Search Results

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.

Ask a specific question about this device

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 I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc contirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. These 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.

PERIMETER® Interbody Fusion Device consists of 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. PERIMETER® Interbody Device is to be used with supplemental fixation instrumentation.

The device is offered in both Titanium Alloy (Titanium-6Aluminum-4Vanadium ELI) and Polyetheretherketone (PEEK). The PEEK implants include tantalum markers for imaging purposes. This interbody device is offered in both sterile (by gamma irradiation) and non-sterile forms.

PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height, 15mm to 28mm in length and between 19mm and 38mm in width. An array of lordosis options are provided for this device spanning from 4 degrees to 15 degrees of angulation. Both the PEEK and Titanium Alloy devices are designed with teeth across both the superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance. Additionally, the Titanium Alloy version of this device offers lateral windows for visibility of the autogenous bone graft.

The PERIMETER® Interbody Fusion Device system includes instrumentation that enables the surgeon to implant the devices via either an open or a minimallyinvasive approach (including anterior, lateral, and oblique).

The purpose of this submission is to modify the two piece implant inserter used with PERIMETER® Interbody Fusion Device. The modified design of the subject device does not affect the device's intended use or alter the device's fundamental scientific technology. No changes are being made to PERIMETER® Interbody Fusion Device implants as part of this submission.

This 510(k) submission (K131669) for the PERIMETER® Interbody Fusion Device is for a modification to an existing medical device, specifically the implant inserter, not for a new device requiring extensive clinical trials to prove its effectiveness. Therefore, the information provided focuses on demonstrating substantial equivalence to the predicate device through non-clinical testing rather than clinical performance acceptance criteria and studies in the traditional sense.

Here's an analysis based on the provided text, addressing your points where applicable:

1. Acceptance Criteria and Reported Device Performance

Note: Since this is a modification to an existing device inserter, the "acceptance criteria" here relate to demonstrating that the modified inserter performs equivalently to, and no worse than, the predicate inserter, and that the overall device (implant + inserter) remains safe and effective.

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

• Test Set Sample Size: The document does not specify a numerical sample size for the mechanical testing. "Mechanical testing" was conducted, implying that a sufficient number of tests were performed to support substantial equivalence, but the exact count is not given.
• Data Provenance: The testing was conducted by Medtronic Sofamor Danek. This is non-clinical bench testing. The data's "country of origin" is implied to be within Medtronic's testing facilities (likely in the USA, where the company is headquartered). The data is not clinical data, so terms like "retrospective or prospective" do not apply in this context.

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

Not applicable. This submission is for a device modification validated through engineering assessments and mechanical bench testing, not clinical data requiring expert human interpretation or ground truth establishment. The "ground truth" here is based on engineering principles, material science, and mechanical performance metrics.

4. Adjudication method for the test set

Not applicable for a device modification based on non-clinical engineering and mechanical testing. There are no human "readers" or adjudicators in the context of this type of study.

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 a physical interbody fusion device and an inserter tool, with no AI component. Therefore, no MRMC study or AI-related comparative effectiveness was performed or is relevant.

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

Not applicable. There is no algorithm.

7. The type of ground truth used

The "ground truth" for this submission is based on:

• Engineering principles and design specifications: Ensuring the modified inserter met its functional requirements.
• Material science properties: Verifying the suitability of the materials used.
• Mechanical performance metrics: Quantifiable results from bench testing (e.g., strength, durability, securement force) that demonstrate equivalence to the predicate device.
• Established safety and performance of the predicate device: The fundamental basis for substantial equivalence argues that if the modified device behaves identically (or acceptably similarly) to a previously cleared safe and effective device, then it too is safe and effective.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device or a clinical study that requires a training phase.

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

Not applicable (as there is no training set).

Ask a specific question about this device

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 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. The PERIMETER® Interbody Device is to be used with supplemental instrumentation. The device is offered in Titanium Alloy (Titanium-6Aluminum-4Vanadium ELI) or PEEK Optima LT1 (Polyetheretherketone). This interbody device is offered in sterile (PEEK) or non-sterile (PEEK and Titanium Alloy) forms. The PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height, 21mm to 28mm in length and between 19mm and 38mm in width. An array of lordosis options are provided for this device spanning from 4 degrees to 15 degrees of angulation. Both the PEEK and Titanium Alloy (Titanium-6Aluminum-4 Vanadium EL.I) devices are designed with teeth across both the superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance. Additionally, the Titanium Alloy (Titanium-6Aluminum-4 Vanadium ELI) version of this device offers lateral windows for visibility of the autogenous bone graft.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, though it's important to note that this document is a 510(k) summary for a medical device and not a detailed clinical study report for a device that relies on an AI algorithm.

This document describes a medical device (Interbody Fusion Device) that does not involve an AI algorithm. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation will not be applicable. The study performed here is a non-clinical validation for a labeling change.

Therefore, for aspects related to AI (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies), the answer will be "Not applicable" or "No AI component in this device."

Acceptance Criteria and Device Performance for PERIMETER® Interbody Fusion Device (K132700)

1. Table of Acceptance Criteria and Reported Device Performance

Study Information (Pertaining to non-clinical validation for labeling change)

Since this document describes a conventional medical device (an interbody fusion implant) and not an AI/ML-driven device, many of the AI-specific questions are not applicable.

1. Sample size used for the test set and the data provenance:

   • Test set sample size: Not explicitly stated as a number of "samples" in the context of an AI test set. The validation involved "surgeons performing the procedure on cadavers." The number of cadavers or procedures is not specified.
   • Data provenance: Cadaveric testing. The country of origin is not specified, but the applicant is based in Memphis, Tennessee, USA. This was a non-clinical, prospective evaluation of the labeling change using cadavers.

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

   • Number of experts: "Surgeons" (plural) were involved. The exact number is not specified.
   • Qualifications of experts: Implied to be medical professionals qualified to perform spinal fusion procedures. No specific years of experience or sub-specialty are explicitly stated in this summary.

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

   • Not applicable in the context of an AI-driven "test set" and ground truth adjudication. The validation appears to be a direct confirmation by surgeons that the modified labeling aligns with their practical experience during cadaveric procedures. There's no indication of a consensus-based adjudication process for a binary or categorical ground truth.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This was not an AI-assisted device, and therefore no MRMC study comparing human readers with and without AI assistance was performed.

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

   • No. This device does not have an algorithm component.

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

   • The "ground truth" here is the practical confirmation by surgeons during cadaveric procedures that the modified labeling accurately reflects how the device is used and its features. It's a pragmatic validation against expert surgical practice rather than a diagnostic "truth" like pathology.

7. The sample size for the training set:

   • Not applicable. There is no AI algorithm being developed or trained for this device.

8. How the ground truth for the training set was established:

   • Not applicable. There is no AI algorithm being developed or trained for this device.

Ask a specific question about this device

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 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. The PERIMETER® Interbody Device is to be used with supplemental fixation instrumentation.

The device is offered in both Titanium Alloy (Titanium-6Aluminum-4Vanadium ELI) and PEEK (Polyetheretherketone). This interbody device is offered in both sterile and non-sterile forms.

The PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height, 15 mm to 28mm in length and between 19mm and 38mm in width. An array of lordosis options are provided for this device spanning from 4 degrees to 15 degrees of angulation. Both the PEEK and Titanium Alloy devices are designed with teeth across both the superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance. Additionally; the Titanium Alloy version of this device offers lateral windows for visibility of the autogenous bone graft.

The purpose of this submission is to add a new inserter to the PERIMETER® Interbody Fusion Device system and to provide the package insert for this reusable device as well as other instruments for use with PERIMETER® Interbody Fusion Device. Additionally, the package insert for Medtronic's CATALYST® instruments, which can also be used with PERIMETER® Interbody Fusion Device, is provided. The modified design of the subject PERIMETER® Interbody Fusion Device does not affect the device's intended use or alter the device's fundamental scientific technology.

This 510(k) premarket notification (K113642) is for a modification to an existing medical device, the PERIMETER® Interbody Fusion Device. The primary purpose of the submission is to add a new inserter to the system and provide updated package inserts. It explicitly states that the "modified design of the subject PERIMETER® Interbody Fusion Device does not affect the device's intended use or alter the device's fundamental scientific technology." Therefore, there are no clinical studies on human subjects to prove device performance or establish new acceptance criteria. The approval relies on demonstrating substantial equivalence to previously cleared devices and adherence to relevant non-clinical testing standards.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. This submission is for a modification to an existing device, focusing on non-clinical testing and substantial equivalence. There are no new clinical studies or test sets involving human patients where a sample size would be traditionally reported for device performance.
• Data Provenance: Not applicable for clinical data. The data provenance described relates to manufacturing and reprocessing standards for medical devices.

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

• Number of Experts/Qualifications: Not applicable. As there is no clinical test set for new device performance, there's no "ground truth" to be established by experts in the context of clinical outcomes or diagnostic accuracy. The "ground truth" here is compliance with engineering and sterilization standards.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set requiring adjudication.

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

• MRMC Study: No. This type of study is for evaluating diagnostic accuracy or reader performance with medical imaging devices, which is not relevant to an interbody fusion device and its inserter.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: No. This applies to AI/ML algorithms, which are not part of this device submission.

7. Type of Ground Truth Used

The "ground truth" for this submission is established through:

• Engineering specifications and material properties: Demonstrating that the new inserter design and materials are equivalent to already cleared devices.
• Compliance with recognized industry standards: For cleaning, sterilization, and manufacturing processes (listed in section V, IX, and X).
• Risk analysis: Identifying and mitigating potential risks associated with the device and its modifications.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This refers to AI/ML device development, which is not relevant here.

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

• Ground Truth for Training Set: Not applicable. As above, this is for AI/ML device development.

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

The study proving the device meets its acceptance criteria is a non-clinical equivalency assessment and adherence to recognized standards.

The key aspects of this "study" are:

• Comparison to Predicate Devices: The submission establishes substantial equivalence by demonstrating that the PERIMETER® Interbody Fusion Device, including the new inserter, is identical in terms of indications for use, intended use, performance specifications, and fundamental technological characteristics to its predicate devices (PERIMETER® Interbody Fusion Device cleared in K090353 and K111525, and the CAPSTONE® Spinal System [K103731] for the inserter design).
• Design Control Processes: Medtronic's internal design control processes were used to assess the instrument modifications.
• Cleaning and Sterilization Validations: Extensive validations were performed and submitted demonstrating adherence to a comprehensive set of international and national standards (ISO 17664, ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO TIR 17665-2, AAMI TIR 12, ANSI/AAMI ST79 & A1, AAMI TIR 30, ANSI/AAMI ST81). These validations ensure that the new reusable inserter and other instruments can be safely cleaned and sterilized for clinical use.
• Risk Analysis: A completed risk analysis supports the safety and effectiveness of the modified system.

In essence, the "proof" is a comprehensive documentation package demonstrating that the changes made (primarily a new inserter and updated instructions) do not introduce new safety or effectiveness concerns and that the device remains functionally equivalent to its cleared predicate.

Ask a specific question about this device

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. Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous surgery. 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 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. The PERIMETER® Interbody Device is to be used with supplemental instrumentation.

The device is offered in Titanium Alloy (Titanium-6Aluminum-4Vanadium ELI ) or PEEK Optima LT1 (Polyetheretherketone). This interbody device is provided in sterile forms. Refer to the package label for specific implant sterility information.

The PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height, 21mm to 28mm in length and between 19mm and 38mm in width. An array of lordosis options are provided for this device spanning from 4 degrees to 15 degrees of angulation. Both the PEEK Optima LT1 and Titanium Alloy devices are designed with teeth across both the superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance. Additionally, the Titanium Alloy version of this device offers lateral windows for visibility of the Autogenous bone graft.

This 510(k) summary describes a medical device, not an AI/ML powered device, therefore, many of the typical acceptance criteria for AI/ML performance metrics are not applicable. The device is the PERIMETER® Interbody Fusion Device, an implant used for interbody fusion in the spine. The "study" mentioned refers to non-clinical tests conducted to prove substantial equivalence to a predicate device.

Here's the information based on the provided text, recognizing the difference in device type:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify a distinct "test set" in the context of clinical trials or data analysis. The performance evaluation was based on non-clinical mechanical testing. For the mechanical tests, the sample size would refer to the number of physical devices tested or the specifications of the finite element analysis model. This information is not provided in the summary.
• Data Provenance: Not applicable as this refers to non-clinical, in-vitro/computational testing, not patient data.

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

• Not applicable. For mechanical testing, the "ground truth" is defined by the physical laws and engineering standards (e.g., ASTM 2077-03). Expert interpretation would be involved in designing the test and analyzing results, but not in establishing a "ground truth" in the sense of clinical diagnoses.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies among expert readers. This document details mechanical testing, not clinical reader studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• No. This is a mechanical device, not an AI/ML system that would involve human readers.

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

• Not applicable. This relates to an implantable medical device, not an algorithm. The performance described is the device's inherent mechanical properties.

7. The type of ground truth used

• The "ground truth" for the mechanical performance tests is established by engineering standards and physical principles as outlined in ASTM 2077-03 and finite element analysis (FEA) methodology. The goal was to demonstrate performance equivalent to a predicate device.

8. The Sample Size for the Training Set

• Not applicable. This document describes a medical device, not an AI/ML system. There is no concept of a "training set" in this context. The device's design and properties are based on engineering principles and materials science.

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

• Not applicable. As there is no training set for an AI/ML model, there is no ground truth to be established for it. The device's design is based on established engineering and biomechanical principles for intervertebral fusion devices, not on data training.

Ask a specific question about this device

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 cages 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. The PERIMETER® Interbody Device is to be used with supplemental instrumentation. This device is offered in both titanium alloy and PEEK (POLYETHERETHERKETONE) versions. This interbody device is provided in both sterile and non-sterile forms. Refer to the package label for sterility information. The subject PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height and between 19mm and 28mm in width. The device is designed with teeth across both superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance.

The provided text is a 510(k) summary for the PERIMETER® Interbody Fusion Device. It focuses on demonstrating substantial equivalence to previously cleared devices through mechanical testing and literature review. It does not contain information about clinical studies with human participants, AI algorithms, or detailed performance metrics that would typically be found in an acceptance criteria and study section for a medical device with an AI component.

Therefore, I cannot extract the specific information requested about acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

Here's what I can infer from the document and how it relates to the requested information:

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

• Acceptance Criteria: The primary acceptance criterion for this 510(k) submission was "substantial equivalence" to predicate devices. This is demonstrated through mechanical testing results and published literature, which would compare the PERIMETER® device's mechanical properties (e.g., strength, stiffness, resistance to expulsion) to those of the predicate devices. The document does not explicitly state numerical acceptance criteria, but rather implies they would be "comparable" or "equivalent" to the predicate devices.
• Reported Device Performance: The document states "Documentation, including mechanical test results and published literature, was provided which demonstrated that the subject PERIMETER® Interbody Fusion Device is substantially equivalent to several recently down classified interbody cages..." This indicates that performance was evaluated mechanically, but the specific numerical results or metrics are not detailed in this summary.

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

• This document refers to mechanical test results, not clinical test sets with human data. Therefore, there is no information on human sample sizes, data provenance, or retrospective/prospective study design in this submission. Mechanical testing typically involves a set number of devices tested under specific conditions.

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 as the submission is based on mechanical testing and comparison to predicate devices, not human-read interpretations or ground truth established by medical experts for a diagnostic or AI device.

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

• Not applicable, as this is related to human interpretation of data, which is not the focus of this 510(k) summary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, this document does not mention any MRMC study, AI, or human-in-the-loop performance. It pre-dates widespread AI integration in medical devices and focuses on the physical implant.

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

• No, there is no mention of any algorithm or standalone performance being evaluated.

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

• The "ground truth" here would be the mechanical properties and performance specifications of the predicate devices, against which the PERIMETER® device was compared. The exact tests and their respective "ground truth" values (e.g., maximum load at failure, subsidence measurements) are not detailed but are implied to be part of the documentation submitted to the FDA.

8. The sample size for the training set:

• Not applicable. This is not an AI-based device, so there is no concept of a "training set."

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

• Not applicable.

In summary, this 510(k) summary for the PERIMETER® Interbody Fusion Device pertains to a physical medical implant and demonstrates substantial equivalence through mechanical testing and literature review, not through clinical trials or studies involving AI algorithms. Therefore, most of the requested information regarding AI device performance metrics, human reader studies, and ground truth establishment for diagnostic purposes is not present in the provided text.

Ask a specific question about this device