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The Parafleet SC 014 / Parafleet SC 035 is intended to dilate stenoses in the iliac. femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae.

This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

The Parafleet balloon dilatation catheter family consists of Parafleet SC 014, Parafleet SC 018 and Parafleet SC 035 PTA balloon catheter. The PTA (OTW type) device is an over the wire (OTW) peripheral balloon catheter, specially designed for Percutaneous Transluminal Angioplasty (PTA). The Parafleet SC catheter is available in working lengths of 40cm, 90cm, 120cm, 150cm and 200cm, with balloon diameters ranging from 1.25mm to 12.0mm. The Parafleet features an outer tube and inner tube lumen shaft ending in a Y-hub manifold with luer lock fittings. One lumen is used for inflation of the balloon and accessed via the side leg port. The second lumen, starting at the straight entry port, allows access to the distal tip of the catheter for a standard 0.014 inch / 0.018 inch / 0.035 inch guide wire insertion. The catheter is sterilized with EO and for single use only. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The BrosMed Medical Co., Ltd.'s Parafleet SC 014, Parafleet SC 018, and Parafleet SC 035 PTA Balloon Dilatation Catheters underwent various performance tests to ensure substantial equivalence to predicate devices and suitability for their intended use.

1. Acceptance Criteria and Reported Device Performance:

The document lists several performance tests conducted, implying that the acceptance criteria for these tests were met to demonstrate substantial equivalence. The reported device performance is that "The test results met all acceptance criteria, were same or similar to the predicate devices, and ensure that the Parafleet SC 014 / Parafleet SC 018 / Parafleet SC 035 PTA Balloon Dilatation Catheter design and construction are suitable for its intended use."

While specific numerical acceptance criteria and precise performance values are not provided in the summary, the general categories of tests and their "met" status serve as the reported performance against inferred acceptance criteria derived from FDA guidance and predicate device characteristics.

Here’s a table summarizing the types of tests (representing categories of acceptance criteria) and the reported performance:

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

The document does not specify the exact sample sizes used for each of the performance tests. The data provenance (e.g., country of origin, retrospective/prospective) for these tests is also not explicitly stated in the provided text. However, it's typical for such bench and biocompatibility tests to be conducted in a laboratory setting by the manufacturer (BrosMed Medical Co., Ltd. in China) or a contract research organization.

3. Number of Experts and Qualifications for Ground Truth:

This section is not applicable to the provided document. The submission pertains to a medical device's performance characteristics (e.g., mechanical, material, biocompatibility) rather than an AI/ML-driven diagnostic or prognostic device that would require expert-established ground truth for interpretation of images or patient data. The tests performed are objective, physical, and chemical evaluations.

4. Adjudication Method for the Test Set:

This section is not applicable for the same reasons as point 3. No subjective interpretation requiring adjudication is mentioned for the performance testing of these physical medical devices.

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

This section is not applicable as the device is a PTA Balloon Dilatation Catheter, not an AI-assisted diagnostic tool. Therefore, there is no human-in-the-loop performance or comparison with AI assistance.

6. Standalone Performance (Algorithm Only):

This section is not applicable as the device is a physical medical device, not an algorithm or AI system.

7. Type of Ground Truth Used:

The "ground truth" for the performance tests in this context is established by objective engineering specifications, material standards, and regulatory guidance documents (e.g., FDA guidance 'Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions, Guidance for Industry and FDA Staff' and ISO 10993-1 for biocompatibility).

For example:

• Dimensional verification checks against the device's design specifications.
• Balloon Rated Burst Pressure tests against the manufacturer's specified burst pressure and regulatory safety limits.
• Biocompatibility testing assesses against established biological safety endpoints defined by ISO standards.

8. Sample Size for the Training Set:

This section is not applicable as the device is a physical medical device and does not involve machine learning or a "training set."

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

This section is not applicable for the same reasons as point 8.

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The PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including illac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The PTA Balloon Catheters (PVQ) is a sterile, single use, non-pyrogenic balloon catheter for peripheral indication. The device features an ultra-low profile, semi-compliant balloon combined with a low-profile tip.

The PTA Balloon Catheters (PVQ) has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of 0.014 in (0.36 mm), 0.018 in (0.46mm), guidewires to facilitate advancement of the catheter to and through the stenosis to be dilated. The PTA Balloon Catheters (PVQ) features a dual lumen shaft that provides rapid inflation/deflation times for the catheters compatible with 0.035 in (0.89mm) guidewires. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The catheter includes a tapered tip to facilitate advancement of the catheter. The working lengths of the balloon catheter range between 10 mm and 280 mm. and are selected based on patient requirements for PTA. The radiopaque marker(s) (see RMD in Figure 1) are placed beneath the "usable balloon length" of the balloon and are visible when used in conjunction with fluoroscopy and aid in the placement of the balloon. The effective length could increase by 1 cm in a fully hydrated state.

Each balloon inflates to the stated diameter and length at a specific pressure. The maximum rated burst pressure is different for each size. It is important that the balloon not be inflated beyond the rated burst pressure.

The proximal portion of the catheter includes one female luer-lock port connected to the inflation lumen, and one female luer-lock port for the guidewire lumen. The devices can be supplied with and without hydrophilic coating. The hydrophilic coating when applied is applied proximally to the balloon for a length of 20 mm and 40 mm.

Each PTA Balloon Catheters (PVQ) is packaged as follows:

• . The balloon is protected within a protective tube with an inner lumen protective stainless-steel wire.
• The entire catheter is provided in a Polyethylene or Poly propylene Protectivetubing ● spiral dispenser.
• The protected catheter is placed in a Tyvec pouch, which is sealed to form the sterile ● barrier.
• Then the pouch is placed into an outer box. .

The PTA Balloon Catheters (PVQ) is used with commercially available sheath introducers, guide catheter and guidewires. These are not included with the PTA Balloon Catheter (PVQ).

The provided text is a 510(k) summary for the QualiMed USA PTA Balloon Catheter (PVQ). It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to predicate devices. However, this document does not describe the acceptance criteria or a study proving the device meets said criteria in the format requested for AI/ML devices.

The document outlines performance testing for a medical device (a balloon catheter), which involves established engineering and biocompatibility tests to ensure the catheter's physical characteristics, safety, and functionality. These tests are not AI/ML-related performance studies.

Therefore, I cannot extract the requested AI/ML specific information from this document. The concepts of "test set," "training set," "ground truth," "experts," "adjudication," and "MRMC studies with AI assistance" are not applicable to the type of device and testing described in this 510(k) summary.

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Ultraverse® 014 and Ultraverse® 018 PTA Balloon Dilatation Catheters are recommended for use in percutaneous trasluminal angioplasty (PTA) of the renal, popliteal, tibial, femoral, and peroneal arteries. These catheters are not for use in coronary arteries.

The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheter is a small vessel balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. For all balloon lengths, radiopaque markers delineate the working length of the balloon and aid in balloon placement. For balloon lengths of 100 mm and greater, two radiopaque markers are positioned on the distal portion of the balloon and one radiopague marker is positioned on the proximal portion of the balloon to differentiate between the distal and proximal ends of the balloon. The catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis as well as a hydrophilic coating. The coaxial lumen, over the wire catheter is compatible with an 0.014" guidewire for the 014 platform, and compatible with an 0.014" or 0.018″ guidewire on the 018 platform, and is available in 75, 90, 100, 150 and 200 cm working lengths. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon. This product is not manufactured with any latex.

The GeoAlign® Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. The GeoAlign® markings are designated on the catheter shaft by 1cm increment bands with an accuracy within ±1mm. The distance from the distal catheter tip is labeled in 10cm increments. Thicker bands denote the midway point (5cm) between the labeled distances. The GeoAlign® Marking System is designed to be used as a tool to externally measure the intravascular advancement and/or retraction of the catheter. This can provide an intravascular reference regarding the location of the distal tip of the catheter or an approximate intravascular length measurement between two points. The GeoAlign® Marking System may also facilitate geographic alignment of an adjunctive therapy that includes the same GeoAlign® Marking System.

The provided document is a 510(k) summary for the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study for novel performance claims.

Therefore, much of the requested information regarding acceptance criteria for device performance in clinical settings and studies proving said performance in a context of a novel claim (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) is not applicable or not explicitly detailed within this type of regulatory submission. This submission primarily relies on non-clinical (bench) testing to show that the new device's modifications do not alter its safety or efficacy compared to the predicate.

Here's an analysis of what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists numerous in vitro tests performed (Page 6) and states that "The results from these tests demonstrate that the technological characteristics and performance criteria of the Ultraverse® 014 & 018 PTA Balloon Dilatation Catheters are substantially equivalent to the predicate device." It also states, "The subject device...met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

However, the specific acceptance criteria values (e.g., minimum tensile strength, maximum burst pressure deviation) and the numerical results for each test are not provided in this 510(k) summary. The document only confirms that the device met these criteria.

List of in vitro tests performed (serving as performance aspects tested):

• Catheter Shaft Length
• Balloon Working Length
• Marker Band Alignment
• Balloon OD at OP
• Balloon Rated Burst Pressure, Leak, & Burst Mode
• Crossing Profile
• Sheath Compatibility
• Shaft Outer Diameter
• Balloon Compliance / Distensibility
• Fatigue
• Hub to Shaft Tensile
• Guidewire Compatibility
• Inflation
• Deflation
• Balloon to Shaft Tensile
• Catheter Elongation
• Flushability
• GeoAlign® Marking Positions
• GeoAlign® Marking Durability
• GeoAlign® Marking Legibility
• Trackability
• Reinsertion
• Kink

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified for any of the in vitro tests. This document doesn't involve human clinical test sets in the way that AI/diagnostic devices often do.
• Data Provenance: Not applicable in the context of clinical data for performance assessment. The tests are in vitro (bench tests).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The "ground truth" here is derived from engineering specifications, industry standards, and the performance of the predicate device, not expert interpretation of clinical data.

4. Adjudication method for the test set:

• Not applicable. This is not a clinical study involving human readers or adjudicators.

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 is a medical device for angioplasty, not an AI or diagnostic imaging device.

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.

7. The type of ground truth used:

• For the in vitro tests, the "ground truth" or reference for comparison would be engineering specifications, design requirements, and performance data from the predicate device (K121856). The goal is to show the new device performs equivalently or acceptably within these established parameters.
• For biocompatibility, the ground truth is established by recognized international standards (ISO 10993-1).

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.

In summary:

This 510(k) submission is for a modified version of an existing PTA balloon dilatation catheter. The primary method of demonstrating "acceptance criteria" is through a comprehensive series of non-clinical (bench) tests to show that the new device remains substantially equivalent to its predicate. The document states that these tests were "performed on the subject device" and "met all predetermined acceptance criteria," but it does not provide the specific numerical acceptance criteria or the raw results of these tests. It leverages previously established predicate device data and existing standards for certain tests and biocompatibility.

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The UltraScore Focused Force PTA Balloon is intended to dilate stenoses in the iliac, femoral, popliteal, infra-popliteal and renal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also recommended for post dilatation of balloon expanding stents, and stent grafts in the peripheral vasculature.

The ULTRASCORE ™ Focused Force PTA Balloon consists of a flexible, over-the-wire (OTW) catheter shaft with a semi-compliant balloon fixed at the distal end. For all balloon lengths, radiopaque markers delineate the working length of the balloon and aid in balloon placement. For balloon lengths of 100 mm and greater, two radiopaque markers are positioned on the distal portion of the balloon and one radiopaque marker is positioned on the proximal portion of the balloon to differentiate between the distal and proximal ends of the balloon. The catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. Two scoring wires, oriented 180° apart, provide focused force upon dilatation. The ULTRASCORE ™ Focused Force PTA Balloon is compatible with .014" or .035" quidewires, as denoted by the product labeling. The distal portion of the .014" guidewire compatible catheters is hydrophilically coated. The proximal portion of the catheter includes a female luer lock hub connected to the catheter with a guidewire lumen and an inflation lumen. Packaged with every product is a protective sheath that is positioned over the balloon and must be removed prior to use. A stylet is placed into the tip of the catheter. These products are not made with natural rubber latex.

The provided document describes the Bard Peripheral Vascular, Inc.'s UltraScore Focused Force PTA Balloon and its substantial equivalence to a predicate device, the VASCUTRAK® PTA Dilatation Catheter (K103459). The document focuses on demonstrating that the new device meets performance criteria similar to the predicate device and does not raise new safety or effectiveness issues.

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

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

The document lists numerous in vitro tests performed to demonstrate substantial equivalence, implying that acceptance criteria were met for each. However, specific numerical acceptance criteria or detailed performance results (e.g., a specific pressure rating, a defined trackability score) are not provided in this summary. The summary states, "The subject device, the ULTRASCORE™ Focused Force PTA Balloon, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

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

The document lists "in vitro tests" performed. There is no information provided about the sample sizes for these tests, the country of origin of the data, or whether it was retrospective or prospective. Given they are in vitro tests, the concept of "prospective" or "retrospective" data provenance typically applies more to human clinical studies rather than bench testing.

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)

The document describes in vitro (bench) testing. Therefore, the concept of "ground truth established by experts" in the clinical sense (e.g., radiologists, pathologists) is not applicable to the data presented. Ground truth for these tests would be derived from engineering specifications and standardized measurement techniques.

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

Since the tests are in vitro bench tests, clinical adjudication methods like "2+1" or "3+1" are not applicable. The "adjudication" would be based on comparison against predefined engineering acceptance criteria by qualified technicians or engineers performing the tests. No specific adjudication method for discrepancies in measurement is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any discussion of human readers or AI assistance. This document describes the a medical device (a PTA balloon catheter), not an AI diagnostic tool.

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

This question is not applicable as the document describes a physical medical device (a balloon catheter), not an algorithm or AI system.

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

For the in vitro tests conducted, the "ground truth" would be established by engineering specifications, standardized test methods, and measurement accuracy. For biocompatibility, it would be established by reference to international standards like ISO 10993-1:2009. The document does not refer to expert consensus, pathology, or outcomes data for establishing ground truth for these tests.

8. The sample size for the training set

This question is not applicable as the document describes a physical medical device and its predicate equivalence through bench testing, not a machine learning model requiring a training set.

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

This question is not applicable as there is no training set mentioned or relevant to the device described.

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The SIDEKICK® and USHER® Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature.

The SIDEKICK® and USHER® Support Catheters are single lumen catheters with a standard luer fitting hub and separate attachable hemostatic valve to support the CROSSER® CTO Recanalization Catheters 14S and S6. The product hub identifies SD for SIDEKICK® Catheter, USH for USHER® Catheter, A for Angled and T for Tapered in addition to the sheath profile and working length in centimeters. A guidewire introducer is provided to facilitate the guidewire passage through the optional hemostatic valve. The guidewire introducer shaft color matches the shaft color of the recommended support catheter.

The SIDEKICK® Catheter is available in straight, angled, tapered and non-tapered configurations in 70cm and 110cm working lengths. The USHER® Catheter is tapered and is available in straight and angled configurations in 83cm and 130cm working lengths. The SIDEKICK® and straight USHER® Catheters have a single radiopaque marker 1mm from the distal tip. The angled USHER® Catheter configurations have three radiopaque markers at the distal tip for enhanced visualization of the catheter tip and angle under fluoroscopy. The third proximal radiopaque marker is located 15mm from the distal tip.

The GEOALIGN® Marking System has been added to the device. The GEOALIGN® Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. The GEOALIGN® Markings are designated on the catheter shaft by 1cm increment bands with an accuracy within ±1mm. The distance from the distal catheter tip is labeled in 10cm increments. Thicker bands denote the midway point (5cm) between the labeled distances. The GEOALIGN® Marking System is designed to be used as a tool to externally measure the intravascular advancement and/or retraction of the catheter. This can provide an intravascular reference regarding the location of the distal tip of the catheter or an approximate intravascular length measurement between two points. The GEOALIGN® Marking System may also facilitate geographic alignment of an adjunctive therapy that includes the same GEOALIGN® Marking System.

The provided text describes a 510(k) premarket notification for the SIDEKICK® and USHER® Support Catheters, focusing on the addition of the GEOALIGN® Marking System. This is a medical device submission, and the "acceptance criteria" and "device performance" mentioned in the request refer to the performance testing of the device for regulatory approval, not typically the performance of an AI algorithm or a clinical study in the traditional sense.

Based on the document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table with acceptance criteria thresholds and discrete performance values in the way one might expect for an AI algorithm. Instead, it describes general performance testing and concludes that the device is "comparable" and "substantially equivalent" to the predicate device.

2. Sample size used for the test set and the data provenance:

The document does not specify the exact sample sizes used for each of the performance tests (e.g., how many catheters were tested for marking legibility, durability, or dimensions). It refers generally to "nonclinical tests." The data provenance is internal testing performed by the manufacturer, Bard Peripheral Vascular, Inc., in the USA (Tempe, Arizona). These are laboratory and engineering tests, not clinical data from patients. The study is not a clinical study; it's a non-clinical, benchtop performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to the type of testing described in the document. The "ground truth" here is defined by engineering specifications, measurement standards, and regulatory requirements (e.g., ISO 10993 for biocompatibility), not by expert consensus on clinical data. No "experts" were used in the sense of clinical reviewers to establish ground truth for a test set.

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

This is not applicable. The tests performed are objective, measurable non-clinical tests (e.g., dimensional measurements, durability tests, biocompatibility assays). There is no "adjudication" in the sense of conflicting expert opinions on a clinical outcome.

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 is for a physical medical device (support catheters), not an AI algorithm. Therefore, no MRMC study or assessment of human readers with/without AI assistance was performed or described.

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

Not applicable. This document is for a physical medical device (support catheters), not an AI algorithm.

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

The "ground truth" for the performance tests is based on:

• Engineering specifications and design requirements: For dimensional accuracy, legibility, and durability.
• Established scientific and regulatory standards: Such as ISO 10993-1:2009 CORR 1 for biocompatibility.

8. The sample size for the training set:

Not applicable. This document describes the testing of a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable, as there is no AI algorithm training set.

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The CROSSER CTO Recanalization System indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy.

The CROSSER Catheter is only intended for use with the CROSSER Generator. Refer to the CROSSER Generator Manual of Operations for proper use.

The CrossER® Catheter is a high frequency mechanical recanalization system designed for recanalization of obstructed peripheral arteries. The system consists of an electronic CROSSER® Generator, Foot Switch, high frequency Transducer, and CROSSER® Catheter. The CrossER® CTO Recanalization catheter, which is intended for one procedure only, is connected to the CROSSER® Generator through the high frequency Transducer. The Foot Switch is used to activate the CROSSER® Recanalization System. The CROSSER® Generator and Transducer convert AC power into high frequency mechanical vibrations, which are propagated to the tip of the CROSSER® Catheter.

The GEOALIGN® Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. The GEOALIGN® Markings are designated on the catheter shaft by 1cm increment bands with an accuracy within ±1mm. The distance from the distal catheter tip is labeled in 10cm increments. Thicker bands denote the midway point (5cm) between the labeled distances. The GEOALIGN® Marking System is designed to be used as a tool to externally measure the intravascular advancement and/or retraction of the catheter. This can provide an intravascular reference regarding the location of the distal tip of the catheter or an approximate intravascular length measurement between two points. The GEOALIGN® Marking System may also facilitate geographic alignment of an adjunctive therapy that includes the same GEOALIGN® Marking System.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) summary for a medical device (CROSSER CTO Recanalization Catheter) and focuses on demonstrating substantial equivalence to a predicate device. It describes the device, its indications for use, and a summary of nonclinical performance testing related to a new marking system.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance in the context of clinical outcomes or diagnostic accuracy.
2. Details on sample sizes for test sets, data provenance, or information about retrospective/prospective studies.
3. Information about experts, ground truth establishment, or adjudication methods.
4. Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with/without AI assistance.
5. Details on standalone algorithm performance.
6. The type of ground truth used (e.g., pathology, outcomes data).
7. Sample sizes for training sets.
8. How ground truth for training sets was established.

The performance testing mentioned (GEOALIGN® Marking Legibility, Dimensional Analysis, Durability, Compatibility) are all non-clinical tests focusing on the physical characteristics and performance of the device's new marking system, not on its clinical effectiveness or diagnostic accuracy which would typically involve the kind of data you are asking for.

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