The SPACE 360 Delivery System is intended for percutaneous delivery of SPACE CpsXL Bone Cement in vertebroplasty or kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Device Description

The SPACE 360 Delivery System consists of a reusable controller and disposable, single-use components, including a delivery cannula and stylet, a hydraulic assembly and bone cement syringe, and control cables.

AI/ML Overview

This document is a 510(k) Premarket Notification summary for the SPACE 360 Delivery System, a device for delivering bone cement in vertebroplasty and kyphoplasty procedures.

Based on the provided text, a detailed breakdown of acceptance criteria and a study proving the device meets them cannot be fully generated as the information is not present in this document. This document pertains to regulatory approval and focuses on substantial equivalence to predicate devices rather than a detailed performance study with specific acceptance criteria.

Here's what can be extracted and what is missing:

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

Acceptance Criteria	Reported Device Performance
Not specified	"...meets its performance requirements to support its use as a bone cement delivery system." (Specific criteria and reported numerical performance are not provided.)
Not specified	"...demonstrates that the SPACE 360 Delivery System meets its performance requirements..." (Specific criteria and numerical performance are not provided.)

Explanation: The document states that the device "meets its performance requirements," but it does not list those performance requirements as specific acceptance criteria (e.g., flow rate must be X, burst pressure must be Y) nor does it provide the numerical results from the tests against such criteria.

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: Not specified. The document mentions "Mechanical performance and safety testing" but does not detail the number of units tested.
Data Provenance: Not specified.
Retrospective or Prospective: Not specified.

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 Applicable / Not Specified. This device is a bone cement delivery system, not an AI diagnostic or clinical decision support tool that would require expert-established ground truth for performance evaluation in the way a diagnostic algorithm does. The testing likely focused on mechanical and safety aspects.

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

Not Applicable / Not Specified. As above, this is not relevant for a mechanical device's performance testing described here.

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 mechanical bone cement delivery system, not an AI or computational imaging device that would typically undergo an MRMC study.

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

Not Applicable. This is a physical device, not an algorithm.

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

Not Applicable / Not Specified. For mechanical testing, the "ground truth" would be engineering specifications and standards, not clinical ground truth in the diagnostic sense.

8. The sample size for the training set:

Not Applicable. This is a physical device, not an AI model. Therefore, there is no "training set."

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

Not Applicable. No training set exists for this type of device.

Study Summarized in the Document:

The document refers to a study as:

"Mechanical performance and safety testing demonstrates that the SPACE 360 Delivery System meets its performance requirements to support its use as a bone cement delivery system."

This statement confirms that testing was performed to substantiate the device's claims for its intended use, focusing on its mechanical function and safety. However, the details of these tests (e.g., specific parameters measured, test methods, sample sizes, numerical results, and the acceptance thresholds) are not detailed in this 510(k) summary. The purpose of this summary is to demonstrate "substantial equivalence" to predicate devices, not to provide a full scientific report of all validation testing.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Dfine, followed by the address 19450 Stevens Creek Blvd., Suite 100. The next line shows the city, state, and zip code, which is Cupertino, California 95014. The logo is a stylized D with the word "fine" next to it.

Premarket Notification [510(K)] Summary (per 21 CFR 807.92)

510(k) number K070351

1. Submitted by:

DFine, Inc. 3047 Orchard Parkway San Jose, CA 95134

Contact Person:	Robert D. Poser, D.V.M.Vice-President, Scientific and Medical Affairs
Telephone:	408-321-9999 ext 224
Facsimile:	408-321-9402

June 28, 2007 Date Prepared:

2. Device Name

Trade/Proprietary Name:	SPACE 360 Delivery System
Common/Usual Name:	Polymethylmethacrylate Bone Cement
Classification Name:	Polymethylmethacrylate Bone Cement, Cement Dispense d

3. Predicate Device:

The SPACE 360 Delivery System is substantially equivalent to the Equestra, cleared under 510(k) K040483 by Medtronic Sofamor Danek, the Confidence Fenestrated Introducer Needle cleared under 510(k) K063067by Disc-O-Tech, the Disc-O-Tech Cementer Injector classified under Product Code KIH and the ArthroCare System, cleared under 510(k) K040338 by ArthoCare.

4. Intended use of the device

5. Description of the Device

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6. Testing and Conclusion

Mechanical performance and safety testing demonstrates that the SPACE 360 Delivery System meets its performance requirements to support its use as a bone cement delivery system.

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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 features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol. The logo is simple, clean, and easily recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2007

DFine, Inc. c/o Robert D. Poser, DVM Vice President, Scientific and Medical Affairs 3047 Orchard Parkway San Jose, CA 95134

Re: K070351

Trade/Device Name: SPACE 360 Delivery System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: NDN, KIH Dated: May 12, 2007 Received: May 14, 2007

Dear Dr. Poser:

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.

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 vour 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

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Page 2 - Robert D. Poser, DVM

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.

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 Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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Statement of Indications for Use

510(k) Number: K070351

Device Name: SPACE 360 Delivery System

Indications for Use:

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

(PLEASE DO NOT WRITE BELOW THIS LINE - Division Sign-Off)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General Restorative,

and Neurological Devices

510(k) Number: 6070351

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.”