(87 days)
The Arco™-SA Lumbar Cage System is intended for spinal fusion procedures at one level (L2 to S1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) on the non-cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental fixation system cleared by the FDA. The Arco™-SA Lumbar Cage System interbody implants with a lordotic angle less than 20°, when used with the internal fixation screws, do not require use of supplemental fixation.
The Arco™-SA ALIF System is an intervertebral fusion device made from titanium per ASTM F136 with TECOTEX® surface from TECOMET, Inc. or medical grade PEEK per ASTM F2026 with tantalum markers per ASTM F560. The subject device implant cages are offered in a variety of footprints and sizes to accommodate various patient anatomies. The Arco™-SA ALIF System is offered in heights of 12-22mm, widths of 28-43mm, and lengths of 24-32mm. The subject device implant screws are offered in Ø5.0-6.0mm diameters and lengths ranging 20-35mm. The subject device implant is offered with a lordosis of 7- 30°. The purpose of this submission is to add larger footprint options and add the titanium implants to the previously cleared system
The provided text is a 510(k) summary for the Arco™-SA Lumbar Cage System, a medical device for spinal fusion. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study proving the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity.
Therefore, many of the requested categories for acceptance criteria and study details cannot be filled from the provided text. This device falls under the category of an "Intervertebral Body Fusion Device," which typically relies on mechanical testing, material biocompatibility, and intended use comparison for FDA clearance, rather than studies involving performance characteristics like those seen in diagnostic or AI-driven devices.
Here's a breakdown based on the provided text, indicating where information is absent:
-
A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document's purpose is to show substantial equivalence to predicate devices, not to present performance data against predefined acceptance criteria for accuracy, sensitivity, etc.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study involving a test set of data for performance evaluation. The "test" for this device involves comparing its characteristics (materials, dimensions, indications for use, technological characteristics) to legally marketed predicate devices.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. "Ground truth" in the context of diagnostic or AI performance studies is not relevant here. The evaluation is based on engineering and material characteristics, and comparison to predicate devices, which are assessed by regulatory bodies and engineering principles.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" in the context of performance metrics adjudication.
-
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 device is not an AI-assisted diagnostic tool or an imaging analysis system, so an MRMC study is not relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical intervertebral fusion device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of performance measurement. The "ground truth" for the device's claims of safety and effectiveness is established through compliance with recognized standards for materials (e.g., ASTM F136 for titanium, ASTM F2026 for PEEK, ASTM F560 for tantalum), mechanical testing (though here a comparison to predicate material was done in lieu of new mechanical testing), and comparison of technological characteristics to already cleared devices.
-
The sample size for the training set
Not applicable. This is a medical device, not a machine learning algorithm requiring a training set.
-
How the ground truth for the training set was established
Not applicable.
Summary of Relevant Information from the Document:
The document describes the Arco™-SA Lumbar Cage System, an intervertebral fusion device. The "study" referenced in the prompt's context is the 510(k) premarket notification process, which aims to demonstrate substantial equivalence to legally marketed predicate devices, not performance against specific clinical acceptance criteria.
Key Findings from the 510(k) Summary:
- Acceptance Criteria & Device Performance: The primary "acceptance criterion" for this submission is substantial equivalence to predicate devices. The "performance" is demonstrated by showing that the subject device shares "nearly identical technological characteristics" with predicate devices and that "the minor differences do not raise any new issues of safety and effectiveness."
- Identical Characteristics to Predicates: Principles of Operation, Indications for Use, Implant Materials, Implant Sizes, Surgical Approach.
- Comparison of Materials: "A comparison of the previously cleared device material and the subject device material was completed in lieu of mechanical testing." This suggests that the materials themselves (titanium per ASTM F136, PEEK per ASTM F2026, tantalum markers per ASTM F560) are the primary basis for demonstrating similar performance to predicate devices (which presumably underwent such testing or had equivalent material specifications).
- Conclusion: "The overall technology and material characteristics lead to the conclusion that the Arco™-SA Lumbar Cage System is substantially equivalent to the predicate device."
This document is a regulatory submission for a physical implant, not a study evaluating the performance of a diagnostic or AI-powered system against quantifiable accuracy metrics.
§ 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.