CEMVAC Ultra pre-packed with DePuy 1 Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.

Device Description

CEMVAC Ultra pre-packed with DePuy 1 Bone Cement is a in-syringe vacuum mixing system prepacked with bone cement powder. The subject device is for single use and helps control monomer fumes during the preparation of the cement. The subject device pre-packed with DePuy 1 Bone Cement is available in a single 60g or 100g unit and also in unit packs of 5. Each single unit (device) pack consists of 1) syringe barrel filled with bone cement powder; 2) central mixing rod; 3) locking plate; 4) filter/vacuum hose; 5) vacuum pump adapter; 6) monomer cartridge with glass ampoules containing bone cement liquid; and 7) plastic disposal bag.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a bone cement dispenser, the CEMVAC Ultra pre-packed with DePuy 1 Bone Cement. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a comprehensive study report with specific performance metrics against those criteria.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device conformance cannot be fully addressed from the provided text.

Here's an analysis based on the available information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a tabular format. Instead, it relies on demonstrating comparable performance to predicate devices. The implicit acceptance criterion is that the new device performs at least as well as, or equivalently to, the predicate devices in terms of key mechanical properties of the bone cement.

Acceptance Criteria (Implicit)	Reported Device Performance
Compatibility and Stability of DePuy 1 Bone Cement powder with CEMVAC Ultra device	"DePuy 1 Bone Cement powder has been found to be compatible and stable in the CEMVAC Ultra device."
Compressive Strength of mixed cement (compared to predicate/traditional mixing)	"Comparable DePuy 1 Bone Cement compressive... strengths were obtained for bowl and spatula and CEMVAC Ultra mixed cements." (Implies the strength is not significantly worse than the existing, approved mixing method or predicate devices).
Flexural Strength of mixed cement (compared to predicate/traditional mixing)	"Comparable DePuy 1 Bone Cement... flexural and impact strengths were obtained for bowl and spatula and CEMVAC Ultra mixed cements." (Implies the strength is not significantly worse than the existing, approved mixing method or predicate devices).
Impact Strength of mixed cement (compared to predicate/traditional mixing)	"Comparable DePuy 1 Bone Cement... flexural and impact strengths were obtained for bowl and spatula and CEMVAC Ultra mixed cements." (Implies the strength is not significantly worse than the existing, approved mixing method or predicate devices).
Monomer Fume Control	The device "helps control monomer fumes during the preparation of the cement." (This is a functional benefit described, but no specific quantitative acceptance criteria or performance metrics related to fume reduction are provided in this summary.)

Study Information

The document describes testing focused on the mechanical properties of the bone cement when prepared using the CEMVAC Ultra system compared to traditional methods ("bowl and spatula") and, implicitly, to predicate devices. This testing is used to support the claim of substantial equivalence.

Sample sizes used for the test set and the data provenance:
- Sample Size: The document does not specify the sample sizes (number of tests, number of cement batches, or number of devices) used for the compatibility, stability, compressive, flexural, or impact strength testing.
- Data Provenance: The testing was conducted internally by DePuy Orthopaedics, Inc. and DePuy International Ltd, as they are the manufacturers/sponsors. The country of origin for the data is not explicitly stated beyond the manufacturing locations (Indiana, USA, and Blackpool, England). The nature of the testing (e.g., lab bench testing of material properties) implies it is conducted in a prospective manner to evaluate the new device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this device. The "ground truth" for mechanical property testing of bone cement is established through standardized material testing procedures (e.g., ISO standards for bone cements), not through expert consensus or interpretation of images. The results of these tests are objective measurements.
Adjudication method for the test set:
- This question is not applicable. Since the "ground truth" is based on objective material testing measurements rather than expert interpretations, an adjudication method for reconciling expert opinions is not relevant.
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:
- This is not applicable. An MRMC study is relevant for diagnostic imaging devices involving human interpretation (readers) and clinical cases. This device is a bone cement mixing and dispensing system, not an imaging or AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This device is a physical medical device, not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance evaluation lies in standardized material science testing and physical characterization of the bone cement properties (compressive, flexural, impact strengths, and stability/compatibility) as defined by relevant industry standards (e.g., ASTM, ISO standards for bone cements, though not explicitly cited in the summary).
The sample size for the training set:
- This is not applicable. There is no "training set" in the context of this device, as it is not an AI/ML device that requires machine learning training data.
How the ground truth for the training set was established:
- This is not applicable for the same reason as point 7.

Summary

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JUL 2 4 2002

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

510(K) SPONSOR:	DePuy Orthopaedics, Inc.700 Orthopaedic DriveP.O. Box 988Warsaw, Indiana 46581-0988
MANUFACTURER:	DePuy International LtdTrading as DePuy CMWCornford RoadBlackpool, LancashireFY 4 4QQ, England
510(K) CONTACT:	Janet Johnson, RACDePuy Orthopaedics, Inc.Group Leader, Regulatory Submissions(574) 371-4907; FAX (574) 371-4987E-mail: jjohnso7@dpyus.jnj.com
TRADE NAME:	CEMVAC Ultra Pre-packed with DePuy 1 Bone Cement
COMMON NAME:	Pre-packed Bone Cement Dispenser
CLASSIFICATION:	Cement Dispenser, Class I Exempt per 21 CFR 888.4200PMMA Bone Cement: Class II per 21 CFR 888.3027
DEVICE CODE:	KIH pre-packed with LOD
EQUIVALENT DEVICES:	DePuy 1 Bone Cement - P960001/Supplement 3Cemex System Gun Application Version - K000943Howmedica Surgical Simplex P Radiopaque Bone Cement Pre-Packed in ACM and Mix Evac II - K002652

DEVICE DESCRIPTION AND INTENDED USE:

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02 1499
page 2 of 2

BASIS OF SUBSTANTIAL EQUIVALENCE:

With the exception of the primary packaging of the powder component of the DePuy 1 Bone Cement in the CEMVAC Ultra device, the DePuy 1 Bone Cement is identical in materials (formulation), and indications for use as the currently marketed DePuy 1 Bone Cement. On testing, DePuy 1 Bone Cement powder has been found to be compatible and stable in the CEMVAC Ultra device. Comparable DePuy 1 Bone Cement compressive, flexural and impact strengths were obtained for bowl and spatula and CEMVAC Ultra mixed cements.

CEMVAC Ultra pre-packed with DePuy 1 Bone Cement has similar indications for use as other bone cements currently marketed in the United States. These predicate devices include:

1. Cemex System Gun Application Version marketed by Tecres,
1. Howmedica Surgical Simplex P Radiopaque Cement Pre-Packed in ACM or Mix Evac II marketed by Stryker Corporation.

All three pre-filled mixing systems are pre-packed with bone cement and are intended to be used for the fixation of artificial joints prostheses to host bone.

Based on similarities of design, materials, intended use, and testing, DePuy believes that the CEMVAC Ultra pre-packed with DePuy 1 Bone Cement is substantially equivalent to the Cemex System Gun Application Version by Tecres, Howmedica Surgical Simplex P Radiopaque Cement Pre-Packed in ACM or Mix Evac II marketed by Stryker Corporation.

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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 2002

Ms. Janet G. Johnson, RAC DePuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 4681-0988

Re: K021499

Trade Name: CEMVAC Ultra Pre-packed with DePuy 1 Bone Cement Regulation Number: 21 CRF 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: LOD Dated: May 8, 2002 Received: May 9, 2002

Dear Ms Johnson:

We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Janet G. Johnson

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 and additionally 21 CFR Part 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" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Mark N Millner

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use:

510(k) Number (if known):	" " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "

Device Name: CEMVAC Ultra Pre-packed with DePuy 1 Bone Cement

Indications for Use:

CEMVAC Ultra pre-packed with DePuy 1 Bone Cement is indicated for the fixation of prostheses to Uning bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.

Concurrence of CDRH, Office of Device Evaluation

Mark N. Millenn

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

510(k) Number.

Prescription Use X_OR

Over-The-Counter U

Over-The-Counter Use ___________ (Per 21 CFR 801.109)

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”