(267 days)
The Device for Sternal Synthesis is indicated for closure and repair of the sternum after sternotomy to stabilize the sternum and promote fusion.
The Device for Sternal Synthesis is a surgical implant that is available in two sizes manufactured of unalloyed titanium sheet. It is applied to the anterior surface of the sternum and inferior surfaces of the adjacent ribs on both the left and right sides of the sternum. It is circumferentially secured with monofilament surgical steel sutures.
The provided text describes a 510(k) summary for a medical device, the "Device for Sternal Synthesis (DSS)," and includes information on its performance testing. However, it does not contain detailed acceptance criteria or a comprehensive study report with all the requested information for a device that relies on complex metrics like accuracy, sensitivity, or specificity, which are typical for diagnostic or AI-driven devices.
The DSS is a surgical implant designed for sternal closure, and its performance is evaluated based on mechanical stability and clinical outcomes related to sternal dehiscence. Therefore, many of the requested categories (like number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of device and its evaluation process as described.
Here's an analysis based on the provided text, addressing the points where information is available or noting when it's not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Stability: | |
| * Sufficient load to breakage for sternal repair. | "Demonstrated a significant difference in load to breakage... of reinforced and unreinforced sternal repairs." (Implied: DSS significantly improves load to breakage compared to unreinforced repairs). |
| * Minimal lateral displacement of sternal repair. | "Demonstrated a significant difference in... lateral displacement of reinforced and unreinforced sternal repairs." (Implied: DSS significantly reduces lateral displacement compared to unreinforced repairs). |
| Clinical Efficacy/Safety: | |
| * Low incidence of intraoperative complications. | "Revealed no intraoperative complications related to the DSS." |
| * Low incidence of postoperative sternal dehiscence (compared | "A low incidence of postoperative sternal dehiscence typical of the post-operative course for patients with identified risk factors." (Implied: The incidence is not worse than expected for this high-risk patient population and comparable to standard care for similar risk factors, suggesting acceptable device performance in preventing dehiscence in a challenging patient group). |
| to typical rates for high-risk patients). |
Note: The acceptance criteria are largely implied based on the performance testing descriptions, as explicit numerical thresholds are not provided in this summary. The goal for this type of device is typically to demonstrate improvement over traditional methods or at least non-inferiority/acceptable performance in a relevant clinical context.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set (Clinical Study): 45 patients undergoing cardiothoracic surgery with sternotomy who were at high risk for sternal wound complications.
- Data Provenance:
- Country of Origin: Not explicitly stated, but the submitter is Sic Brevetti s.r.l. based in Rome, Italy. It's reasonable to infer the clinical study might have been conducted in Italy or Europe unless stated otherwise.
- Retrospective or Prospective: "Published data on testing of the Device for Sternal Synthesis in 45 patients... revealed..." The phrasing "published data on testing" suggests a retrospective analysis of previously collected clinical data, but it doesn't explicitly state whether the original data collection was prospective or retrospective. For regulatory purposes, the study design would have been rigorously defined.
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: For this type of orthopedic surgical device, "ground truth" as typically defined for diagnostic AI (e.g., expert consensus on image interpretation) is not relevant. Clinical outcomes (complications, dehiscence) are observed and recorded by medical staff (surgeons, nurses, etc.) based on objective clinical signs and diagnostic findings, not by a panel of experts establishing ground truth in an interpretive sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: As above, adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., for image-based diagnoses). Clinical outcomes for a surgical device are typically recorded as observed events and diagnoses, not requiring such adjudication among expert interpreters.
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
- Not Applicable: This is an implantable surgical device, not an AI-driven diagnostic or assistive tool for human readers. Therefore, an MRMC study and effects on human readers with/without AI assistance are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: The device is a physical implant, not an algorithm. Standalone performance as an algorithm is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Mechanical Testing: The ground truth for the mechanical testing (load to breakage, lateral displacement) would be objective measurements obtained via standardized engineering tests on the artificial sternal model.
- Clinical Study: The "ground truth" for the clinical part refers to observed clinical outcomes, specifically:
- Absence/presence of intraoperative complications.
- Absence/presence of postoperative sternal dehiscence.
These are observed and documented clinical events, which could be confirmed through various clinical assessments, imaging, or re-interventions.
8. The sample size for the training set
- Not Applicable: This device is not an AI algorithm, so there is no "training set" in the computational learning sense.
9. How the ground truth for the training set was established
- Not Applicable: As above, there is no training set for this type of device.
§ 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.