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The RealHand™ High Dexterity (HD) instruments are intended for grasping, mobilization, dissection, transection, suturing, and/or electrocautery of tissue under direct and endoscopic visualization.

A new electroconductive pathway was added. This change consists of two basic modifications to the existing instruments: 1) a post was added to attach a third party generator via an insulated commercially available legally marketed cable. 2) an internal jumper was added to conduct current from the post to the internal shaft of the instrument. The substantial equivalence of the changes are based on a comparison of physical and functional attributes of the device contrasted with the Novare predicate and the indications of the Pajunk instruments.

The place of manufacture has not changed. The physical appearance of the device, though slightly different, does not adversely affect the modified device. Functional expectations, material suitability, surgical technique and indications for use are just the same as the comparison devices placed in product code GCI by FDA.

RealHand™ High Dexterity Instruments are substantially equivalent to the original instruments with respect to functionality and performance characteristics based the following criteria:

1. RealHand™ High Dexterity Instruments provide hemostatic clamping that allows electrocautery and ligature of tissue. The performance of the systems are essentially identical.

2. The RealHand™ High Dexterity Instruments were carefully evaluated and compared with the original Novare device. Documented testing established that the characteristics are equal to the original.

3. The original device was evaluated for proper function during use. The modified RealHand™ High Dexterity Instruments were evaluated using a valid test methodology, including electrocautery function and the test result was equivalent, and

4. the RealHand™ High Dexterity Instruments worked as intended.

The provided text is a 510(k) summary for the RealHand High Dexterity (HD) Instruments. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval).

Therefore, the information you've requested regarding acceptance criteria, specific study details with sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not present in this document.

The document outlines the rationale for substantial equivalence based on physical and functional attributes. It does not contain data from a study designed to meet specific performance acceptance criteria in the way you've described.

Here's a breakdown of what is available in the document, framed against your request:

1. Table of Acceptance Criteria and Reported Device Performance

• Not Applicable in the traditional sense. The document asserts substantial equivalence, not performance against specific, quantifiable acceptance criteria.
• What is present:
  The document states:
  • "RealHand™ High Dexterity Instruments provide hemostatic clamping that allows electrocautery and ligature of tissue. The performance of the systems are essentially identical." (to the predicate device)
  • "Documented testing established that the characteristics are equal to the original." (predicate device)
  • "The modified RealHand™ High Dexterity Instruments were evaluated using a valid test methodology, including electrocautery function and the test result was equivalent..." (to the predicate device)
  • "...the RealHand™ High Dexterity Instruments worked as intended."

2. Sample Size for Test Set and Data Provenance

• Not Provided. The document mentions "documented testing," but does not specify sample sizes for these tests, the type of data, or its provenance (e.g., country of origin, retrospective/prospective clinical data).

3. Number of Experts and Qualifications for Ground Truth

• Not Provided. This information is relevant for studies establishing ground truth, which is not described in this 510(k) summary.

4. Adjudication Method

• Not Provided. Not applicable given the nature of the submission.

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

• Not Performed/Reported. There is no mention of an MRMC study or any comparative effectiveness study with human readers, with or without AI assistance. This device is a surgical instrument, not an imaging or diagnostic AI-powered tool.

6. Standalone Algorithm Performance

• Not Performed/Reported. This device is a physical surgical instrument, not an algorithm or AI.

7. Type of Ground Truth Used

• Not Applicable in the context of this 510(k). "Ground truth" typically refers to definitive diagnostic or outcome data for evaluating an algorithm's accuracy. Here, the comparison is to the functional attributes of a predicate device. The "ground truth" implicitly refers to the established safety and performance of the predicate device.

8. Sample Size for the Training Set

• Not Applicable. As this is a physical device submission, there is no "training set" in the sense of machine learning algorithms.

9. How Ground Truth for Training Set was Established

• Not Applicable. Same as above.

In summary: The provided document is a 510(k) premarket notification for a modified surgical instrument. It aims to demonstrate "substantial equivalence" to existing legally marketed devices, primarily by comparing physical and functional characteristics. It does not contain the kind of detailed study data, acceptance criteria, sample sizes, or ground truth methodologies that would be present in a submission for an AI/ML-powered diagnostic device or a de novo classification requiring new performance data.

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The RealHand™ High Dexterity (HD) Instruments are intended for grasping, mobilization, dissection, transection and / or suturing of tissue under direct and endoscopic visualization.

The RealHand Instruments are single use, sterile instruments that consist of a handle, jaws, and a shaft which includes distal and proximal articulating sections. The instruments are similar in size to other instruments and are designed for use through an incision or appropriately sized surgical trocars/ports. The instrument jaws (or scissor blades) are activated by compressing and releasing the handle. The handle can include a ratchet and ratchet release which allow the instrument jaws to be locked in place, a rotation control wheel and articulation lock.

The provided text describes a 510(k) submission for the RealHand™ High Dexterity (HD) Instruments. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness or meeting specific performance acceptance criteria through the rigorous study designs typically associated with AI/ML devices. As such, many of the requested categories are not applicable or cannot be extracted from this document in the context of an "AI/ML device."

Here's an analysis based on the provided text, highlighting where information is available and where it's not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document states "Testing comparing the RealHand Instruments to a commercially available predicate product was conducted." but does not quantify the number of instruments tested or the number of procedures performed.
• Data Provenance: Not specified. The study involved "tissue," which could be ex-vivo, in-vivo animal, or human (though less likely for equivalence studies of this nature without explicit mention). The country of origin is not mentioned. The study appears to be prospective testing for regulatory submission.

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 surgical instrument, not an AI/ML diagnostic or predictive tool requiring expert-established ground truth for its performance evaluation in the way an AI algorithm would. Its performance was assessed through functional testing and comparison to a predicate, not clinical accuracy or diagnostic interpretation.

4. Adjudication method for the test set:

• Not applicable. As above, this is for a surgical instrument, not an AI/ML device requiring adjudication of diagnostic outputs.

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 not an AI/ML device, and no MRMC study was performed as described.

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

• Not applicable. This device is a manual surgical instrument and does not involve an algorithm.

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

• For the functional testing, the "ground truth" was likely defined by the successful execution of intended actions (grasping, manipulating, cutting, suturing tissue) as per the product specifications and comparison to the predicate device's performance. There's no mention of expert consensus, pathology, or outcomes data being used to establish ground truth in the context of an AI/ML performance metric.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, and therefore no training set was used.

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

• Not applicable. As there is no training set for an AI/ML model, no ground truth was established for this purpose.

Summary of the Device Evaluation Approach in this Document:

The evaluation of the RealHand™ High Dexterity (HD) Instruments for its 510(k) clearance was based on demonstrating substantial equivalence to an existing legally marketed predicate device (Endolink TM True Movement System™ K043541). This involved:

• Bench Testing: "Product testing was conducted to evaluate conformance to product specification. Testing included grasping, manipulating, cutting and suturing of tissue."
• Comparative Testing: "Testing comparing the RealHand Instruments to a commercially available predicate product was conducted. The products were used per their respective Instructions for Use. The results showed the RealHand Instruments were equivalent to the predicate device."
• Review of intended use, basic overall function, methods of manufacturing, and materials used.

The clearance states that "The RealHand Instruments are equivalent to the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent." This meets the regulatory requirements for a 510(k) submission, confirming it is as safe and effective as the predicate device.

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The Endolink™ True Movement System™ is intended for grasping, mobilization, dissection and transaction of tissue under direct and endoscopic visualization.

The Endolink™ True Movement System™ (Endolink Instruments) are single use, sterile instruments that consist of a handle, jaws, and a shaft which includes distal and proximal articulating sections. The Endolink Instruments are similar in size to other instruments and are designed for use through an incision or appropriately sized surgical trocars/ports. The instrument jaws (or scissors blades) are opened and closed by compressing and releasing the handle. The handle can include a ratchet and ratchet release which allow the instrument jaws to be locked in place.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Product testing" and "Testing comparing the Endolink Instruments to a commercially available predicate product."

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The comparative testing appears to be primarily performance-based (grasping, manipulating, cutting, suturing) against a predicate device, rather than requiring expert-annotated ground truth in the traditional sense.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method. The study described is a comparison against a predicate device, not a human reader study requiring adjudication.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The study described focuses on direct device equivalence to a predicate, not on how human readers improve with AI assistance.

6. Standalone Performance Study

Yes, a form of standalone performance study was conducted. The document states:

• "Product testing was conducted to evaluate conformance to product specifications."
• "Testing comparing the Endolink Instruments to a commercially available predicate product was conducted."
• "results showed the Endolink Instruments were equivalent to the predicate device."

While not a typical "AI standalone performance study," these statements indicate the device's functional performance was evaluated independently and in comparison to a benchmark.

7. Type of Ground Truth Used

The "ground truth" in this context appears to be the performance and characteristics of the predicate device. The Endolink True Movement System™ was evaluated for its ability to match the functional capabilities and material properties of existing, legally marketed devices. This is a form of comparative ground truth rather than a clinical ground truth like pathology or expert consensus on a diagnosis.

8. Sample Size for the Training Set

The document does not mention any training set. This is not an AI/ML device in the modern sense; it's a surgical instrument. Therefore, there's no "training set" as would be relevant for machine learning models.

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

Not applicable, as there is no training set mentioned for this device.

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The ENclose™ II Anastomosis Assist Device is intended for use by cardiac surgeons in place of partial occluding clamps during coronary artery bypass grafting (CABG) procedures requiring one to three proximal anastomoses in ascending aortas free of atheromatous disease.

The modified ENclose™ II Anastomosis Assist Device is an intraoperative device used to assist in the creation of one to three proximal anastomosis sites in the execution of coronary artery bypass grafting (CABG) procedures. Materials for the new device are identical to the previous device with the exception of the colorant. The proposed changes are limited to manufacturing/processing changes, a change in the colorant used in the existing plastic of the device, a change in the shape of the expandable region of the lower jaw and the addition of a fiber reinforced polymer hex driver to assist with deployment of the device if desired.

This document is a 510(k) Premarket Notification for the ENclose™ II Anastomosis Assist Device, seeking clearance based on substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

The document describes a medical device (a vascular clamp) and its physical characteristics, intended use, and comparison to predicate devices, but it does not detail any performance studies in the way one would for an AI/ML device. This submission focuses on demonstrating substantial equivalence to existing devices through feature comparison and material certification, not through clinical performance metrics against specific acceptance criteria.

Specifically, the document does not provide:

1. A table of acceptance criteria and the reported device performance for an AI/ML model.
2. Sample size used for the test set or data provenance for an AI/ML model.
3. Number of experts and their qualifications for establishing ground truth for an AI/ML test set.
4. Adjudication method for an AI/ML test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information (human readers improving with AI vs. without AI).
6. Standalone (algorithm-only) performance data for an AI/ML model.
7. Type of ground truth used (e.g., pathology, outcomes data) for an AI/ML model.
8. Sample size for the training set for an AI/ML model.
9. How ground truth for the training set was established for an AI/ML model.

Because the ENclose™ II Anastomosis Assist Device is a physical surgical instrument and not an AI/ML diagnostic or therapeutic device, the information requested is not applicable to this submission. The "substantially equivalent" claims are based on physical design, materials, manufacturing, intended use, and functional testing, not data-driven performance metrics typical for AI/ML products.

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The ENclose™ Anastomosis Assist Device is intended for use by cardiac surgeons in place of partial occluding clamps during coronary artery bypass grafting (CABG) procedures requiring one to three anastomoses in ascending aortas free of atheromatous disease.

The modified ENclose™ Anastomosis Assist Device is a intraoperative device used to assist in the creation of one or more proximal anastomosis sites in the execution of coronary artery bypass grafting (CABG).

The provided text describes a 510(k) premarket notification for the ENclose™ Anastomosis Assist Device, seeking to expand its indications for use from single-vessel to one-to-three proximal anastomoses during coronary artery bypass grafting (CABG) procedures. The submission claims substantial equivalence to its previously cleared version (InCluder™ Vascular Clamp - K010694).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to demonstrating "functional equivalence" and "substantial equivalence" to the predicate device for the expanded use. The performance is reported in a summary statement rather than specific quantitative metrics.

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

• Sample Size: The text does not provide a specific sample size for the clinical testing. It only states "Clinical testing conducted in Canada and Europe."
• Data Provenance: The data was collected from "Canada and Europe." It explicitly states "Clinical testing," implying prospective collection, though the precise study design (e.g., randomized controlled trial, observational) is not detailed.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth within the clinical testing. It refers to "cardiac surgeons" as the intended users, but doesn't detail their role in defining study outcomes or ground truth.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The device is a surgical clamp, not an imaging interpretation device where MRMC studies are typically performed. The comparison is between the new device's performance for 1-3 anastomoses and the predicate device's performance for single anastomosis, based on overall reported safety and difficulty.

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

This question is not applicable. The ENclose™ Anastomosis Assist Device is a surgical instrument, not an algorithm or AI system. Its performance is directly tied to its use by a human surgeon.

7. The Type of Ground Truth Used

The "ground truth" for the clinical testing appears to be based on observed clinical outcomes (safety, difficulty) during coronary artery bypass grafting procedures performed using the device for 1-3 anastomoses, compared to the previously established performance of the predicate device for single anastomosis. There is no mention of "expert consensus," "pathology," or other specific types of ground truth often seen in diagnostic device studies.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical surgical instrument, not a machine learning model that requires a training set. The development of the device would involve engineering and material testing, not data training.

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

This question is not applicable as there is no training set for a device of this nature.

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For Vascular Work
Suitable for veins and arteries
ENGAGE Jaw Inserts are used with a surgical clamp to occlude a blood vessel temporarily and may be used to clamp over indwelling catheters.
ENGAGE Jaw Inserts are adaptable to Fogarty Hydragrip® Surgical Clamps.

ENGAGE Jaw Inserts are used with a surgical clamp to occlude a blood vessel temporarily and may be used to clamp over indwelling catheters. ENGAGE Jaw Inserts are adaptable to Fogarty Hydra-Grip Surgical Clamps. This surgical clamp is intended for use in vascular surgery.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is primarily a 510(k) summary and FDA clearance letter for the Novare Surgical ENGAGE Inserts, establishing its substantial equivalence to predicate devices. It focuses on the device's intended use, classification, and regulatory approval.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study given the input.

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Ask a specific question about this device