(254 days)
The TELAMON® PEEK Spinal System is indicated for interbody fusion with autogenous bone graft in patients diagnosed 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 are to be used with autogenous bone graft and are intended for bilateral placement in the lumbar spine. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
The subject TELAMON® PEEK Spinal System consists of vertebral body spacers which can be inserted between two lumbar or lumbo-sacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implant allows them to be packed with autogenous bone graft material. The TELAMON® PEEK Spinal System also includes instrumentation that enables the surgeon to implant the devices via an open or a minimally invasive posterior approach. The device sizes are available in various height and lordotic angle options. The implant devices are manufactured from medical grade polyetheretherketone (PEEK - OPTIMA® LT1) per ASTM F2026 and also contain tantalum markers per ASTM F-560 so that the position of the implant can be determined on X-ray or other imaging.
Here's an analysis of the provided 510(k) summary for the TELAMON® PEEK Spinal System, focusing on acceptance criteria and supporting studies:
This document is a 510(k) summary for a medical device (TELAMON® PEEK Spinal System). It does not contain information about an AI/ML powered device or a clinical study in the typical sense of evaluating diagnostic accuracy or clinical outcomes through human-in-the-loop or standalone AI performance.
Instead, this 510(k) is for an interbody fusion device, which is a physical implant. The "performance data" and "acceptance criteria" discussed relate to the mechanical properties and safety of the implant, demonstrating its equivalence to existing predicate devices.
Therefore, many of the requested fields pertinent to AI/ML device evaluations (like sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of medical device submission.
I will provide the information that is available in the document regarding its performance criteria and the study that proves it meets them.
Acceptance Criteria and Device Performance for TELAMON® PEEK Spinal System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Static compression (per ASTM F2077-03) | "Results... were found to be substantially equivalent to legally marketed devices." |
| Dynamic compression (per ASTM F2077-03) | "Results... were found to be substantially equivalent to legally marketed devices." | |
| Static compression shear (per ASTM F2077-03) | "Results... were found to be substantially equivalent to legally marketed devices." | |
| Dynamic compression shear (per ASTM F2077-03) | "Results... were found to be substantially equivalent to legally marketed devices." | |
| Subsidence Performance | Subsidence (per ASTM F2267-04) | "Results... were found to be substantially equivalent to legally marketed devices." |
| Material Equivalence | Device manufactured from medical grade PEEK (PEEK - OPTIMA® LT1) per ASTM F2026 | "The devices are manufactured from the same material..." (in comparison to predicates) |
| Radiographic Visibility | Contains tantalum markers per ASTM F-560 | "so that the position of the implant can be determined on X-ray or other imaging." |
| Design Equivalence | Shape, size, and footprint range similar to predicates | "The device designs are similar in shape, size, and footprint range." |
| Intended Use Equivalence | Same intended use as predicates | "The devices share the same intended use." |
| Sterilization Equivalence | Same sterilization methods as predicates | "...and undergo the same sterilization methods." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for individual tests. The studies were "pre-clinical studies conducted using worst case TELAMON® devices." This implies a limited number of devices were tested to represent the product line.
- Data Provenance: The studies are pre-clinical (laboratory-based mechanical testing), not human or patient data. Therefore, country of origin or retrospective/prospective distinctions are not applicable in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The "ground truth" here is the pass/fail criteria of standardized ASTM mechanical tests, not a clinical diagnosis or interpretation requiring expert consensus. The "experts" would be the engineers and technicians conducting the tests and performing the analysis according to the ASTM standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. This refers to clinical study data adjudication. The mechanical tests follow specific ASTM protocols. Adherence to these protocols is self-contained within the test methodology.
5. 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:
- Not Applicable. This is a physical implant, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used:
- For mechanical performance: The ground truth implicitly refers to the specified performance requirements and acceptance limits defined by the ASTM standards (F2077-03 and F2267-04) for interbody fusion devices, as well as comparison to the performance of legally marketed predicate devices. The "ground truth" is that the device must meet or exceed the performance of the predicate devices under these standardized tests.
8. The sample size for the training set:
- Not Applicable. There is no "training set" in the context of an AI/ML model for this physical medical device.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML model, this question is irrelevant to this device submission.
Summary of the Study Proving Acceptance Criteria:
The "study" that proves the TELAMON® PEEK Spinal System meets its acceptance criteria consists of pre-clinical mechanical and material testing. Specifically, the submission states:
- "The following pre-clinical studies were conducted using worst case TELAMON® devices: static and dynamic compression; and static and dynamic compression shear per ASTM F2077-03; and subsidence per ASTM F2267-04."
The results of these tests, when compared to legally marketed predicate devices, demonstrated that the TELAMON® PEEK Spinal System was "substantially equivalent." This substantial equivalence, based on similar design, materials, intended use, and comparable mechanical test results, formed the basis for its 510(k) clearance by the FDA. The acceptance criterion was primarily meeting comparable performance to already-cleared predicate devices under standardized engineering tests, thereby demonstrating similar safety and effectiveness.
§ 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.