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Ask a specific question about this device

Ask a specific question about this device

The trocars and accessories are used to establish and maintain surgical access to the abdominal or thoracic cavity, access for surgical and laparoscopic instruments, and may provide a port with stopcock for insufflation.

Micro-France trocars are manually operated surgical instruments. They consist of a stainless steel mandrel used to establish surgical access to the abdominal or thoracic cavity, and a sleeve the maintain access for surgical and laparoscopic instruments. The trocars may include an automatic valve feature and a port with stopcock for insufflation. Trocar accessories include threaded and smooth sleeves, reduction sleeves, and parietal elevators.

The provided 510(k) summary for the Micro-France trocars and accessories does not contain specific information regarding acceptance criteria for device performance or a study proving it meets such criteria. This type of submission, often for Class II devices, typically relies on demonstrating substantial equivalence to legally marketed predicate devices rather than requiring de novo clinical performance studies with acceptance criteria.

Therefore, the following information is not available in the provided document:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not applicable as a performance study is not detailed.
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 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. The device is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic tool.
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: Not applicable.
8. The sample size for the training set: Not applicable (no software algorithm).
9. How the ground truth for the training set was established: Not applicable.

Summary of available information:

• Intended Use: The trocars and accessories are used to establish and maintain surgical access to the abdominal or thoracic cavity, access for surgical and laparoscopic instruments, and may provide a port with stopcock for insufflation.
• Substantial Equivalence: The device is deemed substantially equivalent to predicate devices marketed by Richard Wolf (K960299), Pilling Weck (K964450), and Ethicon Endo-Surgery (K965045). This is the primary basis for its clearance, implying that its safety and effectiveness are comparable to these established devices without requiring a new performance study with specific acceptance criteria.

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The Frontal Sinus Trephination Cannula is indicated for patients with sinus disease that require frontal sinus irrigation or repeated frontal sinus irrigation for up to thirty days.

The device consists of a cannula and an occlusion plug.

This medical device submission for the "Frontal Sinus Trephination Cannula" is a 510(k) premarket notification, which establishes substantial equivalence to existing predicate devices rather than proving safety and effectiveness through clinical trials with acceptance criteria. As such, the provided text does not contain any information about:

• Acceptance criteria or reported device performance
• Sample sizes or data provenance for test sets
• Number or qualifications of experts for ground truth
• Adjudication methods
• MRMC comparative effectiveness studies
• Standalone algorithm performance
• Type of ground truth used
• Sample size or ground truth establishment for training sets

The document focuses on:

1. Device Description: It details the device (cannula and occlusion plug).
2. Intended Use: Specifies its indication for frontal sinus irrigation for up to thirty days.
3. Substantial Equivalence (Predicate Devices): It identifies two predicate devices:
   • Medtronic Xomed Frontal Sinus Mini-Trephine Set irrigation cannula (for the trephination aspect).
   • Vansonnenberg Chest Drainage Tubes (K925176) and common peritoneal catheters (for the short-term indwelling aspect as an introduction/drainage catheter).
   • Bard Medical's Catheter Plug (for the occlusion plug).
4. Regulatory Classification: States the device's classification as Class I with specific product codes (77KBF, 79GBX).
5. FDA Clearance Letter: The letter from the FDA confirms substantial equivalence to legally marketed predicate devices and permits the device to be marketed, subject to general controls.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, and performance metrics because this type of information is not typically part of a 510(k) submission focused on substantial equivalence for a Class I device.

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The XPS/PowerSculpt System with reciprocating adapter and suction cannula is indicated for the removal of soft tissue and fluid from the body during general surgical procedures including suction lipoplasty for aesthetic body contouring.

The Power Control Unit, handpiece and principle of operation remain essentially the same as described in K984363. The standard blades that are used for tissue debridement and aspiration will be replaced by suction cannulae equivalent in design to predicate suction lipoplasty cannulae. Lastly, a removable adapter, similar to the adapter cleared for rasping in K983025, will be provided to translate the rotary action of the handpiece to a reciprocating action. The resulting reciprocation will facilitate the movement of the cannula through the adipose tissue.

The provided documents are a 510(k) notification and related FDA correspondence for the Xomed XPS/PowerSculpt System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with specific acceptance criteria and detailed performance metrics as expected for a typical AI/ML device submission.

Therefore, the requested information regarding acceptance criteria, specific study details (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), and ground truth establishment is not available in these documents.

The documents focus on the device's design, intended use, and comparison to legally marketed predicate devices to establish substantial equivalence based on technological characteristics and safety/effectiveness.

Here's what can be extracted and why the other information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Not Applicable / Not Available. The 510(k) submission for the XPS/PowerSculpt System does not present specific acceptance criteria in the form of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) that would be evaluated in a study with a test set. This type of evaluation is more common for diagnostic or AI/ML-driven devices.
• The FDA's substantial equivalence determination is based on the device having the same intended use and similar technological characteristics as predicate devices, without raising new questions of safety or effectiveness. The "performance" assessment is comparative, not based on meeting predefined numerical thresholds.

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

• Not Available. The document does not describe a "test set" in the context of a performance study with human subjects or retrospective data for evaluating accuracy. The device is a surgical system for tissue removal. The "test" it undergoes is primarily verification and validation of its mechanical and electrical components, alongside comparative analysis with existing devices.

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

• Not Applicable / Not Available. This device is a surgical instrument, not a diagnostic tool requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

• Not Applicable / Not Available. No test set or ground truth adjudication process is described.

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

• Not Applicable / Not Available. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. The XPS/PowerSculpt System is a surgical tool; therefore, this type of study is not relevant to its 510(k) submission.

6. Standalone (Algorithm Only) Performance Study

• Not Applicable / Not Available. This device is a mechanical surgical system, not an algorithm or AI model.

7. Type of Ground Truth Used

• Not Applicable / Not Available. As mentioned, the device is a surgical instrument. "Ground truth" in the context of diagnostic accuracy is not relevant here. The "truth" for this device would relate to its ability to perform its intended mechanical function safely and effectively, which is assessed through engineering tests and comparison to predicates.

8. Sample Size for the Training Set

• Not Applicable / Not Available. This device is a surgical instrument, not an AI/ML model that requires a training set.

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

• Not Applicable / Not Available. Again, not an AI/ML model.

Summary of what the documents do provide related to equivalence:

• Device Name: XPS/PowerSculpt System
• Intended Use: For the removal of soft tissue and fluid from the body during general surgical procedures including suction lipoplasty for aesthetic body contouring.
• Predicate Devices:
  • MicroAire PAD-100 "Power Aspiration Device" (K981922)
  • NuMED Power Cannula (510k unknown)
  • Various aspiration cannulae from Wells Johnson Company (K832520)
• Substantial Equivalence Rationale: The XPS/PowerSculpt System is considered substantially equivalent because it has the "same intended use and the same technological characteristics" as the predicate devices. Specifically, it consists of a console, handpiece, and disposable cannulae. An adapter converts rotary action to reciprocating action, simulating the manual motion of a surgeon using a standard aspiration cannula, reducing manual effort, and facilitating penetration of adipose tissue. The "end result and performance" are claimed to be equivalent to the predicate devices.

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Laser-Shield II is intended for endotracheal intubation. It is indicated for use for all types of surgical procedures involving carbon dioxide (10,60 microns) or KTP (532 nm) laser use (normal pulsed or continuous beam delivery in the non-contact mode), when endotracheal intubation is required to administer anesthesia gases or to overcome emergency obstruction of an airway.

Xomed Laser-Shield II is an endotracheal tube provided sterile with laser resistant overwraps of aluminum and fluoroplastic covering the silicone elastomer shaft. The tube is fitted with an inflatable cuff designed to provide tracheal seal. The inflation assembly/balloon contains dry methylene blue that mixes with a liquid inflation media (sterile normal saline) to provide visible detection of inadvertent cuff rupture by the laser. Sterile cottonoid patties are also provided for wetting and placement around the positioned and inflated cuff for additional heat sink.

The provided text is related to a 510(k) submission for a modification to an existing medical device, the Laser-Shield® II Tracheal Tube. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlines the intended use. However, it does not contain the detailed study information needed to fully address your request regarding acceptance criteria and device performance studies.

Here's a breakdown of what can be extracted based on the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document implies that the acceptance criterion for the modified device is "substantial equivalence" to the predicate device. This is a regulatory standard, not a performance metric with specific thresholds (e.g., >95% accuracy). The modification itself is described as "extension of the aluminum wrap under a portion of the cuff and covering of this extension with a flexible silicone sleeve." The key phrase is "The intended use and claims for the modified device remains unchanged and no new materials are being used." This suggests that the modified device should perform as safely and effectively as the original.
• Reported Device Performance: The text does not report specific quantitative performance metrics (e.g., laser resistance levels, cuff integrity under specific conditions) for either the original or the modified device. It merely states that the modification does not change the intended use or claims, implying that the performance is expected to be equivalent to the previously cleared device.

Missing Information:

• Specific numerical or qualitative performance metrics (e.g., "withstanding X joules of laser energy for Y seconds").
• A direct comparison of the modified device's performance against the predicate device using quantitative data.

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

The provided 510(k) summary does not describe a clinical or performance "test set" in the context of typical AI/diagnostic device studies. This submission is for a device modification of an existing physical medical device (an endotracheal tube), not a software algorithm. Therefore, concepts like "test set" in the machine learning sense, "country of origin," or "retrospective/prospective" studies do not apply in this document.

Missing Information: This entire section is not applicable or not present for this type of device submission.

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

Again, this submission is for a physical medical device. The concept of "ground truth" established by experts for a test set (e.g., for image interpretation or diagnosis) is not relevant here. The evaluation involves engineering principles, material science, and safety testing (e.g., biocompatibility guidance, laser resistance testing as per established standards for endotracheal tubes), not expert interpretation of outputs.

Missing Information: This section is not applicable or not present.

4. Adjudication Method for the Test Set

As there is no "test set" in the given context (no diagnostic performance study), an adjudication method is not described or relevant.

Missing Information: This section is not applicable or not present.

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 document describes a physical medical device (an endotracheal tube), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this submission.

Missing Information: This section is not applicable or not present.

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

This is not an algorithm or software device. This question is not applicable.

Missing Information: This section is not applicable or not present.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this type of physical device, "ground truth" would be established through a combination of:

• Engineering specifications and standards: The device is expected to meet certain physical and chemical properties.
• Performance testing: Laboratory tests demonstrating laser resistance, cuff integrity, etc. (though specific results are not in this summary).
• Biocompatibility data: Ensuring the materials are safe for human contact.
• Pre-clinical safety data: If animal or bench testing was done (not described in detail here).

The document states "The modified Xomed Laser-Shield II is identical to the current device with the exception of the extension of the aluminum wrap... The intended use and claims for the modified device remains unchanged and no new materials are being used." This implies that the ground truth for acceptability relies on the established safety and efficacy of the predicate device and the assessment that the modification does not alter this.

Missing Information: Specific details of technical performance studies that would constitute "ground truth" development for a physical device are not included in this high-level summary.

8. The Sample Size for the Training Set

This is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the AI sense.

Missing Information: This section is not applicable or not present.

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

As there is no training set for an AI model, this question is not applicable.

Missing Information: This section is not applicable or not present.

In summary, the provided 510(k) summary is for a physical medical device modification and focuses on demonstrating substantial equivalence to a predicate device. It does not contain the type of detailed performance study information, acceptance criteria, or ground truth establishment relevant to AI/diagnostic device submissions that your questions primarily target.

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The electrosurgical instruments are intended to remove tissue and control bleeding.

The various unipolar and bipolar Micro-France electrosurgical instruments consist of scissors, forceps, and probes, and are available in configurations for laparoscopic / endoscopic access and open field surgery. Accessories include unipolar and bipolar cables available in lengths up to 3 M.

The provided text is a 510(k) summary for electrosurgical instruments. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study on acceptance criteria and performance of the new device.

Therefore, the input does not contain the information necessary to describe:

• Acceptance criteria table and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• Whether a standalone (algorithm only) performance study was done.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily states the device's intended use ("to remove tissue and control bleeding") and identifies predicate devices that it claims substantial equivalence to. It does not provide performance metrics, study designs, or data related to demonstrating the device meets specific acceptance criteria in the way a clinical or performance study report would.

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