(50 days)
This humeral stem will be used as part of a total shoulder system intended for treatment of patients who are candidates for total shoulder arthroplasty because the natural humeral head and/or glenoid has been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis. rheumatoid arthritis, avascular necrosis or proximal humeral fracture, and revision arthroplasty where bone loss is minimal. The humeral stem may be used with or without bone cement. These devices are intended to aid the surgeon in relieving the patient of shoulder pain and restoring shoulder motion.
The humeral stem is manufactured from wrought/forged titanium alloy(Ti-6A1-4V) that conforms to ASTM F136. The entire stem has heavy grit blasting to a surface roughness that ranges from 4um to 6Um.
The proximal body is rectangular in cross-sectional geometry and tapers proximal to distal. The distal stem is cylindrical with four flutes. Anterior, posterior and lateral fins are located on the proximal body to help provide rotational stability. The fins have suture holes to allow reattachment of soft tissue and bone fragments in the case of proximal humeral fracture. A suture hole is also placed medially through the proximal body just below the collar.
A collar is present on the anterior, posterior and medial faces of the proximal body to resist stem subsidence. A 135° neck stem angle is incorporated. The stem has a female Morse type taper to receive modular humeral heads.
This is a premarket notification (510(k)) summary for a medical device, the Grit Blasted Humeral Stem, and not a study describing acceptance criteria and device performance. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the provided text.
Here's what can be extracted based on the provided document:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria or specific device performance data. It is a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting new performance study results against predefined 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)
This information is not provided in the 510(k) summary. A 510(k) typically relies on existing data from the predicate device and in-vitro testing/design analysis rather than a human clinical test set.
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)
This information is not provided because a clinical test set with ground truth established by experts is not described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided as a clinical test set and adjudication method are not discussed.
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
No such study is mentioned or implied in this document. This device is a shoulder prosthesis, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable, as there is no mention of a study requiring ground truth in this context.
8. The sample size for the training set
This information is not provided. A training set is not relevant for this type of device submission.
9. How the ground truth for the training set was established
This information is not provided, as there is no training set described.
Summary of Safety and Effectiveness from the document:
The provided document is a "Summary of Safety and Effectiveness" for the Grit Blasted Humeral Stem, a shoulder prosthesis. The core of this submission is to demonstrate substantial equivalence to a previously marketed predicate device, the humeral stem included in the Total Shoulder System (Encore).
The device aims to aid surgeons in relieving shoulder pain and restoring shoulder motion for patients undergoing total shoulder arthroplasty due to various conditions like osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or proximal humeral fracture.
The summary describes the physical characteristics of the humeral stem, including its material (wrought/forged titanium alloy, Ti-6A1-4V conforming to ASTM F136), surface finish (heavy grit blasting for roughness), and design features (proximal body shape, distal stem, fins for rotational stability, suture holes, collar, 135° neck stem angle, and female Morse type taper for modular heads).
The FDA's letter states that they have reviewed the 510(k) notification and determined the device to be substantially equivalent to legally marketed predicate devices. This determination allows the sponsor to market the device, subject to general controls provisions of the Act (annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration).
In essence, the "study" proving the device meets "acceptance criteria" here is the 510(k) submission process itself, which concludes with the FDA's determination of substantial equivalence to a predicate device. The acceptance criterion is "substantial equivalence," and the proof is the information provided in the 510(k) dossier (which is summarized here but not detailed). Specific performance data against quantitative acceptance criteria for this new device is typically not required for a 510(k) if substantial equivalence can be shown through other means (e.g., similar materials, design, indications for use).
{0}------------------------------------------------
JUN 2 9 1999
Summary of Safety and Effectiveness
Encore Orthopedics®, Inc. Debbie De Los Santos 9800 Metric Blvd. Austin, TX 78758 (512) 834-6237
Common Name: Shoulder prosthesis
Classification Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3660 and Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis per 21 CFR 888.369
Description: The humeral stem is manufactured from wrought/forged titanium alloy(Ti-6A1-4V) that conforms to ASTM F136. The entire stem has heavy grit blasting to a surface roughness that ranges from 4um to 6Um.
The proximal body is rectangular in cross-sectional geometry and tapers proximal to distal. The distal stem is cylindrical with four flutes. Anterior, posterior and lateral fins are located on the proximal body to help provide rotational stability. The fins have suture holes to allow reattachment of soft tissue and bone fragments in the case of proximal humeral fracture. A suture hole is also placed medially through the proximal body just below the collar.
A collar is present on the anterior, posterior and medial faces of the proximal body to resist stem subsidence. A 135° neck stem angle is incorporated. The stem has a female Morse type taper to receive modular humeral heads.
Intended Use: This humeral stem will be used as part of a total shoulder system intended for treatment of patients who are candidates for total shoulder arthroplasty because the natural humeral head and/or glenoid has been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis. rheumatoid arthritis, avascular necrosis or proximal humeral fracture, and revision arthroplasty where bone loss is minimal. The humeral stem may be used with or without bone cement. These devices are intended to aid the surgeon in relieving the patient of shoulder pain and restoring shoulder motion.
Comparable Features to Predicate Device(s):
This device has the same design and indications as the humeral stem included in the Total Shoulder System (Encore).
{1}------------------------------------------------
Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three horizontal lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 1999
Ms. Debbie De Los Santos Encore Orthopedics Regulatory/Clinical Specialist 9800 Metric Blvd. Austin, Texas 78758
Re: K991603 Trade Name: Grit Blasted Humeral Stem Regulatory Class: III Product Code: KWT Dated: May 7, 1999 Received: May 10, 1999
Dear Ms. De Los Santos:
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 controls provisions of the Act. The general controls 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.
{2}------------------------------------------------
Page 2 - Ms. Debbie De Los Santos
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
510(k) Number (if known):
Device Name: Grit Blasted Humeral Stem
Indications For Use:
Grit Blasted Humeral Stem Indications For Use
This humeral stem will be used as part of a total shoulder system intended for treatment of patients who are candidates for total shoulder arthroplasty because the natural head and/or glenoid has been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or proximal humeral fracture, and revision arthroplasty where bone loss is minimal. The humeral stem may be used with or without bone cement. These devices are intended to aid the surgeon in relieving the patient of shoulder pain and restoring shoulder motion.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __ OROver-The-Counter Use _______________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) (Optional Format 1-2-96)_
(Division Sign-Off)
Division General Restorative Devices K991623
510(k) Number
§ 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.”