(323 days)
CONCORDE, COUGAR, DEVEX, and LEOPARD Systems Indications: The CONCORDE, COUGAR, DEVEX, and LEOPARD Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLIF (CONCORDE), TLIF (CONCORDE, DEVEX, LEOPARD) or anterior (COUGAR) approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation. The CONCORDE, COUGAR, DEVEX, and LEOPARD Systems are indicated for use in the thoracolumbar spine (i.e., T1-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. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are 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 these systems are intended for use with DePuy Spine supplemental internal fixation.
BENGAL System Indications: The BENGAL System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. BENGAL implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, DePuy Spine supplemental fixation may be used. The BENGAL System is indicated for use in the thoracolumbar spine (i.e., T1-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. This 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 BENGAL, CONCORDE, COUGAR, DEVEX, and LEOPARD Systems consist of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft materials. These Systems also contain Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of specific pass/fail metrics. | Performance data were submitted to characterize the BENGAL, CONCORDE, COUGAR, DEVEX and LEOPARD Systems. |
Explanation: The document does not explicitly define quantifiable acceptance criteria (e.g., minimum tensile strength, specific fatigue life cycles) or report numerical outcomes for the device's performance against such criteria. Instead, it states that "Performance data were submitted to characterize" the systems. This suggests a submission of various tests (likely mechanical and biocompatibility) whose results were evaluated against established standards for spinal implants, rather than specific P&F metrics stated in this summary.
Study Details
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Sample sizes used for the test set and data provenance:
- Test Set Sample Size: Not specified. The document states "Performance data were submitted to characterize the BENGAL, CONCORDE, COUGAR, DEVEX and LEOPARD Systems," but does not mention the number of units or test subjects involved in these performance tests.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document focuses on the technical aspects and regulatory approval rather than clinical study design or data origin.
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Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. The document discusses performance data for medical devices (spinal implants), which typically involves engineering and material testing rather than expert-based ground truth establishment as seen in diagnostic imaging or clinical trials.
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Adjudication method for the test set: Not applicable. As this pertains to mechanical performance data of spinal implants, adjudication methods like 2+1 or 3+1 are not relevant. Testing would follow standardized protocols (e.g., ASTM, ISO).
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is relevant for diagnostic devices that involve human interpretation of images or data. The submitted document pertains to spinal implants, which are surgical devices.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This concept is for AI/software devices. The devices in question are physical spinal implants.
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The type of ground truth used: For physical spinal implants, the "ground truth" for performance would typically be established through engineering standards, mechanical testing results, and material specifications. For instance, fatigue testing to a certain number of cycles, static compression strength, and biocompatibility testing results would constitute the "ground truth" for their physical properties and safety.
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The sample size for the training set: Not applicable. There is no mention of an algorithm or AI model requiring a training set.
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How the ground truth for the training set was established: Not applicable, as there is no training set.
§ 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.