(105 days)
The Ardis Interbody System is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment.
The Ardis Interbody System is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.
The Ardis® Interbody System is an implant device for interbody fusion of the anterior column of the spine. It is available in various height, width and length options. The device has a textured "tooth" pattern on both the cranial and caudal sides of the device and teardrop holes on the medial and lateral sides of the device. The implant incorporates an internal cavity that allows for the placement of bone graft material.
The system includes the single-use spacer implant, as well as the associated reusable instruments used for site preparation, trialing, and placement/extraction of the device, such as rasps, tamps, shavers, bone funnel, bone tamp, slap-hammer, T-handle and trials.
The provided document pertains to the 510(k) summary for the Ardis® Interbody System, an implantable medical device, not an AI/ML powered device. As such, it does not contain information typically found in studies for AI/ML devices, such as acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity), sample sizes for test sets in an AI/ML context, data provenance, ground truth establishment by experts, adjudication methods, MRMC studies, standalone performance, or training set details.
The "Summary of Performance Testing" section describes a simulated surgical evaluation using a cadaver specimen. This type of test is for the physical and functional aspects of the surgical device and instruments, not for an AI/ML algorithm's performance.
Here's the relevant information that can be extracted, interpreted in the context of a non-AI medical device:
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Table of acceptance criteria and the reported device performance:
Acceptance Criteria Reported Device Performance Meet documented user needs and intended use (of the Ardis Interbody System and associated instruments) "All responses met the established acceptance criteria." Function (of the associated instruments) Evaluated and met criteria. Performance (of the associated instruments) Evaluated and met criteria. Conformance to user needs and intended use (of the associated instruments) Validated and met criteria. -
Sample size used for the test set and the data provenance:
- Sample Size: A "cadaver specimen" was used. The document does not specify the number of cadaver specimens.
- Data Provenance: The cadaver specimen provides biological/anatomical data. The study involved "participating healthcare professionals" suggesting a U.S. or similar clinical setting for the evaluation. Prospectiveness is implied as it's a simulated surgical evaluation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "Participating healthcare professionals" were involved. The exact number is not specified.
- Qualifications of Experts: Not explicitly stated, but "healthcare professionals" implies medical doctors or other qualified clinical staff who would typically perform or assist in spinal surgeries.
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Adjudication method for the test set:
- Not applicable in the context of this type of performance testing for a physical device. The "function, performance, and conformance to user needs and intended use" were "validated based on responses received from the participating healthcare professionals," indicating an expert review or feedback process. It doesn't describe a formal adjudication method as understood for diagnostic accuracy studies.
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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 study is for a physical surgical implant system, not an AI tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not an AI/ML algorithm. The performance testing was for the physical device and instruments, involving human interaction (healthcare professionals performing a simulated surgery).
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The type of ground truth used:
- For this type of device, "ground truth" relates to the physical and functional suitability of the device and instruments during a simulated surgical procedure. The "ground truth" was established by the feedback and validation from participating healthcare professionals on whether the device and instruments met their needs and intended use in a cadaver model.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device; therefore, there is no "training set." Device development would involve design, engineering, and iterative testing, but not in the sense of training a machine learning model.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML model.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.