(108 days)
Anatomic Total Shoulder Indications:
The Encore® Shoulder Prosthesis Stem is indicated as an Anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:
- Noninflammatory degenerative joint disease including osteoarthritis;
- Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis;
- Post-traumatic arthritis of the glenohumeral joint;
- Avascular necrosis of the humeral head with and without involvement of the glenoid;
- Correction of functional deformity
The all-poly glenoid is intended for cemented use
Hemi Shoulder Indications:
The Encore® Shoulder Prosthesis Stem is indicated as a hemi shoulder joint replacement for patients suffering from pain and dysfunction due to:
- Noninflammatory degenerative joint disease including osteoarthritis;
- Inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis;
- Post-traumatic arthritis of the glenohumeral joint;
- Avascular necrosis of the humeral head with and without involvement of the glenoid:
- Correction of functional deformity;
- Rotator cuff tear arthropathy;
- Humeral fracture.
- Failed previous shoulder surgery
Reverse Total Shoulder Indications:
The Encore® Shoulder Prosthesis Stem is as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:
- Severe arthropathy with a grossly deficient rotator cuff;
- Previously failed joint replacement with a grossly deficient rotator cuff;
- Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after turnor resection;
- Bone defect in proximal humerus:
- Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid;
- Inflammatory arthritis including rheumatoid arthritis;
- Correction of functional deformity.
The glenoid baseplate is intended for cementless application of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures
All humeral stems are intended for cemented or cementless use.
The Encore® Shoulder humeral stem is a single component manufactured from wrought/forged titanium allov. The stem distal body is cylindrical with four flutes. The stem's body flares proximally to a trapezoidal crosssectional midbody, and a hemispherical shell is most superior. The stem has porous coating applied on, and around, the outer spherical diameter of the shell. Porous coating is applied, under the shell, to the stem's medial, anterior, and posterior surfaces. Two fins are located in symmetry on the stem's antero-lateral midbody corners to promote shoulder humeral fracture tuberosity reduction in addition to providing rotational stability. The fins protrude at 45° from the frontal plane. Each fin has two suture holes for reattachment of soft tissue or bone fragments in cases of proximal humeral fracture. A larger hole is located under the steel 's shell which traverses the stem body through the medial-lateral plane to allow through a cerclage wire or suture anchorage point. Four suture holes are located through the stem's shell to aid in soft tissue reattachment and fractured shoulder tuberosity reduction. A larger hole spans the stem's midbody within the medial-lateral plane. The hole is tapered to maintain constant stem wall thickness without compromising fatigue strength. This hole can be used for temporary or long-term bone graft fixation in addition to soft-tissue reattachment. Three slots are located through the stem's shell: anterior, posterior, and medial. These slots allow surgical access by osteotome, or other instruments, for stem removal and separation from bone during revision surgery. A central screw thread within the stem's shell allows mating interface with other surgical instruments or implants.
The document provided describes the Encore Humeral Shoulder Stem, a medical device, and its 510(k) summary submitted to the FDA. It does not include information about AI/ML device performance or a study proving its performance against acceptance criteria in the context of an AI-driven device.
Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for an AI product. The document focuses on the substantial equivalence of a physical medical implant to existing predicate devices based on non-clinical mechanical testing.
Here's a breakdown of why I cannot fulfill your request based on the provided text:
- No AI/ML Device: The "Encore Humeral Shoulder Stem" is a physical implant (shoulder prosthesis), not an AI/ML software device.
- No Acceptance Criteria for AI/ML: Consequently, there are no acceptance criteria related to AI/ML performance (e.g., sensitivity, specificity, AUC) or reported device performance metrics for such a device.
- No Study for AI/ML Performance: The document explicitly states "Clinical Testing: None provided" and relies on "Non-Clinical Testing: Mechanical testing" to demonstrate substantial equivalence to predicate physical devices.
- Missing Information Categories: All categories related to AI/ML device evaluation (sample sizes for test/training, data provenance, number of experts, adjudication, MRMC studies, standalone performance, type of ground truth) are absent because the device itself is not an AI/ML product.
§ 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.”