The Lateral Cage System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. The system is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device, this system is intended for use with DePuy Spine supplemental internal fixation.

The Lateral Cage System is also indicated for intervertebral body fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive lateral approach. When used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.

Device Description

The Lateral Cage System consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of allograft and/or autogenous bone graft (autograft), depending on intended use.

The Lateral Cage System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

AI/ML Overview

The provided text is a 510(k) summary for the DePuy Spine Lateral Cage System, which is an implantable medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The summary mentions "Performance data were submitted to characterize the Lateral Cage System." However, it does not describe any acceptance criteria or a specific study that proves the device meets such criteria in the manner requested by the prompt for AI/software devices (e.g., diagnostic accuracy metrics, sensitivity, specificity, etc.).

For a medical implant like the Lateral Cage System, performance data typically refers to:

Mechanical Testing: Such as compression, torsion, fatigue, and expulsion tests to demonstrate strength, durability, and resistance to deformation under physiological loads.
Biocompatibility Testing: To ensure the material (Carbon Fiber Reinforced Polymer) is safe for implantation in the human body.
Sterilization Validation: To confirm the proposed sterilization method is effective.
Dimensional Verification: Ensuring the implants meet specified dimensions.

These types of tests are performed to demonstrate substantial equivalence to predicate devices and to ensure the device is safe and effective for its intended use. However, the summary does not detail the specific acceptance criteria or the numerical results of these tests.

Therefore, most of the specific questions about acceptance criteria, study design, sample sizes for test/training sets, experts, ground truth, and MRMC studies, which are highly relevant for software or AI based medical devices, cannot be answered from this document.

Here's an attempt to answer the prompt based only on the provided text, acknowledging its limitations for this type of device:

1. Table of acceptance criteria and reported device performance:

The provided document does not list quantitative acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) or device performance values that would typically be found for AI/software. For a spinal implant, acceptance criteria would be based on mechanical, biocompatibility, and sterilization standards. The document only generally states: "Performance data were submitted to characterize the Lateral Cage System."

2. Sample size used for the test set and data provenance:

Not applicable. The "performance data" mentioned would likely involve mechanical testing of device prototypes/samples, not a clinical "test set" of patient data in the context of an AI/software device. There is no information on data provenance.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

Not applicable. Ground truth for a physical implant would typically be established through engineering specifications, material standards, and biomechanical principles, not expert consensus on diagnostic interpretations.

4. Adjudication method for the test set:

Not applicable.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:

No, an MRMC study is not mentioned as this is a physical medical device (spinal implant), not a diagnostic algorithm.

6. Standalone (algorithm only without human-in-the-loop performance) study:

Not applicable. This is not an algorithm.

7. Type of ground truth used:

For a physical implant, ground truth regarding its performance would be based on:

Pre-established engineering specifications: For dimensions, material properties, and mechanical strength.
Biomechanical testing standards: Ensuring the device can withstand physiological loads.
Biocompatibility standards: Ensuring the material is safe for implantation.

8. Sample size for the training set:

Not applicable. This is not an AI/software device that requires a "training set."

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

Not applicable.

Summary based on the document:

The K090899 submission for the Lateral Cage System is for a physical spinal implant. The "Performance data" mentioned would entail mechanical, biocompatibility, and sterilization testing to demonstrate substantial equivalence to predicate devices. The document does not provide the specific numerical acceptance criteria or the results of these tests, nor does it detail studies relevant to AI/software performance metrics (like diagnostic accuracy, expert consensus, or MRMC studies).

Summary

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K090899

510(k) Summary SUBMITTER:

DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02780

CONTACT PERSON: Hande Tufan

MAY 19 2009

DATE PREPARED: March 31, 2009

CLASSIFICATION NAME: Spinal Vertebral Body Replacement Device $888.3060

Intervertebral Body Fusion Device 888.3080

PROPRIETARY NAME: Lateral Cage System

PREDICATE DEVICES: Lateral Cage System (K082128) Concorde VBR Spinal System (K041722, K052746) Stackable Cage System (K001340, K013382)

DEVICE DESCRIPTION: The Lateral Cage System consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of allograft and/or autogenous bone graft (autograft), depending on intended use.

The Lateral Cage System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

The Lateral Cage System is indicated for use in the INTENDED USE: thoracolumbar spine (i.e.. T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. The system is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device, this system is intended for use with DePuy Spine supplemental internal fixation.

The Lateral Cage System is also indicated for intervertebral body fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiquous

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levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive lateral approach. When used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.

MATERIALS:

Manufactured from Carbon Fiber Reinforced Polymer.

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. ·

PERFORMANCE DATA:

Performance data were submitted to characterize the Lateral 1 Cage System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body, symbolizing the department's mission to protect and promote the health and well-being of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

MAY 19 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Depuy Spine, Inc. % Ms. Hande Tufan Sr. Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K090899

Trade Name: Lateral Cage System Regulation Number: 21 CFR 888.3080 Regulation Names: Intervertebral body fusion device Regulatory Class: II Product Code: MAX, MOP Dated: March 31, 2009 Received: April 3, 2009

Dear Ms. Tufan:

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 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 (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. Hande Tufan -

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

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 IV.

510(k) Number (if known):

Lateral Cage System Device Name:

Indications For Use:

Prescription Use: OR Over-The-Counter Use: (Per 21 CFR 801.109)

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S 88390 1931 1 Concurrence of CDRH, Office of Device Evaluation (ODE

16 09 0899

1999 margist.

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

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.