(29 days)
The Encore Reverse Shoulder Prosthesis (RSP) is intended for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.
During primary surgery, after the humerus is prepared for the RSP humeral stem, if the glenoid bone stock appears "insufficient" to bear the load of the glenoid baseplate, a RSP humeral stem adapter can be used to convert the RSP humeral stem to a hemiarthroplasty prosthesis. During revision surgery of an RSP, if the glenoid bone stock appears to be "insufficient" to bear the load of the glenoid baseplate device; a RSP Humeral Stem Adapter is used to convert the RSP device to a hemiarthroplasty prosthesis.
The Encore Reverse Shoulder Prosthesis (RSP) is indicated for salvage procedures for irreparable rotator cuff, failed hemi or total shoulder arthroplasty with irreparable rotator cuff, and for fracture in which the tuberosity and rotator cuff are irreparable. Unlike traditional total shoulders, the RSP is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulation fits into a metal cup attached to the humeral stem. The RSP Humeral Stem Adapter is used to convert the RSP to a hemiarthroplasty when the glenoid bone stock appears to be "insufficient" to bear the load of the glenoid baseplate device. There is no change to the intended use or fundamental scientific technology of the RSP with the modifications in this Special 510(k) submission.
The provided text describes a medical device, the Encore Reverse Shoulder Prosthesis (RSP), and its approval via a 510(k) submission. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.
The 510(k) process is primarily a demonstration of substantial equivalence to a legally marketed predicate device, rather than a clinical trial proving specific performance acceptance criteria. The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." and "The modified Encore RSP is similar in design, materials, and intended use to the previously cleared Encore RSP devices, K041066 and K051075."
Therefore, I cannot provide the requested information as it is not present in the given text.
To answer your specific questions, based on the provided text:
- A table of acceptance criteria and the reported device performance: Not available. The document does not describe specific performance criteria or a study that measures the device against them.
- Sample sized used for the test set and the data provenance: Not available. No "test set" in the context of performance evaluation is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
- 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 device is a shoulder prosthesis, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available. The approval is based on substantial equivalence to predicate devices, not on direct performance against a "ground truth" as might be seen for diagnostic devices.
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.”