The Asfora Bullet Cage™ (ABC) is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two levels from L2 to S1. The DDD patients may also have up to Grade I spondylolisthesis at the involved level. The ABC cage devices are used with autogenous bone graft and are implanted via an open posterior approach. Patients should have had at least six (6) months of non-operative treatment prior to implant.

Device Description

The Asfora Bullet Cage™ is comprised of two hollow, threaded, self-tapping titanium fusion devices (cages) with closed tapered medial ends. The distal end has a small orifice that can be closed with a threaded cap. There are six equidistant slit apertures along the longitudinal axis of the device for placement of autogenous bone graft material. The cage has large cutting threads, angled toward the proximal end. The Asfora Bullet Cage™ is available in ten sizes: 5 diameters (10mm, 12mm, 14mm, 16mm, and 18mm) and 2 lengths (21mm or 25mm). This device, with associated instrumentation is intended for use in posterior lumbar interbody fusion to immobilize adjacent vertebrae and promote arthrodesis (fusion) across the disc space.

AI/ML Overview

The provided document is a 510(k) summary for the Asfora Bullet Cage™. It details device description, indications for use, and a statement of substantial equivalence to predicate devices. However, the document does not contain information about:

Specific acceptance criteria for device performance (e.g., success rates, mechanical thresholds in a clinical context).
Any studies involving patient data or device performance against such criteria. The "testing" mentioned in the summary refers to technical characteristics comparison, not clinical or performance outcome studies that would generate the requested metrics.
Sample sizes for test or training sets, data provenance, expert ground truth establishment, or adjudication methods for an AI/device performance study.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance.
Specific types of ground truth used (e.g., pathology, outcomes data).

Therefore, based only on the provided text, it's not possible to answer most of the prompt's questions as they pertain to clinical performance studies or AI/device performance metrics against acceptance criteria. The document describes a device comparison/equivalence filing, not a study demonstrating performance against specific clinical acceptance criteria.

The "study" that proves the device meets acceptance criteria, in this context, is the assessment of substantial equivalence to predicate devices. This is based on comparing technical characteristics and intended uses, implying that if the device is substantially equivalent to legally marketed and safe predicate devices, it also meets the necessary safety and effectiveness "acceptance criteria" for market clearance via the 510(k) pathway.

Here's an attempt to answer the questions based only on the available text, highlighting where information is absent:

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

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Devices (INTER FIX™ Threaded Fusion Device and Ray TFC™ Device) in terms of technical characteristics and intended uses.	"Testing and comparison of technological characteristics and intended uses found that all components of the Asfora Bullet Cage™ are equivalent to the predicates."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No information provided in the document regarding a test set or data provenance for performance evaluation. The "testing" refers to technical comparisons, not clinical performance data from patients.

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. No ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is described.

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
Not applicable. This is a medical device clearance document, not an AI performance study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device clearance document, not an AI performance study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices based on their prior marketing clearance.

8. The sample size for the training set
Not applicable. No training set is described for device performance evaluation.

9. How the ground truth for the training set was established
Not applicable. No training set is described.

Summary

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AUG 1 4 2009

2. 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with 21 CFR 807.92

General Information:

A.	Submitted By:	Medical Designs, LLC.1210 W. 18th Street, Suite 104Sioux Falls, South Dakota 57104Tel: 605-275-1032Fax: 605-335-3734
	Contact Person:	Kristi Vondra, Vice President of Operations
	Date Prepared:	August 12, 2009
B.	Device Trade Name:	Asfora Bullet Cage™
	Classification Name:	Orthopedic Devices, Prosthetic DevicesIntervertebral Fusion Device with Bone Graft, Lumbar21 CFR 888.3080 (MAX)
C.	Predicate Devices:	INTER FIX™ Threaded Fusion Device (P970013;Downclassified to Class II)Ray TFC™ Device (P950019; Downclassified to Class II)

Device Description: D.

The Asfora Bullet Cage™ is available in ten sizes: 5 diameters (10mm, 12mm, 14mm, 16mm, and 18mm) and 2 lengths (21mm or 25mm). This device, with associated instrumentation is intended for use in posterior lumbar interbody fusion to immobilize adjacent vertebrae and promote arthrodesis (fusion) across the disc space.

E. Indications for Use:

The Asfora Bullet Cage™ (ABC) is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at

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one or two levels from L2 to S1. The DDD patients may also have up to Grade I spondylolisthesis at the involved level. The ABC cage devices are used with autogenous bone graft and are implanted via an open posterior approach. Patients should have had at least six (6) months of non-operative treatment prior to implant.

Substantial Equivalence Comparison of Technical Characteristics to Prodicate Device(s): F.

The clinical and performance data provide adequate information to demonstrate that the Asfora Bullet Cage™ and its predicates, the INTER FIX™ Threaded Fusion Device (P970013; Downclassified to Class II) and the Ray RFC™ Device (P950019; Downclassified to Class II) are substantially equivalent.

H. Summary:

Testing and comparison of technological characteristics and intended uses found that all components of the Asfora Bullet Cage™ are equivalent to the predicates.

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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three parallel lines that curve and converge, resembling a human figure or abstract representation of health and well-being.

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

Medical Designs, LLC % Kristi Vondra 1210 W 18th St. North Center, Suite 104 Sioux Falls, South Dakota 57104

Re: K090048

AUG 1 4 2009

Trade/Device Name: Asfora Bullet Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 12, 2009 Received: August 13, 2009

Dear Ms. Vondra:

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 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); 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.

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Page 2 – Ms. Kristi Vondra

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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Oaubay buelus

Mark N. Mettler

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

510(k) Number (if known): K090048

The Asfora Bullet Cage™ Device Name:

Indications for Use:

X Prescription Use (Part 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

1090048 510(k) Number_

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.