(307 days)
The GLOBAL UNITE Platform Shoulder System is intended for cemented total or hemi-shoulder arthroplasty in treatment of the following:
- A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
- Fracture of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
- Irreducible 3- and 4-part fractures of the proximal humerus
- Ununited humeral head fractures
- Avascular necrosis of the humeral head
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component)
Hemi-shoulder arthroplasty is also indicated for:
- Deformity and/or limited motion
The GLOBAL UNITE Reverse Fracture Epiphyseal Component, in conjunction with components from the existing DELTA XTEND™ Reverse Shoulder System and GLOBAL UNITE Platform Shoulder System, is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. It is intended for cemented reverse shoulder arthroplasty in treatment of the following:
- Fracture of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
- Irreducible 3- and 4-part fractures of the proximal humerus
- Ununited humeral head fractures
The GLOBAL UNITE Reverse Fracture Epiphyseal Component is only intended for use in the treatment of proximal humeral fractures. Bone preparation instrumentation has not been validated to accommodate its use in a non-fracture press-fit application.
GLOBAL UNITE Humeral Stems, in conjunction with existing DELTA XTEND Epiphyseal Components, are indicated for use in reverse shoulder arthroplasty in treatment of a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint must be anatomically and structurally suited to receive the reverse implant(s), and a functional deltoid muscle is necessary to use the device.
When used in a total shoulder arthroplasty, the GLOBAL UNITE Implants are to be used with DePuy glenoid components. The glenoid components are for cemented use only. GLOBAL UNITE Humeral Implants are for cemented or uncemented use.
When used in a reverse shoulder arthroplasty, the GLOBAL UNITE and DELTA XTEND Humeral Implants are to be used with the HA-coated DELTA XTEND Metaglene Devices. The metaglene implants are intended for uncemented use only with additional screw fixation. The HA-coated DELTA XTEND Humeral Implants are intended for uncemented use only. GLOBAL UNITE humeral implants are for cemented use. The DELTA XTEND epiphyseal components are HA-coated and are intended for uncemented use.
The subject device expands the GLOBAL UNITE Platform Shoulder System (K101996, K133834) to include new porous-coated reverse fracture epiphyseal bodies made from titanium alloy that mate with existing GLOBAL UNITE (K101996) or DELTA XTEND (K071379) stems. In fracture cases with a grossly rotator cuff deficient glenohumeral joint with severe arthropathy where a surgeon deems reverse shoulder arthroplasty appropriate, the surgeon can use a GLOBAL UNITE (K101996) or DELTA XTEND (K071379) stem with the GLOBAL UNITE reverse fracture epiphysis and the DELTA XTEND metaglene and glenosphere (K062250).
The provided text is a 510(k) Summary for the GLOBAL UNITE Platform Shoulder System. It details non-clinical tests performed to demonstrate substantial equivalence to predicate devices, but explicitly states that no clinical testing was conducted. Therefore, it is not possible to describe acceptance criteria and a study proving a device meets them in the traditional sense of clinical performance or diagnostic accuracy.
However, I can extract the information related to the non-clinical acceptance criteria and the studies that demonstrate compliance with those engineering and material performance requirements.
Here's the information based on the provided text:
1. Table of acceptance criteria and the reported device performance:
Since this is a non-clinical submission, the "acceptance criteria" are implied by the nature of the tests (e.g., passing a fatigue test, demonstrating biocompatibility according to standards). The "reported device performance" is summarized as the device meeting these requirements to demonstrate substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| - Fracture stem with fracture epiphysis (high torque) - Fatigue Resistance | Met requirements (demonstrated substantial equivalence) |
| - Fracture stem with fracture epiphysis (low torque) - Fatigue Resistance | Met requirements (demonstrated substantial equivalence) |
| Fretting Corrosion Potential | Comparable to existing product |
| Epiphysis Comparison | Met requirements (demonstrated substantial equivalence) |
| 135° Neck Shaft Angle Verification | Verified compatibility |
| 128° and 142° Neck Shaft Angle Verification | Verified compatibility |
| Range of Motion Analysis | Met requirements (demonstrated substantial equivalence) |
| Rationale for 155 Degree Neck-Shaft Angle | Provided rationale |
| Biocompatibility: | |
| Biocompatibility Standards | Met requirements (demonstrated substantial equivalence) |
| Design/Manufacturing: | |
| Mating Parts Analysis | Performed (demonstrated substantial equivalence) |
| Effect of Screw Retention Insert on Humeral Cup Seating | Evaluated (demonstrated substantial equivalence) |
| Print Review of Product Marking | Reviewed for compliance |
| Print Review of Suture Features | Reviewed for compliance |
| Review of Label Content | Reviewed for compliance |
| Print Review of Porocoat | Reviewed for compliance |
| Sterilization: | |
| Bacterial Endotoxin Testing (ANSI AAMI ST-72:2011) | Met the requirement |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified in the provided text. For non-clinical tests like fatigue or biocompatibility, samples would typically refer to the number of physical devices or components tested. The exact number is not detailed here.
- Data provenance: The tests were performed on the GLOBAL UNITE Shoulder System by DePuy Orthopaedics. Given the context of a 510(k) submission to the FDA in the US, the testing would typically be conducted under recognized standards, likely in a controlled laboratory environment. The origin of the data is from these internal and external laboratory tests, not from patient data from a specific country. The study explicitly states "No clinical testing was conducted." The tests are non-clinical in nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not applicable. For non-clinical (e.g., mechanical, materials, biocompatibility) testing, "ground truth" is established by adherence to recognized engineering standards and measurement techniques, not by expert consensus on clinical findings.
- Qualifications of experts: Not applicable in the context of clinical ground truth establishment. The scientists and engineers performing and interpreting these technical tests would be qualified in their respective fields (e.g., mechanical engineering, materials science, toxicology).
4. Adjudication method for the test set:
- Adjudication method: Not applicable. This concept (e.g., 2+1, 3+1) is relevant for clinical studies where multiple human readers assess data and discrepancies need to be resolved. For non-clinical engineering and material tests, compliance is determined by meeting predetermined specifications and standards.
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:
- MRMC study: No. This is not applicable as the device is a shoulder implant and the submission is for non-clinical testing to demonstrate substantial equivalence, not for an AI/CADe system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone study: No. This is not applicable as the device is a shoulder implant, not a software algorithm.
7. The type of ground truth used:
- Type of ground truth: Not applicable in the clinical or diagnostic sense for this submission. For these non-clinical tests, the "ground truth" is established by:
- Engineering specifications and standards: e.g., ASTM standards for mechanical testing, ISO standards for biocompatibility.
- Reference materials: For comparative tests like fretting corrosion.
- Pre-defined pass/fail criteria: Based on these standards and specifications.
8. The sample size for the training set:
- Sample size for training set: Not applicable. The device is a physical medical implant, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Ground truth for training set: Not applicable (see point 8).
§ 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.”