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The FloSpine KeyLift™ Expandable Interlaminar Stabilization System is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (TI-S1). It is intended for plate fixation/attachment to the spinous processes/lamina for the purpose of achieving supplemental fusion in the following conditions: Lumbar spinal stenosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The KeyLif("M Expandable Interlaminar Stabilization System is intended for use with allograft bone and is not intended for stand-alone use.

The KeyLift™ implant is an expandable, interlaminar stabilization device that is implanted posteriorly between the lamina and spinous processes of the thoracic and lumbar region. The implant features an expanding distal end which increases the height between the vertebral bodies. The superior and inferior wings are crimped to the spinous process, and a clamp is attached to the implant for final fixation. The components of the KeyLift™ system of implants and reusable instruments are manufactured from titanium alloy per ASTM F136 and stainless steel per ASTM F138 and A564. KeyLift™ implants are available in a range of sizes to accommodate surgeon and patient needs. Both the KeyLift implant and KeyLift Clamp are provided pre-assembled.

This 510(k) summary does not contain information about a study proving device performance against acceptance criteria. The submission is for a medical device (KeyLift™ Expandable Interlaminar Stabilization System), not a diagnostic algorithm or AI system that would typically undergo such a study.

The "PERFORMANCE DATA" section mentions:

• "Axial dynamic and static compression, static and dynamic offset torsion, static axial torsion, static and dynamic compression-bending, ring pushout, and axial pulloff testing demonstrated substantially equivalence mechanical performance."
• "Worst-case implants were identified using FEA and/or engineering analyses."
• "Surgeon-user cadaver evaluation demonstrated the KeyLift™ system of implants and instruments performs as described in the surgical technique and instructions for use."

These describe common mechanical and usability testing for orthopedic implants, aiming to show substantial equivalence to existing predicate devices, rather than meeting specific performance criteria related to diagnostic accuracy or AI model performance.

Therefore, I cannot provide the requested information regarding acceptance criteria, sample sizes, ground truth, or MRMC studies, as these types of studies are not relevant to the content of this 510(k) summary for a physical medical implant.

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Ti-Largo™ Cervical Interbody Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Ti-Largo™ Cervical Interbody Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C2 to T 1 disc levels using autograft bone. Ti-Largo™ Cervical Interbody Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

FloSpine Ti-Largo™ Cervical Interbody Cages are keystone shaped devices that have a central lumen and smaller graft windows throughout the structure of the implant. The implants are additively manufactured (ADM) using grade 23 titanium alloy powder per ASTM F3001. The implants are provided sterile (gamma radiation, 25 kGy minimum dose), are intended for single use only, and should not reused under any circumstances. Components from this system should not be used in conjunction with components from other company products.

Ti-Largo™ Cervical Interbody Cages are intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the cervical spine. The Ti-Largo™ Cervical Interbody System was developed for anterior cervical fusion with implants available in keystone shaped footprints ranging in size between 11 x 14mm and 16 x 18mm, thickness ranging from 5 to 14mm in 1 mm increments, 7degree lordosis for all sizes, and 0-degree lordosis for the smallest and largest sizes. The surface texture of the 3D structure of the implants resists expulsion forces.

The provided text does not contain information about acceptance criteria and a study proving a device meets acceptance criteria in the context of an AI/ML medical device. Instead, it is a 510(k) summary for the FloSpine Ti-Largo™ Cervical Interbody System, which is a physical medical device (an intervertebral body fusion device made of titanium alloy).

Therefore, I cannot provide the requested information regarding AI/ML device performance, ground truth, expert adjudication, or training/test set sample sizes, as these concepts are not applicable to the presented document.

The document discusses performance data for the physical interbody system, which includes mechanical and sterilization testing to demonstrate substantial equivalence to predicate devices.

Here's what I can extract regarding the physical device's performance data:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests conducted but does not explicitly state the numerical acceptance criteria for each test or the specific reported device performance values (e.g., actual compression strength in Newtons or number of cycles to failure). It simply states that the outcomes met "all acceptance criteria."

2. Sample size used for the test set and the data provenance: Not applicable. These are mechanical and sterilization tests, not studies on a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert adjudication are not relevant for mechanical and sterilization testing of a physical implant.

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI/ML product.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to mechanical and sterilization testing.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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The FloSpine PANAMA™ Anterior Cervical Plate System is intended for anterior cervical screw fixation of the cervical spine at levels C2-T1. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative discase (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis), or scoliosis), pseudoarthrosis, and/or failed previous fusions.

The PANAMA™ Anterior Cervical Plate System is an anterior cervical spine fixation system that provides cervical spine fixation for intervertebral disk replacement procedures. The PANAMA™ ACP System is designed to stabilize and facilitate fusion in intervertebral disk replacement surgeries.

The PANAMA™ Anterior Cervical Plate (ACP) System consists of cervical plates that are 2.25 mm thick, 16 mm wide, and length options between 18 and 110 mm (end-to-end length) to accommodate 1 to 5 levels of fusion between C2 and T1. The PANAMA ACP System includes fixed and variable angle screws with 4.0mm and 4.5mm diameters and length options between 12mm and 20mm with self-tapping and self-drilling options. The screws and plates are made from Ti-6AI-4V ELI conforming to ASTM F-136.

The plates and screws of the PANAMA™ ACP System include a primary and secondary mechanism to mitigate screw backout. The primary mechanism consists of a cover plate that is rotated in-situ that partially covers the screw. The secondary mechanism consists of a number of radial teeth on the screw head and mating grooves on the underside of the cover plate. In the event that the screws start to back out, the teeth and grooves will engage, thereby preventing further counter-clockwise rotation of the screw. The screws in the system have a threaded hole at the bottom of the drive to provide easy insertion and positioning during surgery. The PANAMA™ ACP System of implants and instruments is provided clean and non-sterile in one sterilization case.

The provided text describes a medical device's 510(k) submission, focusing on its design, indications for use, and a comparison to predicate devices, including performance data. However, it does not contain information related to an AI/ML-driven device or diagnostic software.

Therefore, I cannot extract the specific details required to complete your request, such as:

• A table of acceptance criteria and the reported device performance for an AI/ML device. The document discusses performance testing (biomechanical testing) for a physical implant (spinal plate) per ASTM F1717, which measures properties like static axial compression bend, dynamic axial compression, and static torsion. These are engineering performance metrics for a physical device, not diagnostic performance metrics for an AI model.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• MRMC comparative effectiveness study details.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI model.
• Sample size for the training set.
• How ground truth for the training set was established.

The document is for a PANAMA™ Anterior Cervical Plate (ACP) System, which is a physical implant used for spinal fixation. The "performance data" section G explicitly refers to "Performance testing of the PANAMA™ ACP System was performed per ASTM F1717 'Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model'". This is mechanical testing of a medical device, not an algorithm.

To fulfill your request, you would need documentation pertaining to the regulatory submission of an AI/ML-driven medical device or diagnostic software.

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Largo™ Interbody Cages - Cervical are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Largo™ Interbody Cages - Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Largo™ Interbody Cages - Cervical are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

Largo™ Interbody Cages - Lumbar are indicated for use with autograft bone graft 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). Largo™ Interbody Cages - Lumbar are intended to be used with supplemental spinal fixation systems, such as pedicle screws. Patients should be skeletally mature and have six (6) months of nonoperative therapy prior to treatment with an intervertebral cage.

The Largo™ PEEK Interbody System consists of a variety of hollow vertebral body spacers designed for use in the cervical and lumbar spine. The devices are intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine and cervical spine.

The Largo™ PEEK Interbody Cervical Cage was developed for anterior cervical fusion and is available in footprints from 14 x 12mm up to 17 x 14mm and at 0 and 7 degree lordosis. The cages are trapezoidal in shape and include x-ray markers for positioning. The subject device is with angular teeth to allow the implant to grip the superior and inferior end plates to provide resistance to expulsion.

The Largo™ PEEK Posterior Lumbar Interbody Cage (PLIF) was developed for posterior stabilization of the lumbar spine. These cages feature a convex bullet nose design and an axial void designed to contain autograft material. The subject device is made in various lengths and designed with angular teeth to allow the implant to grip the superior and inferior end plates to provide resistance to expulsion. The devices range from 7mm to 16mm in height, 23mm to 37mm in length, and from 9 to 11mm in width.

The Largo™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF) Cage was developed for posterior stabilization of the lumbar spine. It is a banana-shaped implant featuring a convex, bullet nose design and an axial void designed to hold autograft material. The subject device is made in various lengths and designed with angular teeth to allow the implant to grip the superior and inferior end plates to provide resistance to expulsion. The devices range from 7mm to 16mm in height and footprints of 11 x 28 up to 13 x 37 mm. The cages incorporate an A/P lordotic angle of 5 degrees.

The Largo™ PEEK Anterior Lumbar Interbody Fusion (ALIF) Cage was developed for anterior stabilization of the lumbar spine. The footprint is oval in shape and features a center beam for additional strength. The leading edge is bulleted for ease of insertion and features angular teeth for endplate grip and resistance to expulsion. The devices range from 8mm to 22mm in height and footprints of 30 x 24 up to 47 x 30 mm. The cages incorporate an A/P lordotic angle of 6 or 12 degrees.

The Largo™ PEEK Lateral Lumbar Interbody Fusion (LLIF) Cage was developed for a lateral approach to the lumbar spine. The cage is rectangular in shape and features a center beam for additional strength. The leading edge is bulleted for ease of insertion and features angular teeth for endplate grip and to resist expulsion. The devices range from 8mm to 16mm in height and footprints of 18 x 50 mm up to 22 x 60 mm. The cages incorporate an A/P lordotic angle of 0 or 6 degrees.

This document describes a 510(k) premarket notification for the FloSpine Largo™ PEEK Interbody System. It details the device, its indications for use, and a comparison to a predicate device. The information provided is for a traditional medical device (intervertebral body fusion device), not an AI/ML powered device. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of an AI/ML algorithm's performance metrics (like sensitivity, specificity, AUC) and associated studies (e.g., standalone, MRMC) does not directly apply.

This 510(k) submission focuses on demonstrating substantial equivalence to a legally marketed predicate device based on technological characteristics, materials, design, function, manufacturing processes, surgical techniques, intended use, and performance data from mechanical and sterility testing.

Therefore, many of the specific questions regarding AI/ML performance studies cannot be answered from the provided text.

Here's an attempt to answer the questions based on the information available, noting where AI/ML specific criteria do not apply:

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

   The document does not specify quantitative "acceptance criteria" in the way one would for an AI/ML algorithm's clinical performance (e.g., a target sensitivity or specificity). Instead, substantial equivalence for this device is based on demonstrating that its technological characteristics and performance are comparable to the predicate device. The "performance data" refers to mechanical and sterility testing.

   Performance Test	Reported Device Performance
   Static Compression per ASTM 2077	Performed (Implied to meet requirements for substantial equivalence to predicate)
   Dynamic Compression fatigue per ASTM F2077	Performed (Implied to meet requirements for substantial equivalence to predicate)
   Static Torsion per ASTM 2077	Performed (Implied to meet requirements for substantial equivalence to predicate)
   Dynamic Torsion fatigue per ASTM F2077	Performed (Implied to meet requirements for substantial equivalence to predicate)
   Static Expulsion per ASTM F1839-08	Performed (Implied to meet requirements for substantial equivalence to predicate)
   Subsidence per ASTM F2267	Performed (Implied to meet requirements for substantial equivalence to predicate)
   Wear Debris Analysis	Performed (Implied to meet requirements for substantial equivalence to predicate)
   Sterility Validation	Validated per AAMI TIR33:2005 for SAL of 10⁻⁶

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

   This information is not provided in detail for the mechanical and sterility tests. These are typically laboratory-based tests on device samples, not clinical studies involving patient data. Therefore, "country of origin of the data" and "retrospective or prospective" do not apply in the context of clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   This question is not applicable as this is not an AI/ML device requiring expert-established ground truth from clinical data. The "ground truth" for mechanical testing would be the physical properties and performance metrics measured in the laboratory, guided by engineering standards (e.g., ASTM).

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

   Not applicable. This is not an AI/ML device relying on human interpretation of data where adjudication methods would be used.

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, so no MRMC study to assess human-AI collaboration was performed or would be relevant.

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

   Not applicable. This is a physical intervertebral body fusion device, not an algorithm.

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

   The "ground truth" for the performance data (mechanical and sterility tests) are the established engineering standards (ASTM and AAMI) and the measured physical characteristics/performance of the device in comparison to these standards and the predicate device. Clinical outcomes data or pathology are not described as being used for the substantial equivalence determination in this document.

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. This is not an AI/ML device that requires a training set or associated ground truth establishment.

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The FloSpine Canaveral Pedicle System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

When used for posterior non-cervical pediction in pediatric patients, the Canaveral Pedicle Screw System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Canaveral Pedicle Screw System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is limited to the posterior approach.

The Canaveral Pedicle Screw System is indicated to provide the surgeon with a minimally invasive approach for posterior spine surgery.

The FloSpine Canaveral Pedicle Screw System comprises non-sterile, single use, titanium alloy components for creating a posterior spinal implant construct. The system attaches to the spine through a component system comprising of pedicle screw assemblies for open and minimally invasive procedures, rods, hooks and set screws. The system is designed to stabilize the spine during the fusion process. The screws are available as monoaxial, uniplanar and polyaxial screws in both cannulated and non-cannulated forms. The rods are available as straight and precurved rods and are available in 2 diameters and multiple lengths. Components are made of Ti6Al4V ELI, a titanium based alloy, which complies with ASTM F136. Some rods are made from cobalt chrome which complies with ASTM F1537.

The provided text is a 510(k) Summary for the Canaveral Pedicle Screw System. It outlines the device description, indications for use, and a comparison to predicate devices, along with performance standards for pre-clinical testing.

However, the document does not contain information on acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or details about training sets. The primary focus of this document is to establish substantial equivalence to predicate devices for regulatory clearance based on materials, function, sizes, and mechanical test results, as per ASTM F1717-10.

Therefore,Based on the provided document, the following is what can be extracted:

1. Table of acceptance criteria and the reported device performance:
   The document refers to mechanical testing as per ASTM F1717-10, but does not provide specific acceptance criteria values or the device's reported performance against those criteria in a table format. It states that the device is substantially equivalent to predicate devices based on "mechanical test results."

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   This information is not available in the provided text. The document refers to "pre-clinical testing" for mechanical performance but does not specify sample sizes or data provenance.

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 available. The document describes mechanical performance testing, not a study involving human assessment of images or clinical outcomes that would require expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This information is not applicable and not available. As above, the testing described is mechanical, not involving human adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   This information is not applicable and not available. The device is a "Pedicle Screw Spinal System," a physical implant, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This information is not applicable and not available, as the device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The "ground truth" for the mechanical testing would be defined by the specified parameters and methodologies of the ASTM F1717-10 standard itself. It's about engineering specifications and material properties, not clinical ground truth.

8. The sample size for the training set:
   This information is not applicable and not available. The document describes a physical medical device, not an AI or machine learning model that would require a training set.

9. How the ground truth for the training set was established:
   This information is not applicable and not available, for the same reason as point 8.

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