(197 days)
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid l. arthritis, traumatic arthritis where one or more compartments are involved;
- correction of varus, valgus or posttraumatic deformity; 2.
- correction of revision of unsuccessful osteotomy, arthrodesis, or failure of 3. previous joint replacement procedure.
Femoral components and tibial tray components with porous coating are indicated for cemented and uncemented biological fixation application. Non-coated amiliation only cemented and uncemented blological fixation upprication.
and all polyethylene patellar components are indicated for cemented application only.
The Vanguard™ Anterior Stabilized Tibial Bearings are intended for use in the Device Description. "The Valleula "The knee joint. They offer increased anterior and posterior replacement on the articular portions of they are to be used with the Vanguard™ CR femoral stablization and the with grouter sagtas components cleared in K915132, both of which were Components citation in 10259 10 the title the new learners and withing any Biomet commercially available patella button.
This document is a 510(k) summary for the Biomet Vanguard™ Anterior Stabilized Tibial Bearings. It describes the device, its intended use, and claims substantial equivalence to legally marketed predicate devices.
Here's an analysis of the provided text in relation to your request about acceptance criteria and studies:
1. A table of acceptance criteria and the reported device performance
Based on the provided document, there are no explicit acceptance criteria or reported device performance metrics in the format of a table related to clinical outcomes. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting clinical trial results against specific performance criteria.
The document states:
- "Risk analysis has demonstrated equivalence between the modified and predicate devices."
- "No clinical testing was necessary to support the claim of substantial equivalence."
This indicates that the equivalence was demonstrated through non-clinical testing and risk analysis, not through performance metrics against pre-defined clinical acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical testing was necessary to support the claim of substantial equivalence."
Therefore, there was no clinical test set, no sample size, and no data provenance from human subjects or patient data. The evaluation was based on non-clinical testing and comparison to predicate devices.
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)
Since "No clinical testing was necessary," there was no clinical test set requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since "No clinical testing was necessary," there was no clinical test set and thus no adjudication method for establishing ground truth from clinical data.
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
The document is for a knee prosthesis, not an AI or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is a physical medical device (knee prosthesis), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a physical device like a knee prosthesis, ground truth in design and engineering typically refers to established biomechanical principles, material science properties, and comparison to existing, cleared devices. The document mentions "Risk analysis has demonstrated equivalence between the modified and predicate devices" and that the device "have the same intended use, are made of the same materials and have the same or similar design and sizing as the predicate bearings." This suggests the ground truth was based on:
- Engineering and design specifications: Conforming to established design principles for knee prostheses.
- Material properties: Verifying that the materials meet established standards and are equivalent to those used in predicate devices.
- Biomechanical testing: Although not detailed, "non-clinical testing" would typically include mechanical and fatigue testing to ensure the device performs as expected under simulated physiological conditions. This implicitly relies on an 'engineered' ground truth derived from industry standards and previous device performance.
- Predicate device characteristics: The fundamental premise of a 510(k) is demonstrating substantial equivalence to a device already on the market, meaning the predicate device's safety and effectiveness implicitly serve as a form of "ground truth" for comparison.
8. The sample size for the training set
This is not an AI/ML device, so there is no concept of a "training set" in the context of machine learning. The design and manufacturing of the device would follow established engineering and quality control processes.
9. How the ground truth for the training set was established
As there is no training set for an AI/ML model, this question is not applicable. The design and validation of the device rely on engineering principles, material science, and comparison to predicate devices, not on data-driven "ground truth" for a training set in the AI sense.
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K 05 0222
AUG 1 6 2005
BIOMET
510(k) Summary
| Applicant/Sponsor: | Biomet Manufacturing Corp.56 East Bell DriveWarsaw, IN 46582FDA Registration # 1825034 |
|---|---|
| Contact Person: | Gary BakerBiomet Manufacturing Corp.P.O. Box 587Warsaw, IN 46581-0587Telephone: (574) 267-6639 Ext. 1568Fax: (574) 372-1683 |
| Proprietary Name: | Vanguard™ Anterior Stabilized Tibial Bearings. |
| Common Name: | Knee Prosthesis |
| Classification Name: | Knee joint, patellofemorotibial, polymer/metal/polymer semi-constrainedcemented prosthesis (§888.3560).Knee joint, patellofemorotibial, metal/polymer porous coated uncementedprosthesis (§888.3565). |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Maxim Accel (Vanguard™) CR – Lipped Tibial Bearings – K023546
The Vanguard™ Anterior Stabilized Tibial Bearings are intended for use in the Device Description: Device Description. "The Valleula "The knee joint. They offer increased anterior and posterior replacement on the articular portions of they are to be used with the Vanguard™ CR femoral stablization and the with grouter sagtas components cleared in K915132, both of which were Components citation in 10259 10 the title the new learners and withing any Biomet commercially available patella button.
Intended Use:
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid l. arthritis, traumatic arthritis where one or more compartments are involved;
- correction of varus, valgus or posttraumatic deformity; 2.
- correction of revision of unsuccessful osteotomy, arthrodesis, or failure of 3. previous joint replacement procedure.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
.
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
행
I·AX 574.267.8137
E-MAIL biomet@biomet.com
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KOS0222
p.2/2
Femoral components and tibial tray components with porous coating are indicated for Femoral components and trail tray components with percused (Interlok") devices
cemented and uncemented biological fixation application. Non-coated amiliation only cemented and uncemented blological fixation upprication.
and all polyethylene patellar components are indicated for cemented application only.
Summary of Technologies: The Vanguard™ Anterior Stabilized Tibial Bearings have the same intended Summary of Technologies: The Vanguard™ Anterior Stablined Trical Pour Maring on
use, are made of the same materials and have the same or similar design and sizing as the pre bearings.
Risk analysis has demonstrated equivalence between the modified and predicate Non-Clinical Testing: devices.
No clinical testing was necessary to support the claim of substantial equivalence. Clinical Testing:
All trademarks are property of Biomet, Inc.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around it. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2005
Mr. Gary Baker Regulatory Specialist Biomet Manufacturing Corp. . . . . P.O. Box 587 Warsaw, Indiana 46581-0578
Re: K050222
KV50222 Regulation Number: 21 CFR 888.3560, 21 CFR 888.3565 Regulation Name: Zr CFR 00000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 cemented prosthesis, Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II
Product Code: JWH, MBH Dated: July 22, 2005 Received: July 26, 2005
Dear Mr. Baker:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated to regars attent date of the Medical Device Amendments, or to commerce prior to May 20, 1978, in easonance with the provisions of the Federal Food, Drug, devices mat have been recure approval of a premarket approval application (PMA). and Costicule rece (110) that the device, subject to the general controls provisions of the Act. The r ou may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of the simment of the prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is olassified (600 a00 royals. Existing major regulations affecting your device can may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may ou found in the Overning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that i Dr. Bratian that your device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must of any I catal statutes and equirements, including, but not limited to: registration and listing (21 comply with an the Her Frequirements, and manufacturing practice requirements as set CI K Part 607); adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality by ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Mr. Gary Baker
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manxeing of substantial equivalence of your device to a legally premarket notification: The PDF intembers of the more 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), please If you uesn't specific advice for your acon 2011 276-0120. Also, please note the regulation entitled, Colliact the Office of Complance an (21 notification" (21CFR Part 807.97). You may obtain Misblanding of reference to premains on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octiser http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Smectry, Joan,
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Indications For Use
510(k) Number (IF KNOWN)__K050222
Device Name: Vanguard™ Anterior Stabilized Tibial Bearings
Indications For Use:
-
- Painful and disabled knee joint resulting from osteoarthritis, theumatoid arthritis, traumatic r annut and Gioone or more compartments are involved;
- arthritis where arus, valgus or posttraumatic deformity; 2.
... ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- correction of varias, vargus of postfaultatio decommy, arthrodesis, or failure of previous joint 3. replacement procedure.
Femoral components and tibial tray components with porous coating are indicated for cemented and Femoral components and thial tray components with porcus couldness and all polyethylene patellar ancements are indicated for cemented application only.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)
and/or
Over-The-Counter Use_ (Per 21 CFR 807 Subpart C)
ﺘﺴﺘﺨﻴﺘﺮ ﺑﺘﻘ
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | K050222 |
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.