(106 days)
The Stryker Spine Aero™-LL is an intervertebral body fusion device indicated for use with autogenous bone graff in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
The Aero™-LL Lumbar Cage System is to be implanted via a lateral approach.
The Aero™-LL Lumbar Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems). In addition, the device may be used with or without the included fixation anchors.
The AeroTM-LL Cage is a hollow, bullet-shaped PEEK Optima cage surrounded by a titanium alloy (Ti-6Al-4V) jacket. The PEEK Optima cage portion consists of two closed pockets for graft containment and has serrations on the superior and inferior surfaces of the cage. The implant is designed to be used either with or without the internal supplemental fixation provided (AeroTM-LL Fixation Anchors) in addition to supplemental fixation systems cleared for use in the lumbosacral spine. The AeroTM-LL Fixation Anchors are constructed from titanium alloy (Ti 6Al-4V) and feature rails that mate with dovetail channels located within the AeroTM-LL PEEK cage. Once fully seated into the channels, the anchors are designed to lock into the titanium jacket.
The provided document outlines the 510(k) summary for the Stryker Spine Aero™-LL Lumbar Cage System, focusing on its substantial equivalence to predicate devices based on non-clinical testing. The document does not describe a study involving human readers or AI.
Here's an analysis of the provided information, structured around the requested criteria where applicable:
Acceptance Criteria and Device Performance
The acceptance criteria for the Aero™-LL Lumbar Cage System are based on demonstrating "substantially equivalent performance" to identified predicate devices through non-clinical mechanical testing, as per FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" (June 12, 2007).
The specific performance metrics are derived from various ASTM standards and internal draft standards for intervertebral body fusion devices. The device's performance is reported as meeting these criteria, demonstrating substantial equivalence.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test) | Standard / Description | Reported Device Performance |
|---|---|---|
| Static Compression | Per ASTM F2077 (Standard Test Methods for Intervertebral Body Fusion Devices) | "demonstrated substantially equivalent performance to the identified predicate device systems." (Implied to meet or exceed predicate device performance for this test) |
| Dynamic Compression | Per ASTM F2077 | "demonstrated substantially equivalent performance to the identified predicate device systems." (Implied to meet or exceed predicate device performance for this test) |
| Static Compression Shear | Per ASTM F2077 | "demonstrated substantially equivalent performance to the identified predicate device systems." (Implied to meet or exceed predicate device performance for this test) |
| Dynamic Compression Shear | Per ASTM F2077 | "demonstrated substantially equivalent performance to the identified predicate device systems." (Implied to meet or exceed predicate device performance for this test) |
| Static Torsion | Per ASTM F2077 | "demonstrated substantially equivalent performance to the identified predicate device systems." (Implied to meet or exceed predicate device performance for this test) |
| Dynamic Torsion | Per ASTM F2077 | "demonstrated substantially equivalent performance to the identified predicate device systems." (Implied to meet or exceed predicate device performance for this test) |
| Expulsion | Per ASTM F04-25-02-02 Draft (Likely a draft standard for intervertebral body fusion device expulsion resistance) | "demonstrated substantially equivalent performance to the identified predicate device systems." (Implied to meet or exceed predicate device performance for this test) |
| Subsidence | Per ASTM F2267 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Devices) | "demonstrated substantially equivalent performance to the identified predicate device systems." (Implied to meet or exceed predicate device performance for this test) |
| Wear Debris Assessment | Not specified, but likely involves evaluating generation of wear particles from the device. | "demonstrated substantially equivalent performance to the identified predicate device systems." (Implied to show acceptable wear characteristics compared to predicate devices) |
| Dynamic Cadaver Testing (Fatigue Performance) | Involves implantation into multiple functional spinal units and subsequent evaluation of fatigue performance under multiple loading modes. (This is a more complex mechanical test simulating in-vivo conditions.) | "demonstrated substantially equivalent performance to the identified predicate device systems." (Implied to show durability and fatigue resistance comparable to predicate devices in a cadaveric model when subjected to various physiological loading modes.) |
Study Information (Based on the provided document)
Since this document describes the substantial equivalence of a physical medical device (lumbar cage) based on mechanical testing, many of the requested AI/human-reader related study details are not applicable.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of an AI study. For the mechanical tests, the "sample size" would refer to the number of devices or constructs tested for each mechanical test. This specific number is not provided in the 510(k) summary, but it would typically be a set number per ASTM standard (e.g., n=6 for certain tests).
- Data Provenance: The data is from non-clinical mechanical testing, performed in a laboratory setting. There is no geographical "country of origin for data" in the sense of patient data. The testing is retrospective in the sense that it's performed after design but before market release.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: This pertains to AI performance evaluation where expert consensus defines ground truth. For mechanical testing, the "ground truth" is defined by the physical laws and engineering principles measured by the test equipment against the specified ASTM standards and predicate device performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: This is an AI/human-reader concept. The "adjudication" for mechanical tests is implicit in the compliance with standardized test methods and data analysis by qualified engineers.
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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:
- Not Applicable: This is a physical device, not an AI system that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable: This is a physical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Mechanical Performance Data / Predicate Equivalence: The "ground truth" for the Aero™-LL Lumbar Cage System is its mechanical performance as measured by standardized tests (e.g., ASTM F2077, ASTM F2267) which must be substantially equivalent to the established mechanical performance of legally marketed predicate devices. This type of ground truth is based on engineering specifications and physical testing results, not medical patient outcomes or expert consensus in a diagnostic sense.
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The sample size for the training set:
- Not Applicable: This is a physical device, not an AI model requiring a training set.
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How the ground truth for the training set was established:
- Not Applicable: Applies to AI models.
§ 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.