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K Number
K002998
Device Name
BIOMET BI-POLAR SHOULDER SYSTEM
Manufacturer
BIOMET, INC.
Date Cleared
2000-10-06

(10 days)

Product Code
KWT
Regulation Number
888.3650
Type
Special
Panel
OR
Reference & Predicate Devices
K991585
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Biomet® Bi-Polar Shoulder System is indicated for use in:

  1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
  2. Rheumatoid arthritis
  3. Revision where other devices or treatments have failed
  4. Correction of functional deformity
  5. Treatment of acute fracture of the humeral head unmanageable using other treatment methods
  6. Cuff tear arthroplasty
    This is a single use implant for use with cemented or uncemented humeral components. It is intended for use with Biomet's humeral components previously cleared by the FDA.
Device Description

The Biomet® Bi-Polar Shoulder Prosthesis is a self-retaining humeral shell that can be used with either the Bi-Angular® humeral prosthesis or the Bio-Modular® humeral prosthesis. In assembling, the liner is place over a modular inner head that is already impacted to an implanted humeral stem. The shell is then placed over the liner and the Ring-Loc lock ring snaps into the outer groove of the liner, which completes assembly of the prosthesis. The shell is available in six spherical diameters, 40 mm, 48 mm, 52 mm, 56 mm and 60 mm. The liner and Ring-Loc® locking ring are modular, i.e. there is only one size of each, and each is used with all six shell sizes.

AI/ML Overview

The provided text describes a medical device submission (K002998) for the Biomet® Bi-Polar Shoulder System. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.

The document is primarily a Notice of Substantial Equivalence from the FDA, indicating that the device is substantially equivalent to a previously marketed predicate device (Biomet® Bi-Polar Shoulder, K991585). This type of FDA clearance (510(k)) focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to establish efficacy and safety from scratch.

Therefore, I cannot provide the requested information. The text does not elaborate on:

  1. A table of acceptance criteria and the reported device performance: No such criteria or performance data are presented.
  2. Sample size used for the test set and the data provenance: No test set or corresponding data is described.
  3. Number of experts used to establish the ground truth... and their qualifications: No ground truth establishment is detailed.
  4. Adjudication method: Not applicable as no ground truth establishment is described.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
  6. Standalone (algorithm only without human-in-the-loop performance): This device is a physical shoulder prosthesis, not an algorithm, so this is not applicable.
  7. The type of ground truth used: Not applicable as no ground truth assessment is described.
  8. The sample size for the training set: Not applicable as this is a physical device, not an AI/ML algorithm requiring a training set.
  9. How the ground truth for the training set was established: Not applicable.

The document mainly focuses on:

  • Sponsor and contact information.
  • Device name and classification.
  • Intended use and device description.
  • Potential risks associated with the device (general risks for joint replacement).
  • Identification of the predicate device.
  • The FDA's official letter of substantial equivalence.
  • The Indications for Use statement.

§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”