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The AccuLIF TL and PL Cages are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion 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.

Additionally, the AccuLIF TL and PL Cages can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF TL and PL Cages are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

The AccuLIF 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). As with the predicate expandable AccuLIF TL and PL Cage devices, 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 arrangements using a hydraulic system comprising disposable flexible expansion tubing set and inflation syringe. The device automatically locks at 1mm increments as it expands. The AccuLIF TL and PL Cage come in a variety of sizes, shapes, and lordotic angles to accommodate patient anatomy.

This document is a 510(k) summary for a medical device called AccuLIF® TL and PL Cage. It informs the manufacturer that their device has been found substantially equivalent to a legally marketed predicate device. The document does not describe the acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a clinical performance study would for an AI/ML device.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than proving clinical performance against specific metrics.

Here's a breakdown of why the requested information about acceptance criteria and a study proving performance isn't fully applicable or available in this type of document, but how some related information can be inferred:

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

• Acceptance Criteria: For a 510(k) submission like this, the "acceptance criteria" are typically related to demonstrating that the new device is as safe and effective as a predicate device. This is often achieved through comparison of technological characteristics and performance data (bench testing, not clinical performance for this type of device). Specific numerical acceptance criteria for a "device performance" in terms of clinical accuracy (like sensitivity/specificity) are not typically defined or presented in a 510(k) for an intervertebral body fusion device.
• Reported Device Performance: The document states: "Design verification testing was conducted to assess the device modification. The non-clinical test results demonstrate that the modified device is substantially equivalent to the predicate." This implies that the performance in non-clinical (bench) tests met the criteria for substantial equivalence to the predicate, likely in mechanical properties, material properties, and functionality of the expansion mechanism. Specific numerical results are not provided in this summary.

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

• This is a medical implant (intervertebral fusion device), not an AI/ML diagnostic or prognostic tool. Therefore, there isn't a "test set" of patient data in the typical sense for evaluating algorithm performance.
• The testing mentioned ("Design verification testing") refers to bench testing (e.g., mechanical strength, material compatibility, functionality). The sample sizes for these types of tests would be determined by engineering and statistical requirements for mechanical testing, not by patient data.
• Data provenance for such tests would be related to the lab where the tests were conducted, not patient demographics or origin.

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. There is no "ground truth" to be established by medical experts for the performance of this device in the context of this 510(k) submission. The "performance" being evaluated is the physical and mechanical characteristics of the implant and its accessories.

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

• Not applicable, as there is no expert review or adjudication of a test set of clinical data.

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/ML device, and therefore, no MRMC study would be conducted.

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

• Not applicable, as this is not an algorithm or AI/ML device.

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

• Not applicable in the context of clinical "ground truth." The "truth" for this device's performance would be against engineering specifications, material standards (ASTM F136-08, ASTM F138-08), and functional requirements tested through design verification.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable, as there is no "training set" or a ground truth established in this context.

In summary, the provided document is a 510(k) clearance letter for an intervertebral body fusion device. It demonstrates substantial equivalence to a predicate device primarily through non-clinical (bench) testing of its physical properties and functionality. This type of submission does not typically involve the kinds of clinical performance studies, datasets, expert reviews, or AI/ML specific evaluations that your questions are designed to uncover.

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The AccuLIF TL and PL Cages are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion 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 at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.

Additionally, the AccuLIF TL and PL Cages can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF TL and PL Cages are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

The 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). As with the predicate expandable AccuLIF TL and PL Cage devices, 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 arrangements using a hydraulic system comprising disposable flexible expansion tubing set and inflation syringe. The device automatically locks at 1mm increments as it expands. The AccuLIF TL and PL Cage come in a variety of sizes, shapes, and lordotic angles to accommodate patient anatomy.

This document is a 510(k) premarket notification for the Stryker AccuLIF® TL and PL Cage, specifically for modifications made to the AccuLIF Pressure Syringe. It's a regulatory document demonstrating substantial equivalence to a predicate device, not a study proving the device meets performance acceptance criteria via clinical outcomes or algorithm performance.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies. These elements are typically found in clinical study reports or performance validation reports for devices that rely on diagnostic accuracy or AI performance, which this submission does not cover.

The document states that "Design verification testing was conducted to assess the device modification. The non-clinical test results demonstrate that the modified device is substantially equivalent to the predicate." This refers to engineering and bench testing to ensure the modified syringe still functions as intended and does not negatively impact the implant's performance, maintaining its substantial equivalence to the previously cleared predicate device.

Here's what I can extract from the provided text based on the nature of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no table of acceptance criteria or reported device performance in the sense of clinical outcomes, accuracy metrics, or algorithm performance. The submission focuses on demonstrating substantial equivalence of a modified accessory (the pressure syringe) to a predicate device based on non-clinical (design verification) testing.

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

• Test Set (for the syringe modification): Not explicitly stated in terms of a "test set" for clinical evaluation. The document mentions "Design verification testing," which implies engineering tests to validate the syringe's function. The sample size for these engineering tests is not provided.
• Data Provenance: The nature of the submission (510(k) for an accessory modification) suggests that data would primarily be from internal engineering and lab testing conducted by Stryker Corporation. There is no mention of country of origin for clinical data, as no clinical study demonstrating device performance is presented. The testing is non-clinical.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. For a 510(k) submission concerning an accessory modification and relying on non-clinical design verification, expert consensus for ground truth on clinical outcomes or image interpretations is not typically required or mentioned.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods are relevant for clinical studies or studies involving expert review of data (e.g., image interpretation), which this document does not describe.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This document does not mention an MRMC study. MRMC studies are used to assess the impact of a diagnostic device or AI on human reader performance, which is not the subject of this 510(k).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

No. This device is an intervertebral body fusion cage and its accessory (a pressure syringe), not an algorithm or AI-based device. Hence, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used:

Not applicable in the context of clinical "ground truth" (e.g., pathology, outcomes data). The "truth" for this submission revolves around the functional equivalence of the modified pressure syringe to its predicate, established through engineering design verification tests.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or ground truth in that context.

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The AccuLIF TL and PL Cages are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion 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 at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.

Additionally, the AccuLIF TL and PL Cages can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF TL and PL Cages are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

The AccuLIF 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). As with the predicate expandable AccuLIF TL and PL Cage devices, 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 arrangements using a hydraulic system comprising disposable flexible expansion tubing set and inflation syringe. The device automatically locks at 1mm increments as it expands. The AccuLIF TL and PL Cage come in a variety of sizes, shapes, and lordotic angles to accommodate patient anatomy.

The AccuLIF TL and PL Cage system comprises a packaged sterile AccuLIF implant, an instrument tray, and a packaged sterile Tubing Assembly. Within the TL or PL instrument trays are an inserter, pressure syringe, slap hammer, graft insertion cannula, graft insertion pusher, bone graft block, and TL or PL distractor trials. Additional instruments supplement the instrument trays.

The provided text is a 510(k) summary for the Stryker AccuLIF® TL and PL Cage, an intervertebral body fusion device. This type of regulatory document focuses on establishing substantial equivalence to existing predicate devices, rather than presenting a detailed clinical study demonstrating device performance against specific acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test and training sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods for studies of the device itself.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.

Instead, the document highlights that:

• The device is substantially equivalent to predicate devices (Stryker Spine, ACCULIF® TL and PL Cage K143163, and Medtronic, Capstone Spinal System, K123027) based on material, design, mechanical performance, and indications.
• The primary change in this submission is the expansion of indications to include degenerative scoliosis.
• Published clinical data for lumbar interbody fusion devices similar to the Stryker Spine AccuLIF TL and PL devices was provided in support of this application. This is the closest the document comes to mentioning performance data. It states that "The published clinical outcomes demonstrated that the use of the lumbar interbody fusion procedures to treat patients diagnosed with degenerative scoliosis above does not adversely affect performance of the system and does not represent a new worst case scenario."
• No changes were made to the existing devices, and therefore no additional implant testing was required or performed for this specific 510(k) submission.

In summary, the provided text describes a regulatory submission establishing substantial equivalence, not a study designed to prove the device meets specific acceptance criteria with detailed performance metrics.

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The Stryker Spine AVS® AL and AVS® ALign PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion 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. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS® AL and AVS® ALign PEEK Spacers are to be implanted via anterior or anterolateral approach.

The AVS® AL and AVS® ALign PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

The Stryker Spine AVS® PL and AVS® UniLIF™ PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion 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. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are to be implanted via posterior approach.

The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

The Stryker Spine AVS® TL PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion 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. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS® TL Peek Spacers are to be implanted via posterior approach.

The AVS® TL PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

The Stryker Spine AVS® Navigator PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion 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. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS® Navigator PEEK Spacers are to be implanted via a posterior or posterolateral approach.

The AVS® Navigator PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

The Stryker Spine AVS® ARIA PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion 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. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS® ARIA PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

The AccuLIF TL and PL Cage are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion 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 AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF TL and PL Cages are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

The Stryker Spine AVS® Anchor-L is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion 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. DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS® Anchor-L Lumbar Cage system is to be implanted via an open, anterior approach.

The AVS® Anchor-L Lumbar Cage system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the AVS® Anchor-L Lumbar Cage must be used with the internal screw and plate fixation provided by AVS® Anchor-L Fixation Screws and Locking Plate. If AVS® Anchor-L is used with less than three or none of the provided screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine must be used to augment stability. The accompanying Locking Plate must be used anytime the device is used with any number of screws.

The Stryker Spine Aero™-AL is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion 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. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The Aero™-AL Lumbar Cage System is to be implanted via an anterior approach.

The Aero™-AL Lumbar Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems) in addition to the included fixation anchors.

1. AVS® AL and AVS® ALign PEEK Spacers
   The AVS® AL (Anterior Large) and AVS® ALign PEEK Spacers are intended for use as interbody fusion devices. They are offered in a variety of lengths, heights and lordotic angles. The hollow, ring shaped implant has serrations on the top and bottom for fixation. The spacers are manufactured from PEEK OPTIMA LT1 and include tantalum markers for visualization.

2. AVS® PL and AVS® UniLIF PEEK Spacers
   The AVS® Partial Lumbar (PL) PEEK Spacers and AVS® UniLIF™ PEEK Spacers are intended for use as an aid in spinal fixation. This hollow, rectangular implant is offered in a variety of lengths, heights and lordotic angles to adapt to a variety of patient anatomies. It has serrations on the superior and inferior surfaces of the implant designed to help with fixation, an ergonomically shaped anterior edge, and a flat posterior edge. Radiopaque markers have been embedded within the implant to help allow for visualization in radiographic images. The spacers are manufactured from PEEK OPTIMA LT1 and include tantalum markers for visualization.

3. AVS® TL PEEK Spacer
   The AVS® TL PEEK Spacer is intended for use as an aid in spinal fixation. It is offered in both parallel and wedge shapes. The hollow implant has serrations on the top and bottom which are designed to help with fixation. The spacers are manufactured from PEEK OPTIMA LT1 and include tantalum markers for visualization.

4. AVS® Navigator PEEK Spacer
   The AVS® Navigator PEEK Spacer is intended for use as an interbody fusion device. It is offered in a variety of lengths, heights and lordotic angles. The hollow implant has serrations on the top and bottom for fixation. Radiopaque markers have been embedded within the implant to help allow for visualization in radiographic images. The spacers are manufactured from PEEK OPTIMA LT1 and include tantalum markers for visualization.

5. AVS® ARIA PEEK Spacer
   The AVS® ARIA PEEK Spacer is intended for use as an interbody fusion device. It is offered in a variety of lengths, heights and lordotic angles. The hollow, oblong-shaped implant has serrations on the top and bottom for fixation. The spacers are manufactured from PEEK OPTIMA LT1 and include tantalum markers for visualization.

6. AccuLIF TL and PL Cage
   The AccuLIF TL and PL Expandable Lumbar Interbody Cages are crescent and rectangular-shaped titanium implants. These implants are intended for use as interbody fusion devices and are offered in a variety of lengths, footprints, and lordotic angles designed to adapt to different patient anatomies. The implants can be expanded in height after insertion in the unexpanded state using the system instrumentation. The implants automatically lock at 1mm increments during expansion. The implants have serrations on the superior and inferior surfaces designed for multidirectional fixation and increased surface area for osteointegration, ergonomically shaped anterior edges to facilitate cage insertion with preservation of endplates and flat posterior edges. The cages have a central opening spanning endplate to endplate for graft containment and to permit fusion through the device. The cages are manufactured from implant grade titanium alloy (Ti-6Al-4V), stainless steel (316 LVM), and silicone rubber (MED-4870).

7. AVS® Anchor-L Spacer
   The AVS® Anchor-L Lumbar Cage System consists of a hollow, rectangular-shaped PEEK OPTIMA LT1 cage, titanium alloy (Ti-6Al-4V) bone screws, and a titanium alloy (Ti-6Al-4V) locking plate. Tantalum markers are included for visualization. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints, and lordotic angles to adapt to varying patient anatomies. The AVS® Anchor-L cage consists of one closed pocket for graft containment and has serrations on the superior and inferior surfaces of the cage. The implant is designed to be used exclusively with the internal supplemental fixation provided.

8. Aero™-AL Lumbar Cage System
   The Aero™-AL Cage is a hollow, box-shaped PEEK OPTIMA LT1 cage surrounded by a titanium alloy (Ti-6Al-4V) jacket. The PEEK cage portion consists of three closed pockets for graft containment and has serrations on the superior and inferior surfaces of the cage. The cage is designed to be used with the integrated fixation provided (Aero™-AL Fixation Anchors) in addition to supplemental fixation systems cleared for use in the lumbosacral spine. The Aero™-AL Fixation Anchors are constructed from titanium alloy (Ti-6Al-4V) and feature rails that mate with dovetail channels located within the Aero™-AL PEEK cage. Once fully seated into the channels, the anchors are designed to lock into the titanium jacket.

This document is a 510(k) premarket notification for several intervertebral body fusion devices from Stryker Corporation. The core purpose of this submission is to expand the indications for use of these devices to include the use of allogenic bone graft (comprised of cancellous and/or corticocancellous bone graft) as an adjunct to fusion, in addition to the previously cleared autograft.

The document does not describe a study that proves the device meets acceptance criteria related to a novel AI/ML algorithm or its performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices for an expanded indication of use, specifically concerning the type of bone graft.

Therefore, many of the requested categories for AI/ML device studies will not be applicable. I will address the relevant information provided in the document.

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

Since this is not an AI/ML device performance study, there are no specific numerical acceptance criteria or reported device performance metrics in the way one would see for an AI/ML diagnostic or predictive tool. The "performance" assessment here is conceptual, centered on demonstrating that the change in bone graft type does not adversely affect safety and effectiveness compared to the predicate devices.

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. No new test set for device performance was generated or utilized for this submission as "no additional testing was required or performed." The submission relies on "published clinical data for lumbar interbody fusion devices similar to the Stryker Spine lumbar intervertebral body fusion devices." The provenance of this published data is not specified (e.g., country of origin, retrospective/prospective).

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. No new test set requiring expert ground truth establishment was conducted for this submission. The "ground truth" for the expanded indication is based on existing "published clinical data" for similar devices, which would have implicitly relied on clinical diagnoses and outcome assessments by medical professionals at the time of publication.

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

Not applicable. No new test set requiring adjudication was conducted.

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 submission is for an intervertebral body fusion device (a physical implant), not an AI/ML algorithm. Therefore, no MRMC study, AI assistance, or effect size calculation for human readers is relevant.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" in this context refers to the clinical evidence supporting the use of allogenic bone graft in lumbar interbody fusion devices. This is based on published clinical outcomes data from studies of similar lumbar interbody fusion devices, demonstrating that the use of allogenic bone graft did not adversely affect performance.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm that requires a training set.

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

Not applicable. This is not an AI/ML algorithm that requires a training set.

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Intervertebral Body Fusion Device: The AccuLIF TL and PL Cage 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 AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF TL and PL Cages are to be used with autogenous bone graft.

The AccuLIF® TL and PL Cage device is an expandable interbody fusion cage manufactured from implant grade Titanium alloy (TI6AI4V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F 138-08, 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 l 1mm 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 AccuLIF TL and PL Cage system comprises a packaged sterile AccuLIF implant, an instrument tray, and a packaged sterile Unlock Tubing Assembly. Within the TL or PL instrument trays are an inserter, pressure syringe, slap hammer, graft insertion cannula, graft insertion pusher, bone graft block, and TL or PL distractor trials. Additional instruments supplement the instrument trays.

This document describes the Stryker Spine AccuLIF® TL and PL Cage, an expandable interbody fusion cage. The submission focuses on modifications to the AccuLIF Pressure Syringe, an accessory to the cage, rather than the cage itself. Therefore, the acceptance criteria and study details provided are specific to the performance of this accessory.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The study described is a non-clinical design verification test.

• Test Set Sample Size: The document mentions testing "after 20 cycles" of simulated cleaning, sterilization, and insertion/withdrawal impact. This implies a test regimen with 20 repetitions for each tested parameter, likely on one or a few sample units of the modified AccuLIF Pressure Syringe. The exact number of individual syringes tested is not explicitly stated beyond the "20 cycles" of evaluation.
• Data Provenance: The data is from non-clinical design verification testing, performed by the manufacturer, Stryker Spine. There is no mention of country of origin for the data (as it's laboratory/bench testing) or whether it's retrospective or prospective (as it's not a clinical study).

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

This information is not applicable as the study is a non-clinical design verification of an accessory (the syringe), not a clinical evaluation of the AccuLIF® TL and PL Cage. The ground truth for this type of test is established by engineering specifications and objective measurements, not expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Adjudication methods are typically associated with clinical studies where subjective assessments exist.

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

This information is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic or imaging devices where human readers interpret results. This submission pertains to a surgical implant accessory.

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

This information is not applicable. The device (AccuLIF® TL and PL Cage and its pressure syringe) is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for this design verification study is based on engineering specifications and objective measurements. This includes:

• Observational assessment of damage to the instrument and o-rings.
• Measurement of pressure delivered by the instrument.
• Verification against design input requirements.

8. The Sample Size for the Training Set

This information is not applicable. There is no training set mentioned or implied as this is a device performance test, not a machine learning model.

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

This information is not applicable for the same reasons as point 8.

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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 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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