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510(k) Data Aggregation
(30 days)
K251325**
Trade/Device Name: VersaCross Connect™ Transseptal Dilator
Regulation Number: 21 CFR 870.1310
Classification Name:** CFR 870.1310 – Vessel dilator for percutaneous catheterization
**D.
The VersaCross Connect Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.
The subject VersaCross Connect™ Transseptal Dilator (VXA-AG) is a single-use device that is supplied sterile to the user.
The subject VersaCross Connect™ Transseptal Dilator (VXA-AG) represents modifications to the legally marketed VersaCross Connect™ Transseptal Dilator (K241720).
The VersaCross Connect™ Transseptal Dilator (VXA-AG) is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The dilator provides torque control and is flexible. The dilator features a tapered tip and a shaft that can be reshaped manually. The echogenic shaft and tip and radiopaque tip maximize visualization of the dilator during manipulation in procedures.
The dilator can be used with separately cleared compatible access sheaths such as Agilis™ NxT Steerable Introducer (K061363 or K081645). The dilator provides support and helps guide separately cleared compatible transseptal wires to the atrial septum for puncture. The dilator subsequently dilates the atrial septal defect to enable larger diameter devices to cross the septum. The subject device can be used by electrophysiologists, interventional cardiologists, and other users trained in catheter techniques for any procedure that requires left atrial access via transseptal puncture. Procedures using the devices are performed in fully equipped catheter labs with imaging equipment, including fluoroscopy and echocardiography under sterile technique.
The provided FDA 510(k) Clearance Letter for the VersaCross Connect™ Transseptal Dilator does not contain information related to an AI/ML-driven medical device. The clearance is for a physical medical device (a vessel dilator) which has undergone design modifications.
Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance, human reader improvement with AI assistance, standalone algorithm performance, and ground truth establishment for training and test sets, is not applicable to this document.
The document details the following for the physical device:
- Device: VersaCross Connect™ Transseptal Dilator
- Purpose: Used for procedures requiring access to the left atrium via the transseptal technique.
- Modifications: Design changes (hub color, dilator shaft dimensions, snap fit hub geometry, hub length) and non-patient contacting material changes from its predicate device (K241720).
- Verification and Validation Activities: These focused on the physical and material properties of the dilator, ensuring it meets performance, safety, and biocompatibility standards. Examples include:
- Torque Transmission, Dilator Protrusion Length, Shaft Outer Diameter, Flexural Rigidity, etc.
- Biocompatibility, Sterilization, Pyrogen testing, Packaging integrity.
- Benchtop validation to confirm performance during normal intended use.
- Substantial Equivalence: The submission demonstrates that the modified device is substantially equivalent to its predicate, sharing the same intended use, indications for use, fundamental scientific technology, operating principles, and mechanism of action. The changes do not raise new questions of safety or effectiveness.
In summary, there is no AI/ML component described or evaluated in this 510(k) clearance document, and thus, no information is available to address the specific questions about AI/ML acceptance criteria and performance studies.
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(169 days)
: K242229
Trade/Device Name: Micro Ace Gold Advanced Micro Access System Regulation Number: 21 CFR 870.1310
Percutaneous Catheterization System
Dilator, Vessel, for Percutaneous
Catheterization
2
DRE
870.1310
The Merit Micro Ace™ Gold Advanced Micro Access System is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guidewire into the vascular system.
The Merit Micro Ace™ Gold Advanced Micro Access System (hereafter referred to as Micro Ace™ Gold) provides access to the vascular system and facilitates the placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wires. The system is available in 4 French and 5 French sizes – and includes the coaxial introducer-dilator pair, a 21 gauge needle and a 0.018” (0.46mm) guide wire.
The introducer-dilator assembly that is included in each kit is 10 cm effective length. The system will be offered with optional guidewires: Some catalog codes will include a nitinol wire with platinum guidewire tips; Some catalog codes will be offered with a stainless steel wire with platinum guidewire tips.
The provided text is a 510(k) summary for the Merit Micro Ace™ Gold Advanced Micro Access System. It describes the device, its intended use, comparison to a predicate device, and the safety and performance testing conducted.
However, this document does not describe a study proving a device meets acceptance criteria related to an AI/Software as a Medical Device (SaMD) product. Instead, it pertains to a physical medical device (vessel dilator for percutaneous catheterization) and describes the verification and validation tests for its physical characteristics and biocompatibility.
Therefore, many of the requested items, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "number of experts used to establish ground truth," and "sample size for training set," are not applicable to this type of device and review.
The document focuses on demonstrating substantial equivalence to a predicate device through physical and material property testing, rather than performance of an AI algorithm based on data analysis.
Given this, I will answer the applicable questions based on the provided text, and explicitly state when a question is not applicable.
Acceptance Criteria and Device Performance (for a physical medical device):
The document lists "Design Verification Studies" and "Design Validation Studies" as evidence that the device meets "pre-established performance criteria" and addresses "unacceptable risks." The acceptance criteria are implicitly the successful completion of these tests as per relevant international standards.
1. A table of acceptance criteria and the reported device performance:
The document broadly states: "All tested samples met pre-established performance criteria and were deemed acceptable." It does not provide a quantitative table of specific acceptance criteria values and the measured performance results for each test. Instead, it lists the types of tests performed.
| Acceptance Criteria Category (Implicit via test type) | Test Performed | Reported Device Performance |
|---|---|---|
| Physical Dimensions | Dilator Effective length | All tested samples met pre-established performance criteria and were deemed acceptable. |
| Dilator Outer Diameter | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Dilator Tip Inner Diameter | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Mechanical Properties | Insertion Force | All tested samples met pre-established performance criteria and were deemed acceptable. |
| Pushability and Kink Test | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Shaft Tensile | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Hub Tensile | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Dilator Tip Bend | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Dilator Tip Fracture | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Material/Surface Characteristics | Particulate test | All tested samples met pre-established performance criteria and were deemed acceptable. |
| Lubricity test | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Biocompatibility | Cytotoxicity | All tested samples met pre-established performance criteria and were deemed acceptable. |
| Sensitization | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Irritation | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Acute Systematic Toxicity | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Pyrogenicity | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Hemolysis | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Partial Thromboplastin Time | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Heparinized Blood Platelet and Leukocyte Count | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Complement Activation | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Extract Particulates | All tested samples met pre-established performance criteria and were deemed acceptable. | |
| Design Validation | Clinician feedback assessment | Not specified, but implied satisfactory as part of overall acceptability statement. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document states that "The tests were performed on both 4F and 5F Micro Ace™ Gold products." It also mentions "All samples were manufactured in accordance with existing and validated processes, and when sterile, are representative of product that Merit Medical intends to commercialize." It does not specify the exact number of samples per test for the test set.
- Data Provenance: The data provenance is from internal testing conducted by Merit Medical Systems, Inc. The document does not specify country of origin for the data (beyond the company's location in South Jordan, Utah, USA), nor does it classify the study as retrospective or prospective in the context of clinical data, as this is a device verification/validation study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable in the context of AI/SaMD ground truth establishment.
- For the "Clinician feedback following assessment of design changes" in the Design Validation Studies, the specific number and qualifications of clinicians are not provided. This feedback typically informs the practical usability and design, rather than establishing a 'ground truth' for an AI algorithm.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. This concept is relevant for reconciling discrepancies in expert annotations for AI ground truth, which is not what this document describes.
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:
- No. This type of study is for evaluating the impact of AI on human reader performance, and is not applicable to a physical vessel dilator device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This applies to AI/SaMD performance, which is not the subject of this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the sense of 'ground truth' for AI performance. The "ground truth" for this device's performance is defined by its compliance with engineering specifications, industry standards (ISO 10555-1, EN ISO 11070 2014/A1:2018, ISO 10993-1, ISO 14971), and successful completion of pre-established physical, mechanical, and biocompatibility criteria.
8. The sample size for the training set:
- Not Applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As above, this document does not describe an AI algorithm or its training set.
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(179 days)
| 21 CFR 870.1310
This device is used to dilate strictures in the pancreatobiliary systems and to dilate openings via the transgastric or transduodenal wall. This device is indicated for adult use only.
The Tornus ES is a rotary-operated dilator designed for use in bile duct/pancreatic duct strictures and via transgastric/transduodenal dilation of openings. The Tornus ES is comprised of stainless-steel coils and polymeric materials. The Dilation and Shaft segments are composed of coils materials that are welded together. The Tornus ES is available for prescription use only.
The provided text describes the performance data for the Tornus ES device, specifically focusing on non-clinical testing and biocompatibility assessments. It does not detail a study involving human subjects or AI assistance, which would typically involve acceptance criteria related to accuracy, sensitivity, specificity, or reader performance metrics. Therefore, several points of your request cannot be fulfilled as they are not applicable to the information provided.
Based on the provided text, primarily pages 8 and 9, here's the information regarding the device's acceptance criteria and the study that proves it meets those criteria:
1. A table of acceptance criteria and the reported device performance
The document provides acceptance criteria specifically for biocompatibility testing, and a general "Pass" for non-clinical performance tests.
Table 1: Non-Clinical Testing Performance
| Test Item | Reported Device Performance |
|---|---|
| Appearance | Pass |
| Tensile strength | Pass |
| Guidewire pass-through ability | Pass |
| Dilation ability | Pass |
| Slide durability | Pass |
| Radio-detectability | Pass |
| Corrosion resistance | Pass |
| Polyurethane strength | Pass |
| Guide wire trackability | Pass |
| Kink resistance | Pass |
| Dimension measurement | Pass |
| Simulated use and (torsional strength) | Pass |
Table 2: Biocompatibility Testing Acceptance Criteria and Results
| Test Method | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Cytotoxicity MEM Elution Test | ISO 10993-5 (No deviations) | The test system is considered suitable if no signs of cellular reactivity (Grade 0) are noted for both the negative control article and the medium control. | Non-cytotoxic |
| Sensitization KLIGMAN Maximization Test | ISO 10993-10 (No deviations) | The extracts should show no evidence of causing delayed dermal contact sensitization in the guinea pig. | Non-Sensitizing |
| Irritation Intracutaneous Injection Test | ISO 10993-10 (No deviations) | The test extract and the negative control must exhibit similar edema and erythema scores. | Non-Irritant |
| Systemic Toxicity Acute System Toxicity Test | ISO 10993-11 (No deviations) | The test article must not show significantly greater biological activity than the control. | Non-toxic |
| Systemic Toxicity Rabbit Pyrogen Test (material mediated) | ISO 10993-11 (No deviations) | The test article should not increase the rectal temperature of any of the animals by more than 0.5 degrees Celsius. | Non-pyrogenic |
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 refers to "Non clinical laboratory testing" and "in vitro bench tests". This indicates that the testing was performed on units of the device itself and not on patient data. No specific sample sizes for these tests are provided, nor is the country of origin of the data or whether it was retrospective or prospective, as these terms are generally applicable to clinical trials or studies involving patient data, which is not the case here.
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 testing was non-clinical and benchtop, not requiring human expert interpretation or ground truth establishment in the context of imaging or clinical diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to adjudication of ground truth in clinical data, not bench 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 document describes a medical device (a catheter) and its non-clinical performance and biocompatibility. It does not involve AI or human image readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" would be the engineering specifications and performance standards established for the device. For biocompatibility, the ground truth is established by the methods and criteria defined in the ISO 10993 series of standards.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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(138 days)
name: Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Set Regulation Number: 21 CFR 870.1310
The Super Sheath Introducer Sheath is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature of adult and pediatric patients of all ages.
The Super Sheath Introducer Sheath (hereinafter referred to as the "Subject Device") is used to introduce diagnostic or interventional devices into a blood vessel. The Subject Device is available in two products: one consisting of a Sheath and Dilator (Super Sheath Introducer Sheath without Guidewire), and the other consisting of a Sheath, Dilator, and Guidewire (Super Sheath Introducer Sheath with Guidewire), similar to the Predicate Device K121504. These devices are provided sterile and intended for single use, and the shelf-life is three years.
The main component of the Sheath consists of a Sheath hub, a Sheath shaft connected to the Sheath hub, and a three-way stopcock valve connected to the hub with a side port tube. The Sheath shaft is 3.3 French size and available in 5cm and 7cm lengths. The Sheath hub contains a hemostatic valve and has a suture wing. The shape and dimensions of the three-way stopcock luer connector are modified to comply with the new applicable standard ISO 80369-7:2021.
The Dilator has an open, tapered plastic tube for Guidewire insertion. The Dilator tube is press-fit into the inner hub with a bushing. The length of the Dilator tube corresponds to the length of the Sheath shaft, which is longer and available in 10.5 cm and 12.5 cm.
The 0.018" Guidewire is the smallest size Guidewire and a 40 cm long, thin, flexible wire with a inserter attached to the tip. This Guidewire is a legally marketed product which is cleared by the Food and Drug Administration (K021990).
The upper cap and suture wing of the Sheath hub, and the Dilator hub are colored purple. The Dilator tube and the inserter are colored blue. And the unvented cap of the three-way stopcock is pink.
This document is a 510(k) premarket notification for a medical device called the "Super Sheath Introducer Sheath". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study or performance data like an AI/ML diagnostic device would.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study to prove a device meets those criteria for an AI/ML-based device. The original request is formulated for a performance study of a diagnostic device (likely AI-powered), which requires metrics like sensitivity, specificity, or AUC, and details on clinical validation with ground truth.
The document describes a physical medical device (an introducer sheath), and its substantial equivalence is proven through:
- Bench Testing: Mechanical and physical properties (tensile strength, kink resistance, connection strength, pressure tests, lubricity, radiopacity, corrosion resistance).
- Biocompatibility Testing: Cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, hemocompatibility, pyrogen test, LAL test.
- Comparison of Technological Characteristics: To a predicate device (K121504) across features like French sizes, indications for use, regulation numbers, components, sterilizations, and dimensional comparisons.
In summary, the provided document does not allow for a response to the specific questions regarding acceptance criteria and performance study details for an AI/ML device.
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(28 days)
Re: K241720
Trade/Device Name: VersaCross Connect™ Transseptal Dilator Regulation Number: 21 CFR 870.1310
Classification Name: | CFR 870.1310 - Vessel dilator for
percutaneous catheterization |
| D.
The VersaCross Connect™ Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.
The subject VersaCross Connect™ Transseptal Dilator is a single-use device that is supplied sterile to the user. The subject VersaCross Connect™ Transseptal Dilator represents modifications made to the dilator component of the legally marketed VersaCross Connect™ Transseptal Dilator (K220414) (comprising of a dilator and J-tipped guidewire). A guidewire is not supplied with the subject device. However, the end user can use a separately cleared compatible 0.035″ quidewire. The VersaCross Connect™ Transseptal Dilator is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The dilator provides torque control and is flexible. The dilator features a tapered tip and a shaft that can be reshaped manually. The echogenic shaft and tip and radiopaque tip maximize visualization of the dilator during manipulation in procedures. The dilator can be used with separately cleared compatible access sheaths such as CARTO VIZIGO™ Bi-Directional Guiding Sheath (K231412). The dilator provides support and helps guide separately cleared compatible transseptal wires to the atrial septum for puncture. The dilator subsequently dilates the atrial septal defect to enable larger diameter devices to cross the septum.
The provided document is an FDA 510(k) clearance letter for the VersaCross Connect™ Transseptal Dilator. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Crucially, this document does not describe a study involving "acceptance criteria" for an AI/ML powered device, nor does it detail a study proving such a device meets these criteria.
The device in question, the VersaCross Connect™ Transseptal Dilator, is a mechanical medical device (a vessel dilator), not an AI/ML-powered one. The testing described is typical for a mechanical device and includes:
- Mechanical Testing: Torque Transmission, Torque Withstand, Flexural Rigidity, Shapeability, Curve Retention, Hub-Shaft Tensile, Tip to Tip Cap Cantilever and Tensile, Clamshell Tensile, Clamshell Cantilever.
- General Physical Testing: Luer Tests, Air and Liquid Leakage Tests, Corrosion Test.
- System Verification Testing: Compatibility Test, Snap Force Test.
- Biocompatibility Verification: Evaluated through adopted biological data of the predicate device (K220414).
- Sterilization Verification: Ethylene Oxide sterilization to a SAL of 10-6.
- Pyrogen Testing: Limulus Amoebocyte Lysate (LAL) testing.
- Packaging Verification: Ship testing and sterile barrier integrity.
- Benchtop Validation: To validate performance during normal intended use.
Therefore, I cannot extract the information required to populate the requested table and answer the questions about AI/ML device acceptance criteria and study details from the provided text.
The document states: "The proposed VersaCross Connect™ Transseptal Dilator met all test requirements as specified by applicable standards and test protocols. The verification and validation activities for safety and effectiveness, along with the testing completed for the design changes demonstrated the subject device meets its intended use and is as safe, as effective, and performs in a manner that is substantially equivalent to the predicate device." This is the general statement of compliance, but it does not provide specific acceptance criteria values or performance metrics in a tabulated format that would be relevant for an AI/ML device.
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(30 days)
Re: K233647
Trade/Device Name: VersaCross Connect™ Transseptal Dilator Regulation Number: 21 CFR 870.1310
Classification Name: | CFR 870.1310 - Vessel dilator for
percutaneous catheterization |
| D.
The VersaCross Connect™ Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.
The subject VersaCross Connect™ Transseptal Dilator is a single-use device that is supplied sterile to the user. The device is comprised of a single dilator.
The subject VersaCross Connect™ Transseptal Dilator represents modifications made to the dilator component of the legally marketed VersaCross Connect™ Transseptal Dilator (K220414) (comprising of a dilator and J-tipped guidewire). A quidewire is not supplied with the subject device. However, the end user can use a separately cleared compatible 0.035″ quidewire.
The VersaCross Connect™ Transseptal Dilator is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The dilator provides torque control and is flexible. The dilator features a tapered tip and a shaft that can be reshaped manually. The echogenic shaft and tip and radiopaque tip maximize visualization of the dilator during manipulation in procedures.
The dilator can be used with separately cleared compatible access sheaths such as FARADRIVE™ Steerable sheaths. The dilator may also be used as a standalone device to facilitate access to the left atrium following transseptal puncture. The dilator provides support and helps quide separately cleared compatible transseptal wires to the atrial septum for puncture. The dilator subsequently dilates the atrial septal defect to enable larger diameter devices to cross the septum.
This document describes the premarket notification (K233647) for the VersaCross Connect™ Transseptal Dilator. It is an updated version of a previously cleared device (K220414), with modifications primarily in dimensions and design for compatibility and the absence of a supplied guidewire. The FDA's review confirms substantial equivalence to the predicate device due to identical indications for use, fundamental scientific technology, and operating principles, supported by a comprehensive suite of non-clinical performance tests.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Requirement | Performance Standard/Requirement | Reported Device Performance/Conclusion |
|---|---|---|---|
| Mechanical Testing | Torque Transmission | Compliance with ISO 11070:2014/Amd.1:2018 and Baylis Medical Co. Inc. requirements. | All test requirements met. |
| Torque Withstand | Compliance with ISO 11070:2014/Amd.1:2018 and Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| Hub-Shaft Tensile | Compliance with ISO 11070:2014/Amd.1:2018 and Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| Flexural Rigidity | Compliance with ISO 11070:2014/Amd.1:2018 and Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| Shapeability | Compliance with ISO 11070:2014/Amd.1:2018 and Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| Curve Retention | Compliance with ISO 11070:2014/Amd.1:2018 and Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| Tip to Tip Cap Cantilever and Tensile | Compliance with Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| Clamshell Tensile | Compliance with Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| Clamshell Cantilever | Compliance with Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| Shaft Joint Tensile Strength | Compliance with Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| Shaft Friction test | Compliance with Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| General Physical Testing | Luer Tests | Compliance with ISO 11070:2014/Amd.1:2018, ISO 80369-7:2021, and Baylis Medical Co. Inc. requirements. | All test requirements met. |
| Air and Liquid Leakage Tests | Compliance with ISO 11070:2014/Amd.1:2018, ISO 80369-7:2021, and Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| Corrosion Test | Compliance with ISO 11070:2014/Amd.1:2018, ISO 80369-7:2021, and Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| System Verification | Compatibility Test (with guidewires, introducer, sheaths) | Compatibility with compatible guidewires, introducer, and accessory sheaths, as per Baylis Medical Co. Inc. requirements. | All test requirements met. |
| Snap Force Test (with accessory sheath) | Verification of force required to snap and unsnap with compatible accessory sheaths, as per Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| Biocompatibility | Biological Safety | Compliance with ISO 10993-1:2020 and FDA guidance document (Sept 8, 2023). | Conducted through adopted biological data of the predicate device (K220414). Compliant. |
| Sterilization | Sterilization Assurance Level | Ethylene Oxide sterilization to a SAL of 10-6, compliant with ISO 11135:2014/A1:2019 and ISO 10993-7:2008/A1:2022. | Compliant. |
| Residual Limit Verification | Compliance with ISO 10993-7:2008/A1:2022. | Compliant. | |
| Pyrogen Testing | Endotoxin Levels (LAL testing) | Meets current FDA and USP pyrogen limit specifications, as per ANSI/AAMI ST72:2019 and FDA guidance. | Supplied non-pyrogenic; test requirements met. |
| Packaging Verification | Shipping and Handling Integrity | Maintains packaging integrity through shipping/handling and storage, compliant with ISO 11607-1:2020. | All test requirements met. |
| Sterile Barrier Integrity | Maintains sterile barrier integrity over proposed shelf life, compliant with ISO 11607-1:2020. | All test requirements met. | |
| Benchtop Validation | Performance during normal intended use | Validated performance as per ISO 11070:2014/Amd.1:2018 and Baylis requirements. Customer requirements were validated through benchtop validation. | All test requirements met. (Validation confirms performance for intended use). |
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 exact sample sizes for each mechanical, physical, or system verification test conducted. It generally refers to "test requirements" being met. The data provenance is not explicitly stated in terms of country of origin, but the tests were conducted by Baylis Medical Company Inc., which is based in Canada. These tests are non-clinical (benchtop) and are typically performed in a laboratory setting. They would be considered prospective in the sense that they were designed and executed to evaluate the new device.
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)
This device is a medical dilator, not an AI or diagnostic imaging device that requires expert interpretation for "ground truth" in the traditional sense of clinical data. The "ground truth" for this device's performance is established through adherence to recognized international standards (e.g., ISO, ANSI/AAMI) and the manufacturer's internal engineering requirements. Therefore, the "experts" involved would be a team of engineers, regulatory affairs specialists, quality assurance personnel, and potentially design validation specialists from Baylis Medical Company Inc. with expertise in medical device design, testing, and regulatory compliance. The document does not specify the number or specific qualifications of these individuals, as it's typically understood to be part of standard manufacturing and quality system practices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., reading medical images) to resolve discrepancies among experts. For a physical medical device undergoing non-clinical benchtop testing, the results are objectively measured against predefined scientific and engineering standards, not subject to subjective adjudication among experts.
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 physical medical device (dilator), not an AI algorithm for diagnostic interpretation or a device designed to assist human readers. Therefore, an MRMC comparative effectiveness study, which is relevant for AI-powered diagnostic tools, was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm. Benchtop tests are inherently "standalone" in the sense that the device's physical properties and performance are measured objectively without human-in-the-loop clinical scenarios.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests conducted on the VersaCross Connect™ Transseptal Dilator is based on:
- International Standards: e.g., ISO 11070:2014/Amd.1:2018 (Vessel Dilators), ISO 80369-7:2021 (Luer connectors), ISO 10993-1:2020 (Biocompatibility), ISO 11135:2014/A1:2019 (Sterilization), ISO 10993-7:2008/A1:2022 (EO residuals), ANSI/AAMI ST72:2019 (Pyrogen testing), ISO 11607-1:2020 (Packaging).
- Manufacturer's Internal Requirements: Baylis Medical Company Inc. requirements, often derived from risk assessments and design specifications.
- Predicate Device Data: For biocompatibility, data from the predicate device (K220414) was adopted, indicating that prior established safety profiles serve as a ground truth baseline.
8. The sample size for the training set
Not applicable. This is a physical medical device undergoing non-clinical testing, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical medical device.
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(30 days)
Re: K232609
Trade/Device Name: Micro Ace™ Advanced Micro Access System Regulation Number: 21 CFR 870.1310
Percutaneous Catheterization System
Dilator, Vessel, for Percutaneous
Catheterization
2
DRE
870.1310
The Micro Ace™ Advanced Micro Access System is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guidewire into the vascular system.
The Merit Micro Ace™ Advanced Micro Access System (hereafter referred to as Micro Ace™) provides access to the vascular system and facilitates the placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wire. The system is available in 4 French and 5 French sizes – and includes the coaxial introducer-dilator pair, a 21 gauge needle and a 0.018" (0.46mm) guide wire.
The introducer-dilator assembly that is included in each kit is 10 cm effective length. The system will be offered with optional guidewires:
• Some catalog codes will include a nitinol wire with platinum guide wire tips;
• Some catalog codes will be offered with a stainless steel wire with platinum guidewire tips.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Micro Ace™ Advanced Micro Access System." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on human-in-the-loop or standalone AI performance.
Therefore, the following information cannot be extracted from the provided text:
- No AI/Machine Learning Component: The prompt's questions (e.g., about AI assistance, standalone algorithm performance, training/test set ground truth, expert adjudication) are relevant to a medical device that incorporates AI or machine learning. The Micro Ace™ Advanced Micro Access System is a physical medical device (a vessel dilator for percutaneous catheterization) and does not appear to have any software or AI component described in this document. The term "algorithm" is not mentioned in the context of device performance.
- No "Acceptance Criteria" for AI/Software Performance: The document outlines the performance testing conducted to ensure the device functions as intended and is safe, but these are typical engineering and biocompatibility tests for a physical device, not performance metrics for an AI algorithm.
- No Human Reader Study: Since there's no AI component, there's no multi-reader multi-case (MRMC) comparative effectiveness study with human readers assisting with AI.
- No Training or Test Sets for AI: The concepts of training and test sets and ground truth establishment (expert consensus, pathology, outcome data) are specific to AI/ML model development and evaluation. These do not apply to the physical device described.
Instead, the document details the following for a physical medical device:
1. Acceptance Criteria and Reported Device Performance (Summary):
The document states that "All tested samples met pre-established performance criteria and were deemed acceptable." Specific numeric acceptance criteria are not provided in the text, nor are the detailed reported performance metrics for each test. The document lists the types of tests performed:
| Acceptance Criteria (Type of Test) | Reported Device Performance |
|---|---|
| Design Verification Studies | |
| Leak Test | Met pre-established criteria |
| Marker Band-to-Tip Length | Met pre-established criteria |
| Effective Use Length | Met pre-established criteria |
| Introducer OD | Met pre-established criteria |
| Introducer ID | Met pre-established criteria |
| Dilator Drag | Met pre-established criteria |
| Introducer Stiffness | Met pre-established criteria |
| Sheath Kink Force | Met pre-established criteria |
| Sheath Kink Distance | Met pre-established criteria |
| Tip Insertion Force | Met pre-established criteria |
| Sidewall Compression | Met pre-established criteria |
| Sheath Hub Tensile | Met pre-established criteria |
| Radiopacity | Met pre-established criteria |
| Design Validation Studies | |
| Clinician feedback following assessment of design changes | Deemed acceptable |
| Biocompatibility Studies | |
| Cytotoxicity Study ISO Elution Method | Met pre-established criteria |
| Intracutaneous Irritation Study | Met pre-established criteria |
| Sensitization ISO Guinea Pig Maximum Sensitization Test | Met pre-established criteria |
| Acute Systemic Toxicity Study in Mice | Met pre-established criteria |
| Pyrogen Study USP Rabbit, Material Mediated | Met pre-established criteria |
| Hemolysis Study Extract and Direct Material Contact | Met pre-established criteria |
| Partial Thromboplastin Time Assay with Comparison Article | Met pre-established criteria |
| Heparinized Blood Platelet and Leukocyte Count Assay | Met pre-established criteria |
| Complement Activation (SC5b-9) Assay with Comparison Article | Met pre-established criteria |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions that both 4F and 5F Micro Ace™ products were tested, and testing included sterile devices (following ethylene oxide processing) and aged devices. The exact numerical sample size for each test is not specified.
The data provenance is from Merit Medical Systems, Inc., the manufacturer. It is internal device testing, not patient data from a specific country or retrospective/prospective study in a clinical setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This question is not applicable as the studies relate to physical device performance testing (e.g., mechanical properties, biocompatibility), not the establishment of ground truth for diagnostic imaging or similar applications requiring expert consensus. "Clinician feedback" was part of design validation, but the number and qualifications of these clinicians are not detailed.
4. Adjudication Method for the Test Set:
Not applicable. This refers to consensus building among experts for tasks like image labeling, which isn't relevant to the described device testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This type of study is for evaluating diagnostic performance (often with AI assistance). The Micro Ace™ is a physical medical access system, not a diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This refers to AI algorithm performance.
7. The Type of Ground Truth Used:
Not applicable in the context of diagnostic AI. The "ground truth" for this device's performance is determined by meeting pre-specified engineering and biocompatibility test standards (e.g., a specific tensile strength value, absence of cytotoxic effects).
8. The Sample Size for the Training Set:
Not applicable. There is no AI model or "training set" for this physical device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
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(28 days)
575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013) Regulation Number: 21 CFR 870.1310
| II |
| Classification Regulation: | 21 CFR 870.1310
The TightRail Guardian motorized dilator sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads.
The TightRail Guardian motorized dilator sheath is a sterile, single use, prescription only device used for cardiac leads. The device is comprised of:
- Drive Assembly
- Dilation Extension Selection (DES) Assembly
- Motor Drive Handle
- Outer Sheath Accessory
- Fish Tape Accessory
The motorized dilator sheath is advanced or retracted along the target lead to be removed. Pulling the trigger on the handle of the TightRail Guardian device results in activation of the motor and subsequent rotation of the inner shaft and cam blade. Triager activation results in bidirectional rotation mechanism. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the lead tarqeted for removal, thereby facilitating removal of said lead. The device has two modes of operation, providing dilation with the blades shielded or extended. The diameter sizes range from 9 French (F) to 13 F. The nominal effective length of the TightRail Guardian is 47.5 cm. The outer sheath accessory may be used for additional support by creating a conduit for the device's shaft assembly. The outer sheath may also be used to maintain venous access for quidewire placement, prior to implantation of a new lead. The fish tape accessory may be used to feed a target lead and locking stylet through the inner lumen of the device.
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. As such, it does not contain the detailed information typically found in a clinical study report or a validation study for an AI-powered medical device.
Specifically, this document describes a mechanical device (a motorized dilator sheath) and its validation through engineering and performance testing, not an AI algorithm. Therefore, most of the requested information regarding AI device acceptance criteria, human reader studies, ground truth establishment, and training/test set details is not applicable to this submission.
The document states: "Preclinical and clinical data was not required to demonstrate substantial equivalence. The design characteristics of the subject device are similar to the predicate. The design verification and validation test results demonstrated that the subject device is as safe and clinically effective as the predicate device." This confirms that the approval was based on demonstrating equivalence in mechanical and performance characteristics to a previously cleared device, not on the performance of a novel AI algorithm.
However, I can extract the relevant "acceptance criteria" and "study" information that is present in the document, which pertains to the engineering and performance testing of this mechanical device.
Acceptance Criteria and Study for the TightRail Guardian Motorized Dilator Sheath (Mechanical Device)
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide specific quantitative acceptance criteria or precise reported performance values in a table format. Instead, it lists the types of design verification and validation testing performed to ensure the device met its specifications and performed comparably to its predicate. The implicit acceptance criterion for all these tests is that the device demonstrated performance equivalent to or better than the predicate, and met all engineering specifications for safety and effectiveness.
| Acceptance Criteria Category (Test Type) | Implicit Acceptance Criteria / Reported Performance Summary |
|---|---|
| Design Verification and Validation Testing | "The design verification and validation test results demonstrated that the subject device is as safe and clinically effective as the predicate device." (General summary of all tests) |
| Simulated Use Testing | Device performed as intended during simulated clinical procedures. |
| Simulated Environment Testing | Device maintained performance and integrity under various environmental conditions (e.g., temperature, humidity, storage, transport). |
| Human Factors Evaluation | Usability and safety aspects for human interaction were evaluated and found acceptable. |
| Linear and Radial Dimensional Testing | Dimensions met specified tolerances (e.g., French sizes 9F, 11F, 13F; nominal effective length 47.5 cm). |
| Device Weight Measurement | Device weight met specified limits. |
| Blade Extension Testing | Blades extended and retracted correctly in both shielded and extended modes, consistently meeting design specifications. |
| Atraumatic Surface Testing | Surfaces designed to contact tissue were smooth and non-damaging. |
| Axial Load Testing | Device maintained structural integrity under specified axial forces. |
| Tensile Testing | Device components withstood specified tensile forces without failure. |
| Flexibility Testing | Shaft demonstrated appropriate flexibility for navigation while maintaining necessary columnar stability. |
| Outer Sheath Compression Testing | Outer sheath maintained patency and structural integrity under compression, suitable for its intended use (additional support, maintaining venous access). |
| EMC/EMI and Electrical Medical Safety Testing | Device met relevant electromagnetic compatibility and electrical safety standards. |
| Radiopacity Evaluation | Device was sufficiently visible under fluoroscopy for clinical use. |
| Sterilization | "Product adoption equivalency per AAMI TIR28:2016" - Demonstrated that the sterilization process renders the device sterile as per AAMI TIR28:2016 standards, ensuring patient safety from microbiological contamination. |
| Biocompatibility | All tests (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Material Mediated Pyrogenicity, Acute Systemic Toxicity, Indirect and Direct Hemolysis, Hemocompatibility) demonstrated the device materials are biologically compatible with the human body for their intended use, without causing adverse biological responses. This implicitly means criteria for each test type (e.g., non-cytotoxic, non-sensitizing etc.) were met. |
Since this is not an AI/software device, the following points are not applicable (N/A) based on the provided document:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): N/A (No test set of patient data/images for an AI algorithm). Testing was engineering-based on physical devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No ground truth established by experts for images/data for AI).
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
- 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: N/A (No AI, no human reader study).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (No algorithm).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (No ground truth as defined for diagnostic AI). The "ground truth" for this mechanical device is proper functioning according to engineering specifications and safety standards.
- The sample size for the training set: N/A (No training set for an AI algorithm).
- How the ground truth for the training set was established: N/A (No training set for an AI algorithm).
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(357 days)
: K212784
Trade/Device Name: TightRail Guardian Motorized Dilator Sheath Regulation Number: 21 CFR 870.1310
| II |
| Classification Regulation: | 21 CFR 870.1310
The TightRail Guardian Motorized Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads.
The TightRail Guardian Motorized Dilator Sheath is a sterile, single use, prescription only device used for cardiac leads. The device is comprised of:
- Drive Assembly
- Dilation Extension Selection (DES) Assembly
- Motor Drive Handle
- Outer Sheath Accessory
- Fish Tape Accessory
The motorized dilator sheath is advanced or retracted along the target lead to be removed. Pulling the trigger on the handle of the TightRail Guardian device results in activation of the motor and subsequent rotation of the inner shaft and cam blade. Triager activation results in bidirectional rotation mechanism. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the lead tarqeted for removal, thereby facilitating removal of said lead. The device has two modes of operation, providing dilation with the blades shielded or extended. The diameter sizes range from 9 French (F) to 13 F. The nominal effective length of the TightRail Guardian is 47.5 cm. The outer sheath accessory may be used for additional support by creating a conduit for the device's shaft assembly. The outer sheath may also be used to maintain venous access for guidewire placement, prior to implantation of a new lead. The fish tape accessory may be used to feed a target lead and locking stylet through the inner lumen of the device.
The provided text describes the regulatory clearance for the TightRail Guardian Motorized Dilator Sheath and does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML powered device evaluation.
The document is a 510(k) summary for a medical device (a motorized dilator sheath), outlining its intended use, design, and comparison to predicate devices for regulatory clearance. It focuses on demonstrating substantial equivalence to existing devices, not on evaluating the performance of an AI/ML model.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance (as it relates to AI/ML metrics).
- Sample size and data provenance for an AI/ML test set.
- Number of experts and qualifications for establishing ground truth in an AI/ML context.
- Adjudication method for an AI/ML test set.
- MRMC comparative effectiveness study results for AI vs. without AI assistance.
- Standalone algorithm-only performance.
- Type of ground truth used for an AI/ML model.
- Sample size for the training set of an AI/ML model.
- How ground truth for the training set was established for an AI/ML model.
The document lists various Design Verification and Validation Testing performed, such as Simulated Use Testing, Human Factors Evaluation, and Biocompatibility testing. These are typical engineering and safety tests for a physical medical device, not performance metrics for an AI/ML algorithm.
The statement "Preclinical and clinical data was not required to demonstrate substantial equivalence" further indicates that this is a traditional medical device clearance, not one involving extensive clinical trials or AI/ML performance evaluation studies against specific acceptance criteria for diagnostic/prognostic accuracy.
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(84 days)
Re: K220414
Trade/Device Name: VersaCross Connect™ Transseptal Dilator Regulation Number: 21 CFR 870.1310
Classification Name: | CFR, 870.1310 - Dilator, Vessel, For
Percutaneous Catheterization |
| D.
The VersaCross Connect™ Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired
The subject device is comprised of the following components, which are single-use and supplied sterile to the user:
- One Dilator
- One J-tipped Guidewire
The subject VersaCross Connect™ Transseptal Dilator represents modifications made to the legally marketed ExpanSure™ Large Access Transseptal Dilator (K201288) (comprising a dilator and J-tipped Guidewire).
The VersaCross Connect™ Transseptal Dilator is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The dilator provides torque control and is flexible. The dilator features a tapered tip and a shaft that can be reshaped manually. The echogenic shaft and tip and radiopaque tip maximize visualization of the dilator during manipulation.
The dilator can be used with separately cleared compatible introducer/access sheaths such as WATCHMAN™ Access sheaths. The dilator provides support and helps guide separately cleared compatible transseptal wires to the atrial septum for puncture. The dilator subsequently dilates the atrial septal defect to enable larger diameter devices to cross the septum.
The provided text is a 510(k) summary for a medical device called the VersaCross Connect™ Transseptal Dilator. It describes the device's characteristics, its comparison to a predicate device, and the non-clinical performance testing conducted to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria in a table format alongside specific device performance values. Instead, it states that the device "met all test requirements as specified by applicable standards and test protocols" for various tests. The acceptance criteria are implicitly defined by compliance with specified ISO standards and "Baylis self-enforced requirements."
A summary based on the provided text would look like this:
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Compliance with ISO 11070:2014/Amd.1:2018 and Baylis self-enforced requirements for specific mechanical properties. | Met all test requirements. |
| Torque Transmission | (Defined by standard/internal protocol) | Met all test requirements. |
| Torque Withstand | (Defined by standard/internal protocol) | Met all test requirements. |
| Hub-Shaft Tensile | (Defined by standard/internal protocol) | Met all test requirements. |
| Flexural Rigidity | (Defined by standard/internal protocol) | Met all test requirements. |
| Shapeability | (Defined by standard/internal protocol) | Met all test requirements. |
| Curve Retention | (Defined by standard/internal protocol) | Met all test requirements. |
| Tip to Tip Cap Cantilever and Tensile | (Defined by standard/internal protocol) | Met all test requirements. |
| Clamshell Tensile | (Defined by standard/internal protocol) | Met all test requirements. |
| Clamshell Cantilever | (Defined by standard/internal protocol) | Met all test requirements. |
| General Physical Testing | Compliance with ISO 11070:2014/Amd.1:2018, ISO 80369-7, and Baylis self-enforced requirements. | Met all test requirements. |
| Luer Tests | (Defined by standards/internal protocol) | Met all test requirements. |
| Air and Liquid Leakage Tests | (Defined by standards/internal protocol) | Met all test requirements. |
| Corrosion Test | (Defined by standard/internal protocol) | Met all test requirements. |
| System Verification Testing | Compliance with Baylis self-enforced requirements for compatibility and snap force. | Met all test requirements. |
| Compatibility Test | (Defined by internal protocol) | Met all test requirements. |
| Snap Force Test | (Defined by internal protocol) | Met all test requirements. |
| Biocompatibility Verification | Compliance with ISO 10993-1:2020 and September 4, 2020 FDA guidance document. | Performed through adoption of biological data from predicate and reference devices. |
| Sterilization Verification | Compliance with ISO 11135:2014 and ISO 10993-7:2008/Cor.1:2009; SAL of 10-6. | Met all test requirements. Sterilization with Ethylene Oxide achieved SAL of 10-6. |
| Pyrogen Testing | Compliance with ANSI/AAMI ST72:2011/(R)2016 and FDA guidance, meeting FDA and USP pyrogen limit specifications. | Met current FDA and USP pyrogen limit specifications. |
| Packaging Verification | Compliance with ISO 11607-1:2020 for integrity, seal strength, and sterile barrier integrity over shelf life. | Met all test requirements over proposed intended shelf life. |
| Benchtop Validation | Compliance with 11070:2014/Amd.1:2018 and Baylis self-enforced requirements for performance during intended use. | Met all test requirements. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for any of the non-clinical performance tests (mechanical, physical, system verification, biocompatibility, sterilization, pyrogen, packaging, benchtop).
The data provenance is from non-clinical performance testing conducted by Baylis Medical Company Inc. It is not patient or human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this document. The studies described are non-clinical performance tests on the device itself, not studies involving human interpretation or clinical data where "ground truth" would be established by medical experts for diagnostic or treatment purposes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically employed in clinical studies involving human assessments (e.g., radiology reads) to resolve discrepancies among experts. The studies here are objective engineering and laboratory tests.
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 question is not applicable. The document describes the 510(k) submission for a physical medical device (Transseptal Dilator), not an AI/software device that assists human readers with interpretation. No MRMC study was conducted or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical dilator, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This question is not applicable in the sense of clinical "ground truth." For the non-clinical tests, the "ground truth" is established by the specified ISO standards and internal Baylis requirements/protocols, which define the expected performance characteristics of the device.
8. The sample size for the training set
This question is not applicable. There is no "training set" as this is a physical medical device, not an AI or machine learning model.
9. How the ground truth for the training set was established
This question is not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply.
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