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These devices are intended for various non-permanent intravascular applications including pressure monitoring, fluid administration, and blood sampling.

The various SDM Central Venous Catheters consist of polyurethane bodies with zero to five polyurethane extension tubes. Except for the smallest French sizes of the single lumen devices, the catheters all contain an additional flexible polyurethane distal tip. The proximal end(s) of each catheter terminate in molded-on, fixed, female locking luers. Where present, the extension tubes are joined to the catheter body by insertmolded polyurethane and contain clamps for occluding the tubes. Many configurations are marked with centimeter markings to indicate insertion depth.

Catheters will be offered in "kits" which will include some or all of the following depending on configuration: Catheter, guidewire in dispenser, dilator, syringe, scalpel, suture wing, and introducer needle. The makeup of specific sets can be seen in the Appendix D of this 510(k) submission. These kits will be packaged in semi-rigid vacuum formed trays containing a heat-sealed, ethylene oxide permeable lids, or in standard Tyvek/Poly pouches, depending on the product configuration.

This document describes the Safe-Cath Single- and Multi-Lumen Intravascular Catheter. However, it is a 510(k) Summary of Safety and Effectiveness for a medical device and does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

A 510(k) premarket notification is submitted to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This typically involves demonstrating "substantial equivalence" rather than presenting original clinical studies with detailed acceptance criteria and performance data in the way an AI/ML device submission would.

Therefore, I cannot provide the requested information from this document. It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance data for an algorithm.
7. Type of ground truth used (as it's not an AI/ML device).
8. Sample size for a training set (as it's not an AI/ML device).
9. How ground truth for a training set was established (as it's not an AI/ML device).

The document focuses on comparing the Safe-Cath catheter to predicate devices based on intended use, materials, dimensions, and mechanical properties, to argue for substantial equivalence, not to present a study demonstrating performance against specific acceptance criteria.

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This device provides additional access ports into a standard angiographic fluid delivery system and can be used in conjunction with syringes and other accessories where angiographic injection is indicated. This product's medium/high nressure designation does not preclude its use for low pressure modalities.

The SDM Angiographic Manifold consist of one or more stopcocks, where the multiple stopcock configurations are connected in line to form a manifold, with some models of each also having a high pressure extension line attached. These devices have bodies made of nolvearbonate and handle plugs made of polyethylene. The plugs are lightlv siliconized for smooth rotation. Each of the devices will be supplied single packaged and sterile. Packaging will consist of a standard Tyvek/Poly pouch.

This document describes a 510(k) premarket notification for the "SDM Angiographic Manifold with Extension Lines," a medical device. As such, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of AI/ML or diagnostic performance.

510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than conducting de novo clinical trials to establish acceptance criteria for performance metrics in the way often associated with AI/ML devices (e.g., sensitivity, specificity).

Therefore, I cannot provide the requested information for the following reasons:

The document does not:

• Define "acceptance criteria" related to device performance in a quantified way (e.g., sensitivity, specificity, accuracy).
• Describe a "study that proves the device meets the acceptance criteria" in terms of clinical outcomes or diagnostic performance.
• Mention any AI or machine learning components.
• Discuss sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

Instead, the document focuses on:

• Substantial Equivalence: Comparing the device to existing predicate devices in terms of intended use, materials, and design.
• Biocompatibility Evaluation: Stating that materials are generically the same as predicate devices and that testing showed biocompatibility per ISO Standard 10993, Part I.

Conclusion:

The provided document is a 510(k) summary for a physical medical device (angiographic manifold) seeking to demonstrate substantial equivalence, not a performance study for an AI-powered diagnostic tool. Therefore, the requested information elements (acceptance criteria table, sample sizes, expert details, etc.) are not applicable or present in this context.

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The intrauterine pressure monitoring catheter (IUP) is for use on patients requiring intrauterine monitoring, amniofusion, and sampling of amniotic fluid.

This 510(k) Notification is being submitted prior to marketing introduction of Scientific Device Manufacturer's Intrauterine Tip Transducer Catheter and its insertion device. Two models will be offered, one with a pressure transducer located at the proximal end using a fluid column to transmit pressure waves, the ther has the pressure transducer located in the distal tip. In both cases the transducer is a thick film/ceramic strain gage connected to a proximal connector interfaces with a reusable cable which is designed for proper connection to the monitor being used. Both devices will also have a separate fluid infusion and sampling lumen terminating in the side of the catheter near the distal end and integral to the connector at the proximal end. Incorporated in the tip transducer catheter is a signal interruption switch for electronic zeroing of the system following insertion and prior to commencement of use. This switch is also used for periodic rezeroing of the system during use without the need for removal and replacement of the catheter. Both catheter tips have rounded, blunt ends while the catheter material is soft, flexible polyurethane. This design minimizes the possibility of uterine perforation while at the same time providing maximum comfort for the patient. The catheter introducer, made of a somewhat stiffer polypropylene, is designed for easy insertion of the flexible catheter. It is of a split sheath design for simple removal following insertion. Also, a hook and loop attachment device is supplied for fixing the connector end of the catheter to the thigh following placement in order to prevent inadvertent dislodgement during use.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is a "Summary of Safety and Effectiveness" for an Intrauterine Pressure Transducer Catheter and focuses on describing the device and its equivalence to predicate devices, not on specific performance studies or acceptance criteria.

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Output:
This device is intended for hand injection of contrast media during angiography.

The SDM Control Syringes consist of visibly clear high strength polycarbonate barrels, an elastomeric piston, and a high strength polymeric plunger terminating in a palm plate. The device is modeled in the European style in regard to the finger grips and palm plate. Each barrel is marked to 10cc's of volume in increments of 0.2cc and is very lightly coated with a medical grade silicone oil to enhance smootheness of operation. Two models will be available, one having a 0.5cc reservoir of internal volume remaining in the fully inserted position. The other model will leave no reservoir following full travel of plunger to the bottom of the barrel. These devices will be supplied single packaged and sterile. Packaging will consist of standard Tyvek/Poly pouches.

This document provides a Summary of Safety and Effectiveness for SDM Control Syringes, which are high-pressure syringes intended for hand injection of contrast media during angiography. However, the document does not describe any specific acceptance criteria or a study proving the device meets acceptance criteria.

Instead, it focuses on establishing substantial equivalence to currently marketed devices based on intended use, materials, and design.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies from this document. The document primarily makes the following claims:

• Classification: Class II device; no performance standards established yet.
• Product Description: Visibly clear high-strength polycarbonate barrels, elastomeric piston, polymeric plunger with palm plate. Two models with different internal volume reservoirs. Supplied single-packaged and sterile.
• Intended Use: Hand injection of contrast media during angiography.
• Rationale for Substantial Equivalence: Similar to predicate devices (Medex, Namic, Becton Dickinson, Merit) in intended use, materials, and design. No significant changes or modifications from predicates.
• Biocompatibility: Materials are same type and grade as substantially equivalent devices. Testing performed per ISO Standard 10993, Part I, shows the device to be biocompatible for an externally communicating device (blood path indirect).

The document concludes that, based on these factors, the SDM Control Syringes are substantially equivalent in safety and effectiveness to other high-pressure syringes currently approved for use. None of the detailed study information you requested (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, training set details) is present in this regulatory submission summary.

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These devices are intended for use in percutaneous introduction of various catheters and/or guidewires into the vasculature.

The various SDM Percutaneous Catheter Introducer/Set range in dilator tubing sized from 4 Fr to 13 Fr and in dilator lengths from 100mm to 340mm. Sheaths paired with the dilators are tapered and close fitting to facilitate maximum ease of insertion. The sheaths are offered in both FEP and Pebax depending on customer preference. The sheath hemostasis valve contains a silicone seal and is offered both with a sideport and plain. An 18ga needle and guidewire of appropriate size will also be included with each set. Dilator luers are marked with a numeral and sheath caps are colored coded to indicate french size. These sets will be packaged in semi-rigid vacuum formed trays containing a heat-sealed, ethylene oxide permeable lids. A more economical, reduced version of the set will also be offered containing just a dilator and sheath without hemostasis valve packaged in a Tyvek/Poly chevron pouch

The provided text is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for a medical device called the "SDM Percuglide Percutaneous Catheter Introducer/Set." This document is a 510(k) Premarket Notification.

It's crucial to understand that a 510(k) summary (like the one provided) does not typically contain acceptance criteria or detailed study results proving a device meets them. The 510(k) process is about demonstrating substantial equivalence to a legally marketed predicate device, not about proving clinical efficacy or safety through rigorous studies as would be required for a PMA (Premarket Approval).

Therefore, based solely on the provided text, I cannot describe acceptance criteria or a study proving the device meets those criteria in the way you've requested. The document focuses on demonstrating substantial equivalence by comparing the new device to existing predicate devices based on intended use, materials, dimensions, and mechanical properties.

Here's what I can infer from the text regarding your questions, and what is explicitly missing:

Summary of Findings from the Provided Text:

The document states that the SDM Percuglide Percutaneous Catheter Introducer/Set is substantially equivalent to currently marketed introducer sets.

The rationale for substantial equivalence is based on:

• Intended Use: "for use in percutaneous introduction of various catheters and/or guidewires into the vasculature." - This is the same as predicate devices.
• Materials: "generically the same as those present in the substantially equivalent devices."
• Dimensions: "chosen to match commonly accepted industry standards and to replicate several of the predicate devices."
• Mechanical Properties: "chosen to match commonly accepted industry standards and to replicate several of the predicate devices."

The document mentions that Biocompatibility Evaluation testing (per ISO Standard 10993, Part I) is "currently underway" and "This data will be provided to the office of Device Evaluation prior to completion of review." This indicates that, at the time of this summary, the biocompatibility data was not yet complete or submitted.

Addressing Your Specific Questions Based on the Provided Text:

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

   • Not available in the provided text. The document describes the device's characteristics (e.g., dilator sizes, materials, components) and states they are chosen to "match commonly accepted industry standards and to replicate several of the predicate devices." It does not provide specific, quantifiable acceptance criteria (e.g., "tensile strength > X N") nor does it report specific device performance data against such criteria.

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

   • Not available in the provided text. No specific test sets, sample sizes, or data provenance information is mentioned for performance studies. The rationale for substantial equivalence is based on design choices to match predicate devices, not on direct comparative testing results described in this summary.

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/available. This type of information is typically relevant for studies involving subjective assessment (e.g., image interpretation, clinical outcomes evaluated by experts). The provided text describes a physical medical device and its components, and doesn't mention any such expert evaluations for establishing ground truth of a test set.

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

   • Not applicable/available. See point 3.

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/available. This device is a physical catheter introducer set, not an AI-powered diagnostic or assistive tool. No MRMC studies would be relevant here.

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

   • Not applicable/available. This is not an algorithm or AI device.

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

   • Not applicable/available. For a physical device like this, "ground truth" would typically relate to objective physical and mechanical properties (e.g., material strength, dimensions, flow rates), which are assessed against engineering specifications, not expert consensus or pathology in this context. The document states materials, dimensions, and functionality "match commonly accepted industry standards" and "replicate" predicate devices.

8. The sample size for the training set:

   • Not applicable/available. There is no "training set" as this is not an AI/machine learning device.

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

   • Not applicable/available. See point 8.

Conclusion:

The provided document is a 510(k) summary focusing on demonstrating substantial equivalence, not a detailed report of studies proving a device meets specific performance criteria. It asserts that the device's design, materials, and intended use are similar to existing predicate devices. Information regarding specific acceptance criteria, detailed performance studies, sample sizes, expert involvement, or AI-related data is not included in this type of document. The only mention of ongoing testing is for biocompatibility, with data to be submitted later.

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