The BioPro Bipolar Head is intended for use in combination with a BioPro femoral stem for uncemented primary or revision arthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

Femoral neck and trochanteric fractures of the proximal femur; .
Osteonecrosis of the femoral head;
Revision procedures where other devices or treatments for these indications . have failed.

Device Description

The BioPro Bipolar Head consists of a factory assembled UHMWPE liner in a cobalt chrome outer shell, and UHMWPE retention ring. These bipolar heads include outer diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the patient anatomy. The smaller bipolar heads (38 to 42 mm) have an inner diameter that mates with a 22 mm diameter femoral head; the larger bipolar heads (43 mm to 60 mm) have with a iiim ater that mates with a 28 mm diameter femoral head. The BioPro Bipolar an infor diamotor that may be a BioPro femoral stem (K882146) for arthroplasty.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the BioPro Bipolar Head, a medical device. This type of notification focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the way a new, high-risk device might.

Here's an analysis based on the provided document:

A table of acceptance criteria and the reported device performance
As a 510(k) submission, the primary "acceptance criterion" is demonstrations of substantial equivalence to predicate devices, not performance against specific clinical or technical benchmarks (beyond material properties and design specifications). The document provides a detailed comparison table (Table 1 in section 5. Predicate Device Comparison) between the BioPro Bipolar Head and predicate devices (Ortho Development Pivot Bipolar Head and PLUS Orthopedics PLUS Bipolar Prosthesis).

Feature	BioPro Bipolar Head	Ortho Development Pivot Bipolar Head	PLUS Orthopedics PLUS Bipolar Prosthesis
510(k) Number	Pending	K050966	K982447
FDA Product Code	KWY	KWY	KWY
DESIGN: Head-Liner-Shell	CoCr-UHMWPE-CoCr	CoCr-UHMWPE-CoCr	CoCr-UHMWPE-CoCr
DESIGN: Head Outer Diameter	38 to 60 mm in 1 mm increments	38 to 60 mm in 1 mm increments	43 to 60 mm in 1 mm increments
DESIGN: Self-aligning	Yes	Yes	Yes
DESIGN: Liner Inner Diameter	22.225 or 28 mm	22.225 or 28 mm	28 mm
DESIGN: Liner-Head Assembly	Head snap-fit into bipolar liner	Head snap-fit into bipolar liner	Head held in by retention ring
DESIGN: UHMWPE retention ring	Yes	Yes	Yes
MATERIALS: Outer shell	Cobalt chromium (ASTM F75)	Cobalt chromium (ASTM F75)	Cobalt chromium (ASTM F75)
MATERIALS: Liner & retention ring	UHMWPE (ASTM F648), EtO sterilized (not highly crosslinked)	UHMWPE (ASTM F648), gamma sterilized (not highly crosslinked)	UHMWPE (ASTM F648), EtO sterilized (not highly crosslinked)

Acceptance Criteria Implied: The device is considered to meet "acceptance criteria" if its design, materials, and intended use are substantially equivalent to the predicate devices. The table above shows that the BioPro Bipolar Head is largely identical in design and materials to its predicates, with minor differences (e.g., sterilization method for UHMWPE, range of outer diameters compared to one predicate), which were presumably deemed not to raise new questions of safety or effectiveness.

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a 510(k) submission, which is typically based on mechanical testing, material characterization, and comparison to predicate devices, rather than a clinical "test set" from patient data. There is no mention of a clinical study or a "test set" in the context of patient data for performance evaluation in this document. The data provenance would be laboratory testing data for material properties and design specifications, not patient data.
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)
Not applicable. As this is a 510(k) submission for a physical medical device, there is no "ground truth" establishment by experts in the context of interpreting medical images or clinical outcomes from a test set of data. The "experts" involved would be engineers and material scientists validating the device's physical properties and designers ensuring substantial equivalence.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no clinical "test set" and therefore no adjudication method described.
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
Not applicable. This device is a hip implant, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hip implant, not an algorithm. Its performance is evaluated through material testing and mechanical simulations if needed, and comparison to predicate devices.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the AI/diagnostic sense. For a device like this, "ground truth" relates to compliance with material standards (e.g., ASTM F75 for Cobalt chromium, ASTM F648 for UHMWPE) and design specifications, established through laboratory testing and engineering principles. The "truth" is that the materials meet stated specifications and the device performs its intended mechanical function in a manner equivalent to previously approved devices.
The sample size for the training set
Not applicable. This document does not describe a clinical study or an AI algorithm that would require a training set.
How the ground truth for the training set was established
Not applicable. No training set is mentioned in the document.

Summary

{0}------------------------------------------------

KOB2705 (pg1/2)

510K Summary

DEC 1 5 2008

BioPro Bipolar Head

August 25, 2008

BioPro, Inc. 17 17th Street Port Huron, MI 48060

Contact: David Mrak Director of Product Dev. (810) 982-7777

2. Device Name

Submitter:

BioPro Bipolar Head Proprietary Name: Hip prosthesis, uncemented Common Name: Hip joint femoral metal/polymer cemented or uncemented Classification Name: prosthesis Class II per 21 CFR §888.3390 Requlatory Class:

3. Intended Use

Femoral neck and trochanteric fractures of the proximal femur; .
Osteonecrosis of the femoral head; �
Revision procedures where other devices or treatments for these indications . have failed.

4. Device Description

The BioPro Bipolar Head consists of a factory assembled UHMWPE liner in a cobalt chrome outer shell, and UHMWPE retention ring. These bipolar heads include outer diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the patient anatomy. The smaller bipolar heads (38 to 42 mm) have an inner diameter that mates with a 22 mm diameter femoral head; the larger bipolar heads (43 mm to 60 mm) have with a == iiim ater that mates with a 28 mm diameter femoral head. The BioPro Bipolar an infor diamotor that may be a BioPro femoral stem (K882146) for arthroplasty.

{1}------------------------------------------------

5. Predicate Device Comparison

Substantial equivalence is claimed to the Pivot Bipolar Femoral Head (1882146) Substantial equivalorio is claimot to the PLUS Bipolar Prosthesis (K982447) distributed by Ortho Dovelopment and Smith & Nephew). The following table distributed by Tus Orthopadules (non-Shiken the BioPro Bipolar Head and these predicate devices:

	BioProBipolarHead	OrthoDevelopment PivotBipolar Head	Plus OrthopedicsPLUS BipolarProsthesis
510(k) Number	Pending	K050966	K982447
FDA Product Code	KWY	KWY	KWY
DESIGN
Head-Liner-Shell	CoCr-UHMWPE-CoCr	CoCr-UHMWPE-CoCr	CoCr-UHMWPE-CoCr
Head OuterDiameter	38 to 60 mm in1 mm increments	38 to 60 mm in1 mm increments	43 to 60 mm in1 mm increments
Self-aligning(eccentric head)	Yes	Yes	Yes
Liner Inner Diameter	22.225 or 28 mm	22.225 or 28 mm	28 mm
Liner-HeadAssembly	Head snap-fit intobipolar liner	Head snap-fit intobipolar liner	Head held in byretention ring
UHMWPE retentionring	Yes	Yes	Yes
MATERIALS
Outer shell	Cobalt chromium(ASTM F75)	Cobalt chromium(ASTM F75)	Cobalt chromium(ASTM F75)
Liner and retentionring	UHMWPE (ASTMF648), EtOsterilized (nothighly crosslinked)	UHMWPE (ASTMF648), gammasterilized (not highlycrosslinked)	UHMWPE (ASTMF648), EtOsterilized (nothighly crosslinked)

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 image of an eagle or bird-like figure with outstretched wings.

Public Health Service

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

BioPro, Inc. % Mr. David Mrak Director of Product Development 17 Seventeenth St. Port Huron, Michigan 48060

DEC 1 5 2008

Re: K082705

Trade/Device Name: BioPro Bipolar Head, Models 18130 - 18152 Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis

Regulatory Class: II Product Code: KWY Dated: August 15, 2008 Received: September 16, 2008

Dear Mr. Mrak:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed for we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 to sund in the encreation of the enactment date of the Medical Device Amendments, or to Conninered phor to May 20, 1976, Lie accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Act (Free) that to her ice, subject to the general controls provisions of the Act. The r ou may, ulciclore, thanker and act include requirements for annual registration, listing of general controls provisions of the rise, labeling, and 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 classified the world . Existing major regulations affecting your device can thay be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Court of I courts concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDF is issualles or on device complies with other requirements of the Act that TDA has made a determinations administered by other Federal agencies. You must of any I cucha statutes and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fart 807), idocimig (21 CFR Part 820); and if applicable, the electronic for the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Ms. David Mrak

This letter will allow you to begin marketing your device as described in your Section 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 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

KD827056pg1/1) 510(k) Number (if known):

Device Name: BioPro Bipolar Head

Indications for Use:

The BioPro Bipolar Head is intended for use in combination with a BioPro PSL Hip System femoral stem for uncemented primary or revision arthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

Femoral neck and trochanteric fractures of the proximal femur; .
Osteonecrosis of the femoral head;
Revision procedures where other devices or treatments for these indications have failed.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Niel R.P. Oden for

Page 1 of

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

Regulation Number and Section

§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.