(167 days)
Anatomic Total Shoulder Applications:
· Osteoarthritis
• The patient must be anatomically and structurally suited, as evident by scapula and proximal humerus closure, to receive the implants.
OsseoFit™ Stemless Shoulder humeral components have a porous surface and are indicated for uncemented biological fixation applications.
Compatible Glenoid components are intended to be implanted with bone cement. The porous posts may be inserted without bone cement.
Compatible Convertible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation.
The OsseoFit™ Stemless Shoulder System consists of a stemless humeral head adapter for anatomic total shoulder applications. The OsseoFit humeral implant is an anatomical (left/right specific), asymmetric humeral anchor with six fins whose location, length, and height vary. The OsseoFit humeral implants are available in Onlay and Inlay variants. The Onlay implants sit on top of the prepared bone while the Inlay implants have a dished superior portion with a shorter fin length to sit within the bone. The OsseoFit Humeral Implant also includes anterior suture holes for soft tissue attachment.
The humeral implants are manufactured through additive manufacturing which includes areas of OsseoTi porous technology to allow biological fixation.
The OsseoFit Stemless Shoulder System is intended for cementless applications and is designed to be used with a compatible Identity Shoulder System (K213856) humeral head. The Identity Humeral Head is assembled to the OsseoFit Humeral Head Adapter via a locking taper by a disposable impactor that is packaged together with the head adapter. The Identity heads can be used with a compatible Alliance Glenoid Implant (K191814 and K193180) or Comprehensive Convertible Baseplate liner (K211729).
The provided text describes the regulatory filing for the OsseoFit Stemless Shoulder System, a medical device. It focuses on demonstrating substantial equivalence to existing predicate devices, primarily through non-clinical testing.
However, the document does not contain any information about a study that assesses the device's performance against specific acceptance criteria in terms of algorithm or diagnostic accuracy, or human reader improvement with AI assistance. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states "Clinical Tests: None Provided." The non-clinical tests listed are related to the mechanical and material properties of the device (e.g., fatigue testing, micromotion testing, MRI compatibility, porous coating characterization, manufacturing validation), not to an AI component or a diagnostic performance study.
Therefore, I cannot provide details on:
- A table of acceptance criteria and the reported device performance: This information is not present as there's no mention of a performance study in the context of diagnostic accuracy or AI.
- Sample size used for the test set and the data provenance: No such test set or data are mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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: The document clearly states "Clinical Tests: None Provided." There is no mention of an AI component or human reader study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No algorithm or standalone performance is discussed.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in this context.
- The sample size for the training set: Not applicable as there's no mention of an AI model or training.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary for a medical implant, focusing on its mechanical, material, and design characteristics relative to predicate devices. It does not contain information about studies measuring diagnostic performance, AI performance, or human reader effectiveness with AI assistance.
§ 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.”