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To occlude and ligate vessels, ducts, tracts, and other tubular structures during Laparoscopic and general surgical procedures

The Microline Reusable Laparoscopic Clip Applier with Implantable Titanium Surgical Clips is a reusable instrument designed for use with a disposable clip cartridge that is advanced inside the clip applier shaft. The rotatable clip applier shaft is sized to fit through a 10mm trocar. The Microline Reusable Laparoscopic Clip Applier is sold with a pre-loaded clip cartridge which contains 19 rectangular implantable titanium single-use surgical clips (width 5.4mm) that can be applied one at a time after firing. Cartidge loading is performed through a slot located in the rear of the instrument, in line with the instrument's shaft. Cartridge loading and unloading can be performed in-vivo without removing the Clip Applier from the trocar.

The provided text is a 510(k) summary for the Microline Reusable Laparoscopic Clip Applier with Implantable Titanium Clips. This document asserts substantial equivalence to predicate devices and does not describe a clinical study with acceptance criteria, device performance, or ground truth.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on similarity to already approved devices rather than new performance data.

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Cutting and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures where instruments are introduced into the body through a cannula.

The Microline ACCUSHEAR Laparoscopic Surgical Instruments are a line of nonsterile, reusable 5 mm diameter instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula. The device is used with monopolar electrosurgical generators.

This is a 510(k) premarket notification for a medical device (ACCUSHEAR Laparoscopic Surgical Instruments), not an AI/ML medical device. Therefore, the concept of "acceptance criteria" and "study proving device meets acceptance criteria" as it applies to AI/ML performance metrics and studies is not directly applicable in the same way.

However, based on the provided text, I can infer the "acceptance criteria" for this device from the perspective of substantial equivalence to a predicate device, and the "study" is the information provided in the 510(k) submission itself that demonstrates this equivalence.

Here's how I can interpret and answer your request in the context of this specific regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

For a traditional medical device 510(k), the "acceptance criteria" is typically demonstrating substantial equivalence to a legally marketed predicate device. The "performance" is that the new device performs as safely and effectively as the predicate, with no new questions of safety or effectiveness.

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

This is not applicable for this type of device and submission. There is no "test set" in the context of an AI/ML device relying on data. The submission relies on a comparison of the device's design and intended use to existing devices.

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

This is not applicable. There is no ground truth, test set, or expert review in this sense for a traditional surgical instrument 510(k). The "ground truth" is established by the existing regulatory clearance and safe market history of the predicate devices.

4. Adjudication method for the test set

This is not applicable. There is no test set or adjudication method for this type of submission.

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. This is not an AI/ML device, and no MRMC study would be performed.

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

This is not applicable. This is not an AI/ML device.

7. The type of ground truth used

For a traditional 510(k) like this, the "ground truth" (if you can call it that) is the demonstration of substantial equivalence to a legally marketed device that has already established its safety and effectiveness. This is based on:

• Predicate Device History: The predicate devices ("Re-New" K962119 and "Selec-Tip" K980758) have already been cleared by the FDA, implying their safety and effectiveness have been appropriately assessed.
• Design Rationale: The manufacturer's rationale that the minor modification to the shaft and handpiece connection does not affect safety or effectiveness.

8. The sample size for the training set

This is not applicable. This is not an AI/ML device, and there is no training set.

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

This is not applicable. There is no training set for this type of device.

In Summary for this Specific Device:

The "study" proving the device meets "acceptance criteria" for a 510(k) is the submission itself, which articulates:

• The device's description and intended use.
• The identification of predicate devices with established safety and effectiveness.
• A detailed comparison demonstrating that the new device is substantially equivalent to the predicate, particularly highlighting that any modifications are minor and do not introduce new safety or effectiveness concerns.

The FDA's review of this submission and subsequent clearance (K982984) serves as the "proof" that the device meets the regulatory acceptance criteria for market entry via the 510(k) pathway.

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Cutting, Grasping, and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures.

The Disposable Re-New Forceps Laparoscopic Surgical Tips are an extension of the Re-New Forceps Laparoscopic Instruments product line used to cut, grasp, and dissect various abdominal tissue during Endoscopic (inclusive of laparoscopic) surgical procedures. The Disposable Re-New Forceps Laparoscopic Surgical Tips consist of a series disposable tip configurations. Tip configurations include: Grasper, Fenestreded Forceps, "Dolphin Nose" Dissector, "Babcock", and "Maryland" Dissector.

The provided text is a 510(k) Summary and related FDA correspondence for the "Disposable Re-New Forceps Laparoscopic Surgical Tips." This document primarily focuses on establishing substantial equivalence to a predicate device and gaining market clearance. It does not contain information about acceptance criteria or specific studies proving the device meets particular performance metrics.

The device in question is a manual surgical instrument, not an AI/ML-driven medical device. Therefore, many of the requested fields related to AI/ML device evaluation (like MRMC studies, training set details, or ground truth for AI) are not applicable.

Here's a breakdown based on the provided text, highlighting the absence of the requested information:

Acceptance Criteria and Device Performance Study

As this device is a manual surgical instrument and the documentation is for 510(k) premarket notification, it focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies against specific acceptance criteria. The document states:

• "The technical characteristics of the Disposable Re-New Forceps Laparoscopic Surgical Tips are identical to those of the Microline Re-New Forceps (K974066)."
• "Differences that exist between these devices relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness of the Disposable Re-New Forceps relative to its predicate."

This indicates that the acceptance criteria are implicitly met by demonstrating sameness or non-inferiority in safety and effectiveness compared to the predicate device. Specific quantitative performance metrics and acceptance thresholds are not detailed in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. The 510(k) summary does not describe a "test set" in the context of an AI/ML or diagnostic device validation. The evaluation is based on a comparison of device characteristics to a predicate, not on clinical performance data from a specific test set.

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

Not applicable. No "ground truth" or expert consensus is described for device validation in this 510(k) summary.

4. Adjudication method for the test set

Not applicable. No test set or 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

Not applicable. This is a manual surgical instrument, not an AI-assisted diagnostic device.

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

Not applicable. This device is a manual instrument, not an algorithm.

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

Not applicable. No ground truth is described. The evaluation relies on demonstrating substantial equivalence to a predicate device based on technical characteristics, materials, and intended use.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set mentioned.

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

Not applicable. As there's no training set, there's no ground truth establishment for it.

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The Microline reusable 3 mm and 5 mm diameter Electrosurgical Cautery Probes are intended to deliver energy from an independent monopolar electrosurgical generator to cauterize tissues during laparoscopic (inclusive of endoscopic) surgical procedures where instruments are introduced into the body through a cannula.

The Microline Electrosurgical Cautery Probes are a line of non-sterile, reusable 3 mm and 5 mm diameter instruments used to deliver energy from an independent monopolar electrosurgical generator to cauterize tissue during laparoscopic (inclusive of endoscopic) surgical procedures where instruments are introduced into the body through a cannula.

The provided text is a 510(k) summary for a medical device (Electrosurgical Cautery Probes). It focuses on establishing substantial equivalence to a predicate device rather than presenting extensive performance studies or acceptance criteria for the new device.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not present in the provided text.

However, I can extract the information that is available:

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

This information is not provided in the document. The document primarily focuses on establishing substantial equivalence based on device description and comparison to a predicate, not on specific performance criteria or a study demonstrating meeting those criteria.

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 provided in the document. No specific test set or study data is presented.

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 provided in the document. No ground truth establishment for a test set is discussed.

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

This information is not provided in the document. No test set or 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

This information is not provided in the document. An MRMC study is not mentioned, and AI assistance is not relevant to this device.

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

This information is not provided in the document. As this is an electrosurgical probe, it's a physical instrument, not an algorithm.

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

This information is not provided in the document. No ground truth is discussed in the context of device performance testing.

8. The sample size for the training set

This information is not provided in the document. No training set is mentioned as this is a physical device, not an AI/ML algorithm.

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

This information is not provided in the document. No training set or ground truth establishment for it is discussed.

Summary of available information relevant to "proving the device meets acceptance criteria":

The document primarily states that the Microline Electrosurgical Cautery Probes are "substantially equivalent" to the Olsen Electrosurgical reusable laparoscopic electrodes (K913108). This is the core "proof" presented in a 510(k) submission, meaning that the new device is as safe and effective as a legally marketed predicate device.

Specifically:

• Substantial Equivalence Statement: "The Microline Electrosurgical Cautery Probes are substantially equivalent to the Olsen Electrosurgical reusable lapasocopic electrodes (K913108)."
• Basis for Equivalence: "Differences that exist between these devices relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness of the Microline Electrosurgical Cautery Probes relative to its predicate."
• Indications For Use: The new device shares the same intended use: "to deliver energy from an independent monopolar electrosurgical generator to cauterize tissue during laparoscopic (inclusive of endoscopic) surgical procedures where instruments are introduced into the body through a cannula."

In essence, the "acceptance criteria" here are met by demonstrating that the device is fundamentally similar in function, materials, and safety/effectiveness profile to a previously approved device. The "study" proving this is the detailed comparison and justification presented in the 510(k) submission itself, stating that any differences do not impact safety or effectiveness.

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Cutting and Dissecting Various Abdominal Tissue during . Endoscopic (inclusive of laparoscopic) Surgical Procedures.

The "3 MM Selec-Tip" Laparoscopic Surgical Instruments are a line of non-sterile, reusable small diameter instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic, surgical procedures. The device can be used with monopolar electrosurgical generators.

The provided text describes a 510(k) summary for the "3 MM Selec-Tip" Laparoscopic Instruments, a medical device. This type of regulatory submission is focused on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a study with performance metrics in the same way an AI/ML device would.

Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets them because it's a submission for a traditional medical device, not an AI/ML diagnostic tool that would typically involve such studies.

Specifically:

• No table of acceptance criteria and reported device performance: The document does not define specific performance metrics or acceptance criteria for the "3 MM Selec-Tip" Laparoscopic Instruments. Its purpose is to demonstrate substantial equivalence to predicate devices, not to measure specific clinical performance.
• No sample size for the test set or data provenance: No test sets or data for performance evaluation are mentioned.
• No number of experts or qualifications for ground truth: No ground truth establishment is described as there is no diagnostic or AI/ML component being evaluated.
• No adjudication method: Not applicable given the nature of the device and submission.
• No multi-reader multi-case (MRMC) comparative effectiveness study: This is not an AI-assisted diagnostic device, so such a study would not apply.
• No standalone (algorithm only) performance study: This is not an algorithm-based device.
• No type of ground truth used: Not applicable.
• No sample size for the training set: Not applicable, as there is no AI/ML model being trained.
• No description of how ground truth for the training set was established: Not applicable.

The document primarily focuses on:

• Device Identification: "3 MM Selec-Tip" Laparoscopic Instruments
• Predicate Devices: "Selecta-Tip" (K970826) and Richard Wolf Medical Instruments (K973648)
• Device Description: Non-sterile, reusable small diameter instruments for cutting and dissecting abdominal tissue in endoscopic/laparoscopic procedures, usable with monopolar electrosurgical generators.
• Substantial Equivalence: Claiming that technical specifications, materials, and physical appearance differences do not affect safety or effectiveness compared to predicates.
• Indications For Use: Cutting and dissecting various abdominal tissue during endoscopic (inclusive of laparoscopic) surgical procedures.

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The "Re-New Forceps" Laparoscopic Surgical Tips are intended to cut, grasp, and dissect various abdominal issue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula.

The "Re-New Forceps" Laparoscopic Surgical Tips are an extension of the "Re-New" Laparoscopic Instruments product line used to cut, grasp, and dissect various abdominal tissue during Endoscopic (inclusive of laparoscopic) surgical procedures.

The "Re-New Forceps" Laparoscopic Surgical Tips consist of a series reusable tip configurations. The tip assembly, designed with a double thread, permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. Tip configurations include:

• · Grasper,
• · Fenestreded Forceps.
• · "Dolphin Nose" Dissector,
• · "Babcock", and
• · "Maryland" Dissector

The provided text describes a 510(k) premarket notification for "Re-New Forceps" Laparoscopic Surgical Tips and focuses on demonstrating substantial equivalence to a predicate device ("Re-New" K962119). It does not contain information about acceptance criteria, device performance metrics, or study designs (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies) typically associated with direct studies proving a device meets specific performance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study that proves the device meets those criteria, as this information is absent from the provided document.

The document is a 510(k) summary, which is primarily concerned with establishing substantial equivalence to a legally marketed predicate device, rather than detailed performance study results against specific acceptance criteria.

Here's what can be inferred or stated based on the provided text, addressing the points where information is available:

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

• Information Not Available: The document does not specify quantitative acceptance criteria or provide a table of reported device performance metrics (e.g., force measurements, dissection efficiency, tissue damage scores) against such criteria. The basis for clearance is "substantial equivalence" to a predicate device.

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

• Information Not Available: No information regarding sample sizes for a test set, data provenance, or whether any studies were retrospective or prospective is provided. The submission focuses on device description and comparison to a predicate.

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)

• Information Not Available: There is no mention of experts, ground truth establishment for a test set, or their qualifications.

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

• Information Not Available: No information regarding adjudication methods is provided.

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

• Information Not Available: This device is a surgical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human "readers" and AI assistance is not applicable and not mentioned.

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

• Information Not Available / Not Applicable: This is a manual surgical instrument, not an algorithm. Standalone algorithm performance is not relevant.

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

• Information Not Available: No ground truth data or its source is mentioned in relation to performance evaluation. Substantial equivalence relies on comparing the new device's technical characteristics and intended use to those of the predicate device.

8. The sample size for the training set

• Information Not Available: No training set or associated sample size is mentioned, as this is not an AI/machine learning device.

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

• Information Not Available / Not Applicable: No training set or ground truth for such a set is relevant or discussed for this type of device.

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"Selecta-Tip" Laparoscopic scissors tips are intended for use to cut and dissect various abdominal tissue in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula.

The Selecta-Tip" Laparoscopic Scissors are surgical blades used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic, surgical procedures. The product line includes reusable common handles that can be easily attached and detached from a series of reusable tips. The tip assembly is designed with a proprietary single thread and ball system, which permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. Scissors tip configurations include: Metzenbaum, Mini, Hook, Endocut, and Micro.

Here's an analysis of the provided text, focusing on the request for acceptance criteria and study details.

Based solely on the provided text for K970826, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria.

This document is a 510(k) premarket notification for a medical device. The purpose of a 510(k) is to demonstrate substantial equivalence to a predicate device, not necessarily to prove the device meets specific performance metrics through a clinical study.

Therefore, most of your requested information cannot be extracted from this text.

I will populate the table and answer the questions to the best of what the document offers, making it clear when the information is not present.

Acceptance Criteria and Device Performance Study Analysis (K970826)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable/Not mentioned. No test set or study data is described.
• Data Provenance: Not applicable/Not mentioned. The document describes the device and its predicate.

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

• Number of Experts: Not applicable/Not mentioned. No ground truth establishment described.
• Qualifications of Experts: Not applicable/Not mentioned.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/Not mentioned. No test set or adjudication process 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

• MRMC Study: No. The device is a surgical instrument (scissors tips), not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant or described.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This is a physical surgical device, not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: Not applicable/Not mentioned. No ground truth is described as being established for this submission. The basis for clearance is "Substantial Equivalence" to the predicate, implying the predicate itself established sufficient safety and effectiveness.

8. The sample size for the training set

• Sample Size: Not applicable/Not mentioned. There is no training set described as this is a physical device, not a machine learning model.

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

• Ground Truth Establishment: Not applicable/Not mentioned. No training set or ground truth establishment for a training set is described.

Summary based on the provided text:

The document K970826 is a 510(k) summary focused on establishing substantial equivalence for the "Selecta-Tip" Laparoscopic Scissors to a predicate device, "Re-New (K962119)." It provides details on:

• Submittor information
• Device identification
• Identification of the predicate device
• Device description (reusable handles, detachable scissors tips for various abdominal tissues)
• A statement of substantial equivalence, noting that differences in technical specifications, materials, and physical appearance do not affect relative safety or effectiveness.

Crucially, this document does not contain information about explicit acceptance criteria or a dedicated study with performance metrics, sample sizes, expert adjudication, or ground truth relevant to your specific questions about device performance analysis (e.g., sensitivity, specificity, accuracy often associated with diagnostic tools or complex algorithms). These types of detailed studies are more common for novel devices or those seeking clinical claims beyond substantial equivalence to an already marketed device. For a 510(k) for a surgical instrument, the "proof" often lies in demonstrating that its design, materials, and intended use are similar enough to a device already deemed safe and effective by the FDA.

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The "Quick Switch" and "Re-New" are intended for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula .

The Re-New" Laparoscopic Scissors are surgical instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic, surgical procedures. The product line includes reusable common handles that can be easily attached and detached from a series of surgical tips available, which include : disposable tips, and reusable tips. The tip assembly is designed with a proprietary double thread, which permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. Tip configurations include: Metzenbaum, Mini, Hook, Endocut, and, Micro.

The provided text is a "510(k) Summary" for a medical device called "Re-New" Laparoscopic Instruments. It primarily focuses on demonstrating substantial equivalence to a predicate device, "Quick Switch." The document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or MRMC studies as requested in the prompt.

Therefore, I cannot extract the requested information from the provided text. The document is an FDA submission for market clearance, not a detailed technical study report.

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