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The SJM Confirm® Implantable Cardiac Monitor is indicated for monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, shortness of breath, and patients who are at risk for other cardiac arrhythmias.

The SJM Confirm® Implantable Cardiac Monitor is a minimally invasive, implantable diagnostic monitoring device with subcutaneous electrodes that are used for sensing and a looping memory for storage of electrograms (EGM). The device is comprised of three main components: the implantable cardiac monitor (Model DM2100) and the external patient activator (Model DM2100A). The third component is the programmer the physician uses to communicate to the cardiac monitor and associated programmer software. The programmer is the legally marketed SJM Merlin PCS programmer Model 3650 (with Software Model 3330).

This 510(k) premarket notification (K122090) from St. Jude Medical, CRMD, for the SJM Confirm® Implantable Cardiac Monitor (Model DM2100) describes a change to an existing device, specifically the use of an alternate collector cell battery. The submission uses substantial equivalence to a legally marketed predicate device (SJM Confirm® Implantable Cardiac Monitor System, K081365).

The provided text does not include acceptance criteria for the device's performance in detecting or diagnosing arrhythmias, nor does it detail a study proving such performance specific to this 510(k) submission. Instead, the core of this submission focuses on demonstrating that the new battery component does not negatively impact the device's existing performance, which was presumably established in the predicate device's original clearance.

Therefore, many of the requested sections (e.g., sample size, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted directly from this document.

Here's a breakdown of the information that can be extracted or inferred based on the nature of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: This 510(k) is about a component change. The acceptance criteria are implicitly that the device, with the new battery, performs identically to the predicate device in all relevant aspects (electrical performance, safety, sterilization, etc.). The reported performance is a summary statement that this equivalence has been confirmed through testing.

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

• Sample Size for Test Set: The document mentions "Device testing (documented in 60041954, Attachment 3) and component level testing (documented in QTR40008803, Attachment 4)." However, it does not specify the sample size of devices or components used for these tests. The testing would have been conducted on a representative sample of devices containing the new battery.
• Data Provenance: The testing was conducted by St. Jude Medical, CRMD. Given it's a premarket submission, the testing would be considered prospective in the context of validating the new battery component. The country of origin of the data is not specified but is inferred to be from St. Jude Medical's internal testing.

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

• Not Applicable / Not Provided: This submission focuses on engineering and component-level performance validation post-battery change, not on diagnostic accuracy against a clinical ground truth. Therefore, there's no mention of experts establishing a ground truth for clinical performance.

4. Adjudication method for the test set

• Not Applicable / Not Provided: As explained above, this submission does not involve clinical performance assessment requiring ground truth adjudication.

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 device is an implantable cardiac monitor with diagnostic capabilities (detecting arrhythmias), but the submission focuses on a battery change, not on an AI algorithm or human reader interaction. Therefore, no MRMC study, AI component, or effect size is discussed.

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

• Not Applicable: This submission relates to the hardware component change of an existing implantable cardiac monitor, not a standalone algorithm. The device itself performs sensing and EGM storage as part of its diagnostic function, but the approval here is for the battery, not a new or modified detection algorithm.

7. The type of ground truth used

• Engineering Specifications and Existing Device Performance: For this 510(k), the "ground truth" for the battery change is that the device with the new battery must meet the established engineering specifications for the original device and exhibit performance equivalent to the device with the original battery. This would involve electrical performance metrics, mechanical integrity, and other product and system specifications established for the predicate device. There is no clinical "ground truth" (like pathology or outcomes data) established in this document for the purpose of demonstrating diagnostic accuracy.

8. The sample size for the training set

• Not Applicable / Not Provided: As this submission is about a hardware component change, there is no "training set" in the context of an algorithm.

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

• Not Applicable / Not Provided: As there is no training set for an algorithm in this submission, this question is not applicable.

Summary of Device Performance Study:

The study described is an internal engineering and component-level validation. It involved:

• Device testing: Documented in St. Jude Medical record 60041954, Attachment 3.
• Component level testing: Documented in St. Jude Medical record QTR40008803, Attachment 4.

The conclusion of these tests was that the alternate collector cell battery "has no effects on the device performance." No further details on methodologies, specific results, or quantitative metrics are provided in this summary. The focus is on demonstrating equivalence to the predicate device, not on re-proving the predicate device's efficacy.

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The St. Jude Medical™ CPS Direct™, Mediguide™ Enabled slittable outer guide catheter is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical™ devices (including implantable left heart leads and delivery tools), and support of fluids where minimizing blood loss is essential. The CPS Direct™, Mediguide Enabled slittable outer guide catheter are used with the Mediguide™ System to enable realtime tip positioning and navigation. The Mediguide™ system is indicated for use as an adjunct to fluoroscopy. In addition, the CPS Direct™, Mediguide™ Enabled slittable outer guide catheters can work with inner catheters as a system.

The St. Jude Medical CPS Direct MediGuide Enabled slittable outer guide catheter is made from PEBAX and reinforced with a stainless steel braid. The shaft has progressively decreasing durometers of PEBAX from the proximal to the distal end with a soft, atraumatic distal tip. The distal end is embedded with a sensor coil to enable device tip projection onto the MediGuide system and tungsten stripes for fluoroscopic visibility. The hub contains an integrated hemostasis valve and the proximal shaft is integrated into the hub creating a slit channel. The hub contains a sideport with extension tubing for contrast delivery, aspiration or saline flush using a 3-way stopcock. In addition, the hub contains a port for the connector cable.

The provided text does not contain any information about acceptance criteria or a study proving the device meets them.

The document is a 510(k) summary for a medical device (CPS Direct™ MediGuide™ Enabled Outer Guide Catheter and accessories) submitted to the FDA. It focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance.

Here's a breakdown of what the document does contain, which highlights the absence of the requested information:

• Submitter and Contact Information: Basic administrative details.
• Date Prepared: Date of the submission.
• Trade Name and Classification: Device identification and regulatory classification.
• Product Code: Specific code for the device type.
• Predicate Device: Identifies the legally marketed devices to which the new device is compared for substantial equivalence.
• Device Description: Physical characteristics and components of the new catheter.
• Intended Use: What the device is designed to do.
• Comparison to Predicate Devices: Explicitly states that the new device has "similar intended use and the same fundamental scientific technology as the predicate devices" and that "performance testing demonstrated that these differences do not adversely affect the safety and effectiveness of the subject device." However, it does not detail this performance testing or its results.
• Conclusion: Declares substantial equivalence based on design, technology, operation, materials, and indications for use.
• FDA Correspondence: Official letter from the FDA granting 510(k) clearance, affirming substantial equivalence.
• Indications for Use Statement: A formal statement of the device's intended use, marked for prescription use.

Therefore, I cannot provide the requested table and study details because the information is not present in the provided text. This type of detailed performance data and acceptance criteria is typically found in the full 510(k) submission, not usually in the publicly available summary.

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The St. Jude Medical CPS Excel™ MediGuide Enabled™Guidewire is intended for use with the MediGuide™ System to enable real-time tip positioning and navigation within the coronary and peripheral vasculature (such as to facilitate left heart lead implantation). The MediGuide system is intended for use as an adjunct to fluoroscopy

The St. Jude Medical CPS Excel ™ , MediGuide Enabled ™ guidewire is a MediGuide enabled guidewire with a hydrophilic coating. The CPS Excel, MediGuide Enabled guidewire contains a magnetic sensor allowing it to be visualized using the MediGuide system

This document is a 510(k) summary for a medical device called the "CPS Excel™ MediGuide Enabled™ Guidewire and accessories." It does not describe a study involving algorithms, AI, or human readers, but rather a traditional medical device (a guidewire) seeking FDA clearance based on substantial equivalence to existing predicate devices.

Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/algorithm performance cannot be extracted from this document.

However, I can provide the information that is present, interpreted for a traditional medical device:

Acceptance Criteria and Device Performance (for a traditional medical device)

The document asserts "substantial equivalence" as the primary acceptance criteria. For traditional medical devices seeking 510(k) clearance, the "acceptance criteria" are generally that the device is as safe and effective as a legally marketed predicate device, and any differences do not raise new questions of safety or effectiveness.

Key statements:

• "Where differences exist between the subject device and the predicate devices performance testing demonstrated that these differences do not adversely affect the safety and effectiveness of the subject device."
• "This conclusion is based upon the device similarities in design, technological characteristics, principles of operation, materials and indications for use."

Table of Acceptance Criteria and Reported Device Performance:

Regarding the specific questions about an AI/algorithm study:

As stated previously, this document is about a physical guidewire. Therefore, the following information is not applicable or available from the provided text:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, no "test set" in the AI sense. The "performance testing" referred to for the guidewire would be mechanical, chemical, and biological, not based on data sets of images or algorithms.
2. 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.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Safety and effectiveness for a guidewire would be demonstrated through various tests (e.g., tensile strength, kink resistance, pushability, torqueability, biocompatibility, sterility) and potentially animal or bench testing relevant to its physiological environment and mechanism of action, compared against predicate devices.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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The Agilis™ PF Introducer System is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate electrophysiology studies.

The St. Jude Medical Agilis™ PF Introducer System consisting of an introducer, guidewire, 17Ga Tuohy needle, dilator and obturator is intended to be used to facilitate delivery of SJM devices into the pericardial space for diagnostic and therapeutic purposes.

The Agilis™ PF Introducer System consists of the following components: Deflectable introducer, 13 French, Dilator, Guidewire, Obturator, 17Ga Tuohy Needle.

The deflectable introducer is fitted with a hemostasis valve to minimize air introduction during introducer insertion and/or exchange. A sideport with a three-way stopcock is provided for air or blood aspiration and fluid infusion. A handle equipped with a deflection control mechanism deflects the tip up to 90° both clockwise and counterclockwise. The introducer features a radiopaque tip marker to improve fluoroscopic visualization.

This is a 510(k) summary for the St. Jude Medical Agilis™ PF Introducer System. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed acceptance criteria and a study proving those criteria are met in the same way one might find in a clinical trial report or a performance study for an AI/ML device.

However, based on the provided text, we can infer some "acceptance criteria" through the comparison to the predicate device and the general safety and effectiveness considerations for a medical device of this type. The "study" proving these criteria are met is the "performance testing" referenced implicitly in the comparison.

Here's a breakdown of the requested information, acknowledging the limitations of this type of regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) summary, explicit, quantifiable acceptance criteria with corresponding performance metrics (like sensitivity, specificity, accuracy for AI/ML) are not provided. Instead, the "acceptance criteria" are generally implied to be "substantially equivalent performance" to the predicate device, across various aspects.

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

This document is a 510(k) premarket notification for a medical device (an introducer system), not a data-driven AI/ML study. Therefore, there is no mention of a "test set" sample size or data provenance in the context of an algorithmic performance evaluation. The "performance testing" mentioned likely refers to bench testing, mechanical testing, and potentially animal studies to demonstrate physical equivalence and safety, but details are not provided in this summary.

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

As this is not an AI/ML study, there is no mention of experts establishing a ground truth for an algorithmic test set. The assessment of "equivalence" is based on established engineering principles, regulatory standards, and comparison to the predicate device, not on expert consensus for data labeling.

4. Adjudication Method for the Test Set

Since there is no "test set" in the context of an AI/ML algorithm requiring ground truth, there is no adjudication method described.

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

There is no mention of an MRMC comparative effectiveness study. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to an introducer system.

6. Standalone (Algorithm Only) Performance Study

This is for a physical medical device, not an algorithm. Therefore, no standalone (algorithm only) performance study was conducted or is relevant here.

7. Type of Ground Truth Used

For this type of device, the "ground truth" for demonstrating safety and effectiveness would be based on:

• Engineering specifications and standards: The device meeting its design requirements and relevant medical device standards.
• Biocompatibility testing: Demonstrating the materials are safe for human contact.
• Sterilization validation: Ensuring the device is sterile.
• Performance testing: Bench testing to confirm mechanical properties and functionality.
• Comparison to predicate device: The predicate device serves as the established "truth" of what is safe and effective in the market.

There is no "ground truth" in the AI/ML sense (e.g., pathology, outcomes data, expert consensus on imaging) for this device classification.

8. Sample Size for the Training Set

As this is not an AI/ML device, there is no "training set" sample size mentioned.

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

Not applicable, as this is not an AI/ML device.

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The St. Jude Medical CPS Direct® SL II Slittable Outer Catheters intended use is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical devices, including implantable left heart leads and delivery tools, and support of fluids where minimizing blood loss is essential. In addition, the outer guide catheters can work with inner catheters as a system.

Not Found

I am sorry, but the provided text from the FDA 510(k) approval letter for the "CPS Direct SL II Slittable Outer Catheter Models DS2C007 and DS2C017" does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

This document is a letter confirming the substantial equivalence of the device to pre-existing predicate devices, which is a regulatory step, not a detailed report of clinical or performance studies with specific statistical metrics.

Therefore, I cannot fulfill your request for details on the acceptance criteria and the study proving the device meets them based on this document.

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The Model 4160 PSA disposable threshold cable is intended to connect IS-1 or SJ4 leads to the Biotronik PK-67S PSA patient cable adapter and, in turn, to the SJM Model 3150 PSA or Biotronik Model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field.

The Model 4161 PSA disposable threshold cable is intended to connect IS-1 or SJ4 leads to St. Jude Medical PSA patient cable adapter Models 4053 and 4053A and, in turn, to a testing device such as a PSA (Pacing System Analyzer) located outside the sterile field.

The Model 4053A non-disposable PSA cable adapter is intended to be used with the St. Jude Medical Model 4051 and 4051A cables to connect a cardiac pacing lead to the SJM Model 3150 PSA or Biotronik model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field.

PSA Cable Model Numbers 4160 and 4161 PSA Cable Adapter Model Number 4053A

The provided text is a 510(k) Summary for St. Jude Medical PSA Cables and Adapters. It primarily focuses on demonstrating substantial equivalence to pre-existing devices, rather than presenting a study related to acceptance criteria and device performance in the context of an AI/ML medical device.

Therefore, the requested information elements related to AI/ML device performance (such as sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance) are not present in this document.

The document does not detail specific acceptance criteria for performance metrics that would be relevant to an AI/ML system, nor does it describe a study to prove such criteria were met. Instead, it attests to the substantial equivalence of the new devices (PSA cables and adapter) to previously approved devices based on their intended use and design, as per the 510(k) premarket notification process for conventional medical devices.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance: This information is not provided in the context of performance metrics that would typically apply to an AI/ML device (e.g., sensitivity, specificity, AUC). The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to already legally marketed devices.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as no such performance study for an AI/ML model is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document pertains to the regulatory clearance of cardiac pacing system cables and adapters through the 510(k) pathway, which primarily relies on demonstrating substantial equivalence to predicate devices, not on the performance evaluation of an AI/ML algorithm against specific acceptance criteria.

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The St. Jude Medical CPS Direct® SL II Slittable Outer Catheters intended use is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical devices, including implantable left heart leads and delivery tools, and support of fluids where minimizing blood loss is essential. In addition, the outer guide catheters can work with inner catheters as a system.

Not Found

I am sorry, but the provided document discusses a 510(k) premarket notification for a medical device called "CPS Direct® SL II Slittable Outer Catheter." This document is a regulatory letter from the FDA and outlines the substantial equivalence determination for this device.

The information you requested, such as acceptance criteria, details of a study proving device performance, sample sizes, ground truth establishment, and expert qualifications, is not present in this regulatory document. This type of information would typically be found in a detailed study report or a technical capabilities document submitted as part of the 510(k) application, but not in the FDA's decision letter itself.

Therefore, I cannot fulfill your request using only the provided text.

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The St. Jude Medical Mond™ RVOT Stylet is designed to place SJM right ventricular active fixation leads in the right ventricular outflow tract.

The St Jude Medical (SJM) Mond RVOT Stylet is an accessory implant tool, intended for use in the placement of SJM right ventricular active fixation leads. The Mond stylet is configured in a modified "J" shape designed to position the leads in the RVOT. The stylet uses the same materials and similar manufacturing processes as the currently approved J (4090 and 4091) bradycardia stylets and the S-75-X tachycardia stylets.

The provided text describes a 510(k) premarket notification for the Kogo92 Mond™ RVOT Stylet. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit acceptance criteria with numerical performance targets for the new device.

Therefore, the study summary focuses on device comparison testing and verification and validation to assert equivalency and conformance to requirements, rather than presenting a performance study with defined acceptance criteria for a new device's efficacy or accuracy.

Here's a breakdown based on the available information:

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

Since this is a submission for substantial equivalence based on a predicate device, there are no explicit performance acceptance criteria stated for the Kogo92 Mond™ RVOT Stylet itself. The "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as the predicate devices. The "reported device performance" is essentially that it functions similarly and uses similar materials and processes to the predicate.

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 a "test set" in the context of device performance metrics, as it is a substantial equivalence submission. It mentions "device comparison testing," "verification and validation activities," and "product verification" (documented in QTR 2170). These imply internal technical and functional tests rather than clinical studies with patient data. Therefore, details like sample size for a test set, country of origin, or retrospective/prospective data are not provided.

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 information is not applicable to the provided text. The submission is about demonstrating equivalence of an accessory implant tool based on its design, materials, and manufacturing processes, not about establishing "ground truth" for a diagnostic or AI-driven device.

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

This information is not applicable. There's no mention of a test set requiring adjudication in the context of expert consensus.

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 MRMC study was done, as this device is a medical accessory (a stylet) and not an AI-driven or diagnostic imaging tool. Therefore, there's no discussion of human reader improvement with or without AI assistance.

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

This is not applicable, as the device is not an algorithm or AI system. It's a physical medical tool.

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

"Ground truth" as typically understood in performance studies (e.g., for diagnostic accuracy) is not relevant here. The 'truth' established is that the device's characteristics (materials, function, sterilization) are equivalent to those of existing, approved predicate devices, and that verification and validation activities were successfully performed to requirements.

8. The sample size for the training set

This is not applicable, as the device is not an AI/ML algorithm that requires a training set.

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

This is not applicable, as the device is not an AI/ML algorithm that requires a training set.

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The CPS DuoTM guidewire and stylet are indicated for: Facilitation of placement of St. Jude Medical left heart leads to target vessel/site.

CPS Duo™ Left Heart Lead Delivery System is a combination of a CPS Duo™ Stylet and a CPS Duo™ Guidewire designed to facilitate the delivery of a SJM lead to the target vessel/site. The CPS Duo™ stylet has a lumen to allow a CPS Duo™ guidewire to pass through it. The CPS Duo™ Guidewire is specially designed to function in concert with the CPS Duo™ Stylet.

This document ([K072864](https://510k.innolitics.com/search/K072864)) describes a medical device submission that is a 510(k) premarket notification for the CPS Duo™ Left Heart Lead Delivery System. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its effectiveness through clinical trials with specific acceptance criteria as one would find in a PMA (Premarket Approval) application for novel, high-risk devices.

Therefore, the information requested regarding acceptance criteria, device performance against those criteria, and detailed study parameters for device performance evaluation (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone studies) are not present in this document in the manner typically associated with AI/software performance evaluations.

Instead, the submission focuses on demonstrating technological equivalence and safety.

Here's an analysis based on the provided text, addressing the points where information is available and explaining why other points are not applicable:

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

• Not applicable in the context of this 510(k) submission for this type of device. The document does not define specific "acceptance criteria" for clinical performance metrics (like accuracy, sensitivity, specificity) of the CPS Duo™ Left Heart Lead Delivery System in the way an AI/software device would. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices and adherence to design specifications through verification testing.
• Reported Device Performance: The document states:
  • "Device comparison testing was performed to support equivalency of the CPS Duo™ Left Heart Lead Delivery System with the predicate devices, SJM Models 4078S and 4078G."
  • "In addition verification testing was completed, including mechanical, functional and biocompatibility testing with the CPS Duo™ Left Heart Lead Delivery System meeting all specified design and performance specification test report is in QTR 2179."
  • "St. Jude Medical considers the CPS Duo™ Left Heart Lead Delivery System to be substantially equivalent to the legally marketed predicate and referenced devices. The results of the tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use."

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/Not provided. This document does not describe clinical performance "test sets" in the context of evaluating a software algorithm or AI model. The studies mentioned are "device comparison testing" and "verification testing" (mechanical, functional, biocompatibility) to show substantial equivalence and safety, not clinical efficacy or diagnostic accuracy on a patient data set. There's no mention of sample sizes of patients or data provenance.

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/Not provided. As there's no "test set" for clinical performance evaluation (like image interpretation or diagnostic accuracy) in this 510(k), there's no mention of experts establishing ground truth for such a purpose.

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

• Not applicable/Not provided. No clinical "test set" and thus no adjudication method 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

• No. This is not an AI-powered device. Therefore, no MRMC study or AI assistance evaluation was conducted.

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

• No. This is a physical medical device (lead delivery system), not an algorithm or AI. Standalone performance is not applicable in this context.

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

• Not applicable/Not provided in the traditional sense. For a physical delivery system, "ground truth" relates to successful deployment, mechanical integrity, material properties, and biocompatibility rather than diagnostic accuracy. The "ground truth" for the verification testing would be the pre-defined engineering and safety specifications (e.g., tensile strength, flexibility, biocompatibility standards).

8. The sample size for the training set

• Not applicable/Not provided. This is not a machine learning or AI device that requires a "training set."

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

• Not applicable/Not provided. As there is no training set, this is not applicable.

Summary of the Study type in the K072864 submission:

This 510(k) submission describes studies focused on demonstrating substantial equivalence to existing predicate devices and ensuring the safety of the CPS Duo™ Left Heart Lead Delivery System. The studies performed include:

• Device Comparison Testing: To support equivalence with predicate devices (SJM Models 4078S and 4078G). This likely involves comparing design features, materials, and functional aspects.
• Verification Testing: This encompassed:
  • Mechanical Testing: To ensure the device meets specified design and performance specifications (e.g., strength, flexibility, torque).
  • Functional Testing: To confirm the device operates as intended (e.g., guidewire passage through a stylet).
  • Biocompatibility Testing: Performed on patient tissue-contacting materials to ensure they are safe for contact with the body.
  • Sterilization Validation: Using an Ethylene Oxide (EtO) process to ensure the device is sterile.

Conclusion of the Document:

The FDA reviewed the premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use. This allows the device to be marketed, subject to general controls and applicable special controls for Class II devices.

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