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Calibrate LTX Interbody System

The Calibrate LTX Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of a symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Additionally, the Calibrate LTX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

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 to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

Calibrate LTX spacers expanded greater than 20° have integrated fixation tabs and must be used with LTX bone screws in addition to supplemental fixation. Calibrate LTX spacers without integrated fixation tabs may be used with AMP-LTX System as integrated fixation in addition to supplemental fixation.

Calibrate NanoTec LTX Interbody System

The Calibrate LTX Interbody System with advanced NanoTec surface treatment is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of a symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/ or thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Additionally, the Calibrate NanoTec LTX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The Calibrate NanoTec LTX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

Calibrate NanoTec LTX spacers expanded greater than 20° have integrated fixation tabs and must be used with AMP-LTX bone screws in addition to supplemental fixation. Calibrate NanoTec LTX spacers without integrated fixation tabs may be used with AMP-LTX System as integrated fixation in addition to supplemental fixation.

The subject Calibrate LTX Interbody Systems are lordotic expandable thoracolumbar intervertebral body fusion systems designed to be inserted through a lateral or anterolateral surgical approach. The subject interbody spacers are manufactured from titanium alloy (Ti-6Al-4V ELD per ASTM F136. The subject Calibrate NanoTec LTX Interbody System interbody implant endplate surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The Calibrate LTX Interbody Systems consist 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 anti-migration teeth and grit-blast treatment on the bone-contacting endplate surfaces. Certain Calibrate LTX Interbody Systems' offerings also accept fixation bone screws manufactured from titanium alloy per ASTM F136.

The purpose of this Traditional 510(k) is to receive clearance for the new sizes of the modified design of the interbody spacer, including a sterile offering of interbody spacer with hydroxyapatite surface treatment, sterile offering of AMP-LTX anti-migration plate and expanded indications for use for the Calibrate LTX Interbody System, previously cleared in K223611.

This looks like a 510(k) clearance letter and summary for a medical device, specifically the "Calibrate LTX Interbody System" and "Calibrate NanoTec LTX Interbody System". This type of document declares substantial equivalence to predicate devices, meaning it doesn't typically include acceptance criteria or detailed study results for a new device's performance against specific metrics in the way a PMA application or a clinical trial report would.

Here's an explanation based on the provided text:

• No acceptance criteria or study data for the device's performance against predefined metrics are present in this document.
• The document explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This strongly indicates that a clinical study designed to test the device's performance against specific acceptance criteria (like sensitivity, specificity, accuracy, etc.) was not performed or submitted for this 510(k) clearance.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and study details.

Instead, I can explain why this information is absent in this document and what was used for clearance:

This 510(k) submission relies on "Substantial Equivalence" to previously cleared predicate devices. This means the manufacturer demonstrated that the new device (Calibrate LTX Interbody System) is as safe and effective as a legally marketed predicate device (e.g., NuVasive Thoracolumbar Interbody Systems and NuVasive Attrax Putty - K203714, among others).

The "performance data" section in the document, under "VII. PERFORMANCE DATA", states:

• "An engineering analysis was utilized to determine that no new worst-case implants are being introduced compared to the predicate devices to support clearance of Calibrate LTX Interbody Systems."
• "The engineering analysis demonstrates that the subject Calibrate LTX Interbody Systems are substantially equivalent to other predicate devices for nonclinical testing."

This implies that the clearance was based on:

1. Bench testing and non-clinical performance data: This would typically involve mechanical testing (e.g., static and fatigue strength, expulsion resistance), material characterization, and potentially biocompatibility testing to ensure the device meets established standards and performs comparably to or better than the predicate devices. The document refers to "engineering analysis" and "nonclinical testing" as the basis for demonstrating substantial equivalence. It does not provide specific acceptance criteria or results from these tests in this summary, but they would have been submitted to the FDA.
2. Comparison of technological characteristics: The document explicitly states, "The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function, and technology and it was demonstrated that they are substantially equivalent."

In summary, based on the provided document:

• No acceptance criteria or specific device performance data (like sensitivity, specificity, accuracy for an AI system) are detailed because this is a 510(k) clearance based on substantial equivalence, not a new clinical efficacy study.
• No information on sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies for clinical performance is available here. This type of data would be required for devices where clinical performance is a primary metric for safety and effectiveness, often under a PMA pathway or for novel AI/software as a medical device (SaMD) requiring significant de novo clinical validation.

This document focuses on the mechanical and material equivalence of spinal implants to existing ones, rather than the performance of a diagnostic or AI algorithm.

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The Calibrate LTX Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of a symptomative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and or thoracic disc herniation (myelopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Additionally, the Calibrate LTX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

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 to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone marrow aspirate and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

Calibrate LTX spacers expanded greater than 20° must be used with the provided bone screws in addition to supplemental fixation. Calibrate LTX spacers without integrated fixation features may be used with AMP-X System as integrated fixation 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. 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 anti-migration 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.

This purpose of this 510(k) is to receive clearance for an anti-migration plate ("AMP-X") which may be used with certain LTX interbody offerings. AMP-X includes fixation plates. center locking screws, and bone screws manufactured from titanium alloy per ASTM F136. Additionally, the purpose of this 510(k) is to receive clearance for expanded indications for the treatment of degenerative spondylolisthesis, multilevel degenerative scoliosis, spinal stenosis, and sagittal deformity, and use of allogenic bone consisting of cortical bone, as well as allogenic bone consisting of demineralized allograft bone with bone marrow aspirate.

The provided text does not contain information about acceptance criteria or the study that proves a device (in the context of an AI-powered medical device) meets those criteria. The document is an FDA 510(k) clearance letter for the Calibrate LTX Interbody System, which is a spinal fusion device, not an AI or software device.

Therefore, I cannot populate the table or answer the specific questions related to AI device performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.

The document discusses non-clinical testing performed for the interbody system:

• Dynamic Axial Compression (per ASTM F2077)
• Dynamic Compression-Shear (per ASTM F2077)
• Static Screw Push-Out Testing

It concludes that "Since the technological characteristics of the subject Calibrate LTX Interbody System is substantially equivalent to the predicate systems, no further clinical or non-clinical testing is required to support the expanded indications for use of the subject system." and "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This further indicates that the requested information for AI device performance is not present.

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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

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.

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