(48 days)
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.
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 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).
§ 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.