(42 days)
In an anatomic shoulder configuration, the Humeris Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:
- A severely painful and/or disabled joint resulting from osteoarthritis or o rheumatoid arthritis;
- . Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).
In a reverse shoulder configuration, the Humeris Shoulder is indicated for primary or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.
The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The humeral stem of the Humeris Cementless Shoulder is intended for cementless use only. The humeral stem of the Humeris Cemented Shoulder is intended for cemented use only.
The glenoid components of the Humeris Shoulder System are intended for cemented use only. The glenoid baseplate component is intended for cementless use with the addition of screws for fixation.
The Humeris® 135 Shoulder System adds new components to the previously cleared Humeris Shoulder System (K163669). The additional new components are humeral cups eccentric symmetric and a Humeris humeral spacer, which provide a 135 degree angle for articulation with the previously cleared glenospheres and humeral cups (K150488 Humelock II® Reversible Shoulder System and K162455 Humelock Reversed® Shoulder System) when used in a reverse shoulder construct.
The Humeris Shoulder System can be used in either an anatomic or a reverse configuration and includes both cementless and cemented variants of the humeral stems.
The Humeris Cementless Humeral Stem is manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 with a plasma sprayed commercially pure Titanium (CP Ti) and hydroxyapatite (HA) coating at the distal end.
The Humeris Cemented Humeral Stem is also manufactured from Ti-6Al-4V allov conforming to ISO 5832-2 with a trapezoidal a polished surface at the distal end.
This document, K222936, is an FDA 510(k) Premarket Notification for the Humeris® 135 Shoulder System. It asserts substantial equivalence to a previously cleared predicate device rather than presenting a de novo study with novel performance criteria. Therefore, the traditional concept of "acceptance criteria" for a new device's performance, as would be found in a clinical trial or a study designed to prove a device meets specific accuracy or efficacy thresholds, is not directly applicable to this submission.
Instead, the acceptance criteria here are focused on demonstrating substantial equivalence to a predicate device. This means the device performs at least as safely and effectively as the predicate, without raising new questions of safety or effectiveness. The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical testing presented to support this claim of substantial equivalence.
Based on the provided text, here's a breakdown of the information requested, framed within the context of a 510(k) submission for substantial equivalence:
Acceptance Criteria and Device Performance (in the context of Substantial Equivalence)
The acceptance criteria for a 510(k) device like the Humeris® 135 Shoulder System are primarily met by demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use, fundamental technological characteristics, and similar performance to the predicate, or that any differences do not raise new questions of safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (for Substantial Equivalence) | Reported Device Performance (Summary from Submission) |
|---|---|
| Intended Use | The Humeris® 135 Shoulder System has the identical intended use compared to the primary predicate: Anatomic (total and hemi-shoulder replacement for osteoarthritis/rheumatoid arthritis, revision) and Reverse Shoulder (primary or revision total shoulder arthroplasty for massive, non-repairable rotator cuff tears). Any modifications (new humeral cups, spacer) align with these uses. |
| Material | Manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 (cementless) or ISO 5832-2 (cemented), with plasma sprayed CP Ti and HA coating at the distal end for cementless variant. This is noted as being comparable to the predicate. |
| Design | The Humeris® 135 Shoulder System adds new components (humeral cups eccentric symmetric and a humeral spacer) that provide a 135-degree angle for articulation. These are described as design modifications of the currently cleared humeral cup and are stated not to raise different questions of safety and effectiveness. |
| Packaging, Single Use, Sterilization, Shelf Life, Pyrogen Testing, Biocompatibility | Stated to be identical to the primary predicate device. |
| Compatible Components | Stated to be identical to the primary predicate device, articulating with previously cleared glenospheres and humeral cups. |
| Mechanical Performance (Range of Motion) | Range of motion analysis demonstrated comparability to the predicate device. |
| Mechanical Performance (Construct Fatigue) | Construct fatigue testing was completed with test constructs completing all cycles with no failures and taper connections remaining firmly fixed. The results indicate adequate performance for intended use. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the "Range of motion analysis" or "Construct fatigue testing." These types of tests typically involve a defined number of test articles (e.g., specific numbers of implants subjected to fatigue cycling) rather than patient samples.
- Data Provenance: The testing described (Range of motion analysis, Construct fatigue testing) is non-clinical/bench testing. It is conducted in a controlled laboratory environment, not on human subjects. Therefore, provenance like country of origin for patient data or retrospective/prospective status is not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This is a 510(k) submission primarily relying on bench testing and comparison to a predicate device. The concept of "ground truth" established by experts for a test set (e.g., for diagnostic accuracy) is not applicable here.
- The determination of substantial equivalence is made by the FDA based on the submission and relevant regulations. Design engineers, materials scientists, and biomechanical engineers would have conducted and interpreted the non-clinical tests.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or outcomes, where human expert consensus is needed to establish ground truth or evaluate performance. This submission relies on non-clinical engineering tests.
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
- Not applicable. This is a medical device (shoulder prosthesis) with no AI component or interpretative function. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a surgical implant, not an algorithm or diagnostic imaging device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- For the non-clinical testing, the "ground truth" is defined by established engineering and material science standards, specifications, and test methodologies (e.g., ISO standards, ASTM standards). The "truth" is whether the device meets predefined mechanical performance thresholds (e.g., completing a certain number of fatigue cycles without failure, demonstrating comparable range of motion as determined by engineering analysis).
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as this is not an AI/ML device requiring a training set.
§ 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.”