(54 days)
The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:
- significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
- united humeral head fractures of long duration;
- irreducible 3- and 4-part proximal humeral fractures;
- avascular necrosis of the humeral head.
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.
The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.
The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads, and a glenoid component. The humeral stems are manufactured from Cobalt Chrome (CoCr) and have fins to provide rotational stability. The fins have suture holes for the attachment of soft tissue and bone in the case of proximal humeral fracture. A collar is present to resist stem subsidence. The stems have a male Morse-type taper to interface with the modular humeral heads.
The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a female Morsetype taper to interface with the humeral stems.
The glenoid components are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid implants are available in a multi-peqged and keeled design and are intended for cemented fixation only.
Based on the provided K110905 510(k) summary for the Shoulder Innovations Total Shoulder System, here's an analysis of the acceptance criteria and study information:
This submission is a Special 510(k) for a device modification, specifically the addition of a keeled design glenoid implant. The primary goal is to demonstrate equivalence to predicate devices, not necessarily to establish de novo performance against acceptance criteria for a new device type. Therefore, many of the typical AI/ML study questions about ground truth and reader studies are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Equivalence (Overall) | The "Substantial Equivalence" section states that the design, function, intended use, and indications for use of the modified device (with the keeled glenoid) should be substantially equivalent to the predicate device (K102670 and K052472). This is the overarching acceptance criterion for a 510(k) submission. | "The results of non-clinical testing and comparative analysis demonstrate that the design, function, intended use, and indications for use of the Shoulder Innovations Total Shoulder System is substantially equivalent to the predicate device." |
| Keeled Glenoid Design | The keeled design glenoid implant was evaluated to demonstrate equivalence to the predicate devices. This implicitly means that the performance characteristics of the keeled design specific to its intended function (e.g., stability, fixation in cement) should be comparable to or not worse than the predicate's glenoid component. The listed engineering studies evaluate specific aspects of this design related to its performance. | Performance demonstrated through an engineering study. |
| Medial Cement Contact Area | Implied criterion: The medial cement contact area of the keeled design should be adequate for cemented fixation and comparable to the predicate device. | Evaluated in the engineering study. (Specific values for acceptance and performance are not detailed in the summary.) |
| Keel Design | Implied criterion: The geometry and structural integrity of the keeled design should be appropriate for its function, providing sufficient stability and fixation. | Evaluated in the engineering study. (Specific details are not provided.) |
| Dimensional Comparison | Implied criterion: Key dimensions of the keeled glenoid (especially articulating surface geometry and polyethylene thickness) should be equivalent to the predicate device to maintain current biomechanical characteristics and compatibility. | Evaluated in the engineering study. The summary explicitly states: "The glenoid shares the same articulating surface geometry and polyethylene thickness as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in terms of number of physical units or test replicates. The performance data section refers to an "engineering study," which typically involves bench testing.
- Data Provenance: The study is an "engineering study," which implies it was conducted by Shoulder Innovations, LLC, likely in a laboratory setting. There is no mention of country of origin of data or retrospective/prospective clinical data for this specific modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This submission does not involve an AI/ML device or a diagnostic requiring expert-established ground truth. The evaluation is based on engineering principles and comparative analysis with predicate devices.
4. Adjudication Method for the Test Set
- Not Applicable. As there are no human readers or diagnostic interpretations, no adjudication method is relevant.
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. An MRMC comparative effectiveness study was not done. This is a modification to an orthopedic implant, not an AI/ML diagnostic or assistive device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is an orthopedic implant, not an algorithm.
7. The Type of Ground Truth Used
- For the engineering study, the "ground truth" would be the established performance characteristics or specifications of the predicate device, against which the modified device's engineering test results (e.g., measurements, mechanical properties, cement contact area) are compared. The goal is to show that the modified design performs equivalently.
8. The Sample Size for the Training Set
- Not Applicable. This is an orthopedic implant, not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As above, no training set is relevant for this type of device.
§ 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.”