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angiOCCLUDE ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of vessel or tissue structure to be ligated based upon their experience, judgment, and needs.

AngiOCCLUDE ligating clips are permanent implant, non-absorbable, sterile, surgical clips made from an implantable grade of Titanium and are available in six different sizes (micro, small-wide, medium, medium-large and large).

The provided text describes a 510(k) submission for the "angiOCCLUDE Ligating Clips" aiming for substantial equivalence to the Teleflex Medical Horizon Ligating Clips. This document primarily focuses on regulatory approval based on comparison to a predicate device and does not contain information about acceptance criteria or a study proving that the device meets those criteria in the way a clinical study would for an AI-powered diagnostic device.

However, I can extract the "performance data" that was summarized to show substantial equivalence, which can be thought of as criteria for demonstrating equivalence to the predicate device.

Here's the breakdown based on your request, with an important note that this is not a clinical study of device performance against specific clinical acceptance metrics, but rather a comparison study for substantial equivalence according to FDA 510(k) regulations:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices seeking 510(k) clearance, the "acceptance criteria" are generally tied to demonstrating substantial equivalence to a legally marketed predicate device. In this instance, the criteria are based on direct comparison to the Teleflex Medical Horizon Ligating Clips.

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

The document does not specify a "test set" in the context of clinical or AI performance evaluation. Instead, the "study" is a comparison conducted by the manufacturer against the predicate device. The sample sizes for the quantitative and qualitative performance analyses are not explicitly stated (e.g., number of clips tested for closure, number of units measured for dimensions). The "data provenance" is internal testing and comparison performed by A2 Medical Systems, LLC.

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

This information is not applicable and not provided in the document. The study described is a technical and material comparison, not one requiring expert human interpretation or establishment of ground truth in a diagnostic sense.

4. Adjudication Method

Not applicable as there is no human interpretation or diagnostic ground truth to adjudicate.

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

No MRMC study was done. This device is a surgical clip, not a diagnostic imaging device that would typically involve human readers or AI assistance in interpretation.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

This device is a physical surgical clip, not an algorithm. Therefore, a standalone performance study without human-in-the-loop performance, in the context of AI/algorithms, is not applicable. The performance studies conducted were mechanical and material comparisons, as outlined in the table above.

7. Type of Ground Truth Used

The "ground truth" here is the established design, material properties, and performance characteristics of the legally marketed predicate device (Teleflex Medical Horizon Ligating Clips), against which the new device is compared. This is based on demonstrable physical properties and existing regulatory acceptance of the predicate.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device. The "ground truth" for the comparison was the predicate device's characteristics.

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angioLOCK® Non-Absorbable Polymer Ligation Clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

AngioLOCK ligating clips are permanent implant, non-absorbable, sterile single use, surgical clips made of implantable grade polymer and are available in multiple sizes.

ligating clips are non-absorbable, non-active implantable devices to be used for ligation of vessels and tissue structures. The clips are made of acetal homopolymer and are offered in three sizes; medium/large, large and x-large. Each clip size is compatible with a corresponding clip applier that may be designed for either general or endoscopic procedures. The clips are supplied in quantities of six according to size in color coded cartridges that are prepackaged sterile and single-use.

angioLOCK® open and Laparoscopic Ligation Clip Appliers are for use as delivery devices for angioLOCK® Non-Absorbable Polymer Ligation Clips. Other ligation clips cannot be used with these appliers. angioLOCK® Laparoscopic Polymer Ligation Clip Appliers are designed for use with specific size cannulas.

This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the angioLOCK Polymer Ligating Clip. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study with acceptance criteria.

Therefore, the information regarding acceptance criteria, device performance tables, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used, training set sample size, and ground truth establishment for the training set cannot be extracted from the provided text because these elements are typically associated with performance studies against established criteria, which are not detailed in this regulatory submission for substantial equivalence.

The document does provide information about the device's comparison to a predicate device, which is a different type of assessment.

Here's an analysis of the information that is available:

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

• This information is not present in the document. The document focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific quantitative performance acceptance criteria in a dedicated study.

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

• This information is not present. The document describes qualitative and dimensional comparisons to a predicate device, but not a study involving a "test set" in the context of performance metrics.

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 present. Ground truth establishment for a test set is not discussed.

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

• This information is not present. Adjudication methods are not discussed.

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 present. This device is a polymer ligating clip, not an AI-assisted diagnostic tool, so an MRMC study is not applicable.

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

• This information is not present. This device is a physical surgical clip, not an algorithm.

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

• This information is not present. The concept of "ground truth" in the context of performance evaluation against clinical outcomes is not applicable or discussed for this type of device and submission.

8. The sample size for the training set:

• This information is not present. This device does not involve a "training set" in the context of machine learning or AI.

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

• This information is not present. This device does not involve a "training set" or its ground truth establishment.

Information that is extractable regarding the comparison to a predicate device (instead of a performance study):

The document details a substantial equivalence analysis between the angioLOCK Polymer Ligating Clip and the predicate device, Teleflex Medical Hem-o-lok Ligating Clips (510k - K030311).

Summary of Performance Data (as presented for substantial equivalence):

The document states that "AngioLOCK ligating clips are made of an implantable grade of polyacetal polymer with same dimensions and same material characteristics as the predicate Teleflex Medical Hem-o-lok ligating clips."

The following analyses (not performance studies against acceptance criteria) were performed to demonstrate substantial equivalence:

• i. Dimensional comparison: angioLOCK clip to predicate clip dimensional comparison was completed at an open and closed state within an applier, resulting in "having the same function as Hem-o-lok when clips are applied and closed."
• ii. Material comparison: "Both biocompatibility and polymer material comparisons prove that the molded and sterilized material used for the angioLOCK clip is as safe and the same as the material used in Hem-o-lok."
• iii. Qualitative closure testing: "angioLOCK clip closure testing proved that the clips latch/lock, are secure in the applier, and release from applier's jaws equivalent to Hem-o-lok."
• iv. Qualitative dimensional/geometry comparisons: "dimensional/geometry comparisons using precise overlays prove that angioLOCK and Hem-o-lok clips are the same size."
• v. Mechanism of action comparison: "Mechanism of action is the same between angioLOCK and Hem-o-lok; cartridge and clip design allows for an applier to easily load a clip, haptic feedback occurs when the clip bosses locate in the applier grooves, and clips are then removed for use. When the clip is closing the upper and lower curved legs with inner teeth pivots in from a hinged section and haptic feedback occurs as clips are latched closed."

The document concludes with a "Statement of Substantial Equivalence: The angioLOCK® Ligating Clips are substantially equivalent to their predicate device... based upon similarities in intended use, design, principles of operation and performance specifications."

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The devices presented in this submission are intended for use in endoscopic and/or open surgery for ligating and marking vessels and tubular structures whenever ligating clips are used/indicated.

Aescular's Clip Appliers are reusable stainless steel instruments. The clip appliers can be used in laparoscopic surgery. The clip appliers are available in 12mm diameter with a length of 330mm. The clip appliers are a non-modular, one-piece design for single fire use. These appliers are designed for use with a disposable clip magazine. The new clip magazine cartridge holds 4 clips.

The provided text is a 510(k) Premarket Notification for an endoscopic clip system, specifically a line extension for Aesculap's Endoscopic Clip Appliers with Disposable Clip Magazine.

Based on the information provided, no specific acceptance criteria or a study proving that the device meets acceptance criteria are detailed in the document.

The document states:

• "No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for these devices." This indicates that there are no specific, formally established performance standards that the device needs to meet for regulatory approval.
• The submission focuses on establishing substantial equivalence to an existing predicate device (K080753). This means the primary argument for approval is that the new device is as safe and effective as a legally marketed device, rather than a demonstration of meeting new, specific performance criteria through a dedicated study.

Therefore, the following points, which would typically be included in a description of acceptance criteria and study results, cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: No test set or associated study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set or ground truth establishment is described.
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. This device is a mechanical surgical tool, not an AI-assisted diagnostic device.
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.
9. How the ground truth for the training set was established: Not applicable.

The document primarily describes the device, its intended use, and argues for substantial equivalence to a predicate device based on similar technological characteristics (shape, size, materials). Regulatory approval in this case relies on demonstrating that the modified device does not raise new questions of safety or effectiveness compared to the already approved predicate device.

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The devices presented in this submission are intended for use in endoscopic and/or open surgery for ligating and marking vessels and tubular structures whenever a ligating clip is used/indicated.

Aesculap's Clip Appliers are reusable stainless steel instruments. The clip appliers can be used in either laparoscopic or open surgery. The laparoscopic appliers are available in either a 10 or 12mm diameter with a length of 310mm. The Clip Appliers are a nonmodular, one-piece, design for single fire use.

The Open Surgery Appliers are available in lengths of 150mm (small) to 280mm (Xlarge) with jaw angles of 25, 65, and 90 degrees. The handles of the open surgery appliers will be color coded for easy identification of the matching clip size.

Both types of appliers are designed for use with a disposable clip magazine. The new clip magazine cartridge hold either 8, 6, or 2 clips per cartridge based on the size of the clip.

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

Explanation: The document states, "No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for these devices." Therefore, explicit acceptance criteria in terms of quantitative performance metrics are not provided. The basis for clearance is substantial equivalence to a predicate device.

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

Not applicable. This 510(k) submission relies on demonstrating substantial equivalence to a predicate device, not on a new clinical study with a test set of data.

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

Not applicable. See point 2.

4. Adjudication Method for the Test Set

Not applicable. See point 2.

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

No. This document does not describe an MRMC comparative effectiveness study. The submission focuses on demonstrating substantial equivalence.

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

Not applicable. This is a medical device (endoscopic clip system), not an AI algorithm.

7. The Type of Ground Truth Used

Not applicable. The clearance is based on substantial equivalence, implying that the new device's design, materials, and intended use are similar enough to a previously cleared device. The "ground truth" in this context is the established safety and effectiveness of the predicate device.

8. The Sample Size for the Training Set Not applicable. This is a medical device, not an AI algorithm requiring a training set.

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

Not applicable. See point 8.

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The Miltex Ligating Clip is an extra-vascular, implanted device intended to occlude by compression blood flow within small, non-intracranial vessels. The clip is available in several sizes and the practitioner chooses the size of clip to fit the procedure, insuring that the tissue to be occluded fits completely within the clip.

The Miltex Ligating Clip is constructed exclusively of CP Grade 1 titanium wire having a heart-shaped cross-section. The clip is chevron-shaped. The inside (tissue-engaging) surfaccs of the clip legs have a longitudinal groove intersected by a number of angled transverse grooves. The longitudinal grooves do not extend fully to the distal ends of the legs, but leave distal flat surfaces at the ends of the legs. When the clip is closed, tissue will fill in the grooves, providing secure retention on the vessel. This feature also improves the occluding functions of the clip. The distal flat ends of the legs provide surfaces that will contact each other initially as the clip is closed. The contact of the distal flat surfaces will cause the legs to straighten in alignment with cach other, thereby minimizing the possibility of scissoring. Clips are available in 4 sizes: small, medium, medium-large, and large. The clips are packaged six per disposable cartridge holder. The clips and cartridge holder are supplied sterile. Cartridge holders are color-coded using the industry standard color-coding system.

The provided document, a 510(k) Pre-Market Notification for the Miltex Ligating Clip, focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance criteria or a study proving those criteria are met. Therefore, much of the requested information cannot be found in the provided text.

Here is what can be extracted and inferred:

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

The document states that the Miltex Ligating Clip functions "in the same manner as the predicate device" and is "as safe, as effective, and performs as well as the Horizon Ligation System (K982313)."

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

This information is not provided in the document. The submission relies on a comparison to a predicate device rather than a new clinical study.

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

This information is not provided as there's no mention of a test set or ground truth established by experts in this context. The claim is based on substantial equivalence to the predicate device.

4. Adjudication method for the test set:

This information is not provided as there's no mention of a test set.

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. The device is a physical ligating clip, not an AI-powered diagnostic or assistive technology.

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

This is not applicable. The device is a physical ligating clip, not an algorithm.

7. The type of ground truth used:

This information is not explicitly stated in the context of a "ground truth" for a study. The "truth" in this submission relies on demonstrating the physical and functional similarity to a legally marketed predicate device. This is a regulatory pathway of "substantial equivalence" rather than proving new efficacy from scratch.

8. The sample size for the training set:

This information is not provided as it is not relevant for this type of device submission. There is no training set for a machine learning model.

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

This information is not provided as it is not relevant for this type of device submission. There is no training set for a machine learning model.

In summary, the Miltex Ligating Clip's acceptance relies not on a clinical trial with specific performance criteria and ground truth, but on demonstrating "substantial equivalence" to a legally marketed predicate device (Horizon™ Ligation System by Weck Closure Systems, K982313) based on material, design, dimensions, and intended use. The document asserts that due to these similarities, the Miltex Ligating Clip is "as safe, as effective, and performs as well" as the predicate.

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The Coalescent Surgical Sutured-Clip™ is intended for endoscopic and non-endoscopic use in the creation of anastomoses in blood vessels, grafts and other tubular structures.

The Coalescent Surgical Sutured-Clip™ is a single self-closing clip for vascular anastomosis and tissue approximation applications. The Sutured-Clip consists of a specially designed vascular clip with a needle connected to one end via a flexible member. This design allows precise placement of clips prior to closure. The device is fabricated from standard medical and implantable grade materials.

The provided text is a 510(k) summary for the Coalescent Surgical Sutured-Clip, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or extensive study data as one might find for a novel device undergoing clinical trials to prove efficacy.

Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, or standalone algorithm performance for AI devices is not explicitly available within the provided K994160 document.

However, based on the text, I can infer and extract some relevant information as best as possible within the limitations of the provided document.

Acceptance Criteria and Reported Device Performance

The document states:
"All data fell well within, both, internal specification requirements, as well as external standard requirements and predicate performance expectations."
"Design analysis, in vitro, in situ and in vivo data confirm that basic functional characteristics are substantially equivalent to the predicate devices cited."

Given this, the "acceptance criteria" are implicitly tied to demonstrating substantial equivalence to the predicate devices and meeting "internal specification requirements" and "external standard requirements." The reported device performance is that it met these unstated criteria.

Study Details (Based on available information)

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

• Sample Size for Test Set: Not specified. The document mentions "in vitro, in situ and chronic in vivo studies" but does not quantify the number of tests or subjects.
• Data Provenance: Not specified, but generally, pre-market studies for medical devices like this would be conducted by the manufacturer, likely in a controlled laboratory setting or animal models for in vivo studies. No country of origin for data is stated, nor is it explicitly retrospective or prospective, though in vivo studies would typically be prospective for testing a new device.

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

• Not applicable/not specified. The document describes engineering and biological performance testing, not diagnostic performance where expert ground truth would be established.

4. Adjudication method for the test set:

• Not applicable/not specified.

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-powered diagnostic device, but a physical surgical implant.

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:

• For the in vitro and in situ testing, ground truth would likely be based on established engineering principles, physical measurements (e.g., tensile strength, leak resistance, securement force), and comparison to the performance of predicate devices.
• For the in vivo studies, ground truth would be biological outcomes (e.g., successful anastomosis, tissue integration, absence of adverse reactions, long-term patency of vessels) assessed against expected physiological norms and predicate device performance.

8. The sample size for the training set:

• Not applicable/not specified. This is a physical device, not an AI model requiring a "training set."

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

• Not applicable.

Conclusion from the K994160 Summary

The K994160 summary focuses on demonstrating "substantial equivalence" of the Coalescent Surgical Sutured-Clip to existing predicate devices based on design analysis, in vitro, in situ, and in vivo testing. The document highlights that the device met internal specifications and external standards, confirming its basic functional characteristics are on par with marketed devices. It does not provide the detailed statistical analysis or reader study information typically associated with AI/diagnostic device approvals, as it is a different class of medical product.

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The Applied Medical Modular Clip Applier System is indicated for ligation of tubular structures or vessels where a non-absorbable ligating device is indicated.

The Applied Medical Modular Clip Applier System (MCAS) is a modular reposable device intended for ligation of tubular structures or vessels where a nonabsorbable ligating device is indicated. The reusable clip applier is made of stainless steel and is similar to standard clip appliers and surgical clamp designs currently on the market. The disposable clip cartridge is made of various plastic and metal materials and will be sold sterile. The clip cartridges will be available in four sizes, small, medium/large, and large and will house six to ten titanium clips depending on the clip size to be used. The cartridges are color coded Yellow, Blue, Green and Orange respectively according to their size. The key difference between the Applied MCAS and the predicate device is the modular design which provides the user with multiple clips inside a cartridge which is loaded onto a reusable applier instead of manually loading individual clips into the applier during surgical procedures.

The provided text is a 510(k) summary for the Applied Medical Modular Clip Applier System (MCAS). It states that the device passed all testing to demonstrate substantial equivalence to the predicate device and introduces no new safety and effectiveness issues when used as instructed.

However, the document does not describe specific acceptance criteria or the details of any studies, including sample sizes, ground truth establishment, or expert involvement. It is a regulatory submission focused on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against predefined criteria.

Therefore, most of the requested information cannot be extracted from this document.

Here's an attempt to populate the table and answer the questions based only on the provided text, highlighting what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

4. Adjudication method for the test set

• Adjudication method: Not specified.

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. This device is a surgical instrument (clip applier), not an AI-powered diagnostic or interpretive system, so an MRMC study comparing human readers with and without AI assistance is not applicable.

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

• Standalone performance: No. This device is a mechanical surgical instrument. "Standalone performance" in the context of an algorithm or AI is not applicable here.

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

• Type of ground truth: Not specified. The document refers to "testing to demonstrate substantial equivalence," which likely involved mechanical and functional testing against specifications and comparison to the predicate device, rather than a "ground truth" as might be established for diagnostic image analysis.

8. The sample size for the training set

• Sample size for training set: Not applicable/not specified. As a mechanical device, there is no "training set" in the sense of machine learning.

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

• Ground truth for training set: Not applicable/not specified.

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The Elective Vascular Intervention (EVI) Sutured-Clip™ and Sutured-Clip Applier™ are intended for endoscopic and non-endoscopic use in the creation of everting anastomoses in blood vessels, grafts and other tubular structures.

The Elective Vascular Intervention (EVI) Sutured-Clip™ and Clip Applier is a single fire applier that applies EVI Sutured-Clips™ for vascular anastomsis and tissue approximation applications. The Sutured-Clip consists of a vascular clip with a needle swaged or connected to one end. This design allows precise placement of clips prior to closure. The device is fabricated from standard medical and implantable grade materials.

The provided document, K971588, is a 510(k) premarket notification for the EVI Sutured-Clip™ and Sutured-Clip™ Applier. This device is a Class I (Exempt) Clip Applier and Class II Implantable Clips, intended for use in endoscopic and non-endoscopic creation and repair of arteriovenous fistulae, creation of everting anastomoses in blood vessels, grafts, and other tubular structures, and approximation of other soft tissue structures.

Due to the nature of this submission being a 510(k) for a medical device (an implantable clip and applier), the acceptance criteria and study detailed differ significantly from what would be expected for a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool. The "acceptance criteria" here refer to demonstrating substantial equivalence to predicate devices through design analysis and in vitro testing, rather than performance metrics like sensitivity, specificity, or AUC, which are common for diagnostic algorithms.

Here's an analysis of the provided information, framed to address your specific points where applicable, and noting where the information is not relevant to a traditional AI/SaMD assessment:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" revolve around established safety and effectiveness of predicate devices, and the "reported device performance" demonstrates equivalence through mechanical testing.

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

This information is not provided in the 510(k) summary for the in vitro testing. The summary states "In Vitro Test Data" and refers to "design analysis and in vitro data," but does not explicitly detail the number of clips, appliers, or specific test configurations used. Data provenance generally refers to the source of patient data. Since this is an in vitro study, there are no patient data, and thus no country of origin or retrospective/prospective classification in the typical sense for clinical studies.

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

This applies to studies assessing diagnostic accuracy or subjective interpretation. For this pre-market notification of a mechanical device, there is no ground truth established by experts in the context of interpreting images or clinical outcomes. The "ground truth" for mechanical performance is defined by engineering specifications and predicate device performance.

4. Adjudication Method for the Test Set

This is typically relevant for studies involving human interpretation or subjective assessments where discrepancies need resolution. For an in vitro mechanical test, no adjudication method between human interpreters is mentioned or 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

A MRMC study evaluates human reader performance with and without AI assistance, common for AI-powered diagnostic tools. This is a mechanical surgical device, not an AI or diagnostic tool. Therefore, no MRMC comparative effectiveness study was done, and this question is not applicable to this submission.

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

This question is applicable to algorithms. The EVI Sutured-Clip™ and Applier is a physical medical device, not an algorithm. Therefore, no standalone performance study of an algorithm was conducted or is applicable.

7. The Type of Ground Truth Used

For this device, the "ground truth" for the in vitro testing was based on engineering specifications, internal specification requirements, external standard requirements, and predicate performance expectations. This is not pathology, outcomes data, or expert consensus in the clinical sense, but rather defined mechanical and functional parameters.

8. The Sample Size for the Training Set

This refers to the data used to train an AI model. Since this is a mechanical device with no AI component, there is no training set, and therefore, no training set sample size.

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. The "ground truth" for the device's design and manufacturing would be established through engineering design principles, material science, and quality control processes.

In Summary for K971588:

The provided document describes a 510(k) application for a physical medical device. The "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to existing predicate devices through in-vitro mechanical testing and design analysis, rather than clinical efficacy through human studies or performance metrics typical of AI or diagnostic software. Many of the questions posed are specifically designed for evaluating AI/SaMD and are therefore not applicable to this type of device submission.

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The Multifire Clip Applier is designed to automatically deliver small hemostatic clips for ligation of blood vessels. The device is intended for use on vessels, which in the opinion of the surgeon, require a small ligating clip. The Multifire Clip Applier may be used during endoscopic procedures such as the endoscopic harvesting of the Internal Mammary Artery.

The Heartport Multifire Clip Applier is a sterile, use disposable device containing 15 small Titanium ligating clips. The device is designed to automatically deliver small hemostatic clips for ligation of blood vessels.

This document is a 510(k) summary for the Heartport Multifire Clip Applier, submitted in 1996. It details the device's classification, intended use, and comparison to predicate devices, but it heavily lacks the specific information requested in your prompt regarding acceptance criteria and a structured study.

Here's a breakdown of why this document cannot fulfill your request comprehensively:

Missing Information:

• Acceptance Criteria Table: The document states the device "was safe and effective" and "meeting the anticipated clinical requirements," but it does not provide any quantitative acceptance criteria (e.g., success rates, force measurements, specific closure percentages) or numerical performance data to fill a table.
• Detailed Study Information:
  • Sample size for the test set: Not specified beyond "in vitro" and "in vivo studies."
  • Data provenance: Not mentioned (country of origin, retrospective/prospective).
  • Number of experts and qualifications: Not mentioned.
  • Adjudication method: Not mentioned.
  • MRMC comparative effectiveness study: Not mentioned.
  • Standalone algorithm performance: This is a physical device, so "standalone algorithm" doesn't apply in the typical sense of AI software. The performance here refers to the device itself.
  • Type of ground truth: Not explicitly stated, though "clip feeding and clip closure" are the performance elements observed.
  • Sample size for the training set: Not applicable for a physical device where "training" isn't a discrete software development phase.
  • How ground truth for the training set was established: Not applicable.

What can be extracted (and why it's limited):

The document broadly mentions performance testing and biocompatibility.

• Performance: "The Multifire Clip Applier was evaluated in vitro for clip feeding and clip closure In addition, the Clip Applier was evaluated during in vivo studies. functions. Performance testing demonstrated that the Heartport Multifire Clip Applier was safe and effective, while meeting the anticipated clinical requirements for its intended use."
• Biocompatibility: "The patient contacting materials used in the Multifire Clip Applier are identical to those used in the Pilling Weck - Hemoclip S15 Automatic Applier."

Conclusion:

This 1996 510(k) summary is very high-level and focused on demonstrating substantial equivalence to already approved predicate devices. It does not contain the detailed, quantitative acceptance criteria or a structured study description that would be required to complete your request. The standards for regulatory submissions, especially for device performance studies, have evolved significantly since 1996, and a modern submission would likely include much more of this specific information.

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