Search Results

The stand-alone intersomatic IMPIX ALIF S/A implants are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine 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 at the involved level(s).

This device is to be used with autogenous bone graft.

Patients should have a satisfactory course of conservative treatment (usually at least six (6) months of non-operative treatment) prior to treatment with an IMPIX-ALIF-S/A stand-alone cage.

The IMPIX ALIF S/A devices should be used with the three (3) bone screws (Small Footprint) or four (4) bone screws (Medium. Large Footprints) accompanying the device. Otherwise, an additional fixation system (e.g., pedicle screw system) should be implanted.

The MEDICREA® IMPIX ALIF S/A is an intervertebral fusion device with integrated fixation use as an adjunct to fusion. The implant is composed of:

• one PEEK cage with tantalum markers
• either 3 or 4 IMPIX ALIF S/A screws , depending on the footprint of cage considered.

The IMPIX ALIF S/A screw is manufactured from titanium alloy (Ti-6Al-4V) meeting ASTM F136 and ISO 5832-3 standards, and the PEEK cage is manufactured from PEEK OPTIMA® LT1 meeting the ASTM F 2026.The tantalum markers are manufactured from tantalum meeting the ASTMF560 and ISO 13782 standards.

Materials: Titanium alloy (Ti-6Al-4V) and PEEK OPTIMA® LT1 and tantalum

The provided document is a 510(k) premarket notification for a medical device (IMPIX ALIF S/A), primarily focusing on demonstrating substantial equivalence to predicate devices for regulatory clearance. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically expected for an AI/ML powered device, or a clinical trial showing efficacy.

The "performance data" section in the document refers to biocompatibility and mechanical testing, which are standard for implantable medical devices, not for assessing the performance of an AI model against specific acceptance criteria.

Therefore, for the requested information regarding acceptance criteria and a study proving the device meets those criteria, most of the fields cannot be filled from the provided text as they are not applicable to the type of regulatory submission presented.

Here's a breakdown of what can be extracted and why other parts cannot be:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The "performance data" refers to engineering and laboratory tests of the physical device, not performance on a dataset of patient 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)
Not applicable. This information is irrelevant for the mechanical and biocompatibility 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. The device is an intervertebral fusion device, 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
Not applicable. This device is a physical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For biocompatibility: Adherence to established ISO and ASTM standards for materials and biological reaction.
For mechanical testing: Adherence to established ASTM standards for mechanical properties.
No clinical ground truth (like pathology or outcomes data) was used or provided as no clinical studies were performed.

8. The sample size for the training set
Not applicable. This document describes a physical medical device, not an AI/ML algorithm that would have a "training set."

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

Summary of what the document confirms regarding performance:

• No clinical studies were performed.
• No animal studies were performed.
• The device's performance was assessed through biocompatibility testing and mechanical testing against relevant ISO and ASTM standards, demonstrating compliance and substantial equivalence to predicate devices.
• The biocompatibility testing included cytotoxicity, sensitization, irritation, systemic toxicity, and pyrogen testing.
• The mechanical testing included FEA, static and dynamic axial compression, static and dynamic compression shear, subsidence, expulsion, and screw clip-out evaluation, all performed in compliance with FDA guidance and ASTM standards for intervertebral body fusion devices.

This document specifically highlights that the "performance data" provided was sufficient to establish "substantial equivalence" for regulatory approval without human or animal clinical studies, or any data-driven AI/ML performance evaluation.

Ask a specific question about this device

The INNESIS PEEK Cervical 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 (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. INNESIS PEEK Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach and packed with autogenous bone. INNESIS PEEK Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The INNESIS PEEK Cervical Cage is an implant for the anterior stabilization of the cervical spinal column using an Anterior Cervical Desectorny and Fusion (ACDF) surgery. The INNESIS PEEK Cervical Cages are offered in a variety of heights, footprints and curved shapes. The INNESIS PEEK Cervical Cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft. The INNESIS PEEK Cervical Cage includes spikes and marker (pin) for radiological evaluation of the position and orientation of the radiolucent PEEK Cage

Here's a breakdown of the acceptance criteria and study information for the INNESIS PEEK Cervical Cage, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to predicate devices and the mechanical performance of the INNESIS PEEK Cervical Cage. The acceptance criteria are based on established ASTM standards for intervertebral body fusion devices.

Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Testing results are for the following:" followed by the list of tests and standards. It then concludes by saying "These materials are both recognized as suitable biomaterials for this intended use and predicate devices have previously been cleared by FDA for this same intended use. Endotoxin testing has demonstrated that the process does not introduce endotoxins as a bi-product of the manufacturing and cleaning process." While it directly states biocompatibility and endotoxin results, for the mechanical tests, it implicitly suggests that the device met the requirements of the standards by stating testing was conducted in accordance with them, which is the typical approach for demonstrating substantial equivalence for mechanical properties.

Study Details

The provided text describes pre-clinical, often benchtop, testing rather than a clinical study. Therefore, some of the requested information regarding clinical study design (e.g., sample size for test sets, expert ground truth, MRMC studies) is not applicable.

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

   • Sample Size: Not specified for individual tests. For mechanical testing of medical devices, samples are typically physical units of the device tested under controlled laboratory conditions.
   • Data Provenance: Not explicitly stated, but implied to be from laboratory testing performed by BK Meditech Co, Ltd. or a contracted testing facility, likely in the Republic of Korea given the company's origin. The data is retrospective in the sense that it's generated for regulatory submission after device development.

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

   • This is not applicable as the testing described is mechanical, material, and chemical (endotoxin) in nature, not based on expert interpretation of clinical data or images. The "ground truth" here is the adherence to the specified ASTM standards and the validated properties of the materials.

3. Adjudication method for the test set:

   • Not applicable for the type of testing performed. Mechanical and material tests have objective pass/fail criteria based on quantitative measurements against a standard.

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:

   • Not applicable. This device is an implantable medical device (cervical cage), not an AI diagnostic or image interpretation tool. Therefore, no MRMC study or AI assistance is relevant.

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

   • Not applicable. This device does not involve an algorithm or AI.

6. The type of ground truth used:

   • For mechanical, material, and chemical tests: The ground truth is the performance specification defined by recognized industry standards (ASTM) and accepted material properties for biomaterials. For endotoxin testing, the ground truth is the absence of endotoxins at or below detectable levels.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of an AI/machine learning model for this type of device submission. The device design and materials are based on established engineering principles and prior art (predicate devices), not machine learning.

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

   • Not applicable, as there is no training set for an AI/machine learning model. The analogous "ground truth" for the device's design and manufacturing is based on established engineering and materials science principles, industry standards, and the performance history of similar predicate devices.

Ask a specific question about this device

IMPIX DLIF Lumbar Interbody Device is indicated for intervertebral body fusion procedures 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. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. IMPIX DLIF Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The purpose of this submission is to submit the new Lumbar Interbody device: IMPIX-DLIF, or Dual Lateral Interbody Fusion, has a rectangular shape with a front beveled and has three areas inside for use with autogenous bone graft. This new device and IMPIX-L Interbody devices previously cleared in K072226 are manufactured in the same material, PEEK OPTIMA® LT1, and have the same Indications for use. The devices differ in geometry and approach.

The provided text describes a 510(k) premarket notification for a medical device called the IMPIX DLIF Lumbar Interbody Device. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than clinical studies or specific acceptance criteria with defined performance metrics.

Based on the provided document, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define acceptance criteria as pass/fail thresholds for specific performance metrics in a way that would typically be seen in a clinical study report. Instead, it describes mechanical tests performed and implies that the device's performance in these tests was comparable to or within acceptable limits for similar predicate devices. The "reported device performance" is essentially the execution of these tests, with the conclusion that the device is "substantially equivalent."

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

The document states:

• Sample Size for Test Set: Not explicitly stated for specific numerical outcomes. For non-clinical tests, it's typically a small number of devices per test (e.g., n=5 or n=10 per test condition). The summary only mentions "The following tests were conducted," implying a standard set of tests for interbody fusion devices.
• Data Provenance: The data is based on non-clinical laboratory testing performed in support of regulatory submission (510(k)). This is not human data (retrospective or prospective), but rather mechanical test data from the device itself. The country of origin for the testing is not specified, but the applicant is from France.

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

• Experts: Not applicable for non-clinical mechanical testing. Ground truth for mechanical tests is established by objective measurements against engineering standards (ASTM F2077, ASTM F2267).
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Mechanical tests have objective, quantifiable outcomes which don't require expert adjudication.

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

• MRMC Study: No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or reported.

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

• Standalone Performance: No. This device is an interbody fusion device (an implant), not a software algorithm or an AI-powered diagnostic tool. Therefore, the concept of "standalone performance" for an algorithm is not applicable.

7. The Type of Ground Truth Used

• Ground Truth: For this device, the "ground truth" for demonstrating substantial equivalence relies on:
  • Engineering Standards: Conformance to recognized ASTM standards (F2077, F2267) for mechanical properties.
  • Material Specifications: Conformance to specified material standards (e.g., PEEK OPTIMA® LT1 (ASTM F2026), Tantalum (ISO 13782)).
  • Comparison to Predicate Devices: Demonstrating similar design, materials, and intended use as legally marketed predicate devices.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

In summary, the provided document is a 510(k) summary for a physical medical implant. The "acceptance criteria" and "study" described are primarily related to non-clinical mechanical testing and material compatibility, demonstrating substantial equivalence to existing predicate devices rather than clinical performance against specific metrics with human data. Most of the requested information regarding AI performance, expert adjudication, or clinical study design is therefore not relevant or available in this context.

Ask a specific question about this device

IMPIX Lumbar Interbody Device is indicated for intervertebral body fusion procedures 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. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft.

IMPIX Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The IMPIX Lumbar Cage is bi-convex in the sagittal plane. It possesses teeth on both superior and inferior surfaces that assist in the anchorage and stability of the device to the bone of the vertebrae. The upper and lower aspects of the IMPIX-L are open, to allow the surgeon to pack the device with bone graft prior to insertion. Lateral holes exist to allow bone growth through the device. In order to the varying morphology of patients, the IMPIX Lumbar Cages are available in various sizes. The IMPIX Lumbar Cage is machined from PEEK OPTIMA LT1.

The provided text describes a 510(k) premarket notification for IMPIX Lumbar Interbody Devices. This submission focuses on establishing substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness through extensive clinical trials. Therefore, the information typically found in acceptance criteria and detailed study descriptions for a device that demonstrates performance against specific metrics with human involvement (like AI-assisted diagnostics) is not present.

Here's an analysis based on the available text:

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

   • Acceptance Criteria: The primary acceptance criterion for this type of device (intervertebral body fusion device) is demonstrating substantial equivalence to a predicate device, primarily through mechanical testing and material equivalence. The text mentions "required mechanical strengths" as the benchmark.
   • Reported Device Performance:

     Performance Aspect	Reported Performance
     Mechanical Strength	"IMPIX Lumbar Interbody Fusion devices meet required mechanical strengths."
     Material	Manufactured from PEEK OPTIMA LT1 (same as predicate).
     Indications for Use	Same as predicate device.
     Design (IMPIX-LA, IMPIX-LAD, IMPIX-TLIF)	Different from the predicate in design, but still deemed substantially equivalent based on testing.

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

   • Test Set Sample Size: Not explicitly stated for mechanical tests. The "cadaver trial" would have involved a small number of cadavers, but the exact count is not provided.
   • Data Provenance: Not specified for the mechanical tests. The cadaver trial likely took place where the manufacturer (MEDICREA Technologies, France) or its contact (Donald W. GUTHNER, PA, USA) conducted R&D.

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 this is a mechanical device submission, not a diagnostic device requiring expert interpretation of images. The "ground truth" here is mechanical integrity and adherence to ASTM standards.

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

   • Not applicable. The "test set" primarily refers to mechanical testing according to ASTM standards, which are objective measurements, not subjective evaluations by experts needing 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

   • Not applicable. This is a medical implant, not an AI-powered diagnostic device. No MRMC study was conducted.

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

   • Not applicable. This is a medical implant, not an AI or algorithm-based device.

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

   • The "ground truth" for this device's performance is based on engineering standards and mechanical testing results (e.g., meeting requirements for axial compression, compressive shear, resistance to subsidence, and expulsion as defined by ASTM F2077 & ASTM F2267). For substantial equivalence, the "ground truth" is also the performance characteristics of the legally marketed predicate device.

8. The sample size for the training set

   • Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

   • Not applicable. There is no training set for this type of device.

In summary, the 510(k) submission for IMPIX Lumbar Interbody Devices relies on demonstrating that the new devices are substantially equivalent to a previously cleared predicate device (IMPIX Lumbar Interbody Device, K072226) through mechanical testing and material similarity, as opposed to extensive clinical testing with patient outcomes or expert reviews.

Ask a specific question about this device

The Phenix Cervical Interbody Device (Phenix CID) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Phenix CID implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device should be used with supplemental fixation.

The Phenix ® Cervical Interbody Device is a cervical interbody fusion device made from PEEK Optima. It is implanted from the anterior approach. The device is provided in various geometries and is designed to fit within the outer cortex of cervical spine vertebrae. It is to be packed with autogenous bone graft to facilitate fusion. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved.

The provided text is a 510(k) summary for the Phenix® Cervical Interbody Device (Phenix® CID). It describes the device, its indications for use, and identifies predicate devices. However, it does not contain details about specific acceptance criteria for device performance or a study demonstrating that the device meets those criteria by comparing it to an AI system or human reader performance.

The "Performance Testing" section states: "The pre-clinical testing performed indicated that the Phenix CID is substantially equivalent to the predicate devices and is adequate for the intended use." This suggests that the device's performance was evaluated against the predicate devices for achieving substantial equivalence, which is a regulatory standard for medical devices. However, it does not provide quantitative acceptance criteria or detailed study results in the context of an AI device and reader performance.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is a summary of what can be inferred or directly stated, with the understanding that detailed performance metrics are not included for AI or reader studies:

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

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

• Not provided. The summary mentions "pre-clinical testing" but does not detail sample sizes, data provenance, or whether the study involved human subjects (which would be the case for a test set in the context of AI/reader studies).

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/Not provided. This device is a physical implant, not an AI diagnostic tool that requires ground truth established by experts for performance evaluation in the way a diagnostic AI would. The "pre-clinical testing" would likely refer to mechanical and material tests rather than expert-adjudicated diagnostic performance.

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

• Not applicable/Not provided. Similar to point 3, this is not relevant for the type of device described.

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 is not an AI device, and therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.

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

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

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

• Not applicable/Not provided in the context of AI/reader studies. For this device, "ground truth" for "pre-clinical testing" would refer to established engineering standards for mechanical and material properties (e.g., strength, durability, biocompatibility).

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable. This is a physical medical device, not an AI model.

In summary, the provided document is a 510(k) summary for a cervical interbody fusion device, focusing on its physical properties and intended use, and demonstrating substantial equivalence to predicate devices. It does not contain information related to AI performance, reader studies, or the types of "test sets" and "training sets" that would be relevant for an AI-powered diagnostic device.

Ask a specific question about this device

The Spinal USA Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space for the ALIF and TLIF system. Two devices are used per intervertebral space for the PLIF system.

The Spinal USA Interbody Fusion Device ALIF, PLIF, TLIF System are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with supplemental fixation and autogenuos bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.

The Spinal USA Interbody Fusion Device consists of implants with various widths, heights and lengths to accommodate individual patient anatomy and graft material size. All components are manufactured from medical grade polyetheretherketone (Peek, LT1). The products are supplied clean and "NON-STERILE".

The provided text does not contain information about acceptance criteria or a study proving the device meets them. Instead, it describes a 510(k) summary for an Intervertebral Body Fusion Device, focusing on its intended use, device description, and substantial equivalence to predicate devices. There is no mention of specific performance metrics, test sets, ground truth establishment, or clinical studies involving AI or human readers.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the questions regarding sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details based on the provided document.

Ask a specific question about this device