(95 days)
The Calibrate LTX Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.
Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy with or without axial pain).
Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
The Calibrate LTX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Callbrate LTX spacers expanded greater than 20° must be used with the provided bone screws in addition to supplemental fixation.
The subject Calibrate LTX Interbody System is a lordotic expandable thoracolumbar intervertebral body fusion system designed to be inserted through a lateral or anterolateral surgical approach. The subject interbody spacers are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and polyetheretherketone (PEEK) Optima LT1 per ASTM F2026. The Calibrate LTX System consists of a variety of shapes and sizes of interbody spacers, inserters, trials, and general instruments to create lordotic expansion, restore sagittal alignment, and provide indirect decompression. Implants are offered with antimigration teeth and grit-blast treatment on the bone-contacting endplate surfaces. Certain Calibrate LTX Interbody System offerings also accept fixation bone screws manufactured from titanium alloy per ASTM F136.
The provided text describes the Calibrate LTX Interbody System, a medical device for spinal fusion, and its FDA 510(k) clearance application (K222455). This document focuses on demonstrating substantial equivalence to existing predicate devices through non-clinical performance testing.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Standard Applied | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Static Axial Compression | ASTM F2077 | "The results demonstrate that the subject Calibrate LTX Interbody System is substantially equivalent to other predicate devices for nonclinical testing." |
| Mechanical Performance | Dynamic Axial Compression | ASTM F2077 | "The results demonstrate that the subject Calibrate LTX Interbody System is substantially equivalent to other predicate devices for nonclinical testing." |
| Mechanical Performance | Static Compression Shear | ASTM F2077 | "The results demonstrate that the subject Calibrate LTX Interbody System is substantially equivalent to other predicate devices for nonclinical testing." |
| Mechanical Performance | Dynamic Compression Shear | ASTM F2077 | "The results demonstrate that the subject Calibrate LTX Interbody System is substantially equivalent to other predicate devices for nonclinical testing." |
| Mechanical Performance | Push-out | ASTM F04-25-02-02 Draft | "The results demonstrate that the subject Calibrate LTX Interbody System is substantially equivalent to other predicate devices for nonclinical testing." |
| Mechanical Performance | Subsidence analysis | N/A (implied standard, likely in accordance with accepted engineering practices for medical devices) | "The results demonstrate that the subject Calibrate LTX Interbody System is substantially equivalent to other predicate devices for nonclinical testing." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices tested) for each non-clinical test. It only states that a set of "nonclinical testing" was performed.
- Sample Size: Not specified for individual tests.
- Data Provenance: The data is from non-clinical testing performed by the manufacturer, Alphatec Spine, Inc. The country of origin is not explicitly stated, but the company is based in Carlsbad, California, USA, suggesting the testing was likely conducted in the US or under similar regulatory/quality standards. It is retrospective in the sense that the testing was completed before the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the provided documentation describes non-clinical performance testing of a medical device, not a study involving human subjects or requiring expert-established ground truth for a test set. The "ground truth" for these tests would be the established engineering and materials science principles and the results obtained from standardized testing methods.
4. Adjudication Method for the Test Set
This is not applicable as the described study is non-clinical performance testing and does not involve human readers, diagnostic interpretations, or a need for adjudication.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. The document explicitly states under "Clinical Information": "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This device is not an AI-powered diagnostic tool, but rather an implantable medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This device is a physical interbody fusion system, not a software algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance tests is based on established engineering standards and material properties. For example, ASTM F2077 specifies standardized methods for static and dynamic compression and shear testing of intervertebral body fusion devices, and the acceptable performance limits are derived from these standards and the comparison to predicate devices. The "Draft" for the Push-out test suggests a recognized or developing standard.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of this non-clinical performance testing for a physical implantable device. The device itself is not "trained" like a machine learning algorithm.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons as #8.
§ 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.