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The SafeSheath MSP™ Introducer Sheath Kit with Integral Hemostasis Valve is for introduction of pacing leads or catheters during pacing lead or defibrillatory catheter placement procedures.

The introducer sets, Adelante®-S Series are intended for introduction of pacing leads or catheters into the body.

The components of the SafeSheath MSP™ Introducer Kit consists of a sheath with sideport tubing, stopcock and heomostasis valve. The distal end of the sheath may be configured for a straight sheath or with a curve. The sheath length must be able to provide a conduit from the insertion site to the epicardial target sites.

A guiding dilator will accompany the straight or curved sheath, to assist with the guiding and steering of the sheath to the intended location.

A standard vessel dilator that will assist in insertion.

A .035" x 135 cm guidewire.

A standard 12cc syringe.

A 18 gauge XTW introducer needle.

A transvalvular insertion tube, which can be used to open the hemostasis valve during insertion of delicate leads or catheters, may also be packaged with the introducer kit,

A Pacing Lead Stabilizer (PLS) that can be used to facilitate the removal of the introducer sheath, may also be packaged with the introducer kit.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SafeSheath MSP™ Introducer Kit and the Adelante-S Series Introducer Set.

It's important to note that the provided text contains information for two separate devices, both of which are Introducer Sets. The first part (up to page 1 of 3) refers to the SafeSheath MSP™ Introducer Kit (K934901 is its predicate device, not its own 510(k) number which is missing). The later part (starting from "AUG 2 9 2012") refers to the Adelante®-S Series (510(k) Number K122084).

Since the request is about "the device" in the singular, and the information is fragmented across two different submissions, I will provide the acceptance criteria and study information for both devices as presented, clarifying which device each section refers to.

Analysis for the SafeSheath MSP™ Introducer Kit (Thomas Medical Products, Inc.)

This submission primarily relies on substantial equivalence to a predicate device (K934901) and includes qualification testing for the new device. It is not a clinical study demonstrating performance against clinical acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criteria (Test)	Reported Device Performance
   Functional Testing	All samples passed the protocol qualification testing requirements.
   Visual Testing	All samples passed the protocol qualification testing requirements.
   Leak Testing	All samples passed the protocol qualification testing requirements.
   Valve Body to Stopcock Pull Test	All samples passed the protocol qualification testing requirements.
   PVC Tubing to Valve Housing Peel Test	All samples passed the protocol qualification testing requirements.

2. Sample Size Used for the Test Set and Data Provenance

   • Sample Size: Not explicitly stated, described as "All samples."
   • Data Provenance: Not specified, but implied to be in-house laboratory testing (retrospective in the context of submission).

3. Number of Experts Used to Establish Ground Truth and Qualifications

   • Not applicable. This was engineering/qualification testing, not a clinical study requiring expert ground truth.

4. Adjudication Method

   • Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

   • No. This was not a comparative effectiveness study involving human readers or AI.

6. Standalone Performance Study (Algorithm Only)

   • No. This is a physical medical device (introducer sheath), not an algorithm.

7. Type of Ground Truth Used

   • Engineering specifications and testing protocols.

8. Sample Size for the Training Set

   • Not applicable. There's no "training set" in the context of device qualification testing.

9. How Ground Truth for the Training Set Was Established

   • Not applicable.

Analysis for the Adelante®-S Series Introducer Set (Oscor Inc.)

This document is an FDA 510(k) clearance letter for the Adelante®-S Series. It states that the device is substantially equivalent to legally marketed predicate devices, but it does not provide details about specific acceptance criteria or the study that proves the device meets those criteria. The clearance letter itself is a determination based on a submission from the manufacturer, which would have contained such details, but those details are not in the provided text.

Therefore, for the Adelante®-S Series, I can only state what is not present in the provided excerpt:

1. Table of Acceptance Criteria and Reported Device Performance

   • Not provided in the given text. The document is the FDA's clearance letter, stating substantial equivalence, but it does not detail the specific performance criteria or the results from the manufacturer's testing.

2. Sample Size Used for the Test Set and Data Provenance

   • Not provided in the given text.

3. Number of Experts Used to Establish Ground Truth and Qualifications

   • Not provided in the given text. (Likely not applicable as it's a physical device validation, similar to the SafeSheath, rather than an expert-adjudicated clinical study).

4. Adjudication Method

   • Not provided in the given text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

   • No. This type of study is not typically required for an introducer sheath and is not mentioned.

6. Standalone Performance Study (Algorithm Only)

   • No. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

   • Not provided in the given text. (Expected to be engineering specifications and testing protocols, similar to the SafeSheath).

8. Sample Size for the Training Set

   • Not applicable / Not provided in the given text.

9. How Ground Truth for the Training Set Was Established

   • Not applicable / Not provided in the given text.

Summary Limitations:

The provided text for both devices is primarily focused on the declaration of substantial equivalence for regulatory clearance. While it alludes to "Qualification Testing" for the SafeSheath, it only states that "All samples passed" without detailing the specific numeric thresholds of the acceptance criteria. For the Adelante-S Series, the provided text is solely the FDA's clearance letter, which does not contain the detailed study results or acceptance criteria themselves. Therefore, much of the requested information cannot be extracted directly from the given input.

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