(131 days)
The Figure 8 Sternotomy Closure Device is indicated for use in sternal closure procedures.
The Figure 8 Sternotomy Closure Device ("Figure 8 SCD") is a permanent, medical grade 316L stainless steel implant intended for use in sternal closure following median sternotomy.
The provided document is a 510(k) Premarket Notification for the Figure 8 Sternotomy Closure Device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to establish specific acceptance criteria and performance metrics for the device itself. Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, and ground truth establishment are not present in this type of submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not detail specific acceptance criteria with quantifiable performance metrics (e.g., accuracy, sensitivity, specificity) for the device's clinical performance. Instead, it states that "All necessary bench testing was conducted on the Figure 8 SCD to support a determination of substantial equivalence to the predicate device, including: Simulated Use Testing and Functional Verification Testing." The success of these tests implies that the device met internal design specifications, but these specifications are not explicitly provided in this summary.
2. Sample size used for the test set and the data provenance
No human or animal test set data is presented in this 510(k) summary. The testing mentioned is "bench testing" (Simulated Use Testing and Functional Verification Testing), which typically involves laboratory-based evaluations of the device's physical and mechanical properties. Therefore, there's no information about the provenance of data as it's not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as no clinical test set requiring expert ground truth establishment is described.
4. Adjudication method for the test set
This information is not applicable as no clinical test set requiring adjudication is 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
This information is not applicable. The device is a surgical sternotomy closure device, not an AI-assisted diagnostic or assistive technology targeting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical medical implant, not an algorithm.
7. The type of ground truth used
For the "Simulated Use Testing" and "Functional Verification Testing" mentioned, the ground truth would likely refer to engineering specifications, mechanical testing standards, or predefined biomechanical outcomes that the device is intended to meet. These specifics are not detailed in the summary.
8. The sample size for the training set
This information is not applicable as there is no mention of a "training set" in the context of this physical device's evaluation.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
Summary of the Study:
The "study" referenced in this 510(k) is a series of bench tests (Simulated Use Testing and Functional Verification Testing) conducted to demonstrate substantial equivalence of the Figure 8 Sternotomy Closure Device to a predicate device (Ethicon Surgical Stainless Steel Suture, K931271). This means the focus was on showing that the new device has similar technological characteristics and is as safe and effective as the already-marketed predicate device, rather than establishing de novo performance metrics against specific, prospective clinical endpoints. The specific details of these bench tests, the exact acceptance criteria for those tests, and the results are not included in this summary. The core of the submission is the claim of substantial equivalence, supported by the statement that "Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness."
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.