(250 days)
When used as an intervertebral fusion device with bone graft, cervical:
Xenco Medical InterAlign Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of nonoperative treatment prior to surgical treatment with the device is intended to be used with supplemental fixation (e.g. anterior plate system).
When used as an intervertebral fixsion, cervical (interbody spacer w/ provided plate, bone screws, and locking cover):
Xenco Medical InterAlign Cervical Interbody System constructs are stand-alone anterior cervical interbody fusion devices intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment with the device. Xeno Medical InterAlign Cervical Interbody System constructs are to be packed with autogenous bone graft and implanted via an open, anterior approach. Xenco Medical InterAlign Cervical Interbody System constructs are intended to be used with the plate, bone screws, and locking cover provided and require no additional fixation.
Xenco Medical IntelAlign Cervical Interbody System devices are generally box shaped with surface teeth and a central channel for packing autogenous bone. These implants are available in a range of shapes and sizes to accommodate variations in patient anatomy. Spacers are manufactured from PEEK polymer (Zeniva ZA-500 per ASTM F2026) and contain titanium (per ASTM F67), titanium alloy (per ASTM F1472), or tantalum (per ASTM F560) markers to assist with radiographic visualization. Stand-alone device constructs additionally utilize a fixation plate and bone screws manufactured from titanium alloy, and a PEEK locking cover. The system also includes instruments manufactured using anodized 6061 T6 aluminum alloy per ASTM B211 / B221. All system implants and instruments are provided sterile packaged and are intended for single use.
The provided text is a 510(k) summary for the Xenco Medical InterAlign Cervical Interbody System. This type of submission is for medical devices that demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance data as might be seen for novel devices or those requiring PMA.
Therefore, the document does not contain information on acceptance criteria for device performance in a clinical study, nor does it detail a study that proves the device meets such criteria in terms of clinical outcomes. Instead, it demonstrates equivalence to existing devices primarily through technological characteristics and non-clinical performance testing.
Here's a breakdown based on the provided text, addressing the points where information is available or relevant to a 510(k):
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not applicable in the context of a 510(k) summary for a cervical interbody system. The 510(k) process focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific clinical performance acceptance criteria in a study. The "Performance Testing" section states: "As the implants are identical to those cleared in K160313 and no changes have been made to indications or claims, no new non-clinical performance testing was required for the subject device implants. The subject device instrumentation is manufactured identically to those described in the reference device (K112913). As such, no biocompatibility testing was required to support the change. A gamma sterilization validation was performed to support the change in device material."
This indicates that equivalence was established through material, design, and manufacturing comparisons, along with sterilization validation. There are no clinical performance metrics or acceptance criteria presented.
2. Sample Size Used for the Test Set and the Data Provenance:
This information is not applicable as there was no clinical "test set" in the context of device performance testing for this 510(k). The evaluation was based on design and material comparisons to predicate devices and non-clinical testing for material changes (sterilization validation).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable. Ground truth establishment for a clinical test set is not part of this 510(k) submission.
4. Adjudication Method for the Test Set:
This information is not applicable. No clinical test set adjudication method is mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
This information is not applicable. An MRMC comparative effectiveness study is a clinical study involving human readers (e.g., radiologists interpreting images affected by an AI device) and is not relevant to this 510(k) for an interbody fusion device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable. This device is a physical implant, not an algorithm, and therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used:
This information is not applicable for clinical performance. The "ground truth" in this 510(k) context relates to the established safety and effectiveness of the predicate devices based on their prior clearances and the technical specifications/materials of the subject device matching or being equivalent to those predicates.
8. The Sample Size for the Training Set:
This information is not applicable, as there is no "training set" in the context of an algorithm or AI.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no "training set" for this device.
In summary, for the Xenco Medical InterAlign Cervical Interbody System as described in this 510(k) submission (K223059):
The device gained clearance by demonstrating substantial equivalence to previously cleared predicate devices (K160313, K140786) and a reference device (K112913). The primary arguments for equivalence are:
- Identical Implants: The implants of the subject device are identical to those cleared in K160313.
- No Change in Indications/Claims: The indications for use and claims are unchanged from the predicate.
- Material Equivalence: The instrumentation material is identical to the reference device (K112913).
- Non-clinical Performance Testing: A gamma sterilization validation was performed to support the change in instrument material. No new non-clinical performance testing was required for the implants because they are identical to the predicate. No biocompatibility testing was required for the instrument material change due to its similarity to the reference device.
The 510(k) process explicitly relies on the premise that if a new device is substantially equivalent to a legally marketed predicate device (in terms of intended use, technological characteristics, and safety/effectiveness), then it does not raise new questions of safety and effectiveness and does not require a full clinical trial to establish performance criteria.
§ 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.