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510(k) Data Aggregation
(98 days)
Cardiovascular surgery - closure of the sternum following sternotomy.
The Sternal Cable System is an alternative over traditional monofilament sternal wire used for cardiovascular sternal closure following sternotomy. The system consists of multi-strand stainless steel and titanium cables and crimps, which are tensioned and secured around the bone using a tensioner/crimper instrument. Multiple “figure 8” constructs work as one unit to provide stabilization.
Cables are manufactured from titanium 6Al-4V ELI alloy (ASTM F136) or 316L stainless steel (ASTM F138); CP titanium (ASTM F67) or 316L stainless steel (ASTM F138) crimps are provided to match the corresponding cable materials. However, the different metals are never to be mixed. Non-implantable leaders are manufactured from 316L stainless steel (ASTM F138) or titanium 3Al/2.5V Alloy (ASTM B863) and needles are 420 or 470 stainless steel.
The implants are provided sterile for single-use but must never be re-sterilized; reusable instruments are supplied non-sterile and must be steam sterilized by the user prior to use in accordance with the instructions for use. Cases are supplied for sterilization and transport of the instruments.
The provided document is a 510(k) Summary for the Sternal Cable System and primarily focuses on demonstrating substantial equivalence to a predicate device, particularly for the addition of Magnetic Resonance (MR) conditional safety labeling. It is not a study that evaluates the performance of an AI medical device, but rather a conventional medical device.
Therefore, many of the requested criteria, such as "acceptance criteria for an AI medical device," "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," and "ground truth establishment," are not applicable to this document as it does not describe an AI medical device or its performance study.
However, I can extract information relevant to the device's MR Conditional safety labeling, which is the core of this submission's "study" aspect:
1. A table of acceptance criteria and the reported device performance (for MR safety):
| Acceptance Criteria (from referenced ASTM standards) | Reported Device Performance |
|---|---|
| Magnetically Induced Displacement Force: Sufficiently low so as not to pose an additional hazard. | The device meets the acceptance criteria (implied by "MR Safety Evaluation following standards listed below" and "Testing identified in this summary has all passed acceptance criteria established by the predicate device where applicable."). |
| Magnetically Induced Torque: Sufficiently low so as not to pose an additional hazard. | The device meets the acceptance criteria. |
| Radio-Frequency (RF) Induced Heating: Heating within acceptable limits (e.g., |
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(87 days)
Cardiovascular surgery - closure of the sternum following sternotomy.
The Sternal Cable System is an alternative over traditional monofilament sternal wire used for cardiovascular sternal closure following sternotomy. The system consists of multi-strand stainless steel and titanium cables and crimps, which are tensioned and secured around the bone using a tensioner/crimper instrument. Multiple "figure 8" constructs work as one unit to provide stabilization.
Cables are manufactured from titanium 6Al-4V ELI alloy (ASTM F136) or 316L stainless steel (ASTM F138); CP titanium (ASTM F67) or 316L stainless steel (ASTM F138) crimps are provided to match the corresponding cable materials. However, the different metals are never to be mixed. Non-implantable leaders are manufactured from 316L stainless steel (ASTM F138) or titanium 3Al/2.5V Alloy (ASTM B863) and needles are 420 or 470 stainless steel.
The implants are provided sterile for single-use but must never be re-sterilized; reusable instruments are supplied non-sterile and must be steam sterilized by the user prior to use in accordance with the instructions for use. Cases are supplied for sterilization and transport of the instruments.
The provided document is a 510(k) summary for the A&E Medical Corporation Sternal Cable System. It primarily discusses the device's substantial equivalence to a predicate device and its indications for use.
Based on the content of this document, no information is available regarding specific acceptance criteria for device performance, nor details of a study proving the device meets such criteria in terms of clinical or algorithmic performance. The document focuses on regulatory clearance based on substantial equivalence, materials, manufacturing processes, and general mechanical performance similarities to a predicate device, rather than detailed performance metrics.
Specifically, the following points pertinent to your request are addressed by the document:
- 1. A table of acceptance criteria and the reported device performance: This information is not provided. The document states, "This submission presents no changes to the devices which required new non-clinical or clinical evidence." It only mentions "Same mechanical performance" when comparing to the predicate, but no specific metrics or acceptance criteria are given.
- 2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): This information is not provided. As no new non-clinical or clinical evidence was required or presented for performance evaluation, there is no test set in this context.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not provided.
- 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 provided. The device is a physical medical device (Sternal Cable System), not an AI algorithm for diagnostic reading.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not provided. The device is a physical medical device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not provided.
- 8. The sample size for the training set: This information is not provided.
- 9. How the ground truth for the training set was established: This information is not provided.
The document mentions a "Pyrogenicity evaluation" for endotoxin levels, which can be considered a performance test.
- Acceptance Criteria for Pyrogenicity: Endotoxin level meets the requirements of maximum endotoxin limit for implantable medical devices [20 EU per device].
- Reported Device Performance for Pyrogenicity: The device was tested to ensure the endotoxin level meets this requirement. However, the exact measured endotoxin level is not stated.
In summary, the document does not contain the detailed performance study information you are seeking for a medical device that would describe specific acceptance criteria and the results of a study demonstrating these criteria were met, particularly in the context of diagnostic performance or AI systems. The focus of this 510(k) submission is on demonstrating substantial equivalence to a predicate device based on similar technological characteristics, materials, and intended use, rather than presenting a de novo performance study with quantitative acceptance criteria and results.
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