(287 days)
When used as a Vertebral Body Replacement Device: The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with bone graft.
When used as an Intervertebral Body Fusion System: The Aesculap PEEK Spinal Implant System consists of A-Space (semi-circular), ProSpace (bullet), and T-Space (curved) components. These implants are indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at involved levels. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems that have been cleared for use in the lumbrosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The Aesculap PEEK Spinal Implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Aesculap device.
The Aesculap PEEK Spinal Implant System is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. Components are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy. Components are manufactured from PEEK - Optima (per ASTM F2026).
Here's an analysis of the provided text regarding the Aesculap PEEK Spinal Implant System, focusing on acceptance criteria and supporting studies:
It's important to note that the provided documents are a 510(k) Summary and an FDA-clearance letter. For medical devices, particularly spinal implants, clearance through the 510(k) pathway usually relies on demonstrating "substantial equivalence" to a legally marketed predicate device rather than conducting a full clinical trial with "acceptance criteria" and detailed "study results" in the way one might expect for a new drug or a novel, high-risk device. Therefore, the "acceptance criteria" here refer to the performance standards met by the device to demonstrate this equivalence, primarily through mechanical testing.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Standard Met) | Reported Device Performance |
|---|---|
| Static Mechanical Testing | Performed in accordance with ASTM F2077 |
| Dynamic Mechanical Testing | Performed in accordance with ASTM F2077 |
| Static Mechanical Testing (if applicable for VBR) | Performed in accordance with ASTM F1717 (if applicable) |
| Dynamic Mechanical Testing (if applicable for VBR) | Performed in accordance with ASTM F1717 (if applicable) |
| Material Composition Equivalence | Manufactured from PEEK - Optima (per ASTM F2026), same as predicate devices. |
| Shape and Size Equivalence | Offered in the same range of shapes and sizes as predicate devices. |
| Intended Use Equivalence | Indications for use are substantially equivalent to predicate devices (Aesculap PEEK VBR System (K060762), Spinal Elements Lucent and Lucent Magnum Interbody Fusion devices (K071724 & K073348)). |
Note: The provided text confirms that the tests were performed according to the standards, but it does not provide the specific numerical results or pass/fail thresholds for these tests. The implicit "acceptance criteria" for a 510(k) clearance based on mechanical testing is that the device "meets" or "performs comparably to" the predicate device when tested under these industry standards.
Study Information
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. For mechanical testing of medical devices, "sample size" refers to the number of individual devices or constructs tested. This information is typically found in the full test reports, not the 510(k) summary.
- Data Provenance: The tests were conducted according to ASTM F2077 (Standard Test Methods for Intervertebral Body Fusion Devices) and/or ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model). These are standardized testing protocols, implying a controlled laboratory environment. The country of origin of the data is not specified, but given the company's US address, it's likely US-based or from an accredited testing facility globally. The data is prospective in the sense that the tests were specifically designed and executed to evaluate the new device before market clearance.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For this type of device and submission (510(k) based on mechanical testing), "ground truth" and "experts to establish ground truth" in the clinical sense are not relevant. Mechanical testing relies on engineering principles and standardized methods, not expert clinical interpretation of data/images. The "ground truth" is established by the validated testing methodologies and the physical properties of the materials and device design.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly those involving human interpretation of clinical data (e.g., imaging). This submission is based on mechanical performance tests, which do not involve such adjudication.
-
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. An MRMC study is not mentioned because this is a mechanical implant device, not an AI-assisted diagnostic or imaging device. The concept of "human readers" and "AI assistance" is not applicable here.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI algorithm. A standalone performance evaluation was done in the form of mechanical testing of the device itself (algorithm only performance is not relevant here).
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Mechanical Test Standards and Engineering Principles. The "ground truth" for this submission is adherence to established mechanical testing standards (ASTM F2077, ASTM F1717) and the physical properties of the PEEK-Optima material as specified by ASTM F2026. The device's performance against these standards, and its equivalence to predicate devices, forms the basis of accepted safety and effectiveness.
-
The sample size for the training set:
- Not Applicable. There is no "training set" in the context of mechanical device testing as this is not a machine learning or AI product.
-
How the ground truth for the training set was established:
- Not Applicable. As there is no training set, this question is not relevant.
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Aesculap PEEK Spinal Implant System
Page 1 of 2
510(k) SUMMARY (as required by 21 CFR 807.92) B.
MAY - 1 2008
Aesculap PEEK Spinal Implant System 3 March 2008
| COMPANY: | Aesculap®Implant Systems, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 3005673311 |
|---|---|
| CONTACT: | Matthew M. Hull800-258-1946 (phone)610-791-6882 (fax) |
| TRADE NAME: | Aesculap PEEK Spinal Implant System |
| COMMON NAME: | Intervertebral Body Fusion Device |
| CLASSIFICATION NAME: | Orthosis, Spinal Intervertebral Fusion |
| REGULATION NUMBER: | 888.3080 |
| PRODUCT CODE: | MAX |
SUBSTANTIAL EQUIVALENCE
Aesculap® Implant Systems, Inc. believes that the Aesculap PEEK Spinal Implant System is substantially equivalent to the Aesculao PEEK VBR System (K060762), the Spinal Elements Lucent and Lucent Magnum Interbody Fusion devices (K071724 & K073348).
DEVICE DESCRIPTION
The Aesculap PEEK Spinal Implant System is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. Components are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy. Components are manufactured from PEEK - Optima (per ASTM F2026).
INDICATIONS FOR USE
When used as a Vertebral Body Replacement Device:
The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with bone graft.
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Aesculap PEEK Spinal Implant System
Page 2 of 2
When used as an Intervertebral Body Fusion System:
The Aesculap PEEK Spinal Implant System consists of A-Space (semi-circular), ProSpace (bullet), and T-Space (curved) components. These implants are indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 Spondy/olisthesis or retrolisthesis at involved levels. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems that have been cleared for use in the lumbrosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The Aesculap PEEK Spinal Implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with autogenous bone graft.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Aesculap device.
TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))
The components of the Aesculap PEEK Spinal Implant System are offered in the same range of shapes and sizes as the predicate devices. The material used for the Aesculap device is the same as that used to manufacture the predicate devices.
PERFORMANCE DATA
Static and dynamic testing of the Aesculap PEEK Spinal Implant System was performed in accordance with ASTM F2077 and/or F1717 as recommended by the FDA Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle-like symbol with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 1 2008
Aesculap Implant Systems, Incorporated % Mr. Matthew Hull Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, PA 18034
Re: K071983
Trade/Device Name: Aesculap PEEK Intervertebral Body Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 16, 2008 Received: April 16, 2008
Dear Mr. Hull:
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 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 (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 - Mr. Matthew Hull
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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millman
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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INDICATIONS FOR USE STATEMENT A.
510(k) Number: K071983
Device Name: Aesculap PEEK Spinal Implant System
Indications for Use:
When used as a Vertebral Body Replacement Device:
The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with bone graft.
When used as an Intervertebral Body Fusion System:
The Aesculap PEEK Spinal Implant System consists of A-Space (semi-circular), ProSpace (bullet), and T-Space (curved) components. These implants are indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at involved levels. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems that have been cleared for use in the lumbrosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The Aesculap PEEK Spinal Implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with autogenous bone graft.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Aesculap device.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(ber 21 CFR 801.109)
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil RPOgL for nx
Division of General, Restorative, and Neurological Devices
510(k) Number_Ko71983
§ 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.