(111 days)
The Porous Coated Comprehensive® Fracture Stems are indicated for:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Revision where other devices or treatments have failed.
- Correction of functional deformity.
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
- Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Humeral/glenoid components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation.)
Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation).
The Comprehensive® Fracture Stems are intended for use with the Bio-Modular Humeral Heads and glenoid components and Versa-Dial Humeral Heads.
The Comprehensive™ Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive™ Fracture Stem.
The Comprehensive™ Shoulder Stems (Fracture, Primary and Revision) are intended for use with the Bio-Modular™ Humeral Heads and glenoid components and Versa-Dial™ Humeral Heads.
The Versa-Dial™ Humeral Head Prosthesis is intended for use only with the Comprehensive™ Shoulder Stems (Fracture, Primary and Revision), the Bio-Modular™ Shoulder Stems, the glenoid components of the Bio-Modular Shoulder System, and the glenoid components of the Comprehensive™ Shoulder System.
When a humeral stem and/or Versa-Dial™ Taper Adapter is being used for a reverse shoulder application, the user should refer to the package insert (01-50-0903) continued with the reverse shoulder components for additional information, including alternate indications.
Biomet's Porous Coated Comprehensive® Fracture Stems consist of a humeral stem comprised of cast Co-Cr-Mo. The Proximal body of the stem contains 4 fins, three of which include suture holes to facilitate multiple attachment sites for the bone. The proximal body also contains a porous plasma-spray coating, which will allow for optimum fixation of the stem in the proximal humerus. The humeral stem contains a reverse taper which allows for the use of either a Bio-Modular® humeral head or glenoid component, a Versa-Dial® humeral head, or the Comprehensive® Reverse Shoulder humeral components.
This document is a 510(k) Premarket Notification from the FDA for a medical device called "Porous Coated Comprehensive® Fracture Stems." It outlines the device's indications for use and compares it to predicate devices to establish substantial equivalence.
Based on the provided text, there is no acceptance criteria or study proving device performance in the context of an AI/ML medical device. The document is for a traditional medical device (shoulder replacement prosthesis) and does not describe an AI/ML algorithm. Therefore, I cannot provide the requested information.
The document discusses:
- Device Name: Porous Coated Comprehensive® Fracture Stems
- Indications for Use: various shoulder conditions including degenerative joint disease, rheumatoid arthritis, fractures of the proximal humerus, and revision surgeries.
- Predicate Devices: Comprehensive Humeral Fracture Stems (K023063), Comprehensive Primary Shoulder Stems (K060692), Kirschner® Neer-III™ Modular Proximal Humerus (K874643).
- Performance Data: "SUMMARY OF NON-CLINICAL TESTS - Median Fatigue Test" and explicitly states "No clinical data submitted" and "No clinical data was necessary for a determination of substantial equivalence."
Since this is for a traditional medical device and not an AI/ML device, the questions regarding acceptance criteria for an AI/ML algorithm, sample sizes, ground truth, expert adjudication, and MRMC studies are 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.”