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510(k) Data Aggregation
(57 days)
ACUITY UNIVERSAL CUTTER
The Boston Scientific ACUITY™ Universal Cutter is intended to be used with Guidant or Boston Scientific cuttable families of guiding catheters, and is intended to facilitate guiding catheter removal after the Guidant or Boston Scientific coronary venous lead is positioned.
The Cutter is an accessory manufactured for use with cuttable guiding catheters, to facilitate removal of the catheter following lead placement. The Cutter attaches to the lead and cuts one wall of the guiding catheter as it is removed from the patient, allowing the guiding catheter to be removed from the lead. The Cutter consists of three sections: a molded plastic handle, a stainless steel blade and a lead management section. The lead management section secures and stabilizes the lead prior to and during the cutting procedure. After the lead has been positioned in the patient, the cutter is connected to the lead body as close to the catheter hub as possible. Holding the cutter stationary and fixed to a surface, the implanter pulls the catheter against the cutter blade. The hub is cut first, followed by the catheter section.
The provided text is a 510(k) submission for the ACUITY™ Universal Cutter, which is a medical device. This document does not describe a study that involves an AI algorithm or performance metrics like accuracy, sensitivity, or specificity commonly associated with AI models. Instead, it focuses on demonstrating substantial equivalence to a predicate device for regulatory approval.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set) are not applicable to this type of medical device submission.
Here's an attempt to answer the questions based on the provided text, while acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria in a table format, nor does it provide specific quantitative performance metrics. Instead, it states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| The Universal Cutter meets acceptance criteria | Testing demonstrates that the Universal Cutter meets the acceptance criteria. |
| Performs similarly to the predicate device | The Universal Cutter performs similarly to the predicate device. |
| No new safety or effectiveness issues raised during testing program | No new safety or effectiveness issues were raised during the testing program. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "testing" without detailing the specific methodology or dataset size.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The device is a mechanical cutter, and its performance evaluation would typically involve functional testing (e.g., cutting efficacy, durability) rather than expert-established ground truth on medical images or diagnoses.
4. Adjudication method for the test set
Not applicable. No expert adjudication method is mentioned or implied for the performance testing of this mechanical device.
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 not an AI-assisted device, and therefore, no MRMC study or AI-related effect size data would be present.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used
The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, outcomes data) does not directly apply here. For this device, the "ground truth" for its performance would be its ability to effectively and safely cut the guiding catheter as intended. This would be established through engineering and performance testing rather than clinical diagnostic ground truth.
8. The sample size for the training set
Not applicable. As a mechanical device, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this mechanical device.
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