(95 days)
The DePuy PULSE Lumbar Cage System is 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 a PLIF or TLIF approach using autogenous bone. When used as intervertebral body fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products.
The DePuy PULSE Lumbar Cage System is designed for use as a lumbar intervertebral body fusion device. The implant devices are available in various geometries and sizes to accommodate patient anatomy. The implant devices are manufactured from medical grade polyetheretherketone (PEEK OPTIMA® LT1) per ASTM F-2026 and tantalum markers per ASTM F-560.
Here is an analysis of the provided 510(k) summary regarding the DePuy PULSE™ Lumbar Cage System, focusing on the acceptance criteria and the study proving its compliance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Type) | Standard | Reported Device Performance |
|---|---|---|
| Static Axial Compression Testing | ASTM F-2077 | "The acceptance criteria was/were met." |
| Dynamic Axial Compression Testing | ASTM F-2077 | "The acceptance criteria was/were met." |
| Static Compression Shear Testing | ASTM F-2077 | "The acceptance criteria was/were met." |
| Dynamic Compression Shear Testing | ASTM F-2077 | "The acceptance criteria was/were met." |
| Subsidence Testing (Static Axial Compression) | ASTM F-2267 | "The acceptance criteria was/were met." |
Study Proving Device Meets Acceptance Criteria:
The study conducted was a series of non-clinical mechanical tests. These tests evaluated the physical performance of the DePuy PULSE™ Lumbar Cage System against established ASTM standards for intervertebral body fusion devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The 510(k) summary does not specify the exact sample size (number of devices tested) for each mechanical test. It only states that the tests were conducted.
- Data Provenance: The data provenance is from non-clinical laboratory testing. This type of test data is generally generated internally by the manufacturer or a contracted lab. The document does not provide details on the country of origin of the data, but it is implied to be from Medos International Sàrl's testing or a lab they utilized. These would be prospective tests, specifically designed to evaluate the product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. For non-clinical mechanical testing, "ground truth" as it's typically understood in clinical or AI studies (e.g., expert consensus on images or pathology results) is not relevant. The "ground truth" is defined by the acceptance criteria established in the ASTM standards (ASTM F-2077 and ASTM F-2267) and the measured physical properties of the device. Evaluation against these standards is performed by engineers or technicians, not clinical experts for ground truth establishment.
4. Adjudication Method for the Test Set
- Not Applicable. As mentioned above, this is non-clinical mechanical testing. There is no adjudication method in the context of clinical expert review. The results are objectively measured and compared against the defined acceptance criteria of the ASTM standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC comparative effectiveness study was not performed. The 510(k) summary explicitly states, "No clinical tests were performed." MRMC studies are clinical studies involving human readers, which were not conducted for this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This device is a physical intervertebral cage system, not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance evaluation is based on pre-defined mechanical performance criteria established in the referenced ASTM standards (ASTM F-2077 and ASTM F-2267). These standards specify the methods for testing and the performance characteristics (e.g., resistance to static/dynamic compression, shear, and subsidence) that the device must meet.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical medical device, not an AI/ML algorithm. There is no "training set" in the context of this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for a training set does not apply.
§ 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.