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When used as an interbody fusion device, the TruLift® Micro Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

When used as an interbody fusion device, the TruLift® Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The TruLift® Micro Expandable System is available in a range of sizes and footprints and can expand to the desired height (8mm to 16mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) and Cobalt Chrome (CO-26Cr-6MO) as described by ASTM F136and ASTM F1537. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration. All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the TruLift® Micro Expandable System components with components from any other system or manufacturer. The TruLift® Micro Expandable System components should never be reused under any circumstances.

The TRULIFT® Expandable Spacer System is available in a range of sizes and footprints and can expand to the desired height (8mm to 16mm) to suit the individual pathology and anatomical conditions of the patient.
· The 8mm-9mm width implants are fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) and Cobalt Chrome (CO-26Cr-6MO) as described by ASTM F136 & ASTM F1537
· The 10mm-12mm width implants are fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136.

The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the TRULIFT® Expandable Spacer System components with components from any other system or manufacturer. The TRULIFT® Expandable Spacer System components should never be reused under any circumstances.

This FDA 510(k) summary describes the TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System, an intervertebral body fusion device. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable as this pertains to a physical orthopedic implant, not an AI/ML algorithm or software.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of medical device generally revolve around demonstrating mechanical performance equivalence to legally marketed predicate devices. The reported performance refers to the results of these mechanical tests.

The study that proves the device meets the acceptance criteria is the demonstration of substantial equivalence through mechanical performance testing (Static Axial Compression, Dynamic Axial Compression, Static Shear, and Dynamic Shear according to ASTM F2077), and comparison of materials, design, and indications for use to legally marketed predicate devices.

Information Not Applicable to This Device (AI/ML Specifics)

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical implant, not an AI/ML algorithm evaluated on a data set. The "test set" here refers to physical specimens subject to mechanical testing. The provenance isn't described in terms of "country of origin of data" but rather the standards (ASTM F2077) governing the testing.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for an orthopedic implant's mechanical performance is established by standardized material and mechanical tests (e.g., ASTM standards), not expert interpretation of images or clinical data.
4. Adjudication method: Not applicable for a physical implant's mechanical testing.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is a physical medical device, not an AI assistance tool for human readers.
6. Standalone (i.e. algorithm only without human-in-the-loop performance): Not applicable. This is a physical implant.
7. The type of ground truth used: For mechanical properties, the "ground truth" is defined by the physical properties measured under standardized testing conditions and compared against performance of predicate devices. For biocompatibility, it's the established safety profile of the materials. For indications for use, it's alignment with predicate devices.
8. The sample size for the training set: Not applicable. This is not an AI/ML model that undergoes "training."
9. How the ground truth for the training set was established: Not applicable.

In summary, for K232611, the "study" demonstrating device acceptance is the suite of mechanical tests and comparative analysis against predicate devices, which collectively establish substantial equivalence as required for 510(k) clearance by the FDA. The specifics of these mechanical tests (e.g., number of samples per test type, detailed results) are typically found in the full 510(k) submission, not in the public summary.

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When used as an interbody fusion device, the ProLift® Micro Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The ProLift® Micro Expandable System is available in a range of sizes and footprints and can expand to the desired height (8mm to 16mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the ProLift® Micro Expandable System components with components from any other system or manufacturer. The ProLift® Micro Expandable System components should never be reused under any circumstances.

This looks like a medical device submission to the FDA, specifically concerning an intervertebral body fusion device. The document primarily focuses on establishing substantial equivalence to previously cleared devices rather than describing a study with acceptance criteria and device performance in the way one might for an AI/software device.

Therefore, many of the requested categories for AI/software-centric studies (like MRMC studies, ground truth establishment for training sets, etc.) are not applicable to this type of submission. The "performance data" here refers to mechanical testing of the physical device, not the performance of an algorithm.

Here's an analysis based on the provided text, indicating where information is not available or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the context of clinical or AI performance. Instead, it refers to mechanical performance tests against ASTM standards to demonstrate substantial equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Test Set): Not applicable for a software/AI test set. The document refers to mechanical testing of physical device samples. No information on the number of physical samples tested is provided in this summary.
• Data Provenance: Not applicable in the context of data for an AI/software device. The tests are for mechanical properties of the device itself.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Not Applicable. This is a physical medical device. Ground truth as typically understood for AI (e.g., expert labels on images) is not relevant to this submission.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. This is a physical hardware device, not an AI/software device. An MRMC study is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• Not Applicable for AI/Software. For the physical device, the "ground truth" or reference standards are the ASTM material and mechanical performance standards (ASTM F136, F2077, F2267) and the characteristics of the predicate devices.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/software device; there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. See point 8.

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When used as an interbody fusion device, the ProLift® Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The ProLift Expandable System is available in a range of sizes and footprints and can expand to the desired height (8mm to 16mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

This document describes the ProLift® Expandable System, an intervertebral body fusion device. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it is a 510(k) Pre-market Notification for a medical device submitted to the FDA, demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information. The document explicitly states: "No additional testing was performed, see comparison analysis." This indicates that the approval was based on demonstrating the new device's substantial equivalence to a previously approved device (the predicate device) through a comparison analysis of design, materials, indications for use, and mechanical performance, rather than through new performance studies with specific acceptance criteria.

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