(181 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) of the non-cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with 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 or retrolisthesis at the involved levels(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 spinal fixation system that has been 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 Lumbar Cage System is an intervertebral fusion device made from medical grade PEEK per ASTM F2026, titanium per ASTM F136, and 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 Lumbar Cage System is offered in heights of 12-22mm, widths of 28- 38mm, and lengths of 24-29mm. 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 provided text describes the 510(k) premarket notification for the Arco™-SA Lumbar Cage System, which is an intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical performance data.
However, the information requested in your prompt regarding acceptance criteria and a study proving a device meets acceptance criteria in a clinical or AI-related performance context is largely absent. The document focuses on non-clinical mechanical testing rather than clinical performance metrics of an AI model or a device's diagnostic accuracy.
Here's a breakdown of what can and cannot be extracted from the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (for mechanical testing): The document references specific ASTM standards (ASTM F2077-11, ASTM F2267-04, ASTM DRAFT F-04.25.02.02) which implicitly contain acceptance criteria for the mechanical tests. However, the exact numerical acceptance values are not explicitly stated in this summary.
- Reported Device Performance (for mechanical testing): The document states: "The results of this non-clinical testing show that the strength of the Arco™-SA Lumbar Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." Specific numerical performance results are not provided.
| Acceptance Criteria (Implied by ASTM Standards) | Reported Device Performance |
|---|---|
| Pass ASTM F2077-11 for Static Axial Compression | Sufficient for intended use, substantially equivalent to predicates. |
| Pass ASTM F2077-11 for Static Compressive Shear | Sufficient for intended use, substantially equivalent to predicates. |
| Pass ASTM F2077-11 for Dynamic Axial Compression | Sufficient for intended use, substantially equivalent to predicates. |
| Pass ASTM F2077-11 for Dynamic Compressive Shear | Sufficient for intended use, substantially equivalent to predicates. |
| Pass ASTM F2267-04 for Static Subsidence | Sufficient for intended use, substantially equivalent to predicates. |
| Pass ASTM DRAFT F-04.25.02.02 for Static Expulsion | Sufficient for intended use, substantially equivalent to predicates. |
The following points cannot be answered from the provided text because the 510(k) summary focuses on substantial equivalence for a physical medical device (lumbar cage) based on mechanical testing and technological characteristics, not on the performance of an AI/software device or a clinical study that would involve ground truth or human readers.
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. The "test set" here refers to the physical devices undergoing mechanical stress tests, not a dataset for an AI model.
- 3. 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/Not provided. Ground truth is not relevant for the mechanical testing described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication is not relevant for the mechanical testing described.
- 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. This is a physical device, not an AI software/diagnostic tool requiring MRMC studies.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. Ground truth is not relevant for the mechanical testing described.
- 8. The sample size for the training set
- Not applicable/Not provided. There is no AI training set mentioned.
- 9. How the ground truth for the training set was established
- Not applicable/Not provided. There is no AI training set mentioned.
In summary: The provided document is a 510(k) summary for a physical medical device (Arco™-SA Lumbar Cage System) demonstrating substantial equivalence through non-clinical mechanical testing against ASTM standards. It does not contain information about clinical studies, AI performance, ground truth establishment, or human reader effectiveness studies as it is not a diagnostic AI/software device.
§ 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.