(116 days)
The Synthes ACIS is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one 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 interior of the spacer of the Synthes ACIS should be packed with autogenous bone graft and implanted via an anterior approach. The Synthes ACIS is intended to be used with supplemental fixation.
The Synthes Vertebral Spacer CR is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one 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 interior of the Synthes Vertebral Spacer CR should be packed with autogenous bone graft and implanted via an anterior approach. The Synthes Vertebral Spacer CR is intended to be used with supplemental fixation.
The Synthes ACIS is a radiolucent cervical intervertebral body fusion device. The Synthes ACIS is fabricated from Invibio® PEEK-Optima® LT-1 (ASTM F2026-10) with two anterior and one posterior titanium alloy (Ti-6Al-4V ELI; TAV; ASTM F136-2a) radiopaque markers. The markers allow intra-operative radiographic assessment of the position of the implant.
The Synthes Vertebral Spacer CR is a radiolucent cervical intervertebral body fusion device. The Vertebral Spacer CR is fabricated from Invibio® PEEK-Optima® LT-1 (ASTM F2026-10) with two anterior and one posterior titanium alloy (Titanium-6Aluminum-7Niobium ASTM F1295-05) radiopaque markers. The markers allow intra-operative radiographic assessment of the position of the implant.
The Synthes Vertebral Spacer CR is available in a range of heights, and is available in three different sagittal profiles. Pyramidal teeth that assist in stabilization of the construct are located on the inferior and superior surfaces of the spacers. The open architecture of the device allows it to be packed with autogenous bone graft material, i.e., autograft.
The provided text describes two medical devices, Synthes ACIS and Synthes Vertebral Spacer CR, and their 510(k) submissions to the FDA. However, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria for artificial intelligence (AI) or an algorithm. Instead, it details the non-clinical performance (bench testing) of these intervertebral fusion devices.
Therefore, most of the requested information regarding AI device acceptance criteria and study details cannot be extracted from the provided text.
Here is what can be inferred or stated based on the provided document:
Acceptance Criteria and Device Performance (based on non-clinical testing)
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance | The devices underwent various bench tests according to ASTM F2077-03 and ASTM F2267-04 standards, including: |
| Static Axial Compression | Passed, demonstrated substantial equivalence to predicate devices. |
| Dynamic Axial Compression | Passed, demonstrated substantial equivalence to predicate devices. |
| Static Compression Shear | Passed, demonstrated substantial equivalence to predicate devices. |
| Dynamic Compression Shear | Passed, demonstrated substantial equivalence to predicate devices. |
| Static Torsion | Passed, demonstrated substantial equivalence to predicate devices. |
| Dynamic Torsion | Passed, demonstrated substantial equivalence to predicate devices. |
| Subsidence | Passed, demonstrated substantial equivalence to predicate devices. |
| Substantial Equivalence | The devices were found to be substantially equivalent in performance to predicate devices based on the conducted bench testing. |
Information NOT Available from the provided text:
The document clearly states: "Clinical data and conclusions were not needed for this device." This implies that the device achieved substantial equivalence based solely on non-clinical testing against predicate devices. Therefore, the following AI-specific study details are not applicable or provided:
- Sample size used for the test set and the data provenance: Not applicable as no clinical or AI-specific test sets were used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth for image interpretation or diagnosis was established.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document describes traditional medical device approval based on non-clinical bench testing and substantial equivalence to existing predicate devices, not an AI or algorithm-driven device with corresponding performance criteria and studies.
§ 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.