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Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF TL and PL Cages are indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.

The CoAlign Innovations AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF TL and PL Cages are to be used with autogenous bone graft.

The CoAlign Innovations Accul.IF® TL and PL Cage device is an expandable interbody fusion cage manufactured from implant grade Titanium alloy (TI6Al4V ELI) as per ASTM F136-08. Stainless Steel (316 LVM) as per ASTM F138-08, and Silicone Rubber (MED-4870). The device is inserted in unexpanded state with a delivery handle and expanded in-situ to the required height via 2 hydraulic cylinder and piston arrangement using a hydraulic system comprising disposable flexible expansion tubing set and inflation syringe. The device locks in 1mm increments as it expands.

The AccuLIF TL and PL Cage comes in three sizes which are expandable from 6mm to 9mm, from 8mm to 12mm. and from 10mm to 16mm in 1mm increments . As well each size comes in two shapes, crescent and straight and each shape comes in two different footprints 11mm x 25mm and 13mm x 25mm for the crescent shape and 11mm x 22mm and 11mm x 25mm for the straight shape. Also the TL crescent shape comes in an 8 degree lordotic model as well as a 0 degree model for a total of 18 TL and PL models. The device has fixation ridges on the top and bottom surface. It also has a graft opening window which extends from the bottom surface to the top surface. The device has a proximal boss which has a threaded connection port for connecting to the inserter and a fluid port for transporting the expansion fluid.

The purpose of the special 510(k) is to introduce several design modifications to increase the surface area of the Top Plate.

The provided text is a 510(k) summary for the CoAlign Innovations AccuLIF TL and PL Cage, which is an intervertebral body fusion device.

Based on the provided text, the device does not involve any AI or software for medical image analysis or interpretation. Therefore, it is not applicable to describe acceptance criteria or a study that proves the device meets those criteria in the context of AI performance.

The document describes a medical device (an expandable interbody fusion cage) and its 510(k) submission for design modifications. The "Discussion of Testing" section explicitly states:

• "The following non-clinical tests were conducted: Surgical technique validation. conducted in the same manner as the predicate surgical technique validation."

This indicates that the testing focused on the mechanical and surgical aspects of the physical device, not on diagnostic performance or AI accuracy. The 510(k) process here is about demonstrating "substantial equivalence" of a modified physical device to a predicate device, primarily through non-clinical (e.g., bench) testing and comparison of technological characteristics.

Therefore, the following information points from your request are not present or applicable in this submission:

1. A table of acceptance criteria and the reported device performance (in the context of AI).
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI.
8. The sample size for the training set (for AI).
9. How the ground truth for the training set was established (for AI).

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Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF XL Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.

The CoAlign Innovations AccuLIF XL Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF XL Cage is to be used with autogenous bone graft.

The AccuLIF XL Cage acts as a spacer to maintain proper intervertebral spacing and angulation following discectomy. The Accul.JF XL Cage is manufactured from TI6A14V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-08, PEEK (Invibio Optima LT1) as per ASTM F2026-07, and Silicone Rubber (MED-4870). The device is inserted in unexpanded state with an articulating delivery handle and expanded in-situ to the required height via 2 hydraulic cylinder and piston arrangement using a hydraulic system comprising disposable flexible expansion tubing set and inflation syringe. The device locks in Imm increments as it expands. The AccuLIF XL Cage comes in 6 to 9mm, 8 to 12mm and 10 to 16mm sizes. The device has fixation ridges on the top and bottom surface. In addition each size comes in 8 foot prints 1) 45mm length x 18mm width, 2) 45mm length x 22mm width, 3) 50mm length x 18mm width, 4) 50mm length x 22mm width. 5) 55mm length x 18mm width, 6) 55mm length x 22mm width 7) 60mm length x 18mm width, and 8) 60mm length x 22mm width. It also has a graft opening window which extends from the bottom surface to the top surface. The device has a proximal boss which has a threaded connection port for connecting to the inserter and a fluid port for transporting the expansion fluid

The provided text describes a 510(k) premarket notification for the CoAlign Innovations AccuLIF XL Cage, an intervertebral body fusion device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study that establishes acceptance criteria and then proves the device meets those criteria through new performance data.

Therefore, many of the requested categories related to clinical study design, sample sizes, expert involvement, and ground truth establishment cannot be answered directly from the provided text. The approach taken here is a comparative one based on existing data from predicate devices.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable. This submission relies on demonstrating substantial equivalence to predicate devices, not on a new clinical study with a distinct test set of patient data. The "testing" mentioned is non-clinical (surgical technique validation), not human patient data.

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

• Not applicable. No external experts were reported as used to establish ground truth for a test set of patient data. The FDA reviews the submission and determines substantial equivalence based on the provided technical and comparative data.

4. Adjudication method for the test set

• Not applicable. No test set of patient data requiring adjudication is mentioned.

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. This document describes a medical implant device, not an AI-assisted diagnostic tool.

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

• Not applicable. This document describes a medical implant device, not an algorithm or AI system.

7. The type of ground truth used

• Implied ground truth for substantial equivalence: For the purpose of this 510(k), the "ground truth" is that the predicate devices (AccuLIF XL Cage K130194 and AccuLIF TL-PEEK Cage K123281) have already been deemed safe and effective by the FDA. The current device's ground truth is its conformance to the performance, design, and material characteristics that made the predicates safe and effective.

8. The sample size for the training set

• Not applicable. This device is an implant, not a machine learning model. There is no concept of a "training set" in this context.

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

• Not applicable. As above, there is no training set for this type of device.

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Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF XL Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to SI. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.

The CoAlign Innovations AccuLIF XL Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF XL Cage is to be used with autogenous bone graft.

The AccuLIF XL Cage acts as a spacer to maintain proper intervertebral spacing and angulation following discectomy. The AccuLIF XL Cage is manufactured from TI6Al4V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-08, PEEK (Invibio Optima LTI) as per ASTM F2026-07, and Silicone Rubber (MED-4870). The device is inserted in unexpanded state with an articulating delivery handle and expanded in-situ to the required height via 2 hydraulic cylinder and piston arrangement using a hydraulic system comprising disposable flexible expansion tubing set and inflation syringe. The device locks in 1mm increments as it expands. The AccuLIF XL Cage comes in 6 to 9mm, 8 to 12mm and 10 to 16mm sizes. The device has fixation ridges on the top and bottom surface. In addition each size comes in 4 foot prints 1) 45mm length x 18mm width, 2) 45mm length x 22mm width, 3) 60mm length x 18mm width, and 4) 60mm length x 22mm width. It also has a graft opening window which extends from the bottom surface to the top surface. The device has a proximal boss which has a threaded connection port for connecting to the inserter and a fluid port for transporting the expansion fluid

The provided text describes a Special 510(k) submission for the CoAlign Innovations AccuLIF XL Cage, a medical device for intervertebral body fusion. This document focuses on the mechanical and material performance of the device rather than the performance of a diagnostic or AI-driven system. Therefore, many of the requested points related to AI studies, ground truth establishment, expert review, and sample sizes for training/test sets are not applicable to this type of device submission.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This submission is for a physical medical device (intervertebral cage) undergoing mechanical and material testing, not a digital device or AI algorithm with test data. The tests are laboratory-based mechanical evaluations as per ASTM standards, not clinical studies with patient data. The "test set" in this context refers to the physical devices tested, but specific numbers are not provided in the summary. The provenance is the testing laboratory.

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

• Not Applicable. As this is a mechanical device, "ground truth" is established by adherence to engineering performance standards (ASTM) and comparison to predicate devices, not by expert interpretation of data.

4. Adjudication method for the test set

• Not Applicable. There is no "adjudication" in the sense of reconciling expert opinions for this type of mechanical testing. Compliance is determined by whether the device meets the specified criteria in the ASTM standards.

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. This is not an AI-driven device, nor is it a diagnostic imaging device typically associated with MRMC studies.

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

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

7. The type of ground truth used

• The "ground truth" for this medical device submission is adherence to established ASTM (American Society for Testing and Materials) standards for mechanical performance of intervertebral body fusion devices, and demonstration of substantial equivalence to predicate devices in terms of design, function, materials, and intended use. The physical and mechanical properties outlined in these standards serve as the "truth" against which the device's performance is measured.

8. The sample size for the training set

• Not Applicable. There is no "training set" for a physical medical device in this context. The manufacturing process and design principles are based on engineering knowledge, material science, and regulatory requirements, not machine learning training.

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

• Not Applicable. As there is no training set, this question is not relevant.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study involved a series of non-clinical biomechanical tests conducted on the AccuLIF XL Cage. These tests were performed in accordance with recognized ASTM (American Society for Testing and Materials) standards, specifically:

• Dynamic Compression testing (ASTM F2077-03)
• Dynamic Shear testing (ASTM F2077-03)
• Static Compression testing (ASTM F2077-03)
• Static Shear testing (ASTM F2077-03)
• Static Subsidence testing (ASTM F2267-04)
• Static Expulsion testing (ASTM Draft Standard F-04.25.02.02)
• Surgical technique validation, which was conducted in the same manner as the predicate device's validation.

The conclusion of these tests was that the AccuLIF XL Cage was substantially equivalent to its predicate devices (AccuLIF-PEEK Cage K123281, AccuLIF TL Cage K1216835 and K113465, and the SEC Interbody Fusion Cage K093669). This substantial equivalence was based on shared indications for use, design, function, and materials of manufacture. The submission explicitly states that "the predicate device testing represented a worst case such that any minor differences do not impact device performance as compared to the predicates." This implies that the new device's performance met or exceeded the established safety and effectiveness profile of the already-approved predicate devices under the specified testing conditions.

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Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF TL-PEEK Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to SI. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondvlolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.

The CoAlign Innovations AccuLIF TL-PEEK Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF TL-PEEK Cage is to be used with autogenous bone graft.

The AccuLIF TL-PEEK Cage acts as a spacer to maintain proper intervertebral spacing and angulation following discectomy. The AccuLIF TL-PEEK Cage is manufactured from Tl6Al4V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-08, PEEK (Invibio Optima LT1) as per ASTM F2026-07, and Silicone Rubber (MED-4870). The device is inserted in unexpanded state with an articulating delivery handle and expanded in-situ to the required height via 2 hydraulic cylinder and piston arrangement using a hydraulic system comprising disposable flexible expansion tubing set and inflation syringe. The device locks in 1mm increments as it expands. The AccuLIF Cage comes in 6 to 9mm, 8 to 12mm and 10 to 16mm sizes. The device has fixation ridges on the top and bottom surface. It also has a graft opening window which extends from the bottom surface to the top surface. The device has a proximal boss which has a threaded connection port for connecting to the inserter and a fluid port for transporting the expansion fluid.

This document is a 510(k) Summary for the AccuLIF® TL-PEEK Cage, a spinal intervertebral body fixation orthosis. The submission seeks to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on mechanical testing to demonstrate the substantial equivalence of the AccuLIF TL-PEEK Cage to its predicates. The acceptance criteria are implicitly that the subject device's performance is comparable to or better than previously cleared predicate devices per the cited ASTM standards, and that minor differences do not raise new issues of safety and effectiveness.

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

• Sample Size for Test Set: The document does not specify the exact sample size (number of devices tested) for each of the non-clinical mechanical tests. It only lists the types of tests performed.
• Data Provenance: The data is from non-clinical (laboratory/mechanical) testing of the device, performed by the manufacturer, CoAlign Innovations. The provenance is internal testing, not patient-derived data, and therefore the concepts of country of origin or retrospective/prospective do not apply in this context.

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

This section is not applicable. The "ground truth" for mechanical testing is established by the defined test standards (e.g., ASTM F2077-03) and the measured physical properties of the device, not by expert consensus on clinical data.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 refer to human clinical review processes (e.g., for radiology reads), which are irrelevant for non-clinical mechanical device testing.

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 section is not applicable. The device is an intervertebral body fusion cage, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and analysis of human reader improvement with AI are not relevant.

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

This section is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for the "test set" (i.e., the non-clinical tests) is based on defined engineering standards (ASTM standards) and the measured physical properties and performance characteristics of the device and its predicate devices. The goal is to demonstrate that the new device meets the performance expectations already established by these standards and by the performance of the legally marketed predicate devices.

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical medical device, not an AI model that requires a training set.

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

This section is not applicable, as there is no "training set" for a physical medical device.

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Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF TL and PL Cages are indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.

The CoAlign Innovations AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF TL and PL Cages are to be used with autogenous bone graft.

The CoAlign Innovations AccuLIF® TL and PL Cage device is an expandable interbody fusion cage manufactured from implant grade Titanium alloy (TI6A14V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-08, and Silicone Rubber (MED-4870). The device is inserted in unexpanded state with a delivery handle and expanded in-situ to the required height via 2 hydraulic cylinder and piston arrangement using a hydraulic system comprising disposable flexible expansion tubing set and inflation syringe. The device locks in 1mm increments as it expands.

The AccuLIF TL and PL Cage comes in three sizes which are expandable from 6mm to 9mm, from 8mm to 12mm, and from 10mm to 16mm in 1mm increments . As well each size comes in two shapes, crescent and straight and each shape comes in two different footprints 11mm x 25mm and 13mm x 25mm for the crescent shape and 11mm x 22mm and 11mm x 25mm for the straight shape or a total of 12 models. The device has fixation ridges on the top and bottom surface. It also has a graft opening window which extends from the bottom surface to the top surface. The device has a proximal boss which has a threaded connection port for connecting to the inserter and a fluid port for transporting the expansion fluid.

The provided text describes the CoAlign Innovations AccuLIF® TL and PL Cage, an expandable interbody fusion cage. It details the device's description, indications for use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices. However, the document does NOT contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the manner requested by your prompt (e.g., performance metrics, sample sizes, ground truth establishment, or expert involvement).

The submission focuses on establishing "substantial equivalence" to legally marketed predicate devices, which is a common pathway for 510(k) clearance. This typically involves demonstrating that the new device has the same intended use and similar technological characteristics to a predicate device, and that any differences do not raise new questions of safety or effectiveness.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study demonstrating device performance against those criteria, as this information is not present in the provided 510(k) summary.

The document states that the following non-clinical tests were conducted to support the claim of substantial equivalence:

• Dynamic compression testing, conducted in accordance with ASTM F2077-03
• Dynamic shear testing, conducted in accordance with ASTM F2077-03
• Static compression testing, conducted in accordance with ASTM F2077-03
• Static shear testing, conducted in accordance with -ASTM F2077-03
• Static Subsidence testing, conducted in accordance with -ASTM F2267-04
• Static Expulsion testing, conducted in accordance with -ASTM Draft Standard F-04.25.02.02
• Surgical technique validation, conducted in the same manner as the predicate surgical technique validation.

The "Conclusions" section states: "The non-clinical test results demonstrate that any minor differences do not impact device performance as compared to the predicates." This is a general statement about meeting the requirements for substantial equivalence, not a detailed report of reaching specific acceptance criteria tied to performance metrics.

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The CoAlign Innovations AccuLIF TL Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.

The CoAlign Innovations AccuLIF TL Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF TL Cage is to be used with autogenous bone graft.

The AccuLIF TL Cage acts as a spacer to maintain proper intervertebral spacing and angulation following discectomy. The AccuLIF TL Cage is manufactured from TI6A14V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-08, and Silicone Rubber (MED-4870), The device is inserted in unexpanded state with an articulating delivery handle and expanded insitu to the required height via 2 hydraulic cylinder and piston arrangement using a hydraulic system comprising disposable flexible expansion tubing set and inflation syringe. The device locks in 1mm increments as it expands. The AccuLIF Cage comes in 6 to 9mm, 8 to 12mm and 10 to 16mm sizes. Each size also comes in an 11mm x 34mm footprint and a 13mm x 34mm footprint. The device has fixation ridges on the top and bottom surface. It also has a graft opening window which extends from the bottom surface to the top surface. The device has a proximal boss which has a threaded connection port for connecting to the inserter and a fluid port for transporting the expansion fluid.

In addition, the AccuLIF TL Cage System includes distractor trials to aid in distracting the disc space and in selecting the appropriate size cage to use in the surgical procedure. The set also contains a variety of other instruments to aid in the implantation of the cages.

The provided text describes a 510(k) premarket notification for a medical device, the AccuLIF TL Cage. This submission is for an update to an existing device, specifically adding new instruments (distractor trials) to the system. Therefore, the "study" conducted is primarily focused on demonstrating that these new additions do not negatively impact the safety and effectiveness of the previously cleared device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for the Test Set: Not explicitly stated as a number. The text mentions "cadaver testing." For cadaver tests in medical devices, sample sizes can vary, but details like the number of cadavers or test repetitions are not provided.
• Data Provenance: The cadaver testing implies a prospective experimental setup. The country of origin for the cadaver data is not specified.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. For cadaver testing, it would typically involve surgeons or other medical professionals experienced in spinal procedures, but their specific qualifications (e.g., years of experience, specialization) are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. In cadaver testing, the "adjudication" would typically involve direct observation and assessment by the testing team and/or the participating medical professionals. There's no mention of a formal consensus method like 2+1 or 3+1.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This submission focuses on the safety and effectiveness of new instruments via cadaver testing, not on comparative effectiveness (e.g., human reader performance with/without AI assistance). The device itself is an implantable surgical device, not a diagnostic or AI-powered system that involves human interpretation of output.

6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done

• Standalone Study: No, a standalone performance study was not done. This is not an AI algorithm or software-only device. The "device" in question is a physical surgical implant system.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the cadaver testing would be based on direct observation and surgical assessment of proper instrument function and implantation success within the cadaveric model. This would include evaluating ease of use, ability to distract the disc space, and proper selection of cage size, as intended by the new distractor trials.

8. The Sample Size for the Training Set

• Sample Size for Training Set: This concept is not applicable here as there is no "training set" in the context of this 510(k) submission. This is not an AI/ML device that requires training data. The device's design and mechanical properties are pre-determined.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device submission.

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Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF TL Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.

The CoAlign Innovations AccuLIF TL Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF TL Cage is to be used with autogenous bone graft.

The AccuLIF TL Cage acts as a spacer to maintain proper intervertebral spacing and angulation following discectomy. The AccuLIF TL Cage is manufactured from TI6Al4V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-08, and Silicone Rubber (MED-4870). The device is inserted in unexpanded state with an articulating delivery handle and expanded in-situ to the required height via 2 hydraulic cylinder and piston arrangement using a hydraulic system comprising disposable flexible expansion tubing set and inflation syringe. The device locks in 1mm increments as it expands. The Accul.IF Cage comes in 6 to 9mm, 8 to 12mm and 10 to 16mm sizes. Each size also comes in an 11mm x 34mm footprint and a 13mm x 34mm footprint. The device has fixation ridges on the top and bottom surface. It also has a graft opening window which extends from the bottom surface to the top surface. The device has a proximal boss which has a threaded connection port for connecting to the inserter and a fluid port for transporting the expansion fluid

The provided text describes the regulatory submission for a medical device called the AccuLIF® TL Cage, an intervertebral body fusion device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics.

However, based on the discussion of testing section, we can infer the types of acceptance criteria being addressed by the non-clinical tests. The "reported device performance" would be the successful completion of these tests in accordance with the specified ASTM standards and the conclusion of substantial equivalence.

Here's an attempt to structure the information based on your request, with the understanding that direct quantitative acceptance criteria and performance values are not explicitly provided in the document for the device itself, but rather compliance with standards is indicated:

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance

Note: The document does not provide specific numerical acceptance thresholds or the raw data for device performance. Instead, it states that tests were "conducted in accordance with" specific ASTM standards, implying successful completion to meet the standards' criteria. The overall conclusion is that these tests demonstrate "any minor differences do not impact device performance as compared to the predicates."

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

• Sample Size: Not specified. The document only mentions that non-clinical tests were conducted. Typically, such tests involve a certain number of samples for each test type, but these numbers are not disclosed.
• Data Provenance: Not applicable in the context of clinical data. These are non-clinical (mechanical and surgical technique) tests conducted in a laboratory setting.

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

• This question is not applicable. The study involves non-clinical engineering and mechanical testing, not a clinical study involving experts establishing ground truth for a test set in the conventional sense (e.g., radiologists interpreting images). The "surgical technique validation" would involve skilled personnel, but their number and specific qualifications are not detailed.

4. Adjudication method for the test set

• Not applicable. This is not a clinical study requiring adjudication of expert interpretations.

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 done. The device is a physical spinal implant, not an AI-powered diagnostic or assistive tool.

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

• Not applicable. The device is a physical spinal implant, not an algorithm. The non-clinical tests performed are inherently "standalone" in the sense that they assess the device's physical properties.

7. The type of ground truth used

• The "ground truth" for the non-clinical tests is based on established engineering principles and the requirements of the specified ASTM international standards (e.g., F2077-03, F2267-04, ASTM Draft Standard F-04.25.02.02). For the surgical technique validation, the "ground truth" would be the successful and safe deployment and function of the device as intended, in a similar manner to the predicate.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI study.

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

• Not applicable. This is not a machine learning or AI study.

Summary Explanation:

The provided document is a 510(k) summary for a medical device (AccuLIF® TL Cage), which aims to demonstrate "substantial equivalence" to existing legally marketed predicate devices. The "study" described consists of a series of non-clinical, biomechanical tests and surgical technique validation. The acceptance criteria for these tests are implicitly defined by compliance with the referenced ASTM standards. The reported device performance is that these tests were conducted "in accordance with" these standards and that the device's performance is comparable to the predicates, without explicitly listing raw data or specific numerical thresholds. The submission's goal is to show that the device meets safety and effectiveness requirements by being functionally equivalent to already approved devices, rather than through a novel clinical trial with quantitative performance metrics against a "ground truth" in a human study.

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Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF® TL-PEEK Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.

The CoAlign Innovations AccuLIF TL-PEEK Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF TL-PEEK Cage may be used with autogenous bone graft.

The CoAlign AccuLIF TL-PEEK Cage is expandable in-situ via a hydraulic system comprising two piston and cylinder arrangements. The device is expanded to the desired height by injecting saline into the cylinders. The device locks in 1mm increments as it expands. The device is provided non-sterile and must be sterilized prior to use.

The CoAlign AccuLIF TL-PEEK Cage device comes in two sizes, a 6mm height which expands up to 9mm and an 8mm height which expands up to 12 mm. Both sizes have a 12mm wide by 25mm long footprint. The device has fixation ridges on the top and bottom surface. It also has a graft opening window which extends from the bottom surface. The device has a proximal boss which has a threaded connection port for connecting to the inserter and a fluid port for transporting the expansion fluid. The device is expanded by using a disposable tubing set and pressure syringe. The device may be implanted through a standard anterior, posterior or transforaminal approach.

The provided text describes a medical device, the AccuLIF® TL-PEEK Cage, and its regulatory submission (K112095) to the FDA. The document outlines the device's indications for use, description, technological characteristics, and importantly, the testing performed to demonstrate substantial equivalence to predicate devices.

However, the information required to fully answer the user's request, specifically regarding a study that proves the device meets acceptance criteria in the context of typical AI/software medical device evaluations (e.g., sample size, ground truth, expert adjudication, MRMC studies, standalone performance), is not present in this document.

This document details non-clinical (mechanical) testing, not clinical studies or AI/software performance evaluations. The device is a physical implant, not a software algorithm. Therefore, many of the requested categories are not applicable.

Here's an attempt to answer based on the provided text, highlighting what is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states the tests were "conducted in accordance with" specific ASTM standards and that "any minor differences do not impact device performance as compared to the predicates." This implies the device met the performance characteristics demonstrated by the predicate devices, which are implicitly acceptable as per the standards. Specific numerical acceptance values are not provided in this summary, but rather the adherence to the testing methodologies.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not applicable and not present in the document. The testing described is non-clinical, mechanical testing of physical device specimens, not a clinical study involving patients or data sets.

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)

This information is not applicable and not present in the document. Ground truth in the context of clinical data or image interpretation is not relevant for the described mechanical device testing.

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

This information is not applicable and not present in the document. Adjudication methods are typically used in clinical studies or expert reviews of data, not for mechanical testing.

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 and not present in the document. An MRMC study is relevant for AI-powered diagnostic/interpretive devices, not for a physical spinal implant.

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

This information is not applicable and not present in the document. This device is a physical implant, not an algorithm.

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

For the non-clinical testing, the "ground truth" or reference performance is adherence to the specified ASTM standards and comparison to the performance of the legally marketed predicate devices. The document concludes that "The non-clinical test results demonstrate that any minor differences do not impact device performance as compared to the predicates."

8. The sample size for the training set

This information is not applicable and not present in the document. This concept applies to AI/machine learning models, not to a physical medical device undergoing mechanical testing.

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

This information is not applicable and not present in the document. This concept applies to AI/machine learning models, not to a physical medical device.

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Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The device is to be used with supplemental fixation.

Vertebral Body Replacement: When used as a vertebral body replacement, the CoAlign Innovations AccuLIF Cage is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable portion of a vertebral body, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.

The CoAlign Innovations AccuLIF Cage is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The device is always to be used with supplemental internal spinal fixation. Additionally, the device may be used with bone graft.

The AccuLIF Cage acts as a spacer to maintain proper intervertebral and vertebral body spacing and angulation following discectomy or partial corpectomy. The AccuLIF Cage is manufactured from Ti6Al4V and stainless steel. The AccuLIF Cage comes in 6 to 9mm, 8 to 12mm and 10 to 16mm sizes.

This is a spinal implant (AccuLIF Cage) and not an AI/ML device, therefore, the requested information about acceptance criteria for AI/ML performance, study design with test sets, ground truth establishment, expert reader qualifications, adjudication methods, MRMC studies, and training set details are not applicable.

The document describes the device, its indications for use, and a comparison to a predicate device (SEC IBF Cage - K093669) to establish substantial equivalence. The "study" referenced in this document are non-clinical bench tests focused on the mechanical properties of the implant.

Here's a breakdown of the provided information, framed to address the prompt's structure where applicable, and noting where it's not relevant for a non-AI/ML device:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not applicable in the context of an AI/ML device. For the non-clinical mechanical tests, the "sample size" would refer to the number of physical devices tested. This specific number is not provided, but it's implied that sufficient samples were tested to meet ASTM standards.
• Data Provenance: Not applicable. The "data" here refers to mechanical test results from laboratory (bench) testing of the physical implant.

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)

• Number of Experts/Qualifications: Not applicable. For mechanical bench testing, ground truth is established by engineering specifications, material properties, and adherence to established ASTM standards, not by expert interpretation.

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

• Adjudication Method: Not applicable. This concept pertains to resolving discrepancies in expert interpretations of medical images or data. For mechanical testing, results are objective measurements.

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

• MRMC Study: No, not applicable. This is a spinal implant, not an AI diagnostic tool.

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

• Standalone Performance: No, not applicable. This is a physical medical device, not an algorithm.

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

• Type of Ground Truth: For the non-clinical tests, the "ground truth" is adherence to established engineering specifications and material properties as defined by ASTM F136 (for material) and ASTM F2077-03 (for mechanical testing). The comparison to the predicate device also serves as a benchmark for performance.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is a physical device, not an AI/ML model that requires training data.

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

• Training Set Ground Truth: Not applicable.

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