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TRI-matrix® X-Force implants are intended for placement in the bone of the maxillary or mandibular arch for the rehabilitation of edentulous and partially edentulous patients. TRI-matrix® X-Force implants allow for one and two stage surgical procedures. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading. TRI-matrix® X-Force implants with lengths of 18, 20, or 22 mm, when placed in the maxilla, are indicated only for multiple unit restorations in splinted applications that utilize at least two implants.

The purpose of this submission is to obtain marketing clearance for TRI-matrix X-Force implants, a line extension of the TRI-matrix implant line previously cleared in K203660. TRI-matrix X-Force implants are tissue-level endosseous dental implants that are an adaptation of the TRI-matrix Tissue Level implants cleared in K203660, with the same prosthetic interface, but with modified external features. They are intended for use in the mandible or maxilla to restore chewing function. This submission includes only implants, and they are compatible with prosthetic components previously cleared in K203660 as part of the TRI-matrix implant line, including the TRI-matrix Crown Abutment.

TRI-matrix X-Force implants have a tapered body, double-lead threads and self-cutting flutes. A gritblasted and acid-etched surface, named the TRI SBA Surface, is applied to the endosseous portion of the implant. TRI-matrix X-Force implants incorporate a pink anodized, machined, 1.8 mm transgingival collar that is not treated with the TRI SBA Surface. Compared with TRI-matrix implants previously cleared in K203660, TRI-matrix X-Force implants have a modified thread design more suited to immediate placement and restoration, a more tapered apical portion (smaller apical diameter for a given coronal diameter), and more aggressive apical cutting flutes.

TRI-matrix X-Force 3.3 mm diameter implants have a platform diameter of 3.7 mm. TRI-matrix X-Force 3.7 mm and 4.1 mm diameter implants are available in two (2) platform diameters: 3.7 mm and 4.5 mm. TRI-matrix X-Force 4.7 mm diameter and 5.7 mm diameter implants have a platform diameter of 4.5 mm.

This document describes the marketing clearance for medical devices and does not contain information about acceptance criteria or a study proving that a device meets such criteria in terms of performance metrics or clinical outcomes.

The document discusses the substantial equivalence of the TRI-matrix® X-Force Implants to legally marketed predicate devices. This means that the FDA determined the device is as safe and effective as a predicate device and does not raise different questions of safety and effectiveness. This type of submission (510(k)) generally does not require proof of meeting specific performance acceptance criteria through the kind of studies you've outlined.

Specifically, the "PERFORMANCE DATA" section states:

• "Non-clinical data submitted to demonstrate substantial equivalence included: Referenced from the primary predicate device K203660: sterilization validation according to ISO 17665-1 and ISO 17665-2; . Provided in this submission: biocompatibility evaluation according to ISO 10993-5 and ISO 10993-12 worst-case analysis and static and dynamic testing according to ISO 14801 on subject devices to demonstrate that static and dynamic testing referenced from the primary predicate device K203660 demonstrates the subject implants do not create a new worst-case as compared to this predicate device with identical connection platform. No clinical data were included in this submission."

Therefore, I cannot provide the requested information for the following reasons:

1. Table of acceptance criteria and reported device performance: This document does not specify general "acceptance criteria" for clinical performance or report clinical performance data. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and design comparisons.
2. Sample size used for the test set and data provenance: No clinical test set was used or described. The non-clinical testing involved "worst-case analysis and static and dynamic testing according to ISO 14801," but specific sample sizes for these engineering tests are not detailed.
3. Number of experts used to establish ground truth and their qualifications: Not applicable, as no clinical test set or ground truth determination by experts is mentioned.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as no clinical studies were included.
6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable, as this is a physical medical device (dental implant), not an AI algorithm.
7. Type of ground truth used: Not applicable, as no clinical data or ground truth determination is described.
8. Sample size for the training set: Not applicable, as no training set for an algorithm is mentioned.
9. How the ground truth for the training set was established: Not applicable.

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The X-Force external, non-invasive, non-narcotic, clectrotherapy system is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee.

The X-Force is also indicated for use as an adjunctive therapy in reducing the level of pain, and stiffess associated with pain, from rheumatoid arthritis of the Hand.

These devices are to be used or sold only under the direct supervision or order of a licensed practitioner. A prescription is required to obtain this product can be used in the home or clinic by all patients in need.

The X-FORCE device is a microcomputer controlled digital device featuring a NT Mode output. The device provides simple programming facility to customize the treatment. The panel and its keys provide easy selection for treatment. It is device that deploys the use of electrotherapy and compression to treat Osteoarthritis (OA) and rheumatoid arthritis of the knee or hand.

The X-Force consists of electrodes, the lead wires, and the signal generator. The device is portable and rechargeable battery operated. The lead wires connect the electrodes to the device. These electrodes complete an electrical circuit allowing current to flow. The stimulator produces a pulsed electrical signal through the lead wires and electrodes at the treatment site.

The provided text describes a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device called "X-Force" and compares it to a predicate device, "J-Stim 1000".

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" through a table or specific quantitative thresholds for performance metrics. Instead, the submission relies on demonstrating substantial equivalence to a predicate device, the J-Stim 1000. The key "acceptance criterion" here is that the new device, X-Force, is "as safe, as effective and performs as well as its predicate device."

The "reported device performance" is essentially that the X-Force operates under the same principles and delivers similar electrical parameters as the J-Stim 1000. The comparison focuses on technological characteristics and basic unit characteristics, where "similarity" or "sameness" acts as the performance metric.

• Device Housing: Similar (ABS material, different sizes/weights).
• Channels: Same (Two Channels).
• Modes: Same (One).
• Display: Similar (Customized LCD).
• Waveform: Same (NT (HiVolt) - Pulsed Monophasic).
• Treatment Timer: Same (YES).
• Target Populace: Same. |
  | Basic Unit Characteristics Equivalence | - Power Source: Different (Rechargeable 4x1.2V vs. 9V Li-ion).
• Line Current Isolation: Same (battery operated, isolated from mains).
• Patient Leakage Current: Same (less than 100μA normal, less than 300µA single fault, Referenced IEC 60601-1).
• Output Modes/Channels: Same (Synchronous, 1 mode, 2 channels).
• Regulated Output: Same (Regulated Voltage).
• Max Output Current/Voltage/Phase Charge/Current Density/Power Density: All reported as identical.
• Software/Firmware/Microprocessors: Same (YES).
• Automatic Trips/Shut-off/Patient Override: All same (YES).
• Indicator Display: Same (YES for On/Off, Low Battery, Voltage/Current).
• Timer: Same (YES).
• Compliance with 21 CFR 898: Same (YES).
• Program Lock Feature: X-Force has this, J-Stim 1000 does not. This is deemed not to affect safety or effectiveness.
• Digital Control of Output Power: X-Force uses digital control via microcontroller, J-Stim 1000 uses analog pots. This difference is presented without explicit safety/effectiveness impact beyond it being a technological variation. |
  | Safety and Effectiveness (Overall Equivalence Conclusion) | X-Force is concluded to be as safe, as effective, and performs as well as the predicate device, J-Stim 1000. |

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

The submission explicitly states:

• "Non-Clinical Testing: Not Applicable as Jstim 1000 is already FDA Approved and the New Device X-Force is same as Predicate Device"
• "Clinical Testing: Not Applicable as Jstim 1000 is already FDA Approved and the New Device X-Force is same as Predicate Device"

This means there was no specific test set or clinical study conducted for the X-Force device to prove its performance in an independent test, nor is there data provenance like country of origin or retrospective/prospective status for such a test set. The submission relies entirely on the established safety and effectiveness of the predicate device.

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

Since no specific test set or clinical study was conducted for the X-Force device, there were no experts used to establish ground truth for a test set in this submission. The ground truth for the device's equivalence is based on engineering and performance specifications comparison to the predicate device.

4. Adjudication Method for the Test Set

As no test set was used, there was no adjudication method applied.

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 device (TENS stimulator) is not an AI-powered diagnostic device, and the submission does not involve any "human readers" or "AI assistance" in the context of interpreting medical images or data. Therefore, no MRMC comparative effectiveness study was done.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not an algorithm-only device. It is a physical medical device. There's no standalone algorithm performance study as it's not applicable.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" in this submission is the established safety and effectiveness of the predicate device (J-Stim 1000), as previously determined by the FDA's approval (K073386). The new device (X-Force) claims equivalence through comparative analysis of its specifications and intended use against this established ground truth.

8. The Sample Size for the Training Set

Since no new clinical or non-clinical testing was performed for the X-Force for this submission, there was no specific training set in the context of device performance studies. The "training" in an abstract sense comes from the design and manufacturing experience informed by devices like the predicate.

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

Given that no specific training set was used for this submission, the question of how its ground truth was established is not applicable. The submission leverages the pre-existing FDA approval of the predicate device as its basis for demonstrating safety and effectiveness.

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The Bard X-Force™ Nephrostomy Balloon Dilation Catheter is recommended for use in the dilation of the nephrostomy tract and for placement of the working sheath.

The Bard X-Force™ Nephrostomy catheter is composed of a dual lumen shaft with inflation and guidewire lumens and a dilation balloon on the distal end. The catheter has a band which corresponds with the distal end of the balloon's working length to radiopaque facilitate radiographic visualization and placement. A high pressure stopcock is used on the inflation lumen to maintain pressure after removal of the pressurization apparatus.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance described in a table, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details.

The document is a 510(k) summary for a medical device (X-Force™ N30 Nephrostomy Balloon Dilation Catheter). It primarily focuses on demonstrating substantial equivalence to a predicate device based on intended use, general design, and fundamental scientific technology. It states: "The X-Force™ N30 Nephrostomy Balloon Dilation Catheter referenced in this submission is held to the same design, manufacture, and performance specifications as those catheters currently manufactured by Bard. The appropriate design verification and validation activities for the modifications to the device were conducted." However, it does not provide the details of these performance specifications or the results of those verification and validation activities.

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The Bard X-Force™ Nephrostomy Balloon Dilation Catheter is recommended for use in the dilation of the nephrostomy tract and for placement of the working sheath.

The Bard X-Force™ Nephrostomy catheter is composed of a dual lumen shaft with inflation and guidewire lumens and a dilation balloon on the distal end. The catheter has a radiopaque band which corresponds with the distal end of the balloon's working length to facilitate radiographic visualization and placement. A high pressure stopcock is used on the inflation lumen to maintain pressure after removal of the pressurization apparatus,

The provided text is a 510(k) Summary for the X-Force™ N30 Nephrostomy Balloon Dilation Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria for device performance as would be expected for a novel device.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, multi-reader studies, standalone performance, and training set details is not present in the provided document.

Instead, the document states:

• "The modified device has the same intended use, general design and fundamental scientific technology as the predicate device."
• "The X-Force™ N30 Nephrostomy Balloon Dilation Catheter referenced in this submission is held to the same design, manufacture, and performance specifications as those catheters currently manufactured by Bard. The appropriate design verification and validation activities for the modifications to the device were conducted."

This indicates that the device's acceptance was based on demonstrating that it meets the same specifications and performance as existing, legally marketed devices, following standard engineering and manufacturing verification and validation processes, rather than a clinical trial with specific performance metrics defined by an acceptance criterion.

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The Bard® X-Force™ Nephrostomy Balloon Dilation Catheter is recommended for use in the dilation of the nephrostomy tract and for placement of the working sheath.

The Bard® X-Force™ Nephrostomy Balloon Dilation Catheter is composed of a dual lumen shaft with inflation and guidewire lumens and a dilation balloon on the distal end. The catheter has a radiopaque band which corresponds with the distal end of the balloon's working length to facilitate radiographic visualization and placement. A high pressure stopcock is used on the inflation lumen to maintain pressure after removal of the pressurization apparatus.

The provided document K051316 is a 510(k) Pre-Market Notification for the Bard® X-Force™ Nephrostomy Balloon Dilation Catheter. This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device. As such, the document focuses on demonstrating substantial equivalence rather than conducting a de novo study with acceptance criteria for a novel device.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment are not applicable in the context of this 510(k) submission.

Here's an breakdown of what can be extracted based on the provided text:

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

• Not Applicable: This 510(k) submission does not present specific acceptance criteria with quantifiable metrics that need to be met by the device. Instead, it relies on demonstrating substantial equivalence to a predicate device through performance testing. The "reported device performance" is summarized as having "the same scientific technology as the predicate device" and that "appropriate testing to determine substantial equivalence was completed."

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: The document describes "appropriate testing to determine substantial equivalence," which includes "testing to accompany Draft Guidance for the Content of Performance Data for Percutaneous Transluminal Balloon Dilation Catheters (January 24, 1992)." This implies physical and functional testing of the catheter itself (e.g., burst pressure, durability, etc.) rather than a clinical study involving patient data or a "test set" of cases. Therefore, concepts like sample size for a test set, country of origin, retrospective/prospective data provenance are not relevant for this type of 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: As there is no clinical "test set" in the sense of patient data requiring expert interpretation, the establishment of ground truth by clinical experts is not relevant to this submission. The "ground truth" for this device would be its physical and mechanical properties meeting engineering specifications.

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

• Not Applicable: Given the absence of a clinical test set requiring human interpretation, adjudication methods are not relevant.

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 a physical medical instrument (a nephrostomy balloon dilation catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or evaluation of AI assistance is entirely irrelevant.

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

• Not Applicable: As stated above, this is a physical medical device, not an algorithm. Standalone algorithm performance is not applicable.

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

• Not Applicable for clinical ground truth: The "ground truth" for this device's performance would be engineering specifications and standards described in the referenced "Draft Guidance for the Content of Performance Data for Percutaneous Transluminal Balloon Dilation Catheters (January 24, 1992)". This would involve physical and mechanical testing to ensure the balloon inflates correctly, the catheter has appropriate strength and flexibility, and other functional parameters are met. Clinical outcomes data or pathology are not used to establish ground truth for this type of device in a 510(k) submission.

8. The sample size for the training set

• Not Applicable: "Training set" is a concept related to machine learning and AI. This device is a physical catheter, so there is no training set.

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

• Not Applicable: As there is no training set, this question is not relevant.

Summary based on the document:

The Bard® X-Force™ Nephrostomy Balloon Dilation Catheter received 510(k) clearance based on substantial equivalence to the Cook® Ultraxx™ Nephrostomy Balloon Catheter. The primary evidence presented involved "appropriate testing to determine substantial equivalence" in accordance with the "Draft Guidance for the Content of Performance Data for Percutaneous Transluminal Balloon Dilation Catheters (January 24, 1992)." This guidance would outline the specific physical and mechanical tests required to demonstrate that the device performs as intended and is as safe and effective as the predicate device. However, the document does not contain the detailed results of these tests or specific acceptance criteria, as is typical for the publicly available 510(k) summary.

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