(27 days)
The Cougar® LS 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 Cougar® LS 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.
The Cougar® LS Lateral System implants are manufactured from Carbon Fiber Reinforced Polymer (CFRP) material. Cages are available with 15° lordotic configurations, widths of 18mm and 21mm, and heights ranging from 10mm to 20mm in 2mm increments. The cages' lengths are 45mm, 50mm, 55mm, and 60mm.
The cage structure is radiolucent with tantalum X-ray wire so that healing can be assessed by normal radiographic methods. The cages have teeth that resist rotation and migration and have cavities to accept packing of autogenous bone graft.
The implants may be utilized in either an open or minimally invasive surgical approach. The implants are placed using a lateral surgical approach.
The provided text describes a 510(k) summary for the Cougar® LS Lateral Cage System, a medical device. This document does not describe acceptance criteria or a study that proves the device meets acceptance criteria in the typical sense of a clinical or performance study with defined metrics like sensitivity, specificity, accuracy, etc., which are common for AI/software devices.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a physical medical implant. The "acceptance criteria" here are implicitly tied to the performance standards set by the predicate devices and general consensus standards for spinal implants. The "study" refers to bench testing to show the device meets these physical and mechanical performance characteristics.
Here’s a breakdown based on your request, interpreting "acceptance criteria" and "study" within the context of this 510(k) submission for a physical implant:
Acceptance Criteria and Device Performance for Cougar® LS Lateral Cage System
The acceptance criteria for this device are implicitly derived from the performance of its predicate devices (DePuy Spine Cougar® LS Lateral Cage System, K082128, K110454) and compliance with recognized ASTM standards for spinal implants. The "study" conducted was mechanical bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|---|
| Mechanical Strength | ASTM F2077-11 (Static & Dynamic Compression) | Device must withstand specified static and dynamic compression loads without failure, comparable to predicate device performance. | Testing was submitted to characterize the subject implants. Implies successful completion meeting performance requirements. |
| Mechanical Strength | ASTM F2077-11 (Static & Dynamic Compressive Shear) | Device must withstand specified static and dynamic compressive shear loads without failure, comparable to predicate device performance. | Testing was submitted to characterize the subject implants. Implies successful completion meeting performance requirements. |
| Expulsion Resistance | ASTM F2267-04 (Expulsion Testing) | Device must resist expulsion under specified forces, comparable to predicate device performance. | Testing was submitted to characterize the subject implants. Implies successful completion meeting performance requirements. |
| Subsidence Resistance | ASTM F2267-04 (Subsidence Testing) | Device must demonstrate acceptable resistance to subsidence under specified loads, comparable to predicate device performance. | Testing was submitted to characterize the subject implants. Implies successful completion meeting performance requirements. |
| Material Equivalence | Carbon Fiber Reinforced Polymer (CFRP) / PEEK | Material properties must be equivalent or superior to predicate device materials. | The proposed cages are manufactured from Carbon Fiber Filled PEEK-OPTIMA LT1 Compound (CFRP), which is identical to the predicate system's materials. |
| Similar Performance | Overall Biomechanical Integrity & Functionality | The device, despite increased lordotic angle, must provide the same strength and performance as the predicate devices. | "The increase in lordotic angle provides the same strength and performance as the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify exact sample sizes (number of units) used for each mechanical test (e.g., number of cages subjected to compression testing). For bench testing of medical devices, it typically involves a set number of units per test condition to achieve statistical significance or meet standard requirements.
- Data Provenance: The data provenance is from mechanical bench testing conducted by the manufacturer, Medos International Sárl / DePuy Spine, Inc. This is prospective testing specifically performed for this 510(k) submission. No country of origin for the data is explicitly mentioned beyond the manufacturer's location in Switzerland and the submitter's location in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts for ground truth) is not applicable to this submission. The "ground truth" for mechanical testing is established by the specified ASTM standards and the physical laws governing material science and biomechanics, not by expert human consensus. The data is generated by testing equipment, and the interpretation of compliance is typically done by engineers and regulatory specialists.
4. Adjudication Method for the Test Set
This is not applicable. Mechanical testing does not involve human adjudication in the way clinical studies or expert review of images would. The results are quantitative measurements against predefined criteria in the ASTM standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or software where human readers interpret output; it is not applicable to a physical spinal implant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone "algorithm only" performance study was not done. This term is only relevant for AI/software devices.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance assessment is based on established mechanical performance standards (ASTM F2077-11, ASTM F2267-04) and the demonstrated performance of legally marketed predicate devices. The goal is to show that the modified device performs equivalently to these benchmarks.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of mechanical bench testing for a physical implant. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the reasons stated above.
§ 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.