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The KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The KLIMT Expandable LIF Cage System is a lumbar intervertebral fusion cage that is implanted in the disc space between the intervertebral bodies to obtain fusion and mechanical stability. The subject cage is vertically expandable i.e., it has a height adjustable feature for ease of implantation and final secure fit to a patient's anatomy. The cage's components are manufactured via Selective Laser Melting (SLM) 3D printing technology using a medical grade metal powder and/or by machining (CNC method) and assembled into a final cage unit. The cages are manufactured from titanium alloy powder per ASTM F3001 and titanium alloy per ASTM F136 and are provided both sterile and nonsterile to the end user. The patient contacting portion of all instruments is made from Stainless Steel per ASTM F899 and all instruments are provided non-sterile and intended to be sterilized by the end user prior to use.

The provided text describes a medical device, the KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System, and its clearance process with the FDA. It does not describe acceptance criteria for a software device or a study proving that a device meets such criteria.

The information provided is for a physical medical device (an intervertebral body fusion device), not a software or AI-driven system. Therefore, I cannot extract the requested information about acceptance criteria for a software device, test set details, ground truth establishment, MRMC studies, or training set specifics, as these concepts are not applicable to the document's content.

The document discusses non-clinical performance data for the physical cage system, primarily focusing on mechanical testing (e.g., static and dynamic compression bending, torsion, subsidence, expulsion) as per ASTM standards, to demonstrate substantial equivalence to predicate devices. There are no clinical tests reported ("O N/A").

The "Summary of Performance Data (Nonclinical and/or Clinical)" section explicitly states:

• Non-Clinical Tests:
  • Static Compression Bending (per ASTM F2077)
  • Dynamic Compression Bending (per ASTM F2077)
  • Static Compression Shear Bending (per ASTM F2077)
  • Dynamic Compression Shear Bending (per ASTM F2077)
  • Static Torsion (per ASTM F2077)
  • Subsidence (per ASTM F2267)
  • Expulsion
• Clinical Tests: "O N/A"

Therefore, I cannot provide the requested details because the document pertains to a physical medical device's engineering performance rather than a software device's analytical or clinical performance using AI.

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The MONDRIAN Lumbar Plate System is indicated as additional support during fusion in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The MONDRIAN Anterior Lumbar Plate System is anterior lumbar fusion devices used to provide structural stability in skeletally mature individuals. The system consists of plates, screws, and instruments to facilitate the installation of the implants. Plates and screws are manufactured from Titanium Alloy per ASTM F136. The instruments are manufactured from Stainless Steel per ASTM F899. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use.

Based on the provided FDA 510(k) Clearance Letter for the MONDRIAN™ Anterior Lumbar Plate System, here's an analysis of the acceptance criteria and the study that proves the device meets them:

Important Note: The provided document is a 510(k) clearance letter, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance data and comparison of technological characteristics. It is not a detailed study report for a novel medical device, especially an AI-powered one. Therefore, many of the requested items related to AI device performance evaluation (such as sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training set details) are not applicable or present in this type of document because the device in question is a physical surgical implant, not an AI/software device.

Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" for a physical implant device like the MONDRIAN™ Anterior Lumbar Plate System are primarily related to its mechanical strength, durability, material safety (biocompatibility), and functionality under simulated physiological loads. The reported device performance is that the non-clinical tests showed the device meets these requirements and performs within its intended uses, indicating no new safety or effectiveness concerns compared to the predicate device. Specific numerical acceptance thresholds are not detailed in this high-level summary but would be part of the full submission.

Study Details (Focusing on the provided document's context)

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

   • Sample Size: Not explicitly stated as a "sample size" in the context of clinical data or AI test sets, as this is a non-clinical bench testing submission for a physical implant. The "test set" for this device refers to the number of implants or test specimens subjected to the various mechanical tests. This information is typically found in the test reports themselves, not the 510(k) summary.
   • Data Provenance: Not applicable in the context of country of origin for clinical data, as no clinical studies were performed ("Clinical Tests: N/A"). The non-clinical tests would have been performed in a laboratory setting, likely within the manufacturing entity's or a contract testing facility's country.

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

   • Not Applicable. This question typically pertains to studies involving human interpretation (e.g., radiologists, pathologists) to establish ground truth for AI algorithms. For a physical implant, "ground truth" is established by engineering specifications, material standards, and validated mechanical testing methodologies.

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

   • Not Applicable. Adjudication methods are used to resolve disagreements among human experts in establishing ground truth for clinical studies or AI performance evaluation. For mechanical testing, results are objective measurements against predefined engineering criteria, eliminating the need for adjudication.

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. An MRMC study is not relevant here as the MONDRIAN™ Anterior Lumbar Plate System is a physical surgical implant, not an AI software device intended to assist human readers.

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

   • No. This refers to the performance of an AI algorithm alone. The MONDRIAN™ Anterior Lumbar Plate System is a physical medical device; thus, this type of standalone performance evaluation is not relevant.

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

   • Engineering Specifications and Material Standards: For this device, the "ground truth" for evaluating its performance comes from established engineering principles, material science (e.g., ASTM F136 and ASTM F899 standards for Titanium Alloy and Stainless Steel), and validated mechanical testing protocols. The device's ability to withstand specified loads (static and dynamic) without failure or excessive deformation, and its material compliance, constitute the 'ground truth' it must meet.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" in the context of machine learning or AI for this physical medical device.

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

   • Not Applicable. As there is no training set for this physical device, the concept of establishing ground truth for it does not apply.

In summary, the provided document details the 510(k) clearance for a physical implant device. The "study" proving it meets acceptance criteria consists of non-clinical mechanical bench testing demonstrating its equivalence in performance and characteristics to legally marketed predicate devices, rather than clinical trials or AI performance evaluations.

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The Advantage Lumbar System - ALIF, PLIF, TLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Advantage Lumbar – ALIF, PLIF, TLIF's implants are interbody fusion devices intended for use as an aid in spinal fixation. These hollow, rectangular implants are offered in a variety of widths, lengths, heights, and lordotic angles designed to adapt to a variety of patient anatomies. They have serrations on the superior and inferior surfaces designed for fixation, ergonomically shaped anterior edges, and flat posterior edges. Radiopaque markers have been embedded within the implants, which are designed to allow for visualization in radiographic images.

The provided document is a 510(k) summary for the Intelivation LLC's Advantage Lumbar System, which is an intervertebral body fusion device. The document explicitly states that no performance testing was required for this device.

The rationale provided is that the "subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring names of systems that have already been cleared under K121567 and K131981."

Therefore, based on the provided text, it is not possible to describe acceptance criteria or a study that proves the device meets the acceptance criteria, as no such study was conducted or deemed necessary by the FDA for this particular 510(k) clearance due to the device's substantial equivalence to already cleared predicates.

All sections of your request related to acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be answered as the submission states no testing was required for this particular device.

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