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4CIS® Marlin ACIF Cage System is indicated for use in cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at the levels from C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have six weeks of non-operative therapy. The 4CIS® Marlin ACIF Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft, and is to be implanted via an open, anterior approach. It is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine, such as Anterior Cervical Plate system.

4CIS® Marlin ACIF cages are hollow, generally rectangular box shape made either from poly-ether-ether-ketone [PEEK-OPTIMA® LT1 (Invibio, Inc., West Conshohocken, PA USA) / VESTAKEEP® i4R (Evonik Industries, Essen Germany)] or Titanium alloy according to ASTM F2026(PEEK), F136(64ELI), F560(Tantalum). The cages are available in a variety of sizes and geometric options to fit the anatomical needs of a wide variety of patients. The device is filled with a bone graft material and inserted into the intervertebral body space of the cervical spine through an anterior cervical approach. As the design requirements, this cage design maintains the spacing between two vertebral bones following discectomy until fusion occurs. Each PEEK cage has three(3) x-ray markers made of tantalum for ease of visualization on the radiographs. Angled shape for lordotic curve and anatomic shape is available to allow maximum preservation of bony endplate with this system and teeth on the surfaces ensure enough contact with bony endplate, which prevents subsidence of the cage into the vertebral body when the teeth increase the anchoring and prevent slipping or expulsion.

This is a medical device 510(k) summary for the "4CIS® Marlin ACIF Cage System," an intervertebral body fusion device. The document describes the device, its intended use, and its comparison to predicate devices for substantial equivalence.

Here's an analysis of the provided text for acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for clinical performance usually seen in AI/software studies (e.g., sensitivity, specificity, AUC). Instead, it focuses on mechanical performance for this implantable device. The "Performance Specification" section states:

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

This document describes a mechanical device, not an AI/software product requiring a "test set" of patient data. Therefore, the concepts of "sample size for the test set" and "data provenance" (country, retrospective/prospective) are not applicable in the context of this medical device submission. The performance data comes from laboratory mechanical testing.

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

As this is a mechanical device submission, there is no mention of experts establishing ground truth for a test set in the way it would be for an AI diagnostic algorithm. Ground truth here refers to the physical properties and performance of the device under mechanical stress, evaluated against established ASTM standards.

4. Adjudication Method for the Test Set

Again, this is not applicable as there is no "test set" in the context of clinical interpretation by experts. Mechanical testing results are objective measurements.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and AI assistance. This submission pertains to an implantable surgical device.

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 device's performance is established by Mechanical Testing Standards (ASTM F2077 and ASTM F2267). This involves objective measurements of physical properties like static and dynamic compression, torsion, subsidence, and expulsion, compared against the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This isn't an AI model requiring a training set. The device's design and manufacturing processes are developed through engineering and material science, not machine learning training.

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

Not applicable. See point 8.

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The Space Vision® PLIF (Posterior Lumbar Interbody Fusion® TLIF (Transforaminal Lumbar Interbody Fusion) and Space Vision® OLIF (Oblique Lumbar Interbody Fusion) systems are intervertebral body fusion devices indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two continuous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least 6 months of non-operative treatment prior to treatment with Space Vision® PLIF, SpaceVision® TLIF systems. These devices are to be filled with autogenous bone graft material. These devices can be implanted via posterior or transforaminal approaches. SpaceVision® PLIF, SpaceVision® TLIF or SpaceVision® OLIF systems must be used in combination with supplemental internal spinal fixation which has been cleared by the FDA for use in the lumbar spine.

The SpaceVision® PLIF system (Posterior Lumbar Interbody Fusion), the SpaceVision® OLIF system (Oblique Lumbar Interbody Fusion) and the SpaceVision® TLIF system (Transforaminal Lumbar Interbody Fusion) are intended as an internal spacer between the vertebral bodies of the lumbar (L2-S1) spine to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain. The design of the cages is adapted to the vertebral anatomy. SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF systems consist of cages differentiated by their approach, with varying dimensions and ancillary products for placement of the cages. The systems are supplied sterile or non-sterile. The SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF cages are made from PEEK Optima (Invibio, Inc.) ASTM F2026 and ASTM F560 Tantalum wire. X-ray markers system on the cages permits the identification of cage position and allows post-operative assessment. SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF implants are supplied with their specific instrumentation and trial spacers.

The provided document describes the SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF systems, which are intervertebral body fusion devices. This is a 510(k) premarket notification, indicating the device's substantial equivalence to legally marketed predicate devices, not requiring extensive clinical trials to demonstrate effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. This is primarily achieved through mechanical testing to show comparable properties.

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

The document does not describe a test set or data provenance in the context of typical clinical studies for performance evaluation. For a 510(k) submission based on substantial equivalence, the "test set" primarily refers to the physical devices undergoing mechanical testing, not a patient cohort.

• Sample Size: Not specified for the mechanical testing. For physical device testing, usually a statistically appropriate number of devices are tested, but the exact count isn't in this summary.
• Data Provenance: Not applicable in the sense of retrospective or prospective patient data from a specific country, as "No clinical data has been presented." The data provenance for the mechanical testing would be the testing facility (ENDOLAB PI-52 protocol is mentioned) and the specific ASTM standards used.

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

This information is not applicable as "No clinical data has been presented." The "ground truth" here is the adherence to mechanical performance standards and comparability to predicate devices, not clinical diagnoses made by experts.

4. Adjudication Method for the Test Set

This information is not applicable as "No clinical data has been presented" and no human expert review or adjudication of a "test set" in the clinical sense was performed.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states, "No clinical data has been presented." Therefore, there is no effect size reported for human readers improving with or without AI assistance.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical intervertebral body fusion system, not a diagnostic algorithm or AI-powered tool. The concept of "algorithm only" performance is not relevant to this type of medical device submission.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established mechanical performance standards (ASTM standards) and the mechanical properties of the legally marketed predicate devices. The goal is to demonstrate that the SpaceVision® systems meet these standards and are comparable. There is no expert consensus, pathology, or outcomes data used as ground truth for this specific submission, as clinical data was not presented.

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical implant, not an AI/ML algorithm that requires a "training set."

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

This information is not applicable. As there is no training set mentioned, the method for establishing its ground truth is irrelevant.

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The Phantom Plus Ceramic Cages-Lumbar are intervertebral body fusion devices indicated for use with autogenous 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). These patients should be skeletally mature and have six (6) months of nonoperative therapy.

The Phantom Plus Ceramic Cage System-Lumbar is to be filled with autogenous bone graft material. The Phantom Plus Ceramic Cages-Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System.

The Phantom Plus Ceramic 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. Phantom Plus Ceramic 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.

The Phantom Plus Ceramic Cages-Cervical are to used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Phantom Plus Ceramic Cage System consists of a variety of hollow vertebral body spacers featuring convex, bullet nose design and an axial void designed to hold bone graft material. The subject device is offered in various lengths. The subject devices are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices range from 6mm to 22mm in height and 14mm to 45mm in length.

The provided text describes a 510(k) premarket notification for the Phantom Plus® Ceramic Cage System, which is an intervertebral body fusion device. The focus of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove the device meets those criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, as well as details about sample sizes, expert involvement, and ground truth establishment, cannot be directly extracted from the provided text because such a study was not presented.

Instead, the submission relies on demonstrating compliance with recognized performance standards and substantial equivalence to predicate devices.

Here's a summary of what can be gathered, addressing the spirit of the request as much as possible given the available information:

1. Table of acceptance criteria and the reported device performance

Since this is a 510(k) submission focused on substantial equivalence to predicate devices and compliance with existing standards, explicit acceptance criteria for a novel performance study are not defined or reported in the text. Instead, the device's performance is demonstrated by meeting the requirements of recognized ASTM and AAMI standards.

• Adherence to ASTM F2077 (for lumbar intervertebral body fusion devices)
• Adherence to ASTM F1839 (for ceramic materials for surgical implants)
• Adherence to ASTM F1877 (for intervertebral body fusion devices with integrated plate fixation) | "Testing and engineering analyses on this device indicate that the Phantom Plus Cage System is substantially equivalent to predicate devices... all applicable requirements were met." |
  | Material/Biocompatibility:
• Adherence to AAMI TIR 33 (Guidance for biocompatibility risk management)
• Same or equivalent materials as predicate devices (ceramic) | "Testing and engineering analyses on this device indicate that the Phantom Plus Cage System is substantially equivalent to predicate devices... all applicable requirements were met." |
  | Design and Function:
• Same or equivalent design and function as predicate devices (e.g., hollow vertebral body spacers, convex, bullet nose design, axial void for bone graft, angular teeth for expulsion resistance) | "The Phantom Plus Ceramic Cage System was shown to be substantially equivalent to previously cleared devices, including itself (K082801) and the Valeo® Spacer System (K091278), and has the same or equivalent indications for use, design, function, and materials used." |
  | Indications for Use:
• Equivalent indications for use as predicate devices (e.g., DDD patients with specific conditions, autogenous bone graft, supplemental fixation) | "The Phantom Plus Ceramic Cage System was shown to be substantially equivalent to previously cleared devices... and has the same or equivalent indications for use..." |

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

The document does not describe a clinical "test set" in the context of a prospective clinical trial. The "testing and engineering analyses" mentioned likely refer to bench testing and mechanical studies conducted in a laboratory setting, not human clinical trials. Therefore, information about sample size (patients), data provenance, or retrospective/prospective nature is not provided.

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, as a clinical test set with human subject data requiring expert ground truth establishment is not discussed in this 510(k) summary.

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 an implant, not an AI-assisted diagnostic tool, and therefore MRMC studies are not relevant.

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

Not applicable.

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

Not applicable, as a clinical study requiring ground truth is not presented. The "ground truth" for this submission is adherence to recognized performance standards and demonstrated mechanical equivalence to predicates.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device requiring a training set. The "engineering analyses" would involve material samples and device prototypes.

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

Not applicable.

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