(109 days)
The PATRIOT® TransContinental™ M Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The PATRIOT® TransContinental™ M Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.
The PATRIOT® TransContinental® M Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. The spacers are inserted using an anterior or lateral approach to the lumbar spine. The PATRIOT® TransContinental® M implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. PATRIOT® TransContinental™ M Spacers are made from PEEK radiolucent polymer, with an integrated titanium alloy nut and titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560.
Here's an analysis of the provided 510(k) summary regarding the PATRIOT® TransContinental™ M Spacer, focusing on acceptance criteria and supporting studies:
It's important to note that the provided document is a 510(k) summary for a medical device (an intervertebral body fusion device) seeking substantial equivalence. The "acceptance criteria" discussed in this context are not typically for an AI/ML diagnostic device's performance metrics (like sensitivity/specificity), but rather for the physical, mechanical, and biological properties of the implant itself, demonstrating that it is as safe and effective as a predicate device.
Description of Acceptance Criteria and Study Proving Device Meets Acceptance Criteria
The PATRIOT® TransContinental™ M Spacer is an interbody fusion device. Its acceptance criteria and the study proving it meets them are focused on demonstrating that the new device is "substantially equivalent" to previously cleared predicate devices in terms of its design, materials, and mechanical performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: |
- Static Compression
- Dynamic Compression
- Static Compression-Shear
- Dynamic Compression-Shear
- Subsidence | "Mechanical testing (static and dynamic compression, static and dynamic compression-shear, and subsidence) was conducted in accordance with ASTM F2077 and F2267, the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004, and 'Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device', June 12, 2007. Performance data demonstrate substantial equivalence to the predicate device." |
| Material Composition and Biocompatibility: - PEEK radiolucent polymer conformance
- Titanium alloy conformance
- Tantalum conformance | "PATRIOT® TransContinental™ M Spacers are made from PEEK radiolucent polymer, with an integrated titanium alloy nut and titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560." (Note: ASTM standards imply specific material properties and often biocompatibility requirements) |
| Design and Indications for Use Similarity to Predicate Device | "The PATRIOT® TransContinental™ M Spacers are similar to the predicate systems with respect to technical characteristics, performance and intended use." |
| Pre-clinical Testing Conformity | The device was tested according to relevant ASTM standards (F2077, F2267) and FDA guidance documents for spinal systems and intervertebral fusion devices. This implies conformity to established safety and performance benchmarks for spinal implants. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the summary. For mechanical testing of medical implants, the "sample size" refers to the number of physical devices or material specimens tested. These are generally small, statistically determined samples to ensure robust testing for design verification and validation.
- Data Provenance: The data is generated from in vitro mechanical testing studies performed under controlled laboratory conditions, not from human patient data. Therefore, notions of "country of origin" or "retrospective/prospective" do not apply.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This question is not applicable in the context of this 510(k) summary. "Ground truth" for mechanical testing is established by engineering standards (e.g., ASTM F2077, F2267) and the results obtained from the tests themselves, measured by calibrated equipment. There is no human interpretation or expert consensus involved in establishing the "ground truth" for the mechanical performance of the device in this context. The experts involved would be the engineers and technicians conducting the testing and interpreting the results against established standards.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like "2+1" or "3+1" are used for interpreting ambiguous human-read data (e.g., medical images). Here, the "test set" consists of mechanical performance data, which is objectively measured and compared against predefined criteria (ASTM standards, FDA guidance).
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 AI/ML diagnostic devices where human readers evaluate cases with and without AI assistance. The PATRIOT® TransContinental™ M Spacer is a physical implant, not a diagnostic AI tool, so this type of study is not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
- No, a standalone performance study was not done. This concept also applies to AI/ML diagnostic algorithms. This device is a passive implant; its "performance" is mechanical stability and biological integration, not diagnostic accuracy.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is based on established engineering standards (ASTM F2077, F2267) and FDA guidance documents for the mechanical properties and material specifications of intervertebral body fusion devices. The device is expected to meet or exceed the performance benchmarks defined by these standards, demonstrating equivalence to already-cleared devices.
8. The Sample Size for the Training Set
- Not applicable. There is no AI/ML "training set" associated with the development or testing of this type of passive medical implant. The design of the device is based on engineering principles, material science, and anatomical considerations, not machine learning from a dataset.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set in this context.
§ 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.