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The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral, and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

The PERIMETER® Interbody Fusion Device consists of interbody cages of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

This 510(k) premarket notification for the PERIMETER® Interbody Fusion Device primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through material and design similarity, and an engineering rationale. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of diagnostic accuracy, which would be typical for an AI-powered diagnostic device.

However, I can extract the information relevant to performance data as presented in the document, which in this case pertains to biocompatibility and mechanical testing for a physical medical device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Meets Criteria: The document states: "The titanium alloy and stainless steel material used for the subject PERIMETER® Interbody Fusion Devices implants and instruments (trials) have a long clinical history of safe and effective use in similar commercially available medical devices. Therefore, no additional biocompatibility testing is required." This indicates that the materials themselves, based on prior use and regulatory acceptance, are deemed biocompatible, and no new testing was necessary to prove this. |
| Mechanical Testing | The device must demonstrate mechanical equivalence to predicate devices, ensuring it can withstand the intended physical stresses in the spinal environment without new worst-case scenarios. (Implied criterion for interbody fusion devices, often aligned with FDA guidance for spinal systems). | Device Performance: The subject devices (new PERIMETER® Interbody Fusion Devices) incorporate additional interbody cages manufactured from medical grade titanium alloy (Ti-6Al-4V ELI) that are packaged sterile, and new instruments (trials).

Meets Criteria: The document states: "In accordance with, Guidance for Industry and FDA Staff - Spinal System - 510(k)'s", Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices. It was determined that subject devices do not represent a new worst case. Therefore, an engineering rationale was used to demonstrate substantial equivalence. As a new worst case has not been indicated and an engineering rationale was deemed adequate to prove equivalence to the predicate device, no additional mechanical testing is required." This indicates that through an engineering rationale, rather than new physical testing, the device was determined to be mechanically equivalent to existing, cleared devices and did not introduce new safety concerns. |

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

This document describes a spinal implant (interbody fusion device), not an AI-powered diagnostic device or a system that uses test sets in the traditional sense of AI/software validation. Therefore, there is no information provided about:

• Sample size used for a "test set."
• Data provenance (country of origin, retrospective/prospective).

The "performance data" provided refers to material characteristics and mechanical equivalence reasoning, not data from patient studies.

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

Not applicable. This device is a physical implant, and its regulatory submission is based on material science, mechanical properties, and equivalence to predicate devices, not on the interpretation of medical images or patient data by experts for establishing ground truth in an AI context.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" in the context of an AI algorithm or diagnostic performance being evaluated.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI device or a diagnostic tool that would typically undergo an MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a physical medical implant, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this type of device is established through:

• Established Material Standards: Compliance with ASTM F136 for Titanium Alloy and the "long clinical history of safe and effective use" for both titanium alloy and stainless steel.
• FDA Guidance Documents: Adherence to "Guidance for Industry and FDA Staff - Spinal System - 510(k)'s" for mechanical evaluation.
• Predicate Device Performance: The safety and effectiveness of the existing predicate devices (K111525 and K090353) serve as the established "ground truth" or benchmark for demonstrating substantial equivalence. The claim is that the new device is "as safe and effective" as the predicates.

8. Sample Size for the Training Set

Not applicable, as this is not an AI device.

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

Not applicable, as this is not an AI device.

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The LT Cage System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

The Medyssey LT Cage System consists of cages of various widths and heights, which can be inserted between two lumbar or lumbrosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The Medyssey LT Cage System is to be used with supplemental fixation.

The device is offered in 64 sizes, with heights ranging from 8 - 15mm, lengths from 25 - 32mm and a width of 11mm. They are also available with 0°, 4° and 8° lordosis. The devices are manufactured from titanium alloy (Ti-6Al-4V) meeting ASTM F136 and are supplied non-sterile.

The purpose of this submission is to provide a device that is manufactured from titanium alloy, which is similar to the PEEK device currently available from Medyssey Co. Ltd.

This 510(k) summary describes a medical device, the Medyssey LT Cage System, which is an intervertebral body fusion device. The submission focuses on demonstrating substantial equivalence to a predicate device, the Medyssey LP Cage.

Here's an analysis of the provided information against the requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

• Static Compression ASTM F2077-03
• Static Torsion ASTM F2077-03
• Static Compressive Shear F2077-03
• Dynamic Compression F2077-03
• Subsidence ASTM F2267-04
  The submission states, "No additional testing is required to support this submission" for the subject device due to the change only being material and the new material being stronger. This implies that the LT Cage is expected to meet or exceed these performance metrics. |
  | Substantial Equivalence to Predicate | The overarching acceptance criterion for this 510(k) is substantial equivalence to the Medyssey LP Cage. This was met, and the FDA provided a clearance letter. |

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

This submission is for a material change to an existing device (the Medyssey LP Cage). No new clinical test set or data was used for the Medyssey LT Cage System to prove its performance directly. The basis for acceptance is derived from the established performance of the predicate device and the recognized properties of the new material. Therefore, information regarding sample size for a test set and data provenance (country, retrospective/prospective) is not applicable or provided in this context.

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

Not applicable. As this is not a study involving a clinical test set requiring expert ground-truthing, this information is not provided.

4. Adjudication Method for the Test Set

Not applicable. There was no test set requiring an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This submission is for a medical device (intervertebral cage) and not an AI or imaging diagnostic tool. Therefore, a MRMC comparative effectiveness study, human readers, or AI assistance is not relevant or described.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is a physical medical implant device, not an algorithm or software. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

The "ground truth" in this context is the established mechanical performance and biocompatibility of the titanium alloy (Ti-6Al-4V) and the mechanical performance data of the predicate Medyssey LP Cage, which was tested against ASTM standards.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this device submission, as it does not involve machine learning or an algorithm.

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

Not applicable. As there is no training set, the establishment of its ground truth is not relevant.

In summary, this 510(k) submission successfully argued for substantial equivalence based on:

• Identical design and fundamental scientific technology between the subject and predicate devices.
• A change only in material (from PEEK to titanium alloy).
• The new material (titanium alloy) being stronger and having established biocompatibility for orthopedic implants.
• Reliance on existing non-clinical test data for the predicate device, which demonstrated compliance with relevant ASTM standards for mechanical performance.

The FDA's clearance (K121246) indicates agreement with the argument that "No additional testing is required to support this submission" for the subject device.

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