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The Incite Anchored Cervical Interbody Device is indicated for use in skeletally mature patients with degenerative disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Incite Anchored Cervical Interbody Device is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation, i.e. an anterior cervical plate, is required to properly utilize this system.

The Incite Anchored Cervical Interbody Fusion Device acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Incite Anchored Cervical Interbody Fusion Device is manufactured from PEEK and Ti6A14V titanium alloy with tantalum radiopaque markers

The provided text describes a Special 510(k) Summary for a medical device called the "Incite Anchored Cervical Interbody Fusion (ACI) Device." This type of submission focuses on demonstrating substantial equivalence to a predicate device, often for minor modifications rather than entirely new devices requiring extensive clinical trials for efficacy.

Based on the provided document, here's a breakdown of the acceptance criteria and the study used:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document explicitly states that "additional mechanical testing on the new size is not warranted." This means there was no new physical test set specifically for the 16x14mm device being cleared in this 510(k). The "test set" for the performance criteria refers to the testing data from the predicate device (K122008). The document does not specify the sample size (e.g., number of devices tested for static compression, torsion, etc.) used for the predicate device's original testing.
• Data Provenance: The data provenance is retrospective, as it relies entirely on the performance testing previously conducted and accepted for the predicate device (K122008). The country of origin of the data is not specified, but it would have been generated as part of the predicate device's original regulatory submission.

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

• This information is not applicable and not provided in the document. The study is a mechanical performance comparison based on engineering principles and previous device testing, not a clinical or diagnostic study involving human expert interpretation for ground truth.

4. Adjudication Method for the Test Set

• This information is not applicable and not provided. As above, this is a mechanical performance study, not a study requiring adjudication of expert opinions.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted interpretation devices to assess the impact on human reader performance. This submission is for an implantable medical device, and the demonstration of substantial equivalence relies on mechanical performance data and comparison of physical attributes.

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

• No, a standalone performance study was not done. This device is a physical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" for the mechanical performance aspects is based on engineering and biomechanical testing standards and the results obtained from the predicate device's testing against those standards. It is not expert consensus, pathology, or outcomes data. The ground for "substantial equivalence" is the direct comparison of design, materials, and intended use to the predicate device, along with the reasoning that the new size does not introduce a "new worst case condition."

8. The Sample Size for the Training Set

• This information is not applicable and not provided. There is no "training set" in the context of this device and its regulatory submission, as it is not an AI/ML algorithm.

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

• This information is not applicable and not provided. As there is no training set, there is no ground truth to establish for it.

In summary:

The study presented here is a Special 510(k) submission based on substantial equivalence to a predicate device (K122008). The "study" for acceptance criteria is primarily a justification based on engineering principles and previously accepted mechanical test data from the predicate device. The key argument is that the dimensional differences of the new device (a larger footprint 16x14mm) do not create a "new worst-case condition" compared to the predicate device, thus making the predicate's performance data applicable to the new size. No new testing was performed for this specific submission for the new size.

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The Incite Anchored Cervical Interbody Device is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Incite Anchored Cervical Interbody Device is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation, i.e. an anterior cervical plate, is required to properly utilize this system.

The Incite Anchored Cervical Interbody Fusion Device acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Incite Anchored Cervical Interbody Fusion Device is manufactured from PEEK and Ti6A14V titanium alloy with tantalum radiopaque markers.

The Incite Anchored Cervical Interbody Fusion Device is a medical device designed to act as a spacer in the cervical spine to maintain proper intervertebral and vertebral body spacing and angulation. The provided text describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain details about a clinical study with acceptance criteria and reported device performance in the way a typical AI/software device would.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed devices, primarily through bench testing (performance testing) and comparison of design, materials, and function.

Here's a breakdown of the requested information based on the provided text, highlighting what is (and isn't) present:

Most of the requested information (points 2-9) pertains to clinical studies involving human patients or detailed software validation, which are not described in this 510(k) summary for this type of medical implant.

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

Note on "Acceptance Criteria" for this device: The acceptance criteria are essentially defined by the recognized ASTM standards listed for each test. The actual numerical thresholds (e.g., minimum load to failure, maximum displacement) are not provided in this summary, but the device is stated to have met the performance requirements implied by these standards and shown substantial equivalence to predicate devices.

Regarding the study that proves the device meets the acceptance criteria:

The "study" in this context refers to the Performance Testing section described. It's a series of bench tests (mechanical and physical tests performed in a lab setting) and a Cadaver Lab, rather than a clinical trial with human subjects for direct outcome measurement.

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

• Test Set Sample Size: Not specified for each individual test. For mechanical tests, this typically involves a certain number of devices tested to failure or under specific load conditions. For the Cadaver Lab, the number of cadavers is not mentioned.
• Data Provenance: The tests are performed in a lab setting (likely by the manufacturer or a contract testing facility) to comply with recognized ASTM standards. This is laboratory-generated data, not human patient data in the context of a "test set" for performance evaluation in a clinical sense.

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

Not applicable to this type of device and testing. Ground truth for mechanical performance is established by objective physical measurements against engineering specifications and standard requirements, not through expert consensus on interpretation. For the Cadaver Lab, surgical experts might have evaluated surgical technique or fit, but details are not provided.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for clinical trials or image interpretation studies where human experts are making judgments. For mechanical testing, the results are quantitative and directly measured.

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 spinal implant, not an AI or imaging device that would involve human readers or AI assistance.

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

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

7. The type of ground truth used

The ground truth for this device's performance is established by:

• Compliance with recognized ASTM standards (e.g., F2077, F2267). These standards define acceptable mechanical properties and performance characteristics for intervertebral body fusion devices.
• Substantial equivalence to already legally marketed predicate devices, meaning its performance, design, and materials are comparable and safe for the intended use.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning or AI. Performance is evaluated against engineering standards and comparison to predicates.

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

Not applicable. As there's no "training set," there's no ground truth to establish for it in this context.

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The Incite Interbody Fusion Device is intended for anterior intervertebral body fusion of the lumbar spine at one or two contiguous levels from L2-S1. The device is indicated for patients with lumbar degenerative disc disease (DDD) with up to Grade I spondylolisthesis 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. Patients treated should be skeletally mature and have received a minimum of six months of non-operative treatment. The Incite Interbody Fusion Device is designed for use with additional supplemental fixation and with autograft to facilitate fusion.

The Incite Interbody Fusion Device (IBFD) is an ALIF implant that incorporates the benefit of a radiolucent interbody spacer equipped with internal fixation anteriorly through the use of an integrated anchoring mechanism. The implant is made from materials with a long history of use in this type of application which include PEEK, titanium alloy, and tantalum. The implant has two chambers to accommodate autograft.

I am sorry, but the provided text from the 510(k) summary (pages 0-3) for the "Incite Interbody Fusion Device" does not contain information regarding acceptance criteria, device performance, or any clinical study details such as sample sizes, data provenance, ground truth establishment, or expert involvement.

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to predicate devices based on design, materials, intended use, and mechanical performance. It details the device description, intended use, and lists predicate devices. It also includes the FDA's clearance letter.

Therefore, I cannot fulfill your request for the specific information about acceptance criteria and the study that proves the device meets those criteria based on the provided text.

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