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The CONDUIT™ ATP Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages.

The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nanoscale features are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S 1. 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 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF 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 CONDUIT™ ATP Inserters are designed for use during Lumbar Interbody Fusion surgery, specifically using the ATP surgical approach. The inserters have been designed to interface with EIT Cellular Titanium® LLIF Cages (K201605). The reusable instruments are provided non-sterile and made from commonly used orthopedic materials with commonly used manufacturing processes. There are no changes to the implants or other compatible instruments provided with the implants.

The provided text is a 510(k) summary for the CONDUIT™ ATP Inserters, which are surgical tools. It clarifies that these inserters are not a device that uses AI or machine learning. The document describes them as reusable instruments made from orthopedic materials, intended for use in Lumbar Interbody Fusion surgery.

Therefore, the requested information regarding AI/ML device acceptance criteria, performance studies involving AI, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance cannot be provided as these concepts are not relevant to this type of medical device.

The "Performance Data" section of the 510(k) summary indicates that non-clinical testing was conducted to confirm device performance, including:

• Impaction endurance testing
• Formative usability testing
• Thread cyclic testing

These tests are standard for mechanical surgical instruments to ensure their durability and functionality, rather than evaluating AI performance.

The conclusion states that the overall technology characteristics and mechanical performance data lead to the conclusion that the CONDUIT™ ATP Inserters are substantially equivalent to the predicate device, K223671, the CONDUIT™ LLIF Straight Inserters manufactured by DePuy Synthes.

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The RI.KNEE Adjustable Tibia Cut Guide is intended to be used in conjunction with the CORI surgical system during total knee arthroplasty.

The subject RI.KNEE Adjustable Tibia Cut Guide is a set of surgical instrument components used during total knee arthroplasty (TKA) to make the resections to the tibia by guiding a surgical saw through the saw slot. The cut guide is used with the Smith and Nephew (Blue Belt Technologies) CORI surgical system. The subject Tibia Cut Guide offers an alternative to the tibia cut guides currently available in the CORI system and provides direct attachment of the tibia tracker to reduce surgical steps for tibia tracker fixation.

The provided text does not contain any information about an AI/ML device or its performance. The document is a 510(k) premarket notification for a physical medical device, the "RI.KNEE Adjustable Tibia Cut Guide," which is a surgical instrument.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, human reader performance, or ground truth establishment for an AI/ML device, as there is no such device described in the input.

The document discusses:

• The device's intended use: a surgical instrument used during total knee arthroplasty.
• Its classification: Class II, Stereotaxic Instrument.
• Performance data from non-clinical testing: Summative Usability Evaluation, Function and Robustness Testing, Biocompatibility, Cleaning, and Sterilization. These are standard tests for physical surgical instruments, not AI/ML algorithms.
• Substantial equivalence to a predicate device (Real Intelligence Cori).

There is no mention of any AI or machine learning components in the RI.KNEE Adjustable Tibia Cut Guide, nor any studies that would involve human-in-the-loop performance with an AI, MRMC studies, or ground truth establishment relevant to AI/ML model training or testing.

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The CONDUIT™ LLIF Straight Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages.

The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nanoscale features are 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 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The CONDUIT™ LLIF Straight Inserters are designed for use during Lumbar Interbody Fusion surgery, specifically using a lateral approach. The instruments have been designed specifically to interface with the EIT Cellular Titanium® Cages (K201605). The reusable instruments are provided non-sterile and made from commonly used orthopedic materials with commonly used manufacturing processes. There are no changes to the implants or to other instruments provided with the implants.

The provided text describes a 510(k) premarket notification for the CONDUIT™ LLIF Straight Inserters, which are instruments used to insert EIT Cellular Titanium® LLIF Cages during Lumbar Interbody Fusion surgery.

However, the document does not contain information related to a study that uses AI or machine learning, nor does it discuss acceptance criteria and device performance in the context of AI. The performance data mentioned refers to non-clinical mechanical testing (impact endurance and thread endurance) for a surgical instrument, not an AI-powered diagnostic or assistive device.

Therefore, I cannot provide a response to your request, as the provided text lacks the necessary information about acceptance criteria and a study proving an AI device meets those criteria.

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The DePuy CONDUIT™ LLIF SQUID Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages.

EIT Cellular Titanium® LLIF Cage

The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nanoscale features are 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 1 spondylolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF 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 DePuy CONDUIT™ LLIF SQUID Inserter is designed for use during Lumbar Interbody Fusion surgery, specifically using a lateral approach. The instrument has been designed specifically to interface with the EIT Cellular Titanium® Cages (K201605). The reusable instrument is provided non-sterile and made from commonly used orthopedic materials. There are no changes to the implants or to other instruments provided with the implants.

The provided document describes a medical device, the "DePuy CONDUIT™ LLIF SQUID Inserter," and its clearance process through the FDA 510(k) pathway. This pathway focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study for novel performance claims.

Therefore, many of the typical acceptance criteria and study components you'd expect for an AI/ML device (e.g., AUC, sensitivity, specificity, physician performance with/without AI, expert adjudication, ground truth establishment) are not applicable to this submission. This document describes a surgical instrument and its mechanical and functional performance, not an AI/ML diagnostic or therapeutic device.

Here's an analysis based on the information provided, explicitly stating where specific requested details are not relevant or available:

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

For this type of device (a surgical instrument), acceptance criteria are typically related to mechanical integrity, functionality, and compatibility, rather than clinical performance metrics like sensitivity or specificity.

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

• Test Set Sample Size: Not explicitly stated as a numerical sample size. The "bench tests" and "formative usability test" would have involved a sufficient number of device units and/or simulated use cases to demonstrate robust performance. However, these are not clinical "test sets" in the sense of patient data.
• Data Provenance: The tests are described as "non-clinical testing" and "bench tests," indicating in-house engineering and laboratory testing rather than patient data from a specific country or retrospective/prospective study.

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

• Not Applicable. This is a mechanical/functional device, not an AI/ML device requiring expert interpretation of medical images or data for ground truth. Ground truth for these tests would be established by engineering specifications and successful completion of physical actions (e.g., the inserter successfully grips the cage).

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

• Not Applicable. As no expert interpretation or diagnostic classification is involved, no adjudication method is relevant.

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, an MRMC study was not done. This device is a surgical instrument, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a physical surgical instrument, not an algorithm.

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

• For surgical instruments, "ground truth" relates to successful mechanical function, adherence to material specifications, and safe interaction with other components (e.g., the implant cage) and the surgical environment. It is established by:
  • Engineering specifications and standards: The device must meet predefined mechanical strength, endurance, and dimensional tolerances.
  • Functional verification: The device must reliably perform its intended action (e.g., grasp, insert, release an implant).
  • Material conformity: Verification that materials meet specified ASTM standards.

8. The sample size for the training set

• Not Applicable. This is a manufactured physical device, not an AI/ML model that is 'trained' on data.

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

• Not Applicable. No training set for an AI/ML model is involved.

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The DePuy CONDUIT™ LLIF Angled Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages.

EIT Cellular Titanium® LLIF Cage

The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nano-scale features are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S 1. 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 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF 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 CONDUIT™ Lateral Angled Inserters are designed for use during Lumbar Interbody Fusion surgery, specifically using a lateral approach. The instruments have been designed specifically to interface with the EIT Cellular Titanium® Cages (K201605). The reusable instruments are provided non-sterile and made from commonly used orthopedic materials with commonly used manufacturing processes. There are no changes to the implants or to other instruments provided with the implants.

The provided text describes the DePuy CONDUIT™ LLIF Angled Inserters, an intervertebral body fusion device tool. However, it does not include information about acceptance criteria and a study proving the device meets those criteria, as typically found in submissions for AI/ML-driven medical devices.

The document is a 510(k) summary for a medical device (a surgical tool), not an AI/ML diagnostic or prognostic device. As such, the typical metrics and study designs (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance) for AI evaluation are not applicable or discussed here.

Instead, the performance data section states: "Non-clinical testing was conducted to confirm device performance per intended use including functionality bench test, impact endurance test, thread endurance test, and formative usability test. The results of this non-clinical testing show that the performance of the DePuy CONDUIT™ LLIF Angled Inserters are sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

This indicates that the device's performance was evaluated through bench testing for physical properties and functionality, not through clinical studies involving patient data or AI algorithm performance metrics.

Therefore, I cannot provide the requested information in the structured format because the document does not contain data related to AI/ML device acceptance criteria and studies.

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