Search Results

The JADE PLUS PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for postdilation of balloon expandable and self-expanding stents in the peripheral vasculature.

The JADE PLUS Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheters are designed for peripheral indications with Over-The-Wire (OTW) structure. The overthe-wire design permits the use of standard 0.014 inch, 0.018 inch and 0.035 inch guidewires respectively.

This document is a 510(k) summary for the JADE PLUS PTA Balloon Dilatation Catheter. It does not describe an AI/ML powered device, therefore the requested information for acceptance criteria and studies are not applicable in the context of an AI/ML device.

The document discusses the substantial equivalence of the JADE PLUS PTA Balloon Dilatation Catheter to a predicate device, based on in vitro performance tests. The acceptance criteria and reported device performance mentioned relate to physical properties and functionality of the catheter, not to an AI algorithm's performance or accuracy.

The relevant information from the document is related to the device's physical performance testing:

Acceptance Criteria and Reported Device Performance:

The document states that "The test results met all acceptance criteria, which are the same or similar to the predicate device and ensure that the JADE PLUS PTA Balloon Dilatation Catheter design and construction are suitable for their intended use."

The specific performance tests conducted and the general nature of their acceptance criteria are listed:

The study that proves the device meets acceptance criteria is an in vitro performance test study conducted on the subject device in accordance with FDA guidance "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters" issued on April 14, 2023.

Given that this is a 510(k) summary for a physical medical device (balloon dilatation catheter) and not an AI/ML powered device, the following points are not applicable and therefore cannot be extracted from the provided text:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Ask a specific question about this device

The JADE PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.

The JADE Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheters are designed for peripheral indications and include both Rapid Exchange (RX) and Over-The-Wire (OTW) designs. The over-the-wire design permits the use of standard 0.018 inch and 0.035 inch guidewires respectively (hereafter referred to as 18 OTW version and 35 OTW version), and the rapid exchange design permits the use of standard 0.018 inch guidewires (hereafter referred to as 18 RX version) as shown in Table 1 below. The JADE PTA balloon dilatation catheter is made of a minimally compliant material with a rated burst pressure of 16 atmospheres for 7.0mm diameters, 18 atmospheres for 4.5-6.0mm diameters and 20 atmospheres for 1.5-4.0mm diameter. Two radiopaque marker bands (Platinum/Iridium) are positioned within the balloon shoulder, and for balloons of working length 180-240mm, two more marker bands (four marker bands in total) are positioned in the middle of the balloon. A hydrophilic lubricious coating is applied to the outside surface of distal section of the catheter. A Silicone coating is applied to wire lumen surface.

The provided text describes a 510(k) submission for a medical device, the JADE PTA Balloon Dilatation Catheter, and its performance testing to demonstrate substantial equivalence to a predicate device. However, it does not pertain to an Artificial Intelligence/Machine Learning (AI/ML) device.

Therefore, the information required to answer the question about the acceptance criteria and study proving an AI/ML device meets those criteria, specifically concerning data provenance, expert ground truth, MRMC studies, or standalone algorithm performance, is not present in the provided document.

The document focuses on in vitro performance tests and biocompatibility tests for a physical medical device (a balloon catheter), not a software-driven diagnostic or AI-assisted system.

Specifically, the document lists performance tests such as:

• Visual Inspection
• Dimensional Verification
• Balloon Preparation, Deployment, and Retraction
• Balloon Rated Burst Pressure (including in-stent)
• Balloon Fatigue (including in-stent)
• Balloon Compliance
• Balloon Inflation and Deflation Time
• Catheter Bond Strength
• Tip Pull Strength
• Flexibility and Kink
• Torque Strength
• Marker Band Radiopacity
• Coating Integrity
• Particulate Evaluation

And biocompatibility tests:

• Cytotoxicity
• Intracutaneous reactivity
• Sensitization
• Acute systemic toxicity
• Hemocompatibility (Hemolysis, Complement activation, Partial thromboplastin time, Platelet and leukocyte counts, In vivo thromboresistance)
• Pyrogenicity
• Genotoxicity (bacterial mutagenicity test, in vitro mouse lymphoma Assay)

It concludes that "The test results met all acceptance criteria," but it does not specify what those numerical criteria were, only the types of tests performed. It certainly does not provide any details related to AI/ML device validation.

Ask a specific question about this device

The Jade PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, poplited, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.

The JADE PTA Balloon Dilatation Catheters is now also available as an over-the-wire balloon catheter for peripheral indications. The balloon diameters range from 1.5mm to 6.0mm and balloon lengths range from 20mm to 240mm, with 90cm, 150cm and 200cm catheter lengths. The balloon material is made of a minimally compliant material with a rated burst pressure of 18 atmospheres for 5.0-6.0mm and 20atm for 1.5-4.0mm. Hydrophilic lubricious coatings are applied to the distal section of the catheter. The shaft of the catheter is composed of a proximal shaft and a distal shaft. The distal shaft is composed of a distal outer tube and tri-extrusion inner tube with a balloon welded to both tubes at the distal tip to aid in tracking through vasculature. The proximal shaft is composed of a proximal outer tube and tri-extrusion inner tube that are bonded to a female luer connector, with the proximal outer tube allowing for proximal pushability with a smooth transition to the distal shaft. The inner lumen of the catheter accepts a maximum 0.014 inch (0.36mm) guidewire. The guidewire enters the catheter tip and advances coaxially out the hub guidewire lumen. Two radiopaque marker bands are positioned within the balloon shoulder, and for balloons of working length 180-240mm, two more marker bands (four marker bands in total) are positioned in the middle of the balloon. One marked section, for the 90cm catheter working length, or two marked sections, for the 150cm and 200cm catheter working lengths, are located on the proximal shaft to indicate catheter position relative to the tip of the guiding catheter or introducer sheath. The Y-type hub is bonded on the proximal end of the catheter at the entrance to the inflation lumen and the guidewire lumen. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The provided text describes the 510(k) summary for the Jade PTA Balloon Dilatation Catheter, which is a medical device. This type of submission is for proving "substantial equivalence" to a legally marketed predicate device, rather than proving that an AI/algorithm-based device meets specific performance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and the study that proves an AI/algorithm device meets those criteria. The provided text details performance testing for a physical medical device (a balloon catheter) to demonstrate its safety and effectiveness, and its equivalence to a predicate catheter.

Specifically, the document does not address any of the following points relevant to an AI/algorithm-based device study:

• 1. A table of acceptance criteria and the reported device performance (for an AI/algorithm)
• 2. Sample sized used for the test set and the data provenance
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
• 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
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• 8. The sample size for the training set
• 9. How the ground truth for the training set was established

The performance data mentioned in the document (Visual Inspection, Marker Band Radiopacity, Dimensional Verification, etc.) are all related to the physical characteristics and functionality of the balloon catheter, not an AI algorithm.

Ask a specific question about this device

The JADE Mobile X-Ray, is a mobile X-ray device, for the purpose of acquiring X-ray images of the desired parts of a patient's anatomy. This device is not intended for mammography, bone density, or dedicated pediatric applications.

The JADE Mobile X-Ray, is a mobile x-ray device that comes in two models: JADE-32 (3.2kw max. output and JADE-40 (4kw max. output). JADE is a non-motorized mobile diagnostic xray device that can facilitate X-ray examinations, in situations where it is not possible or feasible to transport the patient to a ward with fixed equipment. The unit is stable and precise when using the optional Mobile or Portable Stand. The electric tube unit and wheel locks. column rotation, and a simple user interface to provide for added operator convenience and rapid patient positioning. X-Ray technique presets can be saved. The JADE Mobile X-Ray device can be used with a film screen cassette or a flat panel detector which are supplied by the user and are not part of the JADE Mobile X-Ray, device. The software used with the JADE Mobile system is new and is not based on the predicate device.

The JADE device consists of:

• . High-Frequency X-ray Generator
• Collimator with 30 seconds LED lamp timer
• User Programmable APR
• . Exposure Hand Switch
• . Software(SDK, HT Frame and Membrane Console Firmware)

The provided text describes the JADE Mobile X-Ray device and its substantial equivalence to a predicate device (AMADEO M-DR Mini, AMADEO M-AX Mini). However, it does not contain information about specific acceptance criteria related to a device's performance metrics (e.g., sensitivity, specificity, accuracy) or the results of a study designed to prove the device meets such criteria.

Instead, the document focuses on demonstrating substantial equivalence by comparing the technological characteristics of the JADE Mobile X-Ray to those of the predicate device and by listing compliance with various safety and EMC standards. It explicitly states:

• "Clinical testing is not necessary for the JADE Mobile system in order to demonstrate substantial equivalence to the predicate device."
• "Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met."

This indicates that the "acceptance criteria" referred to are likely related to engineering specifications, safety standards compliance, and functional validation of the device's components and software, rather than performance metrics derived from a clinical or diagnostic accuracy study.

Therefore, I cannot provide the requested table or detailed information about a study proving the device meets performance-based acceptance criteria (like sensitivity/specificity), as such a study is explicitly stated as not necessary and not included in this 510(k) summary.

Here's what can be extracted based on the provided text regarding the non-clinical testing and general acceptance:

1. A table of acceptance criteria and the reported device performance:
   As mentioned, no performance-based acceptance criteria (like sensitivity, specificity, or accuracy for image interpretation) are stated in the document. The "acceptance criteria" refer to compliance with various international standards and functional validation of the device's components. Since these are pass/fail assessments against engineering and safety standards, a quantitative "reported device performance" in the context of clinical metrics is not applicable here.

   Acceptance Criterion Type	Reported Device Performance
   Safety Standards (e.g., IEC/EN 60601 series)	Passed all predetermined testing criteria; complies with applicable regulatory requirements and design standards.
   EMC Standards (e.g., EN60601-1-2)	Passed all predetermined testing criteria; complies with applicable regulatory requirements and design standards.
   Functional Validation (input/output, actions)	Validation testing indicated that predetermined acceptance criteria were met.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   Not applicable (N/A). The document refers to non-clinical testing of the device hardware and software against engineering and safety standards, not a test set of patient data.

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):
   N/A. This information is relevant for studies involving human interpretation or diagnostic accuracy, which was explicitly stated as not necessary for this 510(k) submission.

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

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:
   N/A. This is a primary X-ray device, not an AI-assisted diagnostic tool for image interpretation.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   N/A. For engineering and safety tests, the "ground truth" would be the specifications and requirements of the applicable standards.

8. The sample size for the training set:
   N/A. The "software" components mentioned (JADE_HTC, JADE_MCC, CPC_SDK) appear to be firmware and control software for the X-ray generator, not an AI or machine learning model that would require a "training set" of data in the typical sense.

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

Ask a specific question about this device

The Jade PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.

The JADE Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is a rapid exchange balloon catheter for peripheral indications with a working length of 150cm. The minimally compliant balloons, available in diameters from 1.5-6.0mm and lengths from 15-120mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. The balloon material is made of a minimally compliant material with a rated burst pressure of 20 atm (Ø1.5-4.0mm) or 18atm (Ø4.5-6.0mm). Hydrophilic lubricious coatings are applied to the distal section of the catheter. The proximal shaft of the catheter is composed of a female luer connector bonded to a nylon tube which is internally supported by a stainless steel hypotube. Two radiopaque platinum/iridium marker bands are located within the balloon shoulders. The internal lumen of the catheter accepts a maximum 0.014 inch (0.36mm) guidewire. The guidewire enters the catheter tip and advances coaxially out the RX port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. Two marked sections, 3mm in length located on the proximal shaft specifically designed to be highly visible, indicate catheter position relative to the guiding catheter or guiding sheath. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The provided text is a 510(k) Summary for the Jade PTA Balloon Dilatation Catheter. It describes the device, its intended use, and the performance data submitted to support its substantial equivalence to predicate devices. However, it does not contain information about a study proving the device meets acceptance criteria related to an AI/ML algorithm or its performance with human readers. The information provided is for a physical medical device (a balloon catheter), not an AI/ML diagnostic or assistive tool.

Therefore, I cannot fulfill your request as the necessary information regarding AI/ML acceptance criteria, human reader studies, ground truth establishment for AI/ML, sample sizes for training/test sets for AI/ML, or expert qualifications for AI/ML ground truth is not present in the provided document.

The "Performance Data" section in the document refers to in vitro performance tests and biocompatibility tests for the physical catheter, not an AI/ML system.

Ask a specific question about this device

A thixotropic 37% phosphoric acid dental etchant gel for etching enamel, dentin, and glass ionomer cements to produce the necessary micro-retentive surface for successful bonding of restorations.

Thixotropic dental etchant gel with 37% phosphoric acid

The provided text is a 510(k) summary for a dental etchant gel, not a study involving AI or complex medical device performance metrics like sensitivity, specificity, or reader studies. Therefore, many of the requested categories related to AI systems, clinical trials, and expert adjudication are not applicable.

However, I can extract the relevant information regarding the acceptance criteria (comparative performance to a predicate device) and the study that "proves" the device meets these criteria, based on the provided text.

Device Name: Jade 37% Phosphoric Acid Etchant Gel

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

The acceptance criteria for the Jade 37% Phosphoric Acid Etchant Gel are based on demonstrating substantial equivalence to its predicate device, Seity 37% Phosphoric Acid Etchant Gel (K112597). This equivalence is primarily established through comparisons of technological characteristics and bench testing results.

Note: While viscosity and pH values are not identical, the submission asserts that bench testing demonstrates the equivalence of Jade to the predicate device, implying these differences are not clinically significant for the intended use and do not raise new issues of safety or efficacy. The conclusion specifically states that "Even though the chemical compositions are not identical, bench testing has demonstrated that Jade has comparable material properties and performance."

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

The document describes "bench testing" without specifying a particular sample size for each characteristic tested. The data provenance is derived from these bench tests, which are laboratory-based and not tied to patient data or specific countries of origin in this context. It's prospective in the sense that Dharma Research likely conducted these tests specifically for this 510(k) submission.

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

Not applicable. This is not a study involving expert consensus for ground truth but rather laboratory measurements comparing physical and chemical properties.

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

Not applicable. There was no expert adjudication in the context of clinical outcomes or imaging reviews.

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 not an AI-assisted device or a diagnostic imaging device.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" here is the established properties and performance of the legally marketed predicate device (Seity 37% Phosphoric Acid Etchant Gel, K112597) and the measured chemical/physical properties of both the predicate and the new device through laboratory bench testing.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Ask a specific question about this device