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The Selectra Accessory Kit / Selectra Slitter Tool is used in conjunction with the Selectra CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.

The legally marketed Selectra Accessory Kit and Selectra Slitter Tool are accessories to the Selectra lead introducer system, which is specifically used for the placement of coronary sinus leads. The modifications made to the legally marketed devices include a newly designed TVI tool, shelf life extension for the Selectra Accessory Kit/Selectra Slitter Tool, and new sterile packaging for the Selectra Slitter Tool.

The provided document describes modifications to medical devices—the Selectra Accessory Kit and Selectra Slitter Tool—and their clearance through a Special 510(k) Premarket Notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies to prove efficacy against specific acceptance criteria.

Therefore, the document does not contain information about:

• A table of acceptance criteria and reported device performance through clinical studies.
• Sample sizes used for test sets, data provenance, or details about training sets.
• The number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or associated effect sizes.
• Standalone (algorithm-only) performance.
• The type of ground truth used in a new clinical study.
• How ground truth for a training set was established.

Instead, the submission demonstrates substantial equivalence primarily through non-clinical testing and a comparison of technological characteristics between the modified devices and their predicate devices.

Here's the information that is available:

1. A table of acceptance criteria and the reported device performance:

The document provides a table outlining the technical specifications of the predicate and proposed devices, demonstrating that the proposed device maintains similar functionality, or improvements that do not raise new questions of safety or effectiveness. This is a comparison for substantial equivalence, not a performance study against acceptance criteria.

Study that proves the device meets the acceptance criteria:

The "study" conducted for this 510(k) submission is a series of non-clinical tests designed to validate the safety and performance of the modified devices and to justify the shelf-life extension and new packaging. These tests implicitly serve as "acceptance criteria" for demonstrating substantial equivalence. The document states:

"Summary of Non-Clinical Testing: The substantial equivalence claim between the subject and the predicate devices is supported by the information included in this premarket notification. This includes the following:

• Comparison of the attributes and specifications of the subject and predicate devices -
• Subject device risk analysis
• Subject device validation testing which includes the following testing:"

Non-Clinical Validation Testing Performed:

For the New TVI Tool:

• Cytotoxicity
• Sensitization Local Lymph Node Assay (LLNA)
• Irritation or Intracutaneous Reactivity
• Acute Systemic Toxicity in the Mouse with 4 Extracts
• Material Mediated Pyrogenicity Rabbit Pyrogen Test
• Hemocompatibility Evaluation
• Compendium of Biological Evaluation
• EtO Residual Gas Analysis
• Environmental Preconditioning
• Release of Particulate Matter
• Tests After Environmental Preconditioning and Shelf Life (25 months)
• Labeling on Sales / Sterile Package Accompanying Documentation

For the Extended Shelf-Life for the Selectra Accessory Kit and Selectra Slitter Tool:

• Determination of Shelf Life (25 months) Transport Test, Drop Test, Completeness of Unit
• Inspection of Seldinger Guide Wire
• Inspection of Syringe
• Inspection of Check Valve, Stop-Cock, and Sealing Caps
• Inspection of TVI and slitter tool
• Proof of Sterilization after Accelerated Aging of 25 Months

For the New Sterile Packaging for the Selectra Slitter Tool:

• Labelling on Sales / Sterile Package Accompanying Documentation
• Environmental Preconditioning
• Determination of Shelf Life (25 months) and Integrity of Sterile Packaging
• EtO Sterilization Cycle Product Adoption
• Tests after Environmental Preconditioning and Accelerated Aging (25 Months)

2. Sample sized used for the test set and the data provenance: Not applicable. These are non-clinical (laboratory/mechanical/biological) tests, not human studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance is not established as this is a non-clinical submission for device modifications.

4. Adjudication method for the test set: Not applicable. See above.

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 device is a catheter accessory, not an AI or imaging device involving human reader interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. See above.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for the non-clinical tests is based on established scientific and engineering standards, and documented test methods to verify material properties, sterility, mechanical integrity, and biological compatibility.

8. The sample size for the training set: Not applicable. No "training set" in the context of machine learning or AI is relevant here.

9. How the ground truth for the training set was established: Not applicable. See above.

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The Selectra accessory kit is used in conjunction with the Selectra CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.

The Selectra accessory kit includes a variety of commonly used catheter accessories which are combined in a single package. The Selectra accessory kit includes the following components: 1 Selectra Slitter Tool, 1 Seldinger Guide Wire, 4 Transvalvular Insertion (TVI) Tools, 1 Syringe, 1 Torquer, 2 Stopcocks, 2 Check valves, 2 Sealing caps, 1 Technical Manual. The Selectra accessory kit may be used with the Selectra CS lead introducer system, BIOTRONIK's family of guiding catheters specifically used for the placement of coronary sinus leads.

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than clinical performance studies with specific acceptance criteria in the way a clinical trial would. Therefore, many of the requested elements pertaining to clinical performance, ground truth, expert opinions, and AI effect sizes are not applicable here.

Here's a breakdown of what can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance

Since this is a Special 510(k) for a device modification, the "acceptance criteria" are primarily based on ensuring the modified device maintains the same characteristics and performance as the predicate device. The document explicitly states:

• Acceptance Criteria: The usage, indications for use, contraindications, and function of the Selectra accessory kit must remain unchanged compared to the predicate device (ScoutPro ACS accessory kit, K101776). The changes are "minor component modifications."
• Reported Device Performance: The document implicitly states that the device meets these criteria by asserting, "The usage of the Selectra accessory kit remains unchanged and the product characteristics, such as indications for use, contraindications, and function, are the ScoutPro ACS accessory kit cleared on July 23, 2010 (K101776). Therefore, this previously cleared accessory kit will serve as the predicate device for the modified accessory kit included in this Special 510(k)."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This submission is for a device modification (Special 510(k)) and is based on maintaining substantial equivalence to a predicate device, not on specific clinical trial data with a test set in the traditional sense. The evidence provided typically involves engineering and bench testing to demonstrate that the minor component modifications do not alter the safety or effectiveness of the device. There's no mention of a clinical "test set" from patients.

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. As noted above, this is not a study requiring expert-established ground truth on patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No test set or human adjudication process for clinical data 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

• Not Applicable. This device is a component kit for a lead introducer system; it does not involve AI or human readers for diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This device is a physical medical accessory kit, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. The "ground truth" for this type of submission is the documented performance and characteristics of the legally marketed predicate device. The new device is compared against the predicate's established performance through engineering and design verification.

8. The sample size for the training set

• Not Applicable. There is no training set in the context of device modification for substantial equivalence.

9. How the ground truth for the training set was established

• Not Applicable. There is no training set.

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