(152 days)
The Neer III Total Shoulder System is indicated for use as an orthopedic implant for the partial or total replacement of the human shoulder joint articulating either directly against the glenoid face or a compatible glenoid component, respectively.
The Neer III Total Shoulder System is intended for the following:
Proximal Humeral Prosthesis - (1) complex, acute fracture-dislocations of the humeral head (e.g., trauma - three and four-part injuries in the Neer classification, or head impression fractures); (2) complex, chronic fractures or fracture-dislocations of the humeral head with malunion, nonunion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures; (3) avascular necrosis with intact glenoid cartilage; and (4) selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or must engage in moderately heavy activities.
Total Shoulder Arthroplasty (when used in conjunction with a compatible glenoid component) – severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures.
This device is intended only for cemented fixation.
Neer III humeral stems are manufactured from cast CoCr (cobalt chrome) alloy and are available in three stem diameters (8, 10 & 12mm). Four head heights, 15, 19, 22 & 26mm, are available, to allow accurate tensioning of the joint intra-operatively. The 25mm radius of curvature of the heads is constant throughout the stem to be used as a total shoulder replacement in conjunction with various glenoid components. Suture-wire holes are located in two laterally orientated fins to optimize re-attachment of the tuberosities.
The implants in the system are intended fixation into a prepared humeral canal. Neer III humeral stems can be used in conjunction with a compatible glenoid component, such as Neer II Shoulder glenoid components, Coffeld Modular Shoulder glenoid components, Anatomic glenoid components, or in a hem-arthroplasty against an unresurfaced glenoid process.
Neer III Total Shoulder System - Acceptance Criteria and Study Details
The provided documents contain information regarding the Neer III Total Shoulder System and its 510(k) premarket notification. However, the information does not detail specific acceptance criteria in a quantitative format, nor does it describe a stand-alone study with performance metrics (like sensitivity, specificity, accuracy) to prove the device meets these criteria.
Instead, the submission relies on the concept of substantial equivalence to predicate devices. This means the device is considered safe and effective because it is similar in design, materials, and intended use to devices already legally marketed.
Therefore, the requested table of acceptance criteria and reported device performance cannot be fully populated as typically expected for studies directly evaluating performance against numerical targets. Similarly, details about sample size for a test set, expert involvement for ground truth, adjudication methods, or MRMC studies are not present.
Below is an attempt to structure the available information in response to the prompts, highlighting what is provided and what is not.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence and Bench Testing) | Reported Device Performance (from Bench Testing) |
|---|---|
| Safety and Effectiveness: Assumed to be equivalent to predicate devices based on long history of use. | "Consistent with the Neer II and predicate devices" for: |
- Range of Motion
- Finite Element Analysis
- Fatigue Testing
- Stem Strength
- Package Integrity Testing |
| Material Composition: CoCr alloy for humeral stems, UHMWPE for glenoid components (similar to predicate). | Stems manufactured from cast CoCr alloy. Glenoid manufactured from UHMWPE. |
| Design Characteristics: Three stem diameters (8, 10, 12mm), four head heights (15, 19, 22, 26mm), 25mm radius of curvature for heads, suture-wire holes. Anatomical "pear-shaped" design for glenoid. | Device description details these characteristics. |
| Intended Use: Orthopedic implant for partial or total replacement of the human shoulder joint. | Indications for Use are clearly stated and align with predicate devices. |
| Fixation Method: Intended for cemented fixation only. | Explicitly stated: "This device is intended only for cemented fixation." |
Explanation: The "acceptance criteria" here are largely inferred from the regulatory pathway chosen (510(k) substantial equivalence). The device "meets" these criteria by being demonstrated as technologically similar and performing comparably (in bench tests) to predicate devices that have already been accepted as safe and effective. No specific quantitative performance metrics (e.g., success rate, complication rate) are provided as acceptance criteria for this specific submission.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. The submission does not describe a clinical "test set" in the context of evaluating performance against specific outcome metrics for this device. The evaluation relies on substantial equivalence and bench testing.
- Data Provenance: The "long history of use of these devices in the market place" refers to the predicate devices. This suggests a reliance on retrospective market data and clinical experience with similar established devices. Specific country of origin for this implicit historical data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. There was no specific clinical "test set" for which ground truth needed to be established for the Neer III system itself in this submission.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set requiring adjudication was described.
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 a medical device for joint replacement, not an AI or diagnostic imaging device. Therefore, an MRMC study is not relevant to this submission.
- Effect Size of AI Assistance: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: No. This is not an algorithm-based device. The "standalone" evaluation consists of the bench testing described (Range of Motion, finite element analysis, fatigue testing, stem strength, and package integrity testing), which compared the device's physical properties to those of its predicate counterparts.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this context is implicitly established through the long-standing clinical use and regulatory acceptance of the predicate devices. The safety and effectiveness of the Neer III system are established by demonstrating its substantial equivalence to these predicates, which are already considered safe and effective based on their historical performance and regulatory approval. For the bench tests, the "ground truth" would be the established performance characteristics and specifications of the predicate devices.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI-based device, so the concept of a "training set" is not relevant.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable. (See #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.”