(254 days)
The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of:
- · Non- inflammatory degenerative 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:
- · Multifragmental 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 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 glenoids cementless are 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 various options depending upon the size and of each patient. The components can be combined for use in a total (anatomic and reverse) or a hemi shoulder replacement:
Hemi Shoulder:
- Humeral Head Components (AGILON® XO Cap and AGILON® XO CTA Cap)
- Humeral Stems (Cementless)
Total Anatomic Shoulder:
- Humeral Head Components (AGILON® XO Cap)
- Glenoid Components (AGILON® PE-Glenoid, Cemented)
- Humeral Stems (Cementless)
Total Reverse Shoulder:
- Humeral Head Components (AGILON® Cap Inverse and AGILON® PE-Inlay) ●
- Glenoid and Glenosphere Components (AGILON® XO Glenoid Baseplate and AGILON® ● Glenosphere)
- Humeral Stems (Cementless)
Metaphyseal components (including a new line extension 145°), stem extension pieces, and component connection fixation screws are intended to be used for hemi and total (anatomic and reverse) shoulder configurations.
The subject system also includes device-specific reusable instruments for use with the subject implants, including an osteotomy guide, implant trials, and a humeral cutting block.
The provided text describes a 510(k) premarket notification for the AGILON® XO Shoulder Replacement System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove the device meets specific performance acceptance criteria for a novel AI/software component.
Therefore, many of the requested sections regarding acceptance criteria, device performance metrics (such as sensitivity, specificity, or AUC), sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission.
The document primarily relies on "Performance Testing Summary" through engineering analyses and leveraging previous predicate device testing to establish substantial equivalence for a line extension (a new 145° Metaphyseal component).
Here's an attempt to answer the questions based on the provided text, indicating when information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria for a novel device performance study, nor does it report specific performance metrics like sensitivity, specificity, or AUC as would be expected for an AI/software device. Instead, it relies on demonstrating substantial equivalence to predicate devices through engineering analysis and leveraged testing.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Engineering equivalency for new component (145° Metaphyseal component) to predicate device's "worst-case" components | Engineering analyses demonstrated the new 145° Metaphyseal component does not create a new worst-case for the system. |
| Biocompatibility evaluation | Completed per ISO 10993-1. |
| Cleaning, sterilization, shelf-life, packaging, and endotoxin | Leveraged from the predicate AGILON® XO Shoulder Replacement System (K191433/K222482). |
| Material composition | Same materials as predicate. |
| Intended use, design, and fundamental scientific technology | Substantially equivalent to predicate devices. |
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. This submission concerns a physical medical device (shoulder replacement system) and a line extension, not an AI/software device requiring a test set of data. The "testing" primarily refers to engineering analyses and biocompatibility/sterilization testing, not a clinical data evaluation in the context of AI.
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. There is no mention of experts establishing a ground truth for a test set of data, as this is not an AI/software device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is mentioned as there is no human-reviewed test set data in the context of an AI/software 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
Not applicable. This submission is for a physical shoulder joint replacement system, not an AI/software device designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is for a physical shoulder joint replacement system, not an AI/software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There is no mention of ground truth in the context of data for an AI/software device. The "ground truth" for a physical device refers to its physical properties, biocompatibility, and mechanical performance under various conditions, which are addressed through specifications, engineering analyses, and standardized testing (e.g., ISO for biocompatibility).
8. The sample size for the training set
Not applicable. As this is not an AI/software device, there is no training set mentioned in the document.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/software device, there is no training set or associated ground truth establishment mentioned in the document.
§ 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.”