(369 days)
ARROW® Indications for Use: The anatomical shoulder system, depending on the components used, is designed for:
Simple humeral prosthesis:
- Fracture dislocation or complex four part fracture of the proximal humerus
- Humeral head necrosis without injury to the glenoid cavity.
- Extensive humeral head cartilage damage without injury to the glenoid cavity
- Centered osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
- Rheumatoid polyarthritis with thin rotator cuff.
- Off-centered osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.
Total anatomical prosthesis (cemented glenoid implant with 4 pegs)
AND/OR
- Centered glenohumeral osteoarthritis with functional rotator cuff
- Rheumatoid polyarthritis with functional rotator cuff
- Fracture sequela, functional rotator cuff with glenoid injury.
The ARROW® anatomical shoulder system is a modular shoulder prosthesis, composed of the following elements:
- humeral stems,
- humeral heads (centred or off-centred),
- cemented glenoids.
The ARROW® anatomical shoulder system is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.
The provided document is a 510(k) Premarket Notification for the ARROW® anatomical shoulder system, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or clinical outcomes through human studies with strict acceptance criteria based on metrics like sensitivity or specificity.
Therefore, many of the typical acceptance criteria and study design elements requested in the prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of device submission. The "acceptance criteria" here are related to demonstrating mechanical performance and biocompatibility sufficient to show equivalence.
However, I can extract the information that is present and indicate where the requested information is not provided or applicable given the nature of a 510(k) for a shoulder prosthesis.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Equivalence) | Reported Device Performance |
|---|---|
| Material Equivalence: Made of same materials as predicate devices. | The ARROW® anatomical shoulder system and the selected predicate devices are made out of the same materials (titanium alloy for the humeral stem, cobalt chromium alloy for the humeral head, polyethylene for the cemented glenoid). |
| Design Feature Equivalence: Similar design features to predicate devices. | The ARROW® anatomical shoulder system and the selected predicate devices bear design features similarities. |
| Size Range Equivalence: Available in similar ranges of sizes as predicate devices. | The ARROW® anatomical shoulder system and the selected predicate devices are available in similar ranges of sizes. |
| Mechanical Performance: Tested according to recognized standards to ensure appropriate mechanical integrity and function. | The ARROW® anatomical shoulder system was tested according to: |
- ASTM F1738-05 (Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Forgings for Surgical Implants)
- ASTM F1829-98 (Standard Specification for Universal Metallic Extension Fixation Systems)
- ASTM F2028-05 (Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants) for the glenoid components. |
| Performance Conclusion: Performance determined to be substantially equivalent to predicate devices. | After testing, it was determined that the ARROW® anatomical shoulder system performances were substantially equivalent to those of the selected predicate devices. |
| Risk Mitigation: Risks to health addressed through specified materials, processing, quality, and compliance. | Risks to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of device performance testing for substantial equivalence for a shoulder prosthesis. The testing was mechanical/material specific based on ASTM standards, not a clinical test set with patient data.
- Data Provenance: Not applicable. The "test set" here refers to physical components of the device undergoing mechanical testing, not a dataset of patient information.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on clinical findings, is not established for this type of mechanical testing. The "ground truth" for the mechanical tests would be the accepted parameters defined by the ASTM standards.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no clinical test set requiring adjudication in this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a shoulder prosthesis, and this type of study is typically performed for diagnostic devices (e.g., AI for radiology interpretation).
- Effect Size: Not applicable as no MRMC study was performed.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Standalone Performance Study: Not applicable. This device is a physical shoulder prosthesis, not a software algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: For the mechanical performance "testing," the "ground truth" is defined by the established ASTM (American Society for Testing and Materials) standards (ASTM F1738-05, ASTM F1829-98, and ASTM F2028-05). Compliance with these standards demonstrates acceptable mechanical properties and material performance.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no "training set" in the context of a physical medical device like a shoulder prosthesis. The design and manufacturing processes are developed through engineering and materials science, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As there is no training set, there is no ground truth established in this manner. The "ground truth" for the device's design and material selection would be established through established engineering principles, biomechanical understanding, and regulatory requirements, which are inherent to the development of such an 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.”