(221 days)
- Primary total shoulder arthroplasty.
- Non-inflammatory degenerative joint disease including osteoarthritis
Comprehensive Nano Stemless Shoulder humeral components have a porous coated surface coating and are indicated for uncemented biological fixation applications.
The Comprehensive Modular Hybrid Glenoid is intended to be implanted with bone cement. The porous titanium peg may be inserted without bone cement.
The Comprehensive Nano Stemless Shoulder is part of the Comprehensive Shoulder System intended for use in total shoulder arthroplasty. The humeral component is used as part of an anatomic configuration with a Versa-Dial® humeral head that articulates against the Comprehensive hybrid glenoid component. The head is connected to the Nano humeral component by a taper adaptor.
The Comprehensive Nano Stemless Shoulder is manufactured from Ti6Al4V alloy. It consists of a central tapered region and six outer wings. The taper has a machine finish and accepts the taper adaptor of the humeral head component. The bone-contacting outer surface features a porous coating of plasma sprayed titanium alloy for cementless fixation in the proximal humerus. Six sizes are available - 30 mm through 40mm in 2mm increments.
Here's a breakdown of the acceptance criteria and study details for the Comprehensive® Nano Stemless Shoulder, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Study Endpoint | Acceptance Criteria | Reported Device Performance (Comprehensive Nano Stemless Shoulder) |
|---|---|---|
| Endpoint a: ASES mean scores at two years | Non-inferiority to the predicate Comprehensive mini stem (p 2mm in two or more contiguous zones. | All subjects in both groups successfully passed the radiographic endpoint criteria. (Indicates all nano subjects met this criterion). |
| Endpoint c: Radiographic Success (Glenoid Component) | 1. Migration of the glenoid component 2mm around the entire glenoid component. | All subjects in both groups successfully passed the radiographic endpoint criteria. (Indicates all nano subjects met this criterion). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Comprehensive Nano Humeral Component (Investigational): 116 subjects (who reached the two-year follow-up time point or were removed from the study).
- Comprehensive mini stem (Control): 123 subjects.
- Data Provenance: Prospective, randomized, blinded, multicenter study. The country of origin is not specified in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document does not specify the number of experts used to establish the ground truth for the test set.
- It refers to evaluations by Principal Investigators (for adverse events) and implies clinical assessment for outcomes like ASES scores and radiographic success. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed, but they are implicitly qualified medical professionals conducting a clinical study.
4. Adjudication Method for the Test Set
- The document does not explicitly describe a formal adjudication method (e.g., 2+1, 3+1) for the outcomes.
- The adverse events were classified by the principal investigator as definitely related, probably related, or possibly related to the device. This indicates an individual clinical assessment rather than a multi-expert adjudication panel for initial classification of device-related adverse events.
- For the co-primary endpoints (ASES scores, adverse events/revisions, radiographic success), the collection and analysis appear to be based on study protocols and clinical assessments by the investigators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done.
- This was a clinical trial comparing two different medical devices (the Nano Stemless Shoulder vs. the mini stem shoulder prosthesis) in human subjects, not a study evaluating human readers' performance with or without AI assistance. The "readers" here are the patients themselves (their ASES scores and outcomes), and the clinicians assessing their progress and radiographs.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- This is not an AI/algorithm device. The device is a physical shoulder prosthesis (Comprehensive® Nano Stemless Shoulder).
- Therefore, a standalone (algorithm only) performance study is not applicable. The study evaluated the clinical performance of the physical implant itself.
7. The Type of Ground Truth Used
- The "ground truths" in this study are derived from a combination of:
- Clinical Outcomes Data: ASES (American Shoulder and Elbow Surgeons) scores, which are patient-reported and clinician-evaluated functional assessments.
- Adverse Event Reporting: Documented unanticipated device-related adverse events, fractures, perforations, dislocations, and revisions/removals, classified by the principal investigator.
- Radiographic Assessments: Measurable criteria from imaging studies (subsidence, migration, progressive lucency around components) to determine radiographic success.
- This represents real-world clinical performance data from human patients.
8. The Sample Size for the Training Set
- Not applicable. As this is a physical medical device (shoulder prosthesis) and not an AI algorithm, there is no "training set" in the context of machine learning.
- The study described is a clinical study to evaluate the device's performance in patients, not to train a model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8. There is no training set for an AI algorithm.
§ 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.”