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When used as an interbody fusion device, the TruLift® Lateral Expandable Spacer 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® Lateral Expandable Spacer can also be connected to the Lateral Buttress Plate System by a set screw.

The Lateral Buttress Plate System is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The Lateral Buttress Plate System is not intended for use in load-bearing applications. The Lateral Buttress Plate System can also be connected to the TruLift® Lateral Spacer System by a set screw. It may be used with other anterior, anterolateral or posterior spinal systems.

The TruLift® Lateral 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. 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.

The Lateral Buttress Plate System consists of plates and bone screws. The Lateral Buttress Plate System is also intended to provide stabilization and to assist in the development of a solid spinal fusion to the anterior portion of the lumbar vertebral body. The Lateral Buttress Plate System is intended to be used in conjunction with traditional supplemental fixation which includes other anterior, or anterolateral spinal systems made of compatible materials.

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® Lateral Expandable Spacer & Lateral Buttress Plate System components with components from any other system or manufacturer. The TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System components should never be reused under any circumstances.

The provided FDA 510(k) clearance letter for the TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document is a regulatory clearance letter, which confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It focuses on the administrative and regulatory aspects of the clearance, such as:

• Device Name: TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System
• Regulation Number & Name: 21 CFR 888.3080, Intervertebral Body Fusion Device
• Regulatory Class: Class II
• Product Code: ODP, KWQ
• Predicate Devices: Life Spine ProLift Lateral Expandable Cage System (K221806), Life Spine Trulift Lateral Modular 1-Hole Buttress Plate (K221806), Life Spine ProLift HELO Expandable Spacer (K210061), Astura Sirion Lateral Lumbar Plate System (K202495), Life Spine ProLift Lateral Fixated (K200338).
• Indications for Use: Detailed description of the conditions and patient types for which the device is intended.
• Technological Characteristics: States that the device is substantially equivalent in design, materials, indications for use, and sizing.
• Materials: Titanium alloy (Ti-6Al-4V ELI) as per ASTM F136.
• Performance Data: A brief statement indicating that mechanical performance has not changed and the worst-case scenario remains the same, implying equivalence to predicates.

Specifically, the document states:

"Through the Comparison Analysis it is determined that the mechanical performance has not change as the worst case is still the same and therefore is substantially equivalent to the Life Spine ProLift Lateral Expandable Cage System (K221806) & Life Spine Trulift Lateral Modular 1-Hole Buttress Plate (K221806)."

This statement implies that the device's performance was assessed by comparing it to the predicate devices, likely through mechanical testing or analysis, to demonstrate that its performance is equivalent and that it meets the existing performance standards met by the predicates. However, the document does not elaborate on:

• Specific acceptance criteria: What quantitative or qualitative metrics were used to define "acceptable" mechanical performance.
• Detailed study methodology: How the "Comparison Analysis" was conducted.
• Actual reported device performance data: No specific values or results are provided.

Therefore, I cannot extract the requested information from the provided text. The information you're looking for (detailed acceptance criteria, specific study results, sample sizes, ground truth establishment, expert qualifications, etc.) would typically be found in the full 510(k) submission itself, which is a much more comprehensive document than the clearance letter.

To answer your request, I would need a different type of document, such as the actual performance testing report or a detailed summary of the premarket submission that includes these specific study details.

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When used as an interbody fusion device, the PROLIFT® Expandable Spacer 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 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. 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® Expandable Spacer System components with components from any other system or manufacturer. The PROLIFT® Expandable Spacer System components should never be reused under any circumstances.

The provided FDA 510(k) clearance letter for the ProLift Expandable Spacer System does not describe the specific acceptance criteria and study proving the device meets those criteria in the level of detail requested. This document primarily focuses on the regulatory aspects of substantial equivalence for a medical device (an intervertebral body fusion device), not a software or AI-based diagnostic tool, which typically entails the type of performance evaluation outlined in your request.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, and MRMC studies are not applicable or not present in this type of regulatory submission for a physical implant.

However, I can extract the information that is present and explain why other information is not available in this document.

Analysis of the Provided Document for Acceptance Criteria and Study Details

The provided document is an FDA 510(k) clearance letter for a medical device, specifically an intervertebral body fusion device (ProLift Expandable Spacer System). This type of clearance is based on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than a de novo approval that often requires extensive clinical performance data with specific acceptance criteria as you've requested for an AI/software device.

For a physical device like this, performance data typically refers to mechanical testing, biocompatibility, and sterilization validation, not diagnostic accuracy metrics.

Here's what can be gathered from the document, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria and reported device performance in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC). For this physical device, "performance" refers to mechanical properties and material characteristics.

What is present regarding "performance":

• Performance Data Section (Page 6): "Through the Comparison Analysis it is determined that the mechanical performance has not change as the worst case is still the same and therefore is substantially equivalent to the Life Spine ProLift Expandable Spacer System (K190488) and ProLift Micro Expandable Spacer System (K223430 & K212520)."

This indicates that the key "acceptance criterion" related to performance for this 510(k) submission was demonstrating that the mechanical performance of the new device is substantially equivalent to its predicate devices, meaning it performs similarly in relevant mechanical tests (e.g., strength, durability under load). No specific numerical acceptance values for mechanical performance are provided in this regulatory letter itself, as they would typically be detailed in the full 510(k) submission document.

2. Sample sizes used for the test set and the data provenance

• Not applicable/Not provided in this document. For a physical mechanical device, "test set" in the context of AI/software performance is not relevant. Mechanical testing would involve a certain number of device samples, but this is not typically referred to as a "test set" in the same way. The document does not specify the number of devices or test conditions used for mechanical performance comparison. Data provenance (country of origin, retrospective/prospective) is also not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not provided in this document. "Ground truth" established by experts (like radiologists for imaging devices) is for diagnostic devices where human interpretation is being evaluated or augmented. For an intervertebral body fusion device, the "ground truth" of its mechanical properties would be established through engineering tests following industry standards, not expert consensus on interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided in this document. Adjudication methods are relevant for resolving discrepancies in human expert interpretations, which is not the type of evaluation described for this device.

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

• Not applicable/Not provided in this document. MRMC studies are specific to evaluating diagnostic accuracy, especially for AI-assisted image interpretation. This device is a physical implant, not a diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable/Not provided in this document. This applies to algorithms. The device is a physical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For this device, the "ground truth" for its performance would implicitly be based on engineering standards, material specifications (e.g., ASTM F136 for Ti-6Al-4V ELI), and biomechanical testing standards to ensure it meets safety and functional requirements equivalent to established devices. The document explicitly mentions "mechanical performance" and "material."

8. The sample size for the training set

• Not applicable/Not provided in this document. "Training set" is a concept for machine learning models.

9. How the ground truth for the training set was established

• Not applicable/Not provided in this document.

In summary, the provided FDA 510(k) clearance letter for the ProLift Expandable Spacer System is for a physical medical implant, not an AI or software-based diagnostic device. Therefore, the detailed performance study information typically associated with AI/software (acceptance criteria tables, expert adjudication, MRMC studies, ground truth establishment for training/test sets) is not present and generally not part of a 510(k) submission for this class of device.

The "study" that proves the device meets the (unspecified but implied mechanical) acceptance criteria is the "Comparison Analysis" mentioned on Page 6, which determined that the mechanical performance of the new device is substantially equivalent to the predicate devices. The specifics of this comparison (e.g., number of tests, exact parameters) would be in the full 510(k) submission, not typically in the public clearance letter itself.

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The ProLift Pivot Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiquous 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® Pivot Expandable System is available in a range of sizes and footprints and can expand to the desired height (8mm to 15mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6AI-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.

The ProLift® Pivot Expandable Spacer System is available in a range of sizes and footprints and can expand to the desired height (8mm to 15mm) to suit the individual pathology and anatomical conditions of the patient.

• The ProLift implants are fabricated and manufactured from titanium alloy (Ti-6Al-. 4V ELI) as described by ASTM F136.
  . The ProLift Pivot-U 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 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 ProLift Pivot 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® Pivot Expandable Spacer System components with components from any other system or manufacturer.

This document pertains to the clearance of a medical device, the ProLift Pivot Expandable Spacer System, not an AI/ML powered device. As such, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for AI models is not applicable to this submission.

The document discusses the substantial equivalence of the ProLift Pivot Expandable Spacer System to predicate devices based on design, materials, indications for use, sizing, and mechanical performance.

Here's a breakdown of the relevant information provided:

1. A table of acceptance criteria and the reported device performance:
   The document does not present a formal table of acceptance criteria with reported performance values in the context of an AI/ML study. Instead, it states that "Performance Data: Static compression shear, Static Axial Compression, Dynamic Compression Shear and Dynamic Axial Compression according to ASTM F2077 was presented to demonstrate the substantial equivalency of the Life Spine ProLift Expandable Spacer System (K190488)." This implies that the acceptance criteria are adherence to the mechanical testing standards outlined in ASTM F2077, and the device performance met these standards to demonstrate substantial equivalence to the predicate device (K190488).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a medical device clearance based on mechanical testing, not an AI/ML study involving a test dataset of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in the context of this device refers to the mechanical properties and performance standards defined by ASTM F2077 and assessed through engineering tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable, as this is not an AI-assisted diagnostic or therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The ground truth for this device's performance is established by the mechanical testing standards outlined in ASTM F2077. This standard defines the methodologies and expected performance for intervertebral body fusion devices under various loading conditions (static compression shear, static axial compression, dynamic compression shear, dynamic axial compression).

8. The sample size for the training set: Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

In summary, the document describes the clearance of a physical medical implant (ProLift Pivot Expandable Spacer System) based on its substantial equivalence to previously cleared devices, supported by mechanical performance data against recognized ASTM standards.

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The Cervical Plating system is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: 1.) Deqenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); 2). Spondylolisthesis; 3.) Trauma (including fractures or dislocations); 4.) Spinal cord stenosis; 5.) Deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); 6.) Tumors; 7.) Pseudarthrosis; and/or 8.) Failed previous fusions.

When used and connected to a Life Spine cervical interbody, the Cervical Plating System can only be used to treat cervical degenerative disc disease.

Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.

The Life Spine Cervical Plating System consists of a variety of sizes of plates, screws, and associated instruments. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the cervical spine using an anterior approach.

The Life Spine Cervical Plating System implant components are made from titanium alloy described by ASTM F136. Stainless steel and titanium implant components must not be used together in a construct.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the components with components from any other system or manufacturer. The Cervical Plating System components should never be reused under any circumstances.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cervical Plating System, specifically noting what information is available and what is not present in the given document.

It's important to understand that the provided text is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study report for AI/software devices. Therefore, many of your requested items, particularly those related to AI algorithm performance, human expert evaluation, and training data specifics, will not be found as this is a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

This information is not provided in the document. For mechanical testing of physical implants, "sample size" would refer to the number of implants tested per configuration. The document does not specify these details or data provenance beyond stating that testing was done according to ASTM F1717.

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/provided. This device is a physical implant, not an AI/software device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is the physical properties and mechanical performance determined through standardized experimental testing, not human expert consensus on medical images.

4. Adjudication method for the test set

This information is not applicable/provided. No adjudication method is mentioned as this is not a study involving human interpretation of data for medical diagnosis.

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

This information is not applicable/provided. This document concerns a physical medical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be part of this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/provided. This document concerns a physical medical implant, not an algorithm, so standalone algorithm performance is irrelevant.

7. The type of ground truth used

The "ground truth" for this device's performance is established through standardized mechanical testing according to ASTM F1717. This provides quantitative data on the device's physical properties and performance under various loads, which is compared against established engineering standards and the performance of predicate devices.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" in the context of this device as it is a physical implant, not a machine learning model.

9. How the ground truth for the training set was established

This information is not applicable/provided. As there is no training set mentioned, the method of establishing its ground truth is also not relevant.

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When used as an interbody fusion device, the PROLIFT® Wedge 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 is intended to be used with autograft bone graft and/or allogeners 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® Wedge Expandable Spacer System is available in a range of sizes and footprints and can expand to the desired lordosis (0-15°) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6AI-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® Wedge Expandable Spacer System components with components from any other system or manufacturer. The PROLIFT® Wedge Expandable Spacer System components should never be reused under any circumstances.

The provided text describes a medical device called the "ProLift Wedge Expandable Spacer System" and its 510(k) submission to the FDA. This document is a regulatory clearance letter and summary, not a study report that would typically include detailed acceptance criteria and performance data for an AI/ML medical device.

Therefore, the information required to populate the table and answer your specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies for an AI/ML algorithm is not present in the provided text.

The document states:

• "Performance Data: Static compression, dynamic compression, static shear and dynamic shear testing according to ASTM F2077 & load induced subsidence and static expulsion according to F2267, was presented to demonstrate the substantial equivalency of the Life Spine ProLift Wedge Expandable Spacer System (K203361)." This indicates mechanical testing was performed for a physical intervertebral body fusion device, not a software algorithm.

Based on the information provided, I cannot answer the questions as they pertain to the evaluation of an AI/ML device.

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The ARx® SAI Implant System is intended for sacroiliac joint fusion for the following conditions:
· Sacrolliac joint dysfunction and degenerative sacrollitis include conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
· To augment immobilization of the sacroiliac ioint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
When connected to Arx® Spinal System, the ARx SAI Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
· Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed

• by patient history and radiographic studies.
• · Spondylolisthesis
• · Trauma (i.e., fracture or dislocation)
• · Spinal Stenosis
• · Deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis)
• · Spinal tumor
• Pseudarthrosis
• · Failed previous fusion

The ARx® SAI Implant System consists of an assortment of implants in various lengths and diameters, and associated instruments sets for both Open and minimally invasive [MIS] approaches. The bone screw, head, and taper lock are assembled during manufacturing to create the ARx® SAI Implant System screw assembly component. It is intended to provide sacroiliac joint fusion in the sacral alar iliac (SAI) trajectory, and foundational stabilization when connected to pedicle screw fixation systems in both the SAI and the Iliac trajectories. Additionally, ARx® SAI Implant System can be placed into the S1 pedicle. It is designed for connection to the Arx Pedicle Screw System 5.5mm or 6.0mm diameter titanium alloy or cobalt chrome alloy spinal fixation rods. The ARx® SAI Implant System implant components are made from Titanium alloy (Ti- 6A1-4V ELI) as described by ASTM Fl36.

This document is a 510(k) premarket notification for a medical device called the ARx® SAI Implant System. It presents information to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Based on the provided text, there is no study described that involves acceptance criteria, device performance metrics, or any of the detailed questions related to AI/algorithm performance (sample size, ground truth, expert involvement, MRMC study, standalone performance).

The document focuses on the mechanical performance of the implant system and its substantial equivalence to existing devices, not on the performance of a diagnostic or assistive algorithm.

The "Performance Data" section states:
"An engineering analysis to compare technological features and finite element analysis for cantilever bending and torque to failure were performed between the ARx® SAI Implant System and primary predicate device. Screw pullout and driving torque testing per ASTM F543 were performed. All performance data demonstrates substantial equivalence to the predicate devices."

This indicates that mechanical tests were conducted, and the results demonstrated substantial equivalence. However, specific acceptance criteria values and reported performance values are not detailed in this extract. The study design described is a comparison of mechanical properties with predicate devices, not a clinical study involving human or image-based data for an AI or diagnostic tool.

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The ARx® Spinal System implants are non-cervical spinal fixation devices intended for posterior spine (T1 to S2/ilium) and posterior hook fixation (T1-L5) in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scoliosis. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When used as a posterior spine thoracic/lumbar system, the ARx® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). (2) trauma (i.e. fracture or dislocation), (3) curvatures and spinal deformity (scoliosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (pseudarthrosis), (6) spinal stenosis, (7) spondylolisthesis.

In order to achieve additional levels of fixation in skeletally mature patients, the ARx® Spinal System 5.5/6.0 rod system may be connected to the Solstice OccipitoCervicoThoracic Fixation System's 3.5mm rod.

The ARx® Spinal System consists of screws and longitudinal rods intended to provide temporary stabilization and immobilization following surgery to fuse a portion of the thoracic, lumbar, and/or sacral spine. The ARX® Spinal System consists of an assortment of connectors, cross connectors, rods, hooks and screws. The bone screw, head, and taper lock are assembled together during manufacturing to create the ARX® Spinal System screw assembly component. The ARX® Spinal System implant components are made from titanium alloy (Ti- 6Al-4V ELI) as described by ASTM F136 and Cobalt Chrome (Co-28Cr-6Mo) as described by ASTM F1537. Do not use any of the ARX® Spinal System components with the components from any other system or manufacturer.

The provided text is a 510(k) summary for a medical device called the "ARx MIS Spinal Screw System." It does not contain information about studies related to software performance, AI algorithms, or diagnostic accuracy that would typically have acceptance criteria, test sets, expert adjudication, or MRMC studies.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Indications for Use: The ARx MIS Spinal Screw System has similar intended uses for posterior spinal fixation in various conditions.
• Design and Function: The device's design and how it works are comparable to the predicate devices.
• Materials: The device uses materials (titanium alloy (Ti-6Al-4V ELI) and cobalt chrome (Co-28Cr-6Mo)) that are either the same as or comparable to those used in predicate devices.
• Mechanical Performance: The document states that dimensional comparisons were performed to demonstrate substantial equivalency, implying mechanical testing was done to ensure the device performs similarly to the predicate.

Therefore, the requested information regarding acceptance criteria for device performance in the context of AI, diagnostic accuracy, or human reader improvement is not applicable to this document.

The "study" referenced is a comparison study to demonstrate substantial equivalency, not a clinical trial or performance study against specific acceptance criteria for a diagnostic or AI-driven device.

Here's a breakdown of why many of your questions cannot be answered by this document:

1. A table of acceptance criteria and the reported device performance: Not applicable. This is not a study assessing performance against specific clinical or computational metrics. The "performance data" mentioned refers to dimensional comparison, not diagnostic accuracy or AI performance.
2. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of AI or diagnostic performance.
3. Number of experts used to establish the ground truth... and the qualifications: Not applicable. Ground truth for AI or diagnostic performance is not relevant here.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

This document is a regulatory submission demonstrating fundamental safety and effectiveness through substantial equivalence for a physical implantable device, not an AI or diagnostic software.

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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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The Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Pro-Link® Ti Barbs Cervical Spacer System is to be used with autogenous bone graft and implanted via an anterior approach.

The Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System is an interbody fusion device intended to be used with two (2) titanium bone barbs. The Pro-Link® Ti Barbs Cervical Spacer System must be used with supplemental fixation (e.g., anterior plate, posterior cervical screw).

The Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System is offered in various device configurations based on surgical approach and patient anatomy. The Pro-Link® Ti Barbs Cervical Spacer System includes an interbody, containing a titanium alloy locking mechanism, which is implanted with two (2) titanium bone barbs. The interbody is offered in either PEEK (Polyetheretherketone) or in titanium alloy (Ti 6Al-4V ELI). The Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System must be used with supplemental fixation (e.g., anterior plate, posterior cervical screws).

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System components with components from any other system or manufacturer. The Pro-Link® Ti Barbs Cervical Spacer System components should never be reused under any circumstances.

I apologize, but the provided text from the FDA 510(k) clearance letter and related documents for the Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System does not contain information about acceptance criteria, device performance studies, or the methodologies typically associated with evaluating AI/ML-based medical devices (such as sample sizes, ground truth establishment, expert qualifications, or MRMC studies).

The document is a clearance letter for a traditional orthopedic implant (intervertebral body fusion device), not a software or AI-driven device. Therefore, it focuses on demonstrating substantial equivalence to predicate physical devices based on design, materials, indications for use, and performance, primarily through a comparison of physical and mechanical properties, not through clinical or reader studies that would generate the types of data you are asking for.

The relevant sections of your request (2 through 9) are specific to the evaluation of AI/ML software devices, which are not applicable to the information provided in this document.

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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 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.

The provided text describes a medical device, the ProLift® Micro Expandable Spacer System, and its clearance through a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical performance data to establish specific acceptance criteria for device performance in a clinical setting.

Therefore, the document does not contain information typically found in a study that proves a device meets acceptance criteria related to AI/algorithm performance, human reader improvement, or detailed clinical efficacy. It focuses on the mechanical and material equivalence of the new device to existing ones.

Based on the provided text, I can extract information relevant to the device's technical specifications and the basis for its substantial equivalence, but not the specific clinical performance criteria, study design, or AI-related metrics requested in the prompt.

Here's an analysis of the information not present in the provided text, related to your specific questions:

• Acceptance Criteria and Reported Device Performance (Table): The document does not describe clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) or report specific clinical performance metrics. It focuses on mechanical testing for substantial equivalence.
• Sample Size for Test Set and Data Provenance: No clinical test set or patient data is mentioned as part of a performance study.
• Number of Experts and Qualifications: No experts were used to establish ground truth for a clinical test set because no such study is described.
• Adjudication Method: Not applicable as no clinical test set with ground truth is discussed.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No such study is mentioned. The document is about a physical medical implant, not an AI or diagnostic tool that would directly assist human readers.
• Standalone Performance (Algorithm Only): Not applicable, as this is a physical implant, not an algorithm.
• Type of Ground Truth Used: Not applicable for a performance study in the context of your questions. The "ground truth" for this device relates to its mechanical integrity and biocompatibility, which are verified through material specifications and mechanical testing rather than clinical outcomes established by experts or pathology.
• Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable as this is not an AI/machine learning device.

Information that is extractable from the document, though not directly answering your specific questions about AI/clinical performance studies:

The document describes the mechanical performance data used to demonstrate substantial equivalence, which is a different kind of "acceptance criterion" based on engineering standards:

• Acceptance Criteria/Performance (Mechanical):
  • Type of Testing: Static Axial Compression, Dynamic Axial Compression, Static Shear, and Dynamic Shear testing.
  • Standard: According to ASTM F2077.
  • Purpose: To demonstrate substantial equivalency to the predicate device (Life Spine ProLift Micro Expandable System K212520).
  • Reported Performance: The document states that this testing "was presented to demonstrate the substantial equivalency," implying the device met the requirements of the standard consistent with the predicate. Specific numerical results are not provided in this summary.

In summary, the provided FDA 510(k) document is for a physical medical device (an expandable spinal spacer) and therefore does not contain the type of information requested about AI/algorithm performance studies, human-in-the-loop studies, or clinical ground truth establishment.

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