(46 days)
Anatomic Total Shoulder or Hemi-Shoulder
The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:
- · Osteoarthritis
- · Post-traumatic arthrosis
- Focal avascular necrosis of the humeral head
- · Previous surgeries of the shoulder that do not compromise the fixation
The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following:
- · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- · Rheumatoid arthritis.
- · Revision where other devices or treatments have failed.
- · Correction of functional deformity.
- · Fractures of the humeral head (with Short Humeral Stems)
- · Fractures of the humeral head and proximal humerus, where other methods of treatment are deemed inadequate (with Standard or Long Stems)
- · Difficult clinical management problems where other methods of treatment may not be inadequate.
Fixation Methods
The humeral stems are intended for cementless use. The humeral stemless anchor is intended for cementless use. The glenoid is intended for cemented use only.
Reverse Total Shoulder
The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated for conversion from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem.
- · A severely painful, disabling, arthritic joint
- · Fractures of the humeral head (with Short Humeral Stems)
- · Fractures of the humeral head and proximal humerus (with Standard or Long Stems)
- · Revisions of previously failed shoulder joint replacements
Fixation Methods
The humeral stem is intended for cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw fixation.
The INHANCE™SHOULDER SYSTEM with a humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures.
The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total, reverse total, or hemi-shoulder replacement procedures.
The Anatomic Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem or humeral stemless anchor (titanium alloy), an offset taper adapter (titanium alloy), a humeral head (cobalt-chromium) in combination with a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-linked, VE UHMWPE) glenoid.
The Reverse Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy), a shell (titanium alloy), a liner (Cross-linked, VE UHMWPE) in combination with a glenosphere (cobalt-chromium), baseplate (titanium alloy), peripheral screws (titanium alloy), peripheral posts (titanium alloy), and either a central screw (titanium alloy) or a central post (titanium alloy).
The Anatomic Hemi-Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy) an offset taper adapter (titanium alloy), a humeral head (cobaltchromium) (no glenoid component associated).
The provided document describes a 510(k) premarket notification for the INHANCE™ Shoulder System - Humeral Stems and Stemless Anchors. This submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
The information primarily focuses on the non-clinical testing performed to support this claim of substantial equivalence, as clinical testing was not deemed necessary. Therefore, the request for details related to human reader studies, expert ground truth, and training data applies to the scenario of AI/ML device testing, which is not the case here.
However, based on the provided text, we can describe the acceptance criteria and the study that proves the device meets them, primarily from a non-clinical/engineering perspective.
Here's the breakdown of the acceptance criteria and study as described in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Construct Fatigue Testing (based on ASTM F1378 methods) | "The acceptance criteria were met, demonstrating substantial equivalence of the subject and predicate devices." (Implies the subject device performed comparably or better than the predicate devices under fatigue testing, meeting the established thresholds for the predicate). |
| Range of Motion (RoM) Evaluation | "The subject devices do not represent a new worst-case for range of motion when compared to the predicate devices." (Implies RoM performance is not worse than the predicate). |
| Construct Loosening and Disassociation | "The subject devices do not represent a new worst-case for construct loosening and disassociation when compared to the predicate devices." (Implies loosening and disassociation performance is not worse than the predicate). |
| Biocompatibility Assessments | "The subject devices do not represent a new worst-case for biocompatibility when compared to the predicate devices." (Implies biocompatibility is not worse than the predicate). |
| Porous Structure Characterization | "Further characterization was not required" as the porous structure is "identical" to predicate devices. (Implies the porous structure meets the same criteria as the predicate). |
| MRI Compatibility | "The subject devices do not represent a new worst-case for MRI compatibility when compared to the predicate devices." (Implies MRI compatibility is not worse than the predicate). |
| Shelf Life Evaluation | "The subject devices do not represent a new worst-case for shelf life when compared to the predicate devices." (Implies shelf life is not worse than the predicate). |
| Sterilization Validation | "The subject devices do not represent a new worst-case for sterility when compared to the predicate devices." (Implies sterility is not worse than the predicate). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of units or samples used for each non-clinical test (e.g., how many humeral stems were subjected to fatigue testing). It generally refers to "the subject devices" without providing specific counts.
- Data Provenance: Not applicable in the context of non-clinical device testing with patient data. The testing is performed on physical devices in a controlled laboratory environment. The testing methods are "well-established methods" and "per the methods described in ASTM F1378."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This is not applicable as the evaluations are non-clinical (mechanical, material, dimensional, etc.) and do not involve human judgment or interpretation of medical images or patient data. Ground truth is established by engineering standards (e.g., ASTM F1378) and physical measurements.
4. Adjudication Method for the Test Set
- This is not applicable as the evaluation is based on objective, quantifiable engineering tests and comparisons to predicate device performance, not on subjective human interpretation or consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the INHANCE™ Shoulder System Humeral Stems and Stemless Anchors to the predicate devices." Such studies are typically for AI/ML devices assisting human readers with diagnostic tasks.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a "standalone" performance study in the context of an algorithm or AI was not done. The device is a physical shoulder implant, not a software algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical tests is established by engineering standards, validated test methods (e.g., ASTM F1378), and direct comparison to the performance of the legally marketed predicate devices. The goal is to show that the new device's performance is not worse than the predicate.
8. The Sample Size for the Training Set
- This is not applicable. The device is a physical medical implant, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable for the same reason as above.
§ 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.”