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The Arrow Stiffening Stylet is intended to be placed inside a catheter to stiffen the catheter for placement.

The Arrow Stiffening Stylet is a sterile, single use, percutaneous peripheral vasculature catheter stylet intended for transient use (up to 24 hours) to be placed within a catheter to render it stiff to aid in catheter placement. The proposed device will be delivered as a sterile accessory within a convenience kit for the Arrow Peripherally Inserted Central Catheter (PICC)s. The Stylet is a PTFE coated solid nitinol core wire with straight tip. The stylet is available in 0.015-0.017-inch diameters and in 29.5-inch length with distance markings along the stylet body.

The Arrow Stiffening Stylet is provided with an existing, commercially available flushable hub with side arm and slide clamp cleared under K790408. The flushable hub maintains the stylet position within the catheter during catheter placement, is intended to minimize blood loss during catheter introduction, and allows the clinician to flush through the catheter to aid in catheter placement, if needed. There is no change to the flushable hub cleared under K790408 introduced by this submission.

This document describes a 510(k) Pre-Market Notification for the Arrow Stiffening Stylet. The primary purpose of this submission is to demonstrate the substantial equivalence of the Arrow Stiffening Stylet to a legally marketed predicate device, the Galt Medical Corp's GaltTWS Stylet (K182660).

Acceptance Criteria and Device Performance (as derived from the provided document):

The document does not explicitly state "acceptance criteria" as a pass/fail threshold but rather lists the tests performed and implies that the device "passed all acceptance criteria" during non-clinical performance testing. The "reported device performance" is essentially that the device met the requirements of these tests.

Study Details:

1. Sample Size and Data Provenance:

   • Test Set Sample Size: The document does not specify the exact sample sizes for each test. It broadly states "testing conducted" without providing numerical details for the number of units or distinct test conditions evaluated.
   • Data Provenance: The data appears to be entirely from non-clinical performance testing conducted by Arrow International LLC. There is no indication of patient data or clinical trials. The country of origin for the data is not explicitly stated, but as Arrow International LLC is based in Morrisville, North Carolina, USA, the testing was likely performed there or in accordance with US regulatory standards. The data is not retrospective or prospective clinical data as no human clinical data was used.

2. Number of Experts and Qualifications for Ground Truth:

   • Not Applicable. This submission is for a medical device (stylet) that relies on physical and mechanical testing, not interpretation of data like images or patient records that would require expert consensus for ground truth. Therefore, there's no mention of experts establishing ground truth in the context of interpretation. Internal engineering and quality control experts at Arrow International LLC would have developed the test protocols and evaluated the results against internal requirements and relevant ISO standards.

3. Adjudication Method for Test Set:

   • Not Applicable. As this is non-clinical physical/mechanical testing, there isn't an "adjudication method" in the sense of resolving disagreements between human readers or experts. Test results would be objectively measured against predefined specifications.

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

   • No. An MRMC study was not conducted. This type of study is typically performed for AI or diagnostic imaging devices where human interpretation is involved. This submission is for a physical medical device.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

   • Not Applicable. This is a physical medical device, not a software algorithm or AI.

6. Type of Ground Truth Used:

   • The "ground truth" for this device's performance is established by objective measurements against predefined engineering specifications and relevant international standards (e.g., ISO 11070, ISO 10993-1). It is based on physical and mechanical properties, not expert consensus, pathology, or outcomes data from a clinical setting.

7. Training Set Sample Size:

   • Not Applicable. There is no "training set" in the context of this device. This is not an AI/machine learning device. The testing described is verification testing against design specifications.

8. How Ground Truth for Training Set Was Established:

   • Not Applicable. As there is no training set, there is no ground truth established for one.

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The BIOTRONIK Stylets are used in conjunction with the implantable systems (leads and pacemakers or ICD). Therefore, the same indications that apply for the designated active implant and leads, also apply for stylets.

BIOTRONIK stylets are intended for use with long-term implantable BIOTRONIK leads and are used during the implantation procedure of these leads. Stylets predominantly serve to stiffen the flexible lead during implantation in order to facilitate its positioning.

BIOTRONIK stylets consist of metal wires of different stiffness, lengths and shapes that are attached to a small plastic handle on their proximal end to simplify the manipulation of the stylet during lead implantation. The plastic handle carries a color-code that indicates the stylet length and the stiffness. In addition, the wire diameter and the length of the stylet are printed on the handle.

While the supplied text is a 510(k) premarket notification for Biotronik Stylets, it does not contain any information regarding acceptance criteria or a study proving that a device meets such criteria.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Abbott stylets) based on:

• Indications for Use: The Biotronik stylets are used in conjunction with implantable systems (leads and pacemakers or ICDs), and therefore, the same indications and contraindications apply.
• Technological Characteristics: A comparison table highlights similarities and differences in stiffness, diameter, and length, concluding that these differences are non-relevant to equivalence.
• Performance Data: It merely states, "Performance was evaluated in the design validation" without providing any specific data, acceptance criteria, or study details.
• Verification and Validation Testing: It mentions that the stylets underwent and passed "validation and verification testing to ensure functionality," but again, no specific details, criteria, or results are provided. It also notes that particulate matter testing was not conducted due to the device not having body or blood contact.

Therefore, for your request, I must report that the provided input does not offer the necessary information to describe acceptance criteria or a study that proves the device meets those criteria. The document is a regulatory filing focused on substantial equivalence rather than a detailed performance study report.

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The GaltTWS Stylet is a percutaneous catheter stylet placed inside a catheter, lead, or cannula to stiffen the device for placement or extraction.

The GaltTWS stylet is comprised of a stainless steel twisted/braided wire of varying diameters (0.012-0.015 inch), and varying length (30-72cm). The GaltTWS stylet can be configured as a Twisted/Braided wire bonded to a hub, flushable hub, or connected to a flushable adjustable hub using the Galt Gateway Hemostasis Valve (K152528).

This document is a 510(k) premarket notification decision letter for a medical device called the "GaltTWS Stylet." As such, it does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria in the context of an AI/ML-based medical device.

The requested information (acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, etc.) is specific to studies proving the performance of AI/ML algorithms. This FDA letter pertains to a non-AI medical device (a catheter stylet) and focuses on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility.

Therefore, I cannot fulfill the request using the provided text. The document describes:

• Device: GaltTWS Stylet (a percutaneous catheter stylet)
• Purpose: Stiffen a catheter, lead, or cannula for placement or extraction.
• Regulatory Pathway: 510(k) for substantial equivalence.
• Testing: Bench testing (Particulate, Mechanical Properties, Leak, Tortuous Path) and Biocompatibility testing (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemolysis, Pyrogen, EO Residuals).
• Conclusion: Device is substantially equivalent to marketed predicate devices.

This information is relevant to traditional medical device clearance, not the evaluation of AI/ML performance.

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The Liberator® Beacon® Tip Locking Stylet is intended for use in patients requiring the percutaneous removal of cardiac leads, indwelling catheters and foreign objects, with a central lumen.

The Liberator® Beacon® Tip Locking Stylet is a specialized stylet that can be inserted through a cardiac lead's inner conductor lumen, once the proximal connector has been removed. The stylet can then be locked into position within the lead's distal portion allowing for the delivery of tractional forces helpful during the extraction procedure.

The Liberator Beacon® Tip Locking Stylet has a braided Nickel-Chromium integral extender (handle). The locking mechanism that is located at the distal end of the stylet is comprised of a uniquely shaped stainless steel wire-locking coil segment attached to a central stainless steel stylet wire. This locking stylet is activated through the forward advancement of a stainless steel cannula that surrounds the central stainless steel stylet wire. Upon activation by the cannula. the wire-locking coil segment at the distal end of the stylet is advanced forward and is compressed. This compression causes the stacking of successive helices of the wire-locking coil. This stacking results in the outward radial displacement of a number of the wire-locking coil's helices against and into the lead conductor coil through which it has been inserted. This outward radial displacement creates the locking engagement of the Liberator® Beacon® Tip Locking Stylet to the lead conductor central or inner lumen. The device is available in a single size compatible with the internal diameter dimensions of many leads and catheters with a central lumen. Stylet wires for checking lead patency are available separately; they consist of a molded plastic handle on a 0.038 cm (0.015 inches) stainless steel wire, with a wire length of 65 cm.

The Liberator® Beacon® Tip Locking Stylet (and its associated stylet wires) underwent several tests to ensure reliable design and performance and to demonstrate substantial equivalence to the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Unfortunately, the provided text does not explicitly state the specific numerical acceptance criteria for each test (e.g., "minimum pull strength force of X Newtons"). It only confirms that "The acceptance criterion was met" for each test. Therefore, the table below reflects what is verbally stated as acceptance criteria and how the device performed against them.

The provided document describes physical and biological performance tests, not a clinical study involving human patients or ground truth consensus among experts. Therefore, several requested categories are not applicable to this type of submission.

Here's the breakdown:

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

   • The document does not specify the sample sizes used for each test.
   • The data provenance is not explicitly mentioned, but these are typically in-house testing results from the device manufacturer (Cook Incorporated, in Bloomington, IN, USA). The studies are prospective in nature, as they are conducted specifically for the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

   • Not applicable. This submission involves engineering and biocompatibility testing, not clinical data requiring expert human interpretation or "ground truth" establishment in a medical context.

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

   • Not applicable. See point 3. Testing results are typically evaluated against pre-defined engineering specifications.

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 hardware device (a stylet) and not an AI/software as a medical device (SaMD). No MRMC study was conducted or is relevant.

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

   • Not applicable. This is a hardware device, not an algorithm. The "stand-alone" performance refers to the device's inherent physical and material characteristics as tested.

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

   • The "ground truth" for these tests are pre-defined engineering specifications and widely accepted international standards (e.g., ISO 10993-1 for biocompatibility) and FDA guidance for medical device testing. For example, a "minimum pull strength force" would be a specific numerical value derived from design requirements and clinical needs for the device's function.

8. The sample size for the training set

   • Not applicable. No training set is used as this is not a machine learning or AI device.

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

   • Not applicable. No training set is used.

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The Spectranetics Lead Locking Devices, LLD, are intended for use in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads having an inner lumen and using a superior venous approach.

Not Found

This document is an FDA 510(k) clearance letter for a medical device (LLD EZ catheter stylet) and does not contain the information requested about acceptance criteria or a study proving the device meets acceptance criteria.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, which means it has the same intended use and technological characteristics as a device already on the market, or if it has different characteristics, these do not raise new questions of safety and effectiveness.

To answer your questions, I would need to analyze a different type of document, such as a summary of safety and effectiveness data (often submitted with a 510(k)) or a clinical study report. The provided text is solely the FDA clearance letter and an "Indications for Use" statement.

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The stylet is intended to aid in the placement of St. Jude Medical transvenous leads.

The document describes several models of stylets made of stainless steel with molded ABS thermoplastic hubs. They vary in diameter, flexibility (soft, firm, extra firm, extra soft), and length. Some models are ball-tipped. Accessory kits may include tools like a fixation tool or clip-on tool, and a stylet ring holder. The Locator Plus stylet is a deflectable implantation tool.

The provided document is a 510(k) Premarket Notification for various models of St. Jude Medical stylets. The purpose of this notification is to demonstrate substantial equivalence to previously approved predicate devices, not to introduce a new device requiring extensive clinical trials to establish efficacy and safety from scratch. Therefore, the information typically requested for AI-driven diagnostic devices or novel medical technologies (e.g., sample sizes for test/training sets, number of experts, MRMC studies, standalone performance) is not applicable or present in this type of submission.

Instead, the acceptance criteria are primarily based on substantial equivalence to legally marketed predicate devices, meaning the new devices are as safe and effective as existing ones. The "study" proving this involves referencing the previous approvals (PMAs) and demonstrating that the current devices' design, intended use, labeling, packaging, and sterilization are substantially equivalent to those predicates, often through engineering tests rather than clinical studies.

Here's an attempt to structure the available information, noting where specific requested criteria are not applicable in this context:

Acceptance Criteria and Device Performance for St. Jude Medical Stylets (K090163)

The acceptance criteria for the devices listed in this 510(k) submission primarily revolve around demonstrating substantial equivalence to existing, legally marketed predicate devices. This means the stylets (new models or versions of existing ones) are shown to be as safe and effective as their predecessors through comparison of their characteristics, intended use, and performance, often supported by engineering tests rather than de novo clinical trials.

1. Table of Acceptance Criteria and Reported Device Performance

• For 4060, 4062, 4064: QTR 0210866, QTR 02109049
• For 4090, 4091: QTR 1861
• For 4078: QTR 2019 (for 1156T Quickflex leads) and QTR 2020 (for 1158T Quickflex leads)
• For S-65-S/F/X: QTR OTR1403
• For S-60-S/X/F: QTR OTR1472 (Riata 1572), QTR1462 (Riata 1582)
• For S-75-X/S/F: QTR 1606 (Riata 1580/1581)
• For S-60-XS, S-65-XS, S-75-XS: QTR 2041

Sterilization & Packaging Validation: References various QTRs and OTRs (e.g., OTR 1392-A, QTR2264, OTR 1861, QTR 1511, QTR 1392-G), confirming that sterilization and packaging are substantially equivalent to predicate devices or previously validated methods. Locator Plus stylets are double-packaged to maintain sterility.

Shelf Life: Approved shelf lives are specified for each stylet model (e.g., 3 years for many, 2 years for Locator Plus) based on prior PMA approvals, indicating stability and sterility are maintained over time.

Labeling: Labels for commercially available models are included as appendices, demonstrating consistency with predicate device labeling. |
| Clinical Performance | If applicable, clinical data may be required to demonstrate substantial equivalence, especially if there are significant technological differences or new indications. | For this type of device (stylets for lead placement), the submission relies on the established safety and efficacy of the predicate devices, which were approved via PMAs (Premarket Approvals) that would have included significant clinical data. No new clinical studies are presented in this 510(k) submission, as the claim is for substantial equivalence to already approved devices. The previous PMAs themselves served as the evidence for clinical performance. |

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

This information is Not Applicable in the context of this 510(k) submission. 510(k) applications for devices like stylets typically rely on non-clinical (bench) testing and comparison to predicate devices, rather than new clinical trials with patient test sets. The studies referenced (QTRs, OTRs) are engineering/performance qualification tests. The provenance of data for these engineering tests would typically be internal to the manufacturer (St. Jude Medical).

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 is Not Applicable. The determination of "ground truth" by clinical experts is relevant for diagnostic devices interpreting medical images or other clinical data. For a mechanical device like a stylet, "ground truth" pertains to its physical performance meeting engineering specifications, which is verified through objective measurements and validated test methods, not expert consensus on interpretations.

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

This is Not Applicable. Adjudication methods are typically employed in clinical studies where subjective expert assessment is involved. The testing performed for these stylets is objective and prescriptive, based on defined physical parameters and test protocols.

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 is Not Applicable. MRMC studies are specific to evaluating diagnostic imaging systems, particularly those that involve human interpretation, often in conjunction with AI. This 510(k) is for a simple mechanical accessory (stylet) used in lead placement, not a diagnostic or AI-powered system.

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

This is Not Applicable. This document is for a medical device (stylet) that is a physical tool, not an algorithm or AI system.

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

The "ground truth" here is the established performance and safety profiles of the predicate devices, as determined through their original PMA approvals. For the physical testing conducted for this 510(k), the "ground truth" consists of engineering specifications and validated test methods (e.g., for insertion/extraction forces, sterilization efficacy, packaging integrity, and material properties). The device's performance is measured against these objective, predefined standards.

8. The sample size for the training set

This is Not Applicable. There is no "training set" in the context of a 510(k) submission for a non-AI mechanical device. The term "training set" refers to data used to train machine learning models.

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

This is Not Applicable for the same reason as point 8.

Summary of the Study Proving Substantial Equivalence:

The "study" within this 510(k) notification is a comprehensive compilation of existing approvals and non-clinical engineering test data, rather than a new clinical trial. For each stylet model, St. Jude Medical demonstrates substantial equivalence by referencing its previous approval under a specific Premarket Approval (PMA) number, often with amendments (e.g., P960030/S10).

The core of the submission involves:

• Referencing Predicate Devices: Every stylet model presented (4060, 4062, 4064; 4090, 4091; 4078; Locator Plus; S-60 series; S-65 series; S-75 series) is explicitly stated to be substantially equivalent to a previously FDA-approved predicate device, often the same model number that was approved under an earlier PMA.
• Description of Device: Providing detailed descriptions of the stylets, including materials, dimensions, and intended use, and confirming these are consistent with the predicate.
• Performance Testing: Citing Qualification Test Reports (QTRs) for various aspects like stylet insertion/extraction, indicating that the devices perform according to established engineering standards for their intended use. These are mechanical performance tests.
• Sterilization and Packaging Validation: Referencing QTRs and OTRs demonstrating that the devices' sterilization and packaging methods are validated and consistent with predicate devices, ensuring sterility is maintained.
• Shelf Life: Confirming the approved shelf life based on prior PMA submissions.
• Labeling: Showing that the labeling is consistent with the predicate devices.

The conclusion for each section explicitly states that "The information presented supports a determination of substantial equivalence and therefore clearance of the SJM stylet models... through this 510K Pre- Market Notification." The FDA's letter concurs with this finding of substantial equivalence, allowing the devices to be marketed.

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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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For use with compatible, transvenous, left ventricular, pace/sense leads

The ACUITY Steerable Stylet is intended for delivery of the ACUITY Steerable Lead in the coronary veins. The stylets come in either soft or standard stiffness, and in three lengths (to match the ACUITY Steerable Lead lengths).

The stylet consists of a stainless steel wire with a polypropylene knob/cap assembly at the proximal end. The distal end of the wire has a taper and terminates in a bullet shaped tip. Both soft and standard stylets have the same base wire diameter. The difference in stiffness is due to a slight difference in the diameter within the taper at the distal end of the wire.

This document describes the ACUITY™ Steerable Stylet Accessory, a Class II medical device, and its substantial equivalence to predicate devices. The information provided is for regulatory clearance and focuses on device characteristics and testing to meet acceptance criteria, rather than a detailed study comparing its performance against specific clinical metrics.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "Testing demonstrated that the ACUITY Steerable Stylet met the acceptance criteria." However, it does not provide a specific table of acceptance criteria with corresponding performance metrics. The information focuses on demonstrating substantial equivalence to existing predicate devices rather than proving specific clinical safety and effectiveness through quantified performance targets.

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

The document does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The "Testing Data" section broadly states that "Testing demonstrated that the ACUITY Steerable Stylet met the acceptance criteria" without detailing the nature or scope of this testing.

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

This information is not provided. The document is concerned with the physical and functional characteristics of a medical device (a stylet) for regulatory clearance, not with image interpretation or diagnostic performance that would typically involve establishing ground truth by medical experts.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. As mentioned above, the evaluation does not involve diagnostic interpretation or human reader performance that would necessitate an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

This information is not applicable and not provided. The device is a mechanical accessory (a stylet), not an AI-powered diagnostic tool. Therefore, an MRMC study or an assessment of AI assistance for human readers is irrelevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This information is not applicable and not provided. The device is a physical stylet, not an algorithm, so standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

This information is not provided. Given the nature of the device (a stylet), "ground truth" as typically understood in a diagnostic study (e.g., pathology, clinical outcomes) is not the primary focus. The focus is on physical and functional characteristics, and comparison to predicate devices, implying engineering and material testing rather than clinical outcome studies for establishing "ground truth."

8. The Sample Size for the Training Set:

This information is not applicable and not provided. The device is not an AI algorithm that requires a training set.

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

This information is not applicable and not provided. The device is not an AI algorithm that requires a training set or ground truth for its development.

Summary of the Study and Acceptance Criteria (Based on the Provided Text):

The "study" described is a premarket notification (510(k)) submission to the FDA, not a clinical trial or performance study as might be conducted for an AI diagnostic device. The core assertion made is of "substantial equivalence" to legally marketed predicate devices.

• Acceptance Criteria (Implied): The implied acceptance criteria are that the ACUITY™ Steerable Stylet Accessory possesses "technological characteristics such as Intended Use, material, nominal diameter, assembly, dispensing hoop design, package pouch, sterilization method, sterilization indicator, and shelf life" that are substantially equivalent to the predicate devices and that it meets unspecified internal "acceptance criteria" from internal testing. The ultimate acceptance criterion for the FDA is that the device is "substantially equivalent" to predicate devices, meaning it is as safe and effective.
• Reported Device Performance: The document states, "Testing demonstrated that the ACUITY Steerable Stylet met the acceptance criteria." It also lists the technological characteristics that were found to be substantially equivalent to the predicate devices. No specific quantitative performance metrics are provided.
• Study Type: This is a pre-market regulatory submission demonstrating substantial equivalence, not a clinical effectiveness study. It mentions internal "testing" but does not detail the methodology, sample sizes, or specific results of this testing. The focus is on comparing the new device's characteristics to those of established, legally marketed devices.

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The EASYTRAK® 2 Stylet is intended to aid in the placement of a Guidant THE EXS FIRAK® 2 implantable venous lead in the coronary venous vasculature.

The EASYTRAK® 2 Stylet is designed for delivery of the EASYTRAK® 2 lead in the coronary veins. The stylets come in three lengths corresponding to the lengths of the EASYTRAK® 2 leads.

The EASYTRAK® 2 Stylet consists of a stainless steel wire with a polypropylene hub at the proximal end. The distal end of the wire has a stop-coil designed to prevent the stylet from exiting through the distal end of the lead.

Here's an analysis of the provided 510(k) summary regarding the EASYTRAK® 2 Stylet, focusing on acceptance criteria and study information:

Based on the provided document (K052965), the information about acceptance criteria and the study that proves the device meets them is very limited. This is typical for 510(k) submissions, especially for devices seeking substantial equivalence where extensive clinical trials with detailed performance metrics are often not required if the device is sufficiently similar to a predicate.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that testing was performed and the device met the acceptance criteria. However, it does not explicitly list what those acceptance criteria were or provide specific quantitative results for the device performance beyond a general statement of compliance. This typically means the tests related to engineering performance (e.g., tensile strength, flexibility, material compatibility, dimensional accuracy) and possibly simulated use, which are usually compared against internal design specifications derived from the predicate devices.

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

• Sample Size: Not specified.
• Data Provenance: Not specified. Given the nature of a 510(k) for a stylet, the testing would almost certainly be internal, non-clinical (benchtop) testing. There is no indication of clinical data, animal studies, or data from specific countries.

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

This is not applicable as the studies described are not clinical studies requiring expert ground truth for interpretation (e.g., image reading, disease diagnosis). The testing would have focused on engineering specifications and physical properties.

4. Adjudication method for the test set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials involving human interpretation of data, where discrepancies need to be resolved. This document describes non-clinical engineering and performance 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

This is not applicable. MRMC studies are related to evaluating diagnostic devices, often AI-driven, and involve multiple human readers interpreting cases. The EASYTRAK® 2 Stylet is a mechanical accessory, not a diagnostic or AI-powered device.

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

This is not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used

This is not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). For engineering testing, "ground truth" would be established by validated test methods and reference standards against which the device's physical and functional properties are measured. For example, a "pull test" might have an acceptance criterion of "withstands X Newtons of force," and the ground truth for whether the device passes is an objective measurement of the force it withstood.

8. The sample size for the training set

This is not applicable as 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

This is not applicable for the same reason as point 8.

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