(191 days)
The Arthrex Fracture Adapter Hemi Shoulder Prosthesis is indicated for significant disability resulting from degenerative, theumatoid, or traumatic disease or injury of the glenohumeral joint. This includes traumatic or pathological conditions of the shoulder resulting in fracture of the glenohumeral joint, including impression fractures. comminuted fracture, humeral head fracture, displaced 3-or-4-fragment proximal head fractures, of the humeral head, and fractures of the anatomical neck.
The Arthrex Fracture Adapter Hemi Shoulder Prosthesis is for uncemented use. The device may be used for hemi or total shoulder repair, utilizing the appropriate Arthrex Univers Glenoid component, which is to be cemented in place.
The fracture adapters are manufactured from Titanium with a hydroxyapatite (HA) coating and are offered in 10 sizes. The Fracture Adapters mate with a trunnion and FDA cleared Arthrex Humeral Stems and Heads for anatomic hemi shoulder prosthesis.
Here's an analysis of the acceptance criteria and the study conducted for the Arthrex Fracture Adapter Hemi Shoulder Prosthesis (K181555), based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fatigue Resilience | The device demonstrated fatigue strength meeting the same acceptance criteria as the predicate device for the desired indications. |
| Pyrogenicity (Bacterial Endotoxin) | The device meets pyrogen limit specifications. |
| Substantial Equivalence | The device is substantially equivalent to the predicate device in basic design features and intended uses. Minor differences do not raise questions concerning safety or effectiveness, based on indications for use, technological characteristics, and submitted data. This is the overarching goal of a 510(k). |
Study Details
The provided document describes two types of performance studies: dynamic fatigue testing and bacterial endotoxin testing.
1. Dynamic Fatigue Testing
- Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "the proposed construct" and "the proposed devices" but does not specify the number of units tested.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was a mechanical engineering test, not an evaluation requiring expert opinion on diagnostic accuracy.
- Adjudication method for the test set: Not applicable. This was a mechanical engineering test.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a mechanical device, not an AI or imaging diagnostic device that would require an MRMC study.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device, not an algorithm.
- The type of ground truth used: The "ground truth" for this test would be the established mechanical limits and performance characteristics of the predicate device, against which the new device's fatigue strength was compared.
- The sample size for the training set: Not applicable. There is no "training set" for this type of mechanical testing.
- How the ground truth for the training set was established: Not applicable.
2. Bacterial Endotoxin Testing
- Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions that the test was "conducted" but doesn't specify the number of devices or samples tested.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a laboratory test following recognized standards (EP 2.6.14/USP ).
- Adjudication method for the test set: Not applicable. This is a standard laboratory test.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: The "ground truth" is defined by the pyrogen limit specifications outlined in EP 2.6.14/USP .
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary regarding AI/ML specifics:
It's important to note that the provided document is a 510(k) clearance letter for a mechanical orthopedic implant (shoulder prosthesis components). The questions about multi-reader multi-case studies, standalone algorithm performance, training sets, data provenance, and expert ground truth establishment are typically relevant for Artificial Intelligence/Machine Learning (AI/ML) powered medical devices or diagnostic imaging devices. This document does not describe an AI/ML device, hence most of those specific questions are not applicable to the context of this submission. The "study" here refers to mechanical and biocompatibility testing to ensure the safety and effectiveness of the physical implant.
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 humeral resurfacing 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 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”