(153 days)
Anatomic Applications
- 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 proximal humerus, where other methods of treatment are deemed inadequate.
- Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Reverse Applications
The Comprehensive Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is neeessary.
Comprehensive Convertible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation.
Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented application. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.
The proposed device is an orthopaedic total joint intended to replace the damaged or diseased natural shoulder joint in shoulder arthroplasty to provide pain relief and restore function. It is modular in design, consisting of a baseplate held to the bone with bone screws and a modular liner. The device is designed to be implanted as the glenoid component of an anatomic total shoulder with the option to convert to a reverse shoulder configuration without removal of the metal components.
The current submission is to expand the product offering by the addition of a liner manufactured from Vivacit-E Vitamin E Highly Crosslinked Polyethylene (VEHXPE).
This document is a 510(k) premarket notification for a medical device (shoulder prosthesis) and as such, it focuses on demonstrating substantial equivalence to a previously cleared device, rather than providing the kind of extensive performance study data that would be typical for a novel device or a clinical trial.
Therefore, the document does not contain the detailed information required to answer many of your specific questions about acceptance criteria and a study proving the device meets those criteria.
Here's why and what information can be extracted:
- No "Acceptance Criteria Table" or "Reported Device Performance": The 510(k) process for this type of device (a new material liner for an existing, cleared system) primarily relies on demonstrating that the new material (Vivacit-E Liner) performs equivalently to existing materials in relevant non-clinical tests (e.g., mechanical tests). Clinical studies with specific performance metrics and acceptance criteria are generally not required for substantial equivalence for this type of modification.
- No "Study that proves the device meets the acceptance criteria" in the sense of a clinical trial: The "Summary of Performance Data" explicitly states "Clinical Tests: None provided." This means there was no multi-reader, multi-case study, no human-in-the-loop performance measurement, and no standalone algorithm performance assessment. This device is a passive implant, not an AI or diagnostic tool.
Based on the provided text, here's what can be answered or inferred:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional sense. This submission is for a material change (Vivacit-E Liner) to an existing device. The performance data listed are non-clinical tests designed to show that the new liner material performs equivalently to existing cleared materials/devices.
- Types of Non-Clinical Tests Conducted:
- Dissociation Testing
- Shear Testing
- Insertion Testing
- Biocompatibility Assessment
- Packaging Assessment
- "Acceptance Criteria" for these tests: While not explicitly stated with numerical values, the acceptance criterion for a 510(k) submission is that the performance of the new device (Vivacit-E Liner) is "as safe and effective as the legally marketed predicate devices" and that "any differences do not raise new questions of safety and effectiveness." This implies that the results of these non-clinical tests must fall within expected ranges or demonstrate equivalence to the predicate device for each test. Specific numerical thresholds or ranges are not provided in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for the non-clinical tests. For mechanical testing of medical devices, sample sizes are typically determined by engineering standards (e.g., ISO, ASTM) and statistical power requirements to demonstrate equivalence or meet specified performance criteria.
- Data Provenance: Not specified, but given it's a submission by Biomet Manufacturing Corp. (a US company) to the FDA, the testing would typically be conducted according to internationally recognized standards in controlled laboratory environments. The data would be specific to components manufactured by the applicant. This is not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is not a study requiring expert readers or ground truth establishment in the clinical image interpretation sense. The "ground truth" for mechanical testing is the physical property being measured (e.g., force, displacement, material degradation) against defined engineering specifications.
4. Adjudication method for the test set
- Not Applicable. No human adjudication is involved in the non-clinical mechanical testing of an implantable device like this.
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
- No. The "Summary of Performance Data" explicitly states: "Clinical Tests: None provided." This device is a passive implant, not a diagnostic or AI-powered device that would involve human readers or image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. As above, this is a physical implant, not a software algorithm.
7. The type of ground truth used
- For Non-Clinical Tests: The "ground truth" would be engineering specifications and material properties as defined by relevant standards (e.g., ISO, ASTM) and internal design requirements. For example, for "Shear Testing," the ground truth would be the measured shear strength compared to the designed minimum shear strength or the shear strength of the predicate device.
8. The sample size for the training set
- Not Applicable. This is not a machine learning or AI-driven device, so there is no concept of a "training set" for the device itself.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for the device, this question is irrelevant.
§ 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.”