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The Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access. The Transseptal Needle is intended for single use only.

The Transseptal Sharp Needle consists of a stainless-steel needle and nitinol stylet. The needle comes in two lengths equivalent to the lengths of the TSN Transseptal Needle (predicate) - 71cm and 98cm, and two curves, Curve0 (59°) and Curve1 (72°). The size is 18 gauge with an inner diameter of .0325" at the proximal body and necks down to 21 gauge with an inner diameter of 0.0230" at the distal end with a sharp a-bevel offset tip. The transseptal sharp needle includes a 0.018" diameter nitinol stylet wire with an intermediate 0.013" section, a bulbous distal tip, and a proximal clear plastic handle with an internal mechanism configured to both provide feedback on the position of the stylet tip and as well as to maintain the stylet tip in the extended position to reduce the possibility for further penetration of the needle after the initial crossing of the septum. The components of the Transseptal Sharp Needle include the transseptal sharp needle, stylet. sterile packaqing, and labeling.

There are four model numbers for the transseptal sharp needle: CLICK071, CLICK098, CLICK171, and CLICK198. The Transseptal Sharp Needle is sterilized by 100% ethylene oxide cycle and is for single use-only. The Transseptal Sharp Needle is used in a healthcare facility/hospital.

The transseptal sharp needle is used in transseptal procedures to puncture the fossa ovalis and gain access to the left atrium through the right side of the heart. The device is used by inserting the device through a transseptal dilator assembly. The devices are inserted in the femoral vein. The transeptal sharp needle is then advanced to the fossa ovalis. This mimics the procedure with the predicate device, TSN Transseptal Needle. Both the proposed device and the predicate device (K17950) have a needle point, made of stainless steel, have similar hub and handle, and have similar dimensions, design, and functionality. The needle's duration in the body is less than 24 hours.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "SafeSharp Transseptal Needle." It details the device's indications for use, its comparison to a predicate device, and the performance testing conducted to demonstrate substantial equivalence.

However, the request asks for specific information related to acceptance criteria and a study that proves the device meets acceptance criteria, particularly in the context of an AI/Software as a Medical Device (SaMD).

Reading through the entire document, there is no mention of an AI or software component for the "SafeSharp Transseptal Needle." The device is a physical medical instrument (a needle and stylet) used for puncturing the interatrial septum. The performance testing outlined (visual/dimensional inspection, particulate testing, pull tests, leak testing, simulated use) are all standard engineering and material tests for a physical device, not for evaluating an AI algorithm's performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/SaMD.

The document does not describe:

1. A table of acceptance criteria and reported device performance for an AI/SaMD.
2. Sample size, data provenance, number of experts, or adjudication methods for an AI/SaMD test set.
3. MRMC comparative effectiveness study or standalone AI performance.
4. Type of ground truth, training set size, or how ground truth was established for an AI/SaMD.

It seems there might be a misunderstanding or a misapplication of the prompt to this specific document, which describes a conventional hardware medical device.

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SafeSept® is indicated for use in procedures where access to the left atrium via the transseptal technique is desired. The SafeSept® Transseptal Guidewire is intended for single use only.

The SafeSept® .018" Transseptal Guidewire is made of nitinol, a flexible memory wire material, device that is 140cm in length. The proximal end of the wire has 4 sets of laser-etched markings, which increase in quantity toward the proximal end of the wire. An echogenic marker was added along the shaft proximal to the radiopaque coil. A radiopaque coil located along the shaft, made of a platinum/tungsten alloy, aids in visual quidance during transseptal procedures. The sharp distal tip is able to perforate through the fossa ovalis, a thin wall separating the right and left interatrial septum, when it is supported by a transseptal needle and dilator. When the wire is no longer supported, it is atraumatic and operates as typical quidewire.

The components of the SafeSept® include the .018" transseptal guidewire, dispenser and straightener, and sterile packaging and labeling. The model number of the subject device is SS-140. The SafeSept® .018" Transseptal Guidewire is sterilized by 100% ethylene oxide cycle and is for single use-only.

The subject device is used in transseptal procedures to gain access to the left atrium through the right side of the heart. The device is used by a surgeon by inserting the device through the femoral vein. The subject device is then advanced to the fossa ovalis with the support of the transseptal needle and dilator. The guidewire is used in conjunction with a transseptal needle and dilator. Its duration in the body is less than 24 hours. The SafeSept® .018" Transseptal Guidewire is used in a healthcare facility/hospital.

This document is a 510(k) premarket notification for a medical device called the SafeSept® Transseptal Guidewire (SS-140). It focuses on establishing substantial equivalence to a legally marketed predicate device, rather than providing a study proving performance against acceptance criteria in the context of an AI/ML device.

Therefore, the specific information requested in the prompt related to acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies, which are typically associated with AI/ML device evaluations, cannot be found in this document.

The document describes the device, its intended use, and compares its technological characteristics to a predicate device. It also mentions performance testing conducted to support substantial equivalence.

Here's an analysis of what is available in the document, framed as closely as possible to your request, but with the understanding that it's for a traditional medical device, not an AI/ML system:

1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:

The document doesn't present a formal table of "acceptance criteria" with quantitative targets and reported performance outcomes in the way an AI/ML device would. Instead, it states that various performance tests were conducted to demonstrate comparability to the predicate device. The implied acceptance criterion for these tests is that the subject device's performance should be "comparable" or "similar" to the predicate.

• Tip thickness
• Outer diameter
• Overall length
• Proximal marking locations
• Tensile and compressive forces during insertion and withdrawal
• Peak tensile forces
• Torsion withstand
• Puncture force | "These results were comparable to the predicate device."
  "The subject device data was comparable to the predicate device."
  "subject device was able to withstand torsional forces expected during a transseptal procedure."
  "the subject device puncture force... was similar to the predicate device." |
  | Integrity/Coating | - Proximal Marking Integrity
• Lubrication Coating
• 2x Sterile | "Proximal marking integrity was tested according to ISO 11070 and comparable to the predicate device."
  (Details on lubrication and sterile testing comparability are not explicitly stated, but implied by the overall conclusion of substantial equivalence based on performance data.) |
  | Simulated Use | In Vitro Simulated Use Testing | (Details on specific outcomes not provided, but implies satisfactory performance for substantial equivalence.) |
  | Packaging/Transit | - Package integrity (ASTM F88, ASTM 2096, ASTM F1929)
• Transit robustness (ASTM D4169) | "packaging testing per ASTM F88, ASTM 2096, and ASTM F1929."
  "Transit testing was performed per ASTM D4169... and transit testing was similar to the predicate device." |
  | Biocompatibility | Same material and coating as predicate, allowing adoption of predicate's biocompatibility data. | "Biocompatibility testing was performed on the predicate device... the biocompatibility testing was adopted for the SafeSept® .018" transseptal guidewire." |

This device is not an AI/ML device, so the concept of "standalone performance" in the context of an algorithm's output (without human intervention) is not applicable here. The performance described is the standalone performance of the physical guidewire itself.

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

The document does not specify exact sample sizes for bench testing (e.g., number of guidewires tested for dimensions, tensile strength, etc.). It refers to "the subject device data" and "the predicate device."

• Data Provenance: The tests are described as "Bench Testing" and "In Vitro Simulated Use Testing," suggesting they were conducted in a lab environment. There is no mention of country of origin for the data or whether it was retrospective or prospective.

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

Not applicable. This is a physical medical device, not an AI/ML system that requires expert-established ground truth for image interpretation or diagnosis. The "ground truth" for its performance is determined by physical and material testing against established standards and comparison to a predicate device.

4. Adjudication Method for the Test Set:

Not applicable. There is no expert adjudication process described, as it's not relevant for the type of testing performed on this physical device.

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

Not applicable. The device is a guidewire, not an AI system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.

7. Type of Ground Truth Used:

For the performance testing, the "ground truth" is based on:

• Physical and Dimensional Measurements: Conformance to specified engineering dimensions and properties.
• Mechanical Test Standards: Performance against established ISO and ASTM standards for medical devices (e.g., ISO 11070, ASTM D4169, ASTM F88, ASTM 2096, ASTM F1929).
• Comparison to Predicate Device: The primary "ground truth" for substantial equivalence is that the new device's performance is comparable to that of the legally marketed predicate device.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/ML system, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there's no training set for an AI/ML algorithm, this question is not relevant.

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The PathBuilder™ Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.

PathBuilder™ Transseptal Needle is consisted of thin section, curved section, main body, pointer flange, hub and stylet. The distal end of PathBuilder™ Transseptal Needle is curved for easy positioning within the heart when used together with the catheter introducer. The outer diameter of needle stepped down within the curved section for better fitness to the dilator which fixes the maximum length of the needle into the dilator. The distal tip of the needle is beveled to facilitate the transseptal process. The proximal end of PathBuilder™ Transseptal Needle is with a pointer flange which indicates the curve orientation of the needle. And a hub is equipped for aspiration, fluid injection/infusion etc. The stylet is straight. The proximal end of the stylet is curved to lock on the hub when inserted into the needle lumen. The stylet is used to help insert the needle into the dilator.

The provided document is a 510(k) premarket notification for the "PathBuilder™ Transseptal Needle". This document describes the device and its equivalence to a predicate device, but it does not include any information about an AI/ML device.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about a study proving an AI/ML device meets acceptance criteria. The document explicitly states: "No clinical study was used to support this submission."

The closest information provided related to performance testing is for the transseptal needle device (not an AI/ML system):

Non-Clinical Performance Testing:

• Biocompatibility Verification: Verified as per ISO 10993-1:2018 and FDA guidelines. Tests included Cytocompatibility, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility, Complement Activation, and Thrombogenicity.
• Bench Validation: Included visual inspection, dimensional verification, packaging testing (visual inspection, sealing strength, dye penetration), and mechanical failure/performance (joint forces). Compatibility of the needle and dilator was validated with compatibility, puncture force, radio detectability, and luer fitting. All samples were sterilized and aged prior to testing. All tested samples passed bench testing.
• Cleaning and Sterilization Validation: Performed in accordance with ISO 11135:2014, AAMI TIR 28:2009, and FDA guidance.
• Shelf Life Validation: Demonstrated a shelf life of three years.

Since no AI/ML device is described, I cannot answer questions 2 through 9 regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

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The SafeSept Blunt Needle is used in conjunction with a transseptal guidewire to puncture the interatinal septum during a transseptal catheterization procedure to gain left heart access. The SafeSept Blunt Needle is intended for single use only.

The Transseptal Extended Cannula is a stainless-steel device that comes in three lengths, 71cm, 89cm and 98cm. The body of the Transseptal Extended Cannula is equivalent to the transseptal cannula length, 69.7cm for the 71cm extended cannula, 87.7cm for the 89cm extended cannula, and 96.7cm for the 98cm extended cannula, and two distal curves, Curve0 and Curve1. The size is 18 gauge with an inner diameter of .0325" at the proximal body and necks down to 21 gauge with an inner diameter of 0.0195" at the distal end, terminating with a radiused tip. The components of the Transseptal Extended Cannula include the transseptal extended cannula, sterile packaging and labeling. There are six model numbers for the cannula: SBN071, SBN089, SBN098, SBN171, SBN189, and SBN198. The Transseptal Extended Cannula is sterilized by 100% ethylene oxide cycle and is for single use-only. The Transseptal Extended Cannula is used in a healthcare facility/hospital.

The provided text does not describe an AI/ML medical device and therefore does not contain information about acceptance criteria or studies that involved AI/ML performance.

The document is a 510(k) premarket notification for a medical device called the "SafeSept Blunt Needle" (also referred to as "Transseptal Extended Cannula"). It outlines the device's indications for use, technological characteristics, comparison to a predicate device, and performance testing data.

The performance testing listed includes:

• Visual and dimensional inspection
• Particulate testing (USP, Light Obscuration Method)
• Mating Joint Pull test (Handle to Hub)
• Mating Joint Pull test (Cannula to Extension)
• Strength of Union Cannula Hub and Cannula
• Guidewire Restriction Inspection
• Radius Tip Inspection
• Hub Female Luer Taper
• Water Leak Testing
• Air Leak Testing
• Packaging Testing
• Biocompatibility testing (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity, Genotoxicity, Hemocompatibility including Hemolysis and Complement Activation)

These tests are standard for physical medical devices to ensure their safety and effectiveness in their intended use, but they do not relate to the performance of an AI/ML algorithm.

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The Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access. The Transseptal Needle is intended for single use only.

The Transseptal Needle consists of a stainless-steel needle and stylet. The needle comes in three lengths equivalent to the lengths of a conventional Brockenbrough (BRK) needle (predicate) - 71cm, 89cm, and 98cm, and two curves, Curve0 and Curve1. The needle size is 18 gauge with an inner diameter of .033" at the proximal body and necks down to 21 gauge with an inner diameter of .018" at the distal end, terminating with an angled tip. The components of the Transseptal Needle include the Transseptal Needle and Stylet, and sterile packaging and labeling. There are six model numbers for the Transseptal Needle, TSN071, TSN089, TSN098, TSN171, TSN189, and TSN198. The Transseptal Needle is sterilized by 100% ethylene oxide cycle and is for single-use only. The Transseptal Needle is used in a healthcare facility/hospital.

The Transseptal needle is used in transseptal procedures to puncture the fossa ovalis and gain access to the left atrium through the right side of the heart. The device is used by inserting the device through a transseptal dilator and sheath assembly. The devices are inserted in the femoral vein. The Transseptal needle tip is able to perforate through the fossa ovalis, a thin wall between the right and left atrium. The needle's duration in the body is less than 24 hours.

This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the "TSN Transseptal Needle". The information provided pertains to the device itself and its equivalence to a predicate device, not to an AI/ML-based diagnostic or prognostic tool. Therefore, the questions regarding acceptance criteria, study details, expert involvement, MRMC studies, standalone performance, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable to this document.

The document discusses the substantial equivalence of the TSN Transseptal Needle to a legally marketed predicate device (St. Jude Medical, BRK Transseptal Needle, K122587). The focus is on the needle's design, materials, indications for use, and performance testing related to its physical and functional characteristics.

Here’s a breakdown of what is available and why the requested information is not applicable:

• Device: TSN Transseptal Needle
• Purpose: To puncture the interatrial septum during transseptal catheterization.
• Regulatory Classification: Class II, Product Code DRC (Trocar, 21 CFR 870.1390).

Why the Requested Information is Not Applicable:

The provided text describes a mechanical medical device, not an AI/ML system. The concept of "acceptance criteria" in this context refers to engineering specifications and performance tests ensuring the device's physical integrity, functionality (e.g., puncture force, guidewire passage), and biocompatibility, rather than diagnostic accuracy or algorithmic performance.

Therefore, the following specific points from your request cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance (in the context of AI/ML): The document lists performance tests (e.g., visual/dimensional inspection, particulate testing, mating joint pull test, water/air leak testing, biocompatibility tests). These are mechanical and material performance criteria, not AI/ML model performance metrics like sensitivity, specificity, or AUC.
2. Sample sizes used for the test set and the data provenance: Not applicable to a mechanical device. The "tests" here are physical experiments on samples of the device, not a test set of patient data for an algorithm.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for a physical device is established through engineering specifications and industry standards.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is for evaluating human interpretation with and without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no algorithm.
7. The type of ground truth used: For a mechanical device, ground truth relates to meeting design specifications and safety standards, established through physical testing and material science, not clinical outcomes for diagnostic accuracy.
8. The sample size for the training set: Not applicable, as there is no AI/ML model to train.
9. How the ground truth for the training set was established: Not applicable.

Information that is available regarding "performance testing" for this mechanical device:

• Performance Testing Categories: Visual and dimensional inspection, Particulate testing (USP), Mating Joint Pull test, Guidewire Restriction Inspection, Strength of Union Cannula Hub and Cannula, Needle Point Inspection, Hub Female Luer Taper, Water Leak Testing, Air Leak Testing, Packaging Testing.
• Biocompatibility Testing: Conducted per ISO 10993 (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity, Genotoxicity, Hemocompatibility). The device met the requirements.
• Comparison to Predicate: The device was found substantially equivalent to the St. Jude Medical, BRK Transseptal Needle (K122587) in design, technological characteristics, materials, and performance testing. Key differences (reverse bevel, clear hub, stylet handle/diameter, non-skiving) are noted and presumably were addressed in the performance testing to demonstrate equivalence.

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The Transseptal Cannula is used in conjunction with a transseptal guidewire to puncture the interatival septum during a transseptal catheterization procedure to gain left heart access. The Transseptal Cannula is intended for single use only.

The Transseptal Cannula is a stainless steel device that comes in three lengths equivalent to the body of a transseptal needle, 69.7cm for the 71cm cannula, 87.7cm for the 89cm cannula, and 96.7cm for the 98cm cannula, and two distal curves, Curve0 and Curve1. The size is 18 gauge with an inner diameter of .033" at the tip. The components of the Transseptal Cannula include the transseptal cannula, sterile packaging and labeling. There are six model numbers for the cannula: TSC071, TSC089, TSC171, TSC189, and TSC198. The Transseptal Cannula is sterilized by 100% ethylene oxide cycle and is for single use-only. The Transseptal Cannula is used in a healthcare facility/hospital.

The Transseptal Cannula is used in transseptal procedures to provide structural support to a transseptal guidewire to gain access to the left atrium through the right side of the heart. The device is used by a physician by inserting the device through a transseptal dilator and sheath assembly. The devices are inserted in the femoral vein. The transseptal quidewire is then advanced to the fossa ovalis with the support of the Transseptal Cannula and dilator. This allows physicians to use a transseptal guidewire in difficult cases where there is a particularly tough septum as the Transseptal Cannula provides the extra support needed. The cannula's duration in the body is less than 24 hours.

This FDA 510(k) summary is for a medical device called the "Needle Free Transseptal Cannula." It details the device's characteristics and compares it to a legally marketed predicate device to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics like a cut-off value for a pull test. Instead, it lists the types of performance tests conducted, implying that the device was deemed acceptable if it passed these tests, meaning it met internal specifications or comparative standards.

Since quantitative acceptance criteria and specific reported numerical performance values are not given, the table below will list the tests performed and indicate that the device "met requirements" or "passed" as implied by the "Conclusion" section stating the device is substantially equivalent based on performance testing.

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

The document does not provide details on the sample size used for specific performance tests (e.g., number of units tested for pull strength, a specific number of animals or human subjects for biocompatibility). The provenance of the data is not explicitly stated in terms of country of origin, but all tests were conducted according to recognized international standards (e.g., USP , ISO 10993 series). The nature of the tests indicates that these are laboratory/bench tests rather than clinical studies with human patient data; therefore, the terms "retrospective or prospective" do not directly apply in the usual sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This section is not applicable (N/A) as the device is a mechanical instrument and the tests described are primarily material, mechanical, and biocompatibility evaluations, not diagnostic image or data interpretation that typically requires expert "ground truth" establishment.

4. Adjudication Method for the Test Set

This section is not applicable (N/A) for the same reasons as point 3. Adjudication methods (like 2+1 or 3+1) are typically used for disagreements in human expert assessments of data, which is not relevant here.

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 section is not applicable (N/A). The device is a physical medical instrument (a cannula), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI-related effectiveness is irrelevant.

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

This section is not applicable (N/A) as the device is a physical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests would be defined by the specifications and standards that the device had to meet (e.g., a certain pull strength, absence of particulates beyond a threshold, non-toxicity). For biocompatibility, the ground truth is established by the normative criteria outlined in the ISO 10993 standards. It is based on objective measurements and established scientific/engineering criteria rather than expert consensus on complex data or patient outcomes.

8. The Sample Size for the Training Set

This section is not applicable (N/A). As a physical medical device, there is no "training set" in the context of machine learning. The device design and manufacturing processes are validated through design verification and validation testing, not through data training.

9. How the Ground Truth for the Training Set was Established

This section is not applicable (N/A) for the same reasons as point 8.

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The SafeSept® is indicated for use in procedures where access to the left atrium via the transseptal technique is desired. The SafeSept® Transseptal Guidewire is intended for single use only.

The SafeSept® Needle Free Transseptal Guidewire (SafeSept NF) is 0.031" in diameter and 180cm long and consists of a flexible memory wire material called nitinol. The components of the SafeSept NF include the 0.031" transseptal guidewire, dispenser and straightener, and sterile packaging and labeling. There is one model number for the SafeSept NF, SSNF. The SafeSept NF is sterilized by 100% ethylene oxide cvcle and is for single-use only. The SafeSept is used in a healthcare facility/hospital.

The SafeSept NF is used in transseptal procedures to gain access to the left atrium through the right side of the heart. The device is used by inserting the device through a transseptal dilator and sheath located in the femoral vein. The SafeSept NF is then advanced to the fossa ovalis with the support of the dilator and sheath. The SafeSept NF's sharp distal tip is able to perforate through the fossa ovalis, a thin wall between the right and left atrium, when it is supported by a transseptal dilator and sheath. When the wire is no longer supported, it is atraumatic and operates as a typical 0.031" diameter guidewire. A radiopaque coil located along the shaft allows for fluoroscopic visualization of the wire within the left atrium and proximal marker bands help determine the location of the quidewire tip in relation to the needle. The guidewire duration in the body is less than 24 hours.

This document is an FDA 510(k) clearance letter and summary for a medical device, the SafeSept Needle Free Transseptal Guidewire. It does not describe a study involving an algorithm or AI, nor does it present acceptance criteria and performance data for such a device. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device through physical and biological performance testing.

Therefore, many of the requested categories are not applicable to the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

The document lists performance tests but does not explicitly state quantitative acceptance criteria or raw performance data (e.g., specific tensile strength values, fracture thresholds, etc.). It only states that the device "performed equivalently to the predicate device" and "met the requirements set forth in ISO-10993."

2. Sample sized 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 in the document. The testing described is primarily laboratory/bench testing and animal testing for biocompatibility, not clinical data sets.

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. This is not an AI/algorithm study involving expert review for ground truth.

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

Not applicable.

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 document does not describe an AI device or an MRMC study.

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

Not applicable. This is not an AI/algorithm device.

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

For the performance testing, the "ground truth" would be the established engineering and ISO standards/requirements for the mechanical and biological properties of the device, and the performance of the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm device that requires a training set.

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

Not applicable.

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The SafeSept is indicated for use in procedures where access to the transseptal technique is desired. The SafeSept Transseptal Guidewire is intended for single use only.

The SafeSept® Transseptal Guidewire is 0.014″ in diameter and 135cm long and consists of a flexible memory wire material called nitinol. The components of the SafeSept include the 0.014″ transseptal guidewire, dispenser and straightener, and sterile packaging and labeling. There is one model number for the SafeSept, SS-135. The SafeSept is sterilized by 100% ethylene oxide cycle and is for single-use only. The SafeSept is used in a healthcare facility/hospital.

The SafeSept is used in transseptal procedures to gain access to the left atrium through the right side of the heart. The device is used by inserting the device through the femoral vein. The SafeSept is then advanced to the fossa ovalis with the support of the needle and dilator. The SafeSept's sharp distal tip is able to perforate through the fossa ovalis, a thin wall between the right and left atrium, when it is supported by a transseptal needle and dilator. When the wire is no longer supported, it is atraumatic and operates as a typical 0.014″ diameter guidewire. A radiopaque coil located along the shaft allows for fluoroscopic visualization of the wire within the left atrium and proximal marker bands help determine the location of the guidewire tip in relation to the tip of the needle. The guidewire's duration in the body is less than 24 hours.

This document is a 510(k) Pre-market Notification for a medical device called the SafeSept Transseptal Guidewire. It does not describe an AI/ML powered device, therefore, the requested information about acceptance criteria and studies does not apply in the context of an algorithmic device.

The document discusses the substantial equivalence of the SafeSept Transseptal Guidewire to a legally marketed predicate device (Oscor, SafeSept® Transseptal Trocar Guidewire, K081986). The primary difference noted is the length of the guidewire.

Here's an overview of the performance and biocompatibility testing conducted to support substantial equivalence:

Performance Testing:

• Visual and dimensional inspection
• Particulate testing (USP , Light Obscuration Method)
• Surface finish assessment
• Corrosion resistance
• Guidewire tensile strength
• Fracture and Flex testing
• Curve Integrity testing
• Torque Testing
• Packaging testing
• Radiopacity assessment
• Sterilization validation (in accordance with ANSI/AAMI/ISO 11135-1)

These tests demonstrated that the subject device performed equivalently to the predicate device.

Biocompatibility Testing (in accordance with FDA 510(k) Memorandum #G95-1 and ISO 10993):

• ISO 10993-5 Cytotoxicity
• ISO 10993-10 Sensitization
• ISO 10993-10 Irritation/Intracutaneous Reactivity
• ISO 10993-11 Acute Systemic Toxicity
• ISO 10993-11 Pyrogenicity
• ISO 10993-3 Genotoxicity
• ISO 10993-4 Hemocompatibility - ASTM Hemolysis Complete
• ISO 10993-4 Hemocompatibility - In-vivo Dog Thromboresistance
• ISO 10993-4 Hemocompatibility Complement Activation Complete with C3a & SC5b-9

The SafeSept transseptal guidewire is categorized as an external communicating device with circulating blood contact and limited exposure (less than 24 hours), and it met the requirements of ISO-10993.

Regarding your specific questions related to AI/ML powered devices:

• Acceptance Criteria & Device Performance Table: Not applicable as this is not an AI/ML device. The document primarily focuses on demonstrating substantial equivalence to a predicate device through physical and biological performance testing, rather than an algorithmic performance.
• Sample size for test set and data provenance: No "test set" in the context of an algorithm. Performance tests were conducted on the device itself.
• Number of experts for ground truth: Not applicable. Ground truth for an AI/ML algorithm is not relevant here.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

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Intracardiac Catheter Introducer Kit is intended for introducing various cardiovascular catheters into heart. Transseptal Needle is intended for puncture the interatrial septum during a transseptal catheterization procedure.

The proposed device includes Intracardiac Catheter Introducer Kit as well as its accessory, Transseptal Needle. Intracardiac Catheter Introducer Kit is intended for introducing various cardiovascular catheters into heart, including both right side. When left side of heart is accessed, Transseptal Needle is intended for puncture the interatrial septum during a transseptal catheterization procedure.

The Intracardiac Catheter Introducer Kit includes three components, which are (1) sheath introducer, (2) dilator and (3) guidewire. The sheath introduced into a body vessel, along with the dilator, over the guidewire, it is available in variable specification and curve configuration; Dilator is assembled with the sheath introducer and introduced into a body vessel over the guidewire. It is used to provide support to sheath and ensure smooth advancement; the guidewire is percutaneous placed into the body vessel to function as a guide for the introduction into the chambers of the heart.

The transseptal needle includes two components, which are (1) needle and (2) stylet. The needle is used to puncture the the interatrial septum during a transseptal catheterization procedure; the stylet is used to keep the needle luman intact during handling and facilitate the needle advancement within the dilator.

This document describes a medical device, the Intracardiac Catheter Introducer Kit and Transseptal Needle, and its substantial equivalence determination by the FDA. It does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/ML or Diagnostic device.

The acceptance criteria and study described here are for a traditional medical device (catheter introducer and needle) aiming to demonstrate equivalence to a predicate device, rather than proving a diagnostic performance metric.

Therefore, many of the requested fields are not applicable to the information provided in this document.

Here's the closest possible interpretation of the requested information based on the provided text, primarily focusing on "non-clinical tests" as the "study" substitute:

1. Table of acceptance criteria and the reported device performance:

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

The document does not specify the sample sizes for the individual non-clinical tests. The tests were conducted to verify design specifications and substantial equivalence, implying they were performed on samples of the manufactured device. The manufacturer is Synaptic Medical Limited, located in Beijing, PR China, which can be considered the country of origin for the device and likely where these tests were performed. These appear to be prospective tests on newly manufactured devices.

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. The tests are engineering and biological evaluations against established standards, not expert-derived ground truth on patient data.

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

Not applicable. This is for expert review of data, not for engineering or biological testing.

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 a traditional medical device, not an AI/ML-driven diagnostic or assistance tool.

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

Not applicable. This is for an AI/ML algorithm, not a physical medical device.

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

The "ground truth" here is compliance with established international and ASTM standards (e.g., ISO 11070, ISO 10993, ASTM F88, ASTM F1140), and verification of specific performance characteristics (e.g., anti-kink, torque strength). These are objective measurements against defined criteria.

8. The sample size for the training set:

Not applicable. There is no AI/ML model for which a training set would be used.

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

Not applicable. There is no AI/ML model.

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