(103 days)
Biomet's Bipolar Shoulder Prosthesis is indicated for use in most cases where a conventional shoulder hemi-arthroplasty would be indicated. Typical indications include osteoarthritis, avascular necrosis, traumatic arthritis, rheumatoid arthritis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, fracture, and cuff tear arthropathy.
This device is a single use implant intended for cemented application only. It is intended for use with Biomet's humeral components previously cleared by the FDA for cemented application.
The Bipolar Shoulder Prosthesis is a self retaining humeral component. The outer surface of the shell is highly polished. The inner polyethylene liner is preassembled with the outer metal shell. A polyethylene retaining ring is inserted into the shell of the shell.
The shell is available in four outer diameters, 40mm through 52mm. The modular head components are available in various neck lengths to correct laxity in the joint. Two types of modular heads are available to correspond with the geometry of the humeral stems.
The device is designed to articulate with the natural glenoid surface eliminating the need for a separate glenoid component similar to a hemi-arthroplasty. Potentially a greater range of motion can be obtained with this device because of its bi-rotational nature.
The provided document primarily focuses on the FDA's 510(k) clearance for the Biomet Bipolar Shoulder Prosthesis based on substantial equivalence. It does not contain an "acceptance criteria" table or a detailed study proving the device meets those criteria in the way one would typically find for a new device's performance evaluation.
The FDA's 510(k) pathway for medical devices relies on demonstrating "substantial equivalence" to a predicate device, rather than requiring extensive clinical trials to establish new acceptance criteria and prove performance against them.
Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, ground truth establishment, and MRMC studies are not present in this type of regulatory submission.
Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document in the format of a table with quantitative criteria the device needs to meet (e.g., specific range of motion, reduction in pain score by X percent).
- Reported Device Performance: Not presented as quantitative performance metrics from a study designed to meet specific acceptance criteria. The document states the device's "intended use" and describes the biomechanical design (e.g., bi-rotational nature for potentially greater range of motion), but these are not "reported device performance" in the context of meeting defined acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable/not provided. This document is a 510(k) clearance based on substantial equivalence to predicate devices, not a clinical study with a test set.
- Data Provenance: Not applicable/not provided. There isn't data from a study of the Biomet Bipolar Shoulder Prosthesis presented here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts & Qualifications: Not applicable/not provided. There is no mention of a test set with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/not provided.
5. 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
- MRMC Study: Not applicable/not provided. This device is a physical shoulder prosthesis, not an AI-assisted diagnostic or treatment planning tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable/not provided. This device is an implantable prosthesis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable/not provided.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/not provided. This is a medical device, not a machine learning algorithm requiring a training set in the conventional sense. The "training" for such a device would be based on engineering principles, material science, and prior clinical experience with similar devices, not a digital dataset.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable/not provided.
Summary of Information from the Document that Pertains to "Proof":
The "proof" for this device's safety and effectiveness, as per this 510(k) document, relies entirely on demonstrating substantial equivalence to existing, legally marketed predicate devices.
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Predicate Devices:
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Basis of Equivalence: The document states, "In function and overall design the Bipolar Shoulder Prosthesis is equivalent to other commercially available shoulder hemi-arthroplasties." This implies that the device's design, materials, and intended use are similar enough to existing successful devices that it can be presumed to be safe and effective without new, extensive clinical trials proving performance against specific acceptance criteria.
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Potential Risks: The document lists potential risks associated with the device, which are similar to those for other shoulder hemi-arthroplasties (e.g., reaction to bone cement, fracture, loosening/migration, infection, metal sensitivity). This acknowledges common risks for the type of device without providing performance data on their frequency for this specific device.
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SUMMARY OF SAFETY AND EFFECTIVENESS
Biomet, Inc. Sponsor: Airport Industrial Park Warsaw, Indiana 46580
Biomet Device:
Classification Name: Shoulder joint humeral (hemi-shouldcr) metallic prosthesis
Intended Use: Biomet's Bipolar Shoulder Prosthesis is indicated for use in Intended Use: Biomet's Bipolar Shoulder hemi-arthroplasty would be indicated. Typical
most cases where a conventional shoulder hemisatio would be indicated. Typical most cases where a conventional shoulder necrosis, traumatic arthritis, rheumatoid
indications include osteoarthritis, avascular necession procedures where other indications include osteoaring is, as ascular necross, was in the other other
arthritis, correction of severe functional deformity, revision procedures where other arthritis, correction of severe failerial Doctor of 2000 - 37.
treatments or devices have failed, fracture, and cuff tear arthropathy.
This device is a single use implant intended for cemented application only. It is intended This device is a single use implant intended for cements appear.
for use with Biomet's humeral components previously cleared by the FDA for cemented application.
Device Description: The Bipolar Shoulder Prosthesis is a self retaining humeral
The Bipolar Should Chicking Calish Houselished The inner polyethylene line Device Description: The Bipolar Should's highly polished. The iner polyethylene liner is inserted in shell. The outer surface of the siten is inginy pontativlene retaining ring is inserted into preassembled with the outer melaine shell. "A polyenty.one reading of the shell of the shell a
The shell is available in four outer diameters, 40mm through 52mm. The indular head The shell is available in four outer thancess, the market laxity in the joint. Two types
components are available in various neck lengths to correct laxity in the humeral st components are available in various neck lengths to concern of the humeral stems.
of modular heads are available to correspond with the geometry of the humeral stems.
The device is designed to articulate with the natural glenoid surface eliminating the need The device is designed to articulate with the gettroplasty. Potentially a greater
for a separate glenoid component similar to a hemi-arthroplasty. In the for a separate gienoid component shimar to a nem-artis pro-s
range of motion can be obtained with this device because of its bi-rotational nature.
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Potential Risks: The potential risks associated with this device are the same Potential NISKS. The potomial nene . These include, but are not limited to:
Reaction to bone cement Fracture of the components Cardiovascular disorders Implant loosening/migration Soft tissue imbalance Deformity of the joint Delayed wound healing Fracture of the cement Breakdown of porous surface
- Bone fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Metal sensitivity Dislocation
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Substantial Equivalence: In function and overall design the Bipolar Shoulder Substantial Equivalent to other commercially available shoulder hemi-arthroplasties I rosthosis is equivarket. These devices include:
New Jersey Hemi Shoulder (DePuy, 510(k) K800494) New Jersey Trend Bhoulder (Howmedica, 510(k) K802123) Monospherroal Bitichards, pre-amendment) Shoulder Prosthesis (Zimmer, pre-amendment) Dhoulder Probahoulder System (3M, pre-amendment)
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring a human figure with outstretched arms, representing care and protection. The figure is composed of three curved lines, giving it a flowing and dynamic appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 1999
Mr. Fred McClure Regulatory Specialist Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581-0587
K991585 Re:
Trade Name: Bipolar Shoulder Prothesis Regulatory Class: III Product Code: KWT, MJT Dated: May 5, 1999 Received: May 7, 1999
Dear Mr. McClure:
We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Fred McClure
This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will allow you to begin marketing your device to a legaly marketed
notification. The FDA finding of substantial equivalence of your device to notification. The FDA finding of substantial equivalence of your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice tor your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the Office of additionally 809.10 for in rifte diagnostic devices, presso common and vertising of your device, (301) 594-4659. Additionally, for questions on un promotion iso, please note the regulation
please contact the Office of Compliance at (301) 594-4639. Also, please note the please contact the Office of Compliance at (301) 394-4037. The Stop 20197). Other general
entitled, "Misbranding by reference to premarket notification the Division of Small entitled, "Misbranding by reference to premarks from the Division of Small
information on your responsibilities under the Act may be obtained from the Division of Small information on your responsibilities under (80) 638-2041 or (301) 443-6597 or at its
Manufacturers Assistance at its toll-free number (80) 638-2041 or (301) 443-6597 or at it Manufacturers Assistance at to to to to to to to to to smamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
ﮯ
Enclosure
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510 (k) Number (if known) :
Device Name: Bipolar Shoulder Prosthesis
Indications For Use: Biomet's Bipolar Shoulder Prosthesis is indicated for use in most cases where a conventional shoulder arthris shewastid athinated. Typical indications include osteoarthritis, arascular necrosis, traumatic arthritis, rheumatoid arthritis, correction of severe functional deformity, evision the courted and artists, invaniatord arminis, correction of screen unchonal deformity, migropathy,
This device is a single use implant intended for cemented application only. It is intended for use with Biomet's humeral components previously cleared by the FDA for cemented application.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use
(Per 21 CFR 801.109)
.
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Division of General Restorative Devices
510(k) Number K99158
§ 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.”