(226 days)
The Xsert™ Lumbar Expandable Interbody System is intended for spinal fusion procedures at one or two contiguous levels (L2 - S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via a posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
The Xsert™ Lumbar Expandable Interbody System of X-spine Systems, Inc. is an expandable interbody system used to provide structural stability in skeletally mature individuals following discectomy. The Xsert™ Lumbar Expandable Interbody System will consist of spacers offered in various shapes and sizes, and their heights can be intra-operatively expanded to fit the anatomical needs of a wide variety of patients. These spacers are intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft material and have features on the superior and inferior surfaces of each device to grip the endplates of the adjacent vertebrae to resist expulsion.
The implant components of the system are manufactured from medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F-136. All implants will be provided clean and sterile, are intended for single use only, and should not be reused under any circumstances.
A series of manual surgical instruments intended to assist with the insertion and placement of the implants is included in an instrument tray, which is used for instrument sterilization and storage.
Here's the information regarding the acceptance criteria and study for the Xsert™ Lumbar Expandable Interbody System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K160959 510(k) Summary) does not explicitly list specific numerical acceptance criteria (e.g., minimum compression strength in Newtons) and corresponding numerical performance results for the device. Instead, it refers to industry standards that implicitly contain performance requirements for such devices. Therefore, the table below reflects what is stated:
| Acceptance Criterion (Referenced Standard/Guidance) | Reported Device Performance |
|---|---|
| Mechanical Testing: | |
| Static and Dynamic Compression and Compression Shear (per ASTM F2077) | Testing performed; device "found to have an equivalent safety and effectiveness profile compared to the referenced predicate systems." |
| Subsidence (per ASTM F2267) | Testing performed; device "found to have an equivalent safety and effectiveness profile compared to the referenced predicate systems." |
| Expulsion (per FDA Guidance: Class II Special Controls Guidance Document: Intervertebral Body Fusion Device) | Testing performed; device "found to have an equivalent safety and effectiveness profile compared to the referenced predicate systems." |
| Simulated Use: | |
| Design validation with surgeons in a cadaveric laboratory evaluation | Performed, including supplementary evaluations of packing expandable implants with bone graft. |
Explanation of "Acceptance Criteria" in this context: For medical devices, particularly those seeking 510(k) clearance, the "acceptance criteria" are often implicitly met by demonstrating compliance with recognized consensus standards (like ASTM standards) and FDA guidance documents. The submission argues that by meeting these standards and guidance, the device's performance is "substantially equivalent" to legally marketed predicate devices, implying it meets the necessary safety and effectiveness thresholds defined by those standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Mechanical Testing: The document does not specify the exact number of devices tested for each mechanical test (Static/Dynamic Compression, Subsidence, Expulsion). It only states that "Mechanical testing was performed."
- Sample Size for Simulated Use: The document mentions "surgeons in a cadaveric laboratory evaluation" but does not specify the number of cadavers or the number of device placements performed during this simulated use.
- Data Provenance: The data appears to be prospective as it involves laboratory testing and cadaveric evaluations of the specific Xsert™ Lumbar Expandable Interbody System. The country of origin of the data is not explicitly stated but is implied to be from the manufacturer's testing facilities (X-spine Systems, Inc.) in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Mechanical Testing: Not applicable in the sense of human experts establishing ground truth for mechanical test results. The "ground truth" for mechanical testing is based on the objective measurements against the specified ASTM standards and FDA guidance.
- Simulated Use: The document mentions "surgeons" performing a cadaveric laboratory evaluation. It does not specify the number of surgeons involved or their specific qualifications (e.g., years of experience, subspecialty). These surgeons acted as "experts" for the human factors/usability aspect during simulated use, assessing device handling and surgical technique.
4. Adjudication Method for the Test Set
- Mechanical Testing: Not applicable. Performance is measured objectively according to standard protocols.
- Simulated Use: The document does not describe a formal adjudication method. It states that "Design validation... was performed with surgeons," implying their assessment of the device's usability and performance during the simulation serves as the validation. There's no mention of multiple reviewers or a consensus process for the simulated use results.
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 typically associated with AI/imaging diagnostics where human readers interpret medical images. The Xsert™ Lumbar Expandable Interbody System is a physical implant, and its evaluation consists of mechanical testing and simulated surgical use, not image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the Xsert™ Lumbar Expandable Interbody System. This device is a physical implant, not an algorithm or software. Its performance is inherent to its mechanical properties and design, not an algorithm that can operate standalone.
7. The Type of Ground Truth Used
- Mechanical Testing: The ground truth is defined by the objective pass/fail criteria and performance thresholds established within the referenced ASTM standards (ASTM F2077, ASTM F2267) and FDA Guidance for Intervertebral Body Fusion Devices.
- Simulated Use: The ground truth for the simulated use in a cadaveric laboratory evaluation is the effectiveness and ease of use in a simulated surgical environment, as assessed by the participating surgeons. This is functionally a form of "expert assessment" or subjective feedback regarding the device's practical application.
8. The Sample Size for the Training Set
Not applicable. This device is a physical interbody fusion system, not an artificial intelligence or machine learning model that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.