(103 days)
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 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 REVERSE SHOULDER SYSTEM with Glenoid Peripheral Posts is intended for use in reverse total replacement procedures.
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 INHANCE REVERSE SHOULDER SYSTEM includes Peripheral Posts that are offered in 4MM, 6MM and 8MM lengths. The Peripheral Posts can be simply prepared for, and placed through, one of the peripheral holes of the Baseplate to increase contact area and aid in stability. This versatile option allows for interoperative flexibility and simple preparation to address various glenoid morphologies.
Note(s):
- . When using a Peripheral Post implant, the INHANCE Reverse Shoulder System is only indicated for use with a Central Screw and Peripheral Locking Screws that are 25mm or greater in length.
- . The Peripheral Post implants are only indicated for use in anterior, posterior, and superior glenoid defects.
The provided document is a 510(k) premarket notification letter from the FDA to Ignite Orthopedics LLC regarding their INHANCE™ Reverse Glenoid Peripheral Posts. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria through a study with acceptance criteria.
The document discusses non-clinical testing conducted to support substantial equivalence. However, it explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the INHANCE™ Reverse Glenoid Peripheral Posts to the predicate devices."
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance (e.g., diagnostic accuracy, patient outcomes) is not available in this document. The document describes engineering and biocompatibility testing criteria, but not criteria related to clinical performance or human reader studies.
Here's a breakdown of the information that is available based on your request, highlighting what is missing due to the nature of this submission (a 510(k) based on substantial equivalence, not a clinical performance study):
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing):
| Acceptance Criteria Category | Acceptance Criteria (Stated) | Reported Device Performance (Achieved) |
|---|---|---|
| Range of Motion (RoM) | Meet established specifications per ASTM F1378 | "The RoM targets were met." |
| Construct Fatigue Testing | Meet applicable ASTM F1378 criteria | "The acceptance criteria were met." |
| Construct Loosening & Disassociation | Meet applicable ASTM F2028-17 criteria | "The acceptance criteria were met." |
| Biocompatibility | Meet ISO 10993-1 and FDA Guidance standards | "The devices were found to be biocompatible." |
| MRI Compatibility | Inform MRI Conditional Labeling based on ASTM F2052-15 (Force), F2213-17 (Torque), F2182-19e2 (Heating), F2119-07 (Image Quality) | Quantitative data obtained. No new worst-case components. |
| Shelf Life | Establish 5-year shelf life per ISO 11607-1 and ISO 11607-2 | "A five-year shelf life was established based on the resultant data." |
| Sterilization Validation | Achieve Sterility Assurance Level (SAL) of 10-6 per ISO 11137-1 and ISO 11137-2 | "The Sterility Assurance Level (SAL) was found to be 10-6." |
Since "Clinical testing was not necessary," the following points of your request cannot be answered from the provided text:
- Sample sizes used for the test set and data provenance: Not applicable for clinical performance study.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no clinical test set requiring expert ground truth was described.
- Adjudication method for the test set: Not applicable.
- 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, as this is a physical medical device, not an AI-assisted diagnostic tool, and no clinical study was performed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (not an algorithm/AI device).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance. For non-clinical tests, the "ground truth" or reference is the specified ASTM/ISO standard criteria.
- The sample size for the training set: Not applicable (no algorithm/AI device or clinical training set described).
- How the ground truth for the training set was established: Not applicable (no algorithm/AI device or clinical training set described).
§ 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.”