(178 days)
The Entasis™ Dual-Lead Sacroiliac Implant system is intended for sacroiliac joint fusion for conditions including degenerative sacroilitis and sacroiliac joint disruptions.
The Entasis™ Dual-Lead Sacroiliac Implant system is composed of dual-lead sacroiliac screws manufactured from titanium (Ti-6AI-4V ELI) per ASTM F136. The screws are available in lengths of 30-70mm and diameters of 7-11.5mm.
This document is a 510(k) summary for a medical device called the Entasis™ Dual-Lead Sacroiliac Implant. It describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to previously marketed devices. However, it does not provide information on acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.
This document is for a traditional medical implant device, not an AI/ML device. Therefore, the requested information categories typically associated with AI/ML device performance (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this submission.
Here's a breakdown of the information that can be extracted from the provided text, modified to reflect the type of device:
1. A table of acceptance criteria and the reported device performance:
The document refers to "Performance Data" from non-clinical testing but does not explicitly state numerical acceptance criteria for each test. Instead, it concludes that the "strength of the Entasis™ Dual-Lead Sacroiliac Implant is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the acceptance criteria were met by matching or exceeding the performance of the predicate devices.
| Test Mode | Reported Device Performance (Implied Acceptance) |
|---|---|
| Static torsion per ASTM F543 | Sufficient for intended use and substantially equivalent to predicate devices. (Specific values not provided in this summary) |
| Static pullout per ASTM F543 | Sufficient for intended use and substantially equivalent to predicate devices. (Specific values not provided in this summary) |
| Static driving torque per ASTM F543 | Sufficient for intended use and substantially equivalent to predicate devices. (Specific values not provided in this summary) |
| Static three-point bending per ASTM F2193 | Sufficient for intended use and substantially equivalent to predicate devices. (Specific values not provided in this summary) |
| Dynamic three-point bending per ASTM F2193 | Sufficient for intended use and substantially equivalent to predicate devices. (Specific values not provided in this summary) |
Regarding the other information requested for an AI/ML device:
- Sample size used for the test set and the data provenance: Not applicable. This is a physical implant, not an AI/ML algorithm processing data. The "test set" would refer to the physical implants tested.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant's mechanical performance is typically established by engineering standards and measurements, not expert consensus on data.
- 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. This is not an AI-assisted diagnostic or interpretive device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): For mechanical testing, the ground truth is established by standardized measurements according to the ASTM standards listed (F543, F2193).
- The sample size for the training set: Not applicable. There is no "training set" for a physical implant device in this context.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document pertains to a traditional medical device (an implant) and its mechanical performance testing for 510(k) clearance, not an AI/ML-based device. Therefore, most of the requested fields related to AI/ML device evaluation are not relevant or present in this document.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.