CONFIDENCE High Viscosity Spinal Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (haemangioma), or malignant lesions (metastatic cancers, myeloma).

Device Description

CONFIDENCE High Viscosity Spinal Cement is self-curing, radiopaque, polymethyl methacrylate (PMMA) cement, for filling of spinal vertebral body defects, in order to provide stabilisation of the vertebral body and pain relief.

AI/ML Overview

The provided text describes a 510(k) summary for the CONFIDENCE High Viscosity Spinal Cement, which is a PMMA bone cement. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

However, the document focuses on regulatory approval and substantial equivalence based on comparable performance characteristics rather than detailing a specific study with defined acceptance criteria and device performance metrics in the way your request specifies. The text states:

"Chemical composition of the Medos International SARL CONFIDENCE High Viscosity Spinal Cement is similar to subject devices, and testing has confirmed the devices to have comparable performance characteristics."

And later:

"Based on the similarities in indications, intended use, design, materials, method of manufacture and the results of performance testing, Medos International SARL believes that the subject device CONFIDENCE High Viscosity Spinal Cement is substantially equivalent to the previously cleared devices."

This indicates that performance testing was conducted, but the details of that testing, including specific acceptance criteria, reported performance, sample sizes, ground truth establishment, or multi-reader studies, are not provided in this document. This 510(k) summary is a high-level overview for regulatory purposes, not a detailed study report.

Therefore, I cannot populate the table or answer most of your detailed questions directly from the provided text.

Here's how I would answer based on what is available (and clarifying what is not available):

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Not explicitly stated for specific metrics in this document)	Reported Device Performance (Not explicitly stated as specific metrics in this document)
Implicit Acceptance Criteria:	Implicit Reported Performance:
- Device has comparable chemical composition to predicate devices.	- Chemical composition is similar to predicate devices.
- Device exhibits comparable performance characteristics to predicate devices.	- Testing confirmed comparable performance characteristics to predicate devices.
- Device meets the safety and effectiveness profile of legally marketed predicate devices.	- The FDA determined the device to be substantially equivalent to legally marketed predicate devices.

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 specified in this document.
Data provenance: Not specified in this document.

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)

Not specified. The "performance testing" mentioned likely refers to bench or non-clinical testing rather than expert-adjudicated clinical data for this 510(k) submission, given the nature of the device (bone cement) and the focus on substantial equivalence to existing devices.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/not specified. The document does not describe a clinical study with an adjudication process.

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. This is a bone cement, not an AI diagnostic device. Therefore, an MRMC study with AI assistance is not relevant or mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This is a bone cement, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Given the device type (bone cement) and the context of a 510(k) for substantial equivalence, the "ground truth" for performance would likely be established through bench testing against recognized standards or direct comparison to predicate device performance metrics (e.g., mechanical properties like compression strength, setting time, radiopacity, wear resistance, etc. - though these specific metrics are not detailed here). There is no mention of pathology or clinical outcomes data being used as "ground truth" for this specific submission's comparative performance testing.

8. The sample size for the training set

Not applicable/not specified. This is a physical medical device (bone cement), not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable/not specified. This is a physical medical device, not an AI algorithm.

Summary

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i12907

510(k) Summary

DEC 2 2 2011

Date Summary Prepared:	30 September 2011
------------------------	-------------------

510(k) Sponsor: Medos International SARL Chemin-Blanc 38 Le Locle CH 2400 Switzerland

Establishment Registration number: 3008114965

Contact Person:

Robin DiNardo Director, Regulatory Affairs DePuy Spine, Inc. 325 Paramount Drive Raynham MA 02767-0350 USA

Telephone: +1 508 828 3218 Fax: +1 508 828 3797 Email: rdinardo@its.jnj.com

Device Manufacturer: Medos International SARL Chemin-Blanc 38 Le Locle CH 2400 Switzerland

Trade Name of Device: CONFIDENCE High Viscosity Spinal Cement

Part Numbers: 183907001 (16 g Unit Size)

183901001 (20 g Unit Size)

Product Code: NDN

Cement, bone, vertebroplasty

Common Name: PMMA Bone Cement

Classification Name:

Equivalent to:

Disc-O-Tech Confidence High Viscosity Spinal Cement (K060300) DePuy Spine Vertebroplastic™ Radiopaque Bone Cement (K071927)

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Device Description:

Indications for Use:

Contra-indications for Use:

The use of CONFIDENCE High Viscosity Spinal Cement is contraindicated in patients presenting with any of the following conditions:

Non-pathological, acute, traumatic fractures of the vertebra. .
. Patient clearly improving on medical therapy.
Prophylaxis in metastatic or osteoporotic patients with no evidence of acute fracture .
Spinal stenosis (> 20% by retropulsed fragments). .
. Compromise of the vertebral body or walls of the pedicles.
. Compromise or instability of vertebral fractures due to posterior involvement.
. Haemorrhagic diathesis.
. Anatomical damage of the vertebra that prevents a safe access of the needle to the vertebral body.
. Vertebral body collapse to less than 1/3 (33%) original height.
Vertebral plana (collapse >90%). .
Active or incompletely treated infection. .
Coagulopathy or inability to reverse anti-coagulant therapy (both during and . approximately 24 hours post-procedure).
. Severe pulmonary insufficiency.
. Sensitivity to any of the components of the CONFIDENCE High Viscosity Spinal Cement.

Basis for Substantial Equivalence:

The Medos International SARL CONFIDENCE High Viscosity Spinal Cement has identical intended use and indications for use to the predicate devices Disc-O-Tech Confidence High Viscosity Spinal Cement (K060300) and DePuy Spine Inc Vertebroplastic " Radiopaque Bone Cement (K071927).

The packaging of the subject device is equivalent to the predicate device Disc-O-Tech Confidence High Viscosity Spinal Cement (K060300), and the manufacturing and sterilization methods are the same as both predicate devices. Chemical composition of the Medos International SARL CONFIDENCE High Viscosity Spinal Cement is similar to

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subject devices, and testing has confirmed the devices to have comparable performance characteristics.

Based on the similarities in indications, intended use, design, materials, method of manufacture and the results of performance testing, Medos International SARL believes that the subject device CONFIDENCE High Viscosity Spinal Cement is substantially equivalent to the previously cleared devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC 2 2 2011

Medos International SARL % DePuy Spine, Inc. Ms. Robin DiNardo 325 Paramount Drive Raynham, Massachusetts 02767

Re: K112907

Trade/Device Name: CONFIDENCE High Viscosity Spinal Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: September 30, 2011 Received: October 03, 2011

Dear Ms. DiNardo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Robin DiNardo

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. McMullen

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

Enclosure

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Indications for Use

Device Name:

CONFIDENCE High Viscosity Spinal Cement

Indications for Use:

Prescription Use YES (Part 21 CFR 801 Subpart D)

Over-The-Counter Use NO AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Offige of Device Evaluation (ODE)

signature

(DKIslon Sigilia :1) (Division Sign=on Surgical, Orthopedic, and Restorative Devices

510(k) Number K112907

Page 1 of 1

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.”