humeral Stems and Stem Extension Pieces
- Metaphyseal Components ●
- Fixation and Cancellous Screws ●
The subject line extension components are intended for use with previously cleared AGILON XO Shoulder System instruments. There are no changes to packaging, sterility, shelf life, or materials subject to this submission.
The provided text describes a 510(k) premarket notification for the AGILON® XO Shoulder Replacement System, focusing on new cancellous screws. However, it does not include detailed acceptance criteria or a comprehensive study report with the specific information requested in your prompt regarding AI/algorithm performance.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through engineering analysis and limited performance testing of the new cancellous screws. Therefore, I cannot provide all the requested information.
Here's what I can extract and infer from the provided text, along with what is explicitly not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (for cancellous screws) | Reported Device Performance (type of testing) |
|---|---|
| Sufficient performance for intended use (specific numeric criteria not provided) | - Torsional Properties (ASTM F543) |
- Driving Torque (ASTM F543)
- Axial Pull-out Strength (ASTM F543) |
| Predetermined acceptance criteria met (specific numeric criteria not provided) | Testing demonstrated sufficient performance and met predetermined acceptance criteria. |
| Biocompatibility (per ISO 10993-1) | Evaluation completed per ISO 10993-1. |
| Cleaning, sterilization, packaging, shelf-life, and endotoxin standards met | Leveraged from the predicate AGILON® XO Shoulder Replacement System (K231657). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the cancellous screw testing (Torsional Properties, Driving Torque, Axial Pull-out Strength).
- Data Provenance: Not specified. The manufacturer is implantcast, GmbH, located in Buxtehude, Germany, but the location where testing was performed is not mentioned. The study is part of a 510(k) submission, generally involving laboratory testing rather than clinical data provenance in this context.
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. This device is a mechanical shoulder replacement system, and the testing described is mechanical performance (e.g., strength, torque) and biocompatibility, not an AI or diagnostic device that requires expert ground truth for interpretation of medical images or conditions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device is a mechanical shoulder replacement system, not a diagnostic or AI device that requires adjudication of expert interpretations.
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 is a medical device (shoulder replacement system), not an AI-assisted diagnostic tool. No AI component or human reader study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (shoulder replacement system), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing of the cancellous screws, the "ground truth" is established by adherence to recognized ASTM standards (ASTM F543) and engineering principles. For biocompatibility, the ground truth is adherence to ISO 10993-1. This is not related to clinical outcomes or expert consensus on pathologies for AI model training.
8. The sample size for the training set
Not applicable. This device is a mechanical shoulder replacement system, not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a mechanical shoulder replacement system, not an AI/machine learning device.
Summary of what is present:
The document describes the submission of a medical device (AGILON® XO Shoulder Replacement System) for regulatory clearance. The specific focus of this submission (K241944) is the addition of new cancellous screws to an existing system. The performance testing for these screws involved:
- Engineering analysis.
- Characterization per ASTM F543 for torsional properties, driving torque, and axial pull-out strength.
- Biocompatibility evaluation per ISO 10993-1.
- Leveraging existing data for cleaning, sterilization, packaging, shelf-life, and endotoxin from the predicate device (K231657).
The conclusion is that the testing demonstrated "sufficient performance for the intended use" and "met the predetermined acceptance criteria." However, the specific quantitative values for these criteria and the test results are not detailed in the provided text.
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid 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. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”