Search Results

Boston Scientific's Tracker™ Excel™-14 Pre-Shaped Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils into the peripheral, coronary, and neuro vasculature.

The Tracker™ Excel™-14 Pre-Shaped Microcatheter is a single lumen device designed to aid the physician in accessing the distal vasculature when used with a guiding catheter and steerable guidewire. Graded shaft astifiess ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires. A luer fitting located on the catheter hub is used for the attachment of accessories. A radiopaque tip facilitates fluoroscopic visualization. The outer diameter is coated with a hydrophilic surface that reduces friction during manipulation in the vessel. The catheter is packaged individually with a variety of pre-shaped tips.

The provided text describes a 510(k) submission for a modified microcatheter and does not contain information about an AI-powered device or a study involving AI. Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, or AI effectiveness studies.

The document focuses on demonstrating substantial equivalence of the modified microcatheter to a predicate device based on in-vitro testing and biological safety testing, as well as a comparison of product characteristics.

Regarding the specific questions you asked, based on the provided text, the following cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not available as it pertains to AI-powered devices.
2. Sample sized used for the test set and the data provenance: Not relevant for this type of device modification submission. The text mentions "in-vitro testing" but doesn't detail sample sizes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as it pertains to AI ground truth.
4. Adjudication method: 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, as this is not an AI device.
6. If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable for an AI device. The ground truth for this device's performance would be the physical properties and biological safety as measured in the in-vitro tests.
8. The sample size for the training set: Not applicable as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable.

Summary of the provided information:

• Device: Tracker™ Excel™-14 Pre-Shaped Microcatheter
• Modification: The predicate device (Tracker™ Excel™-14 Microcatheter) was modified to include pre-shaped tips, as opposed to a straight, steam-shapeable tip.
• Purpose of Modification: Ease of use for physicians.
• Testing Conducted: In-vitro testing (tip shape retention, appearance of the tip, tip dimensions, static rupture, tensile strength of tip, buckling test, and coil, guidewire and guide catheter compatibility) and biological safety testing.
• Conclusion of Testing: The results support the claim of substantial equivalence to the predicate device.
• Substantial Equivalence Claims: Functionality, intended use, indications for use, materials, method of operation, and biological safety.
• Predicate Device: Tracker™ Excel™-14 Microcatheter (K994155).

Ask a specific question about this device

Boston Scienfitic's Excelsior™ SL-10 Pre-Shaped Microcatheter and Excelsion™ 1018" Pre-Shaped Microcatheter are intended to assist in the delivery of diagnostic agents, therapeutic agents, such as occlusion coils to the peripheral, coronary, and neuro vasculature.

The Excelsior " 1018" Pre-Shaped Microcatheter and the Excelsior" SL-10 Pre-Shaped Microcatheter are intended to assist the physician in accessing the distal vasculature when used with a guiding catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semirigid proximal section aids the physician in tracking over selectively placed guidewires without displacement of the wire. A luer fitting located on the cather hub is used for the attachment of accessories. A radiopague tip facilitates fluoroscopic visualization. The outer diameter is coated with a hydrophilic surface that reduces tip tachitatis nuoroscopic 75the catheters are packaged individually with a variety of Pre-Shaped tips.

This document describes the 510(k) summary for the Excelsior™ 1018™ and SL-10 Pre-Shaped Microcatheters. The core of the submission is to demonstrate substantial equivalence to predicate devices, where the primary modification is the pre-shaped tips for ease of use.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the typical quantitative sense (e.g., a specific percentage accuracy or precision). Instead, the acceptance criteria are implicitly that the modified devices (with pre-shaped tips) retain the same performance characteristics and safety profile as the predicate devices. The study performed is a "testing in support of substantial equivalence determination."

2. Sample Size and Data Provenance

• Test Set Sample Size: Not specified. The document refers to "in-vitro testing" but does not detail the number of units tested for each characteristic.
• Data Provenance: The data appears to be prospective as it involves "in-vitro testing" conducted specifically for this 510(k) submission. No information is given about the country of origin of the data beyond "Boston Scientific" which is a US-based company, suggesting the testing was likely conducted in the US or by a US-affiliated entity.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This submission is for a medical device (microcatheter) and relies on engineering and biocompatibility testing, not on expert interpretations of medical images or clinical data to establish a "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this isn't a study involving human interpretation of data where adjudication would be necessary.

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

No. This type of study is typically performed for diagnostic devices where the performance of human readers, with and without AI assistance, is evaluated. This submission is for a microcatheter, which is an interventional device, not a diagnostic one.

6. Standalone (Algorithm Only) Performance

Not applicable. The device is a physical microcatheter, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation is based on engineering specifications, material science, and established safety standards for medical devices (e.g., biocompatibility standards, mechanical testing standards for catheters). The predicate devices serve as the reference point for equivalence.

8. Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is not an AI/ML-driven device.

9. How Ground Truth for the Training Set was Established

Not applicable, for the same reason as point 8.

Ask a specific question about this device

The Matrix™ Detachable Coils have the same indications for use as the predicate GDC" coils.

Matrix™ Detachable Coils are intended for embolization of those intracranial aneurysms that because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be:

a) very high risk for management by traditional operative techniques, or,

b) inoperable,

and for embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

The Matrix™ Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.

The Matrix™ Detachable Coil system consists of the following, each of which is sold seperately:

• · GDCTM SynerGTM Power Supply
• · Matrix™ Detachable Coil attached to a delivery wire
• · Set of GDCTM SynerGTM connecting cables
• Patient return electrode
• · Two 9-volt batteries

The coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy.

Matrix™ Detachable Coils are manufactured from platinum wire, which is first wound into a primary coil and then formed into a secondary helical shape. Coating the platinum coil is a proprietary biocompatible absorbable polymer mixture.

Coils are attached to a delivery wire, which consists of a ground stainless-steel core wire with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. The delivery wire is identical to that employed for the predicate GDCTM Coils cleared under K001083.

The GDCTM SynerGTM power supply is a battery-operated, selfcontained unit designed to initiate and control the electrolytic detachment of a GDC™ Coil or Matrix™ Detachable Coil inside an aneurysm.

The GDC™ SynerG™ Power Supply is designed to apply a constant current through the GDC™ System and to detect when coil detachment has occurred. It maintains a constant current by:

1. sensing the amount of resistance to current flow through the Matrix™ Detachable Coil, and

2. adjusting the voltage needed to maintain the desired current setting. It is also designed to identify subtle changes in the way current is flowing through the Matrix™ Detachable Coil and to recognize those changes, which indicate detachment.

Once those patterns are identified, the GDCTM SynerGTM power supply signals detachment and stops the flow of current through the Matrix™ Detachable Coil.

The provided document is a 510(k) Premarket Notification for the Matrix™ Detachable Coils, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish novel performance criteria. Therefore, the information typically requested for a software algorithm/AI device, such as detailed acceptance criteria with specific performance metrics (e.g., sensitivity, specificity), sample sizes for test/training sets, blinding protocols, and expert ground truth establishment, is largely absent or not applicable in this context.

However, based on the information provided, I can infer and extract the relevant details as much as possible for a device of this nature.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are predominantly demonstrated by showing that the Matrix™ Detachable Coils are substantially equivalent to the Guglielmi Detachable Coil (GDC™) and GDC™ Power Supply (K001083), the predicate device. The performance is assessed against criteria established for the predicate device, indicating no degradation in safety or effectiveness with the modifications made (addition of a biocompatible absorbable polymer and ultraviolet curing adhesive).

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

The document does not specify a "test set" in the context of diagnostic performance involving patient data or images (as would be common for AI/software devices). Instead, the "tests" refer to engineering and biocompatibility evaluations on the physical device components and system. The sample sizes for these specific engineering tests are not described in this summary. The data provenance is associated with the device manufacturing and testing process by Boston Scientific Target. This is a premarket notification, not a clinical trial report, so concepts like "country of origin of the data" are not directly applicable to an AI device's test set.

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

Not applicable. This device is a physical medical implant (embolization coil) and associated power supply, not an AI/software diagnostic device that requires expert-established ground truth from images or patient data for performance evaluation. The "ground truth" for these engineering tests would be the established specifications and performance parameters for medical devices of this type, ensuring manufacturing quality and safety.

4. Adjudication method for the test set

Not applicable. There is no "adjudication method" in the traditional sense of resolving discrepancies among experts for diagnostic interpretation, as this is not an AI/software diagnostic device. The "tests" described are physical and electrical engineering evaluations.

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

Not applicable. This document pertains to a physical medical device (embolization coil) and its power supply. It is not an AI/software device intended to assist human readers (e.g., radiologists) in diagnostic tasks, so an MRMC study is not relevant.

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

Not applicable. This device is not an algorithm or AI system. Its function is to physically embolize aneurysms and vascular malformations, with human intervention for placement and detachment control.

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

The "ground truth" for the tests performed on the Matrix™ Detachable Coils is based on established engineering specifications, safety standards (e.g., ISO 10993-1 for biocompatibility), and performance metrics defined for the predicate device (GDC™ Coils). For example, "Friction" would have a specified acceptable range of frictional force, and "Polymer Mass Loss Tests" would have a maximum allowable mass loss over a given period. The overall "ground truth" for the submission is demonstrating substantial equivalence to a device already deemed safe and effective.

8. The sample size for the training set

Not applicable. As this is not an AI/software device, there is no "training set" in the context of machine learning.

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

Not applicable. As this is not an AI/software device, there is no "training set" or corresponding ground truth to establish in that context.

Ask a specific question about this device

The Pinnacle Metal-On-Metal Acetabular Cup Liners are indicated for use as the acetabular component in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

The Pinnacle Metal-On-Metal Acetabular Cup Liners are intended for use with DePuy Pinnacle Acetabular Shells and 28mm diameter Co-Cr-Mo femoral heads only.

The Pinnacle Metal-On-Metal (MOM) Acetabular Cup Liner is a metal liner that is intended for use with the Pinnacle Acetabular Shells that have been cleared previously. The liner has a 28mm inner diameter and is offered in a neutral style only. The Pinnacle MOM liner is mechanically locked with the shell via a taper junction, and articulates with commercially available prosthetic femoral heads.

This document is a 510(k) summary for the DePuy Pinnacle Metal-On-Metal Acetabular Cup Liners. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. Therefore, it does not contain a study proving the device meets acceptance criteria.

The document states: "The Pinnacle Metal-On-Metal Acetabular Cup Liners are nearly identical to the Ultima Metal-On-Metal Acetabular Cup Liners that were cleared previously. The intended use, articular surface, material and locking mechanism with the outer shell are the same. The only changes are minor design changes that allow the liners to be used with the Pinnacle Acetabular Shells that have been cleared previously."

This statement indicates that the device's acceptance is based on its substantial equivalence to an already approved device (DePuy Ultima Metal-On-Metal Acetabular Cup Liners), rather than a new study with specific acceptance criteria and performance metrics detailed here.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets those criteria, as this document is not a study report.

Ask a specific question about this device