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The SILS™ Clincher* single use articulating clincher has application in a variety . of endoscopic, gynecological, and general laparoscopic procedures for temporarily clamping or grasping tissues and small tubular structures.

The SILS™ Dissector* single use articulating dissector with monopolar cautery has application in a variety of endoscopic, gynecological, and general laparoscopic procedures to temporarily grasp or clamp tissues and small vessels or body structures, and for use in blunt dissection. When connected to an electrosurgical power source, the device may be used to apply monopolar cautery in accordance with the recommendations of the electrosurgical unit's manufacturer.

The SILS™ Grasper* single use articulating grasper has application in a variety of endoscopic, gynecological, and general laparoscopic procedures to temporarily grasp or clamp tissues and small vessels or body structures, and for use in blunt dissection.

The SILS™ L-Hook* single use articulating hook with monopolar cautery has application in endoscopic, gynecological, and general abdominal and thoracic laparoscopic procedures. When connected by a standard cable to an electrosurgical power source, the device may be utilized for monopolar cautery.

The SILS™ Shears* single use articulating shears with monopolar cautery has application in a variety of endoscopic, gynecologic, and general laparoscopic procedures for transection and cutting of tissues. When connected to an electrosurgical power source, the device may be used to apply monopolar cautery in accordance with the recommendations of the electrosurgical unit's manufacturer.

Each single use SILSTM Hand Instrument contains a pistol grip, a rigid shaft with an articulating and rotating end effector, and opposing jaws or an electrocautery hook at the distal end.

The clincher, dissector, grasper, and shears contain opposing jaws to manipulate tissue, and the dissector, L-hook, and shears administer electrocautery. The end effector of each instrument articulates when the handle is deflected relative to the shaft and rotates when a rotation wheel is turned.

The provided text describes a 510(k) summary for several endoscopic hand instruments (SILS™ Clincher, Dissector, Grasper, L-Hook, and Shears). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical studies proving specific performance criteria in a clinical setting. Therefore, many of the requested details, particularly those related to AI algorithm performance studies, will not be present in this document.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity, accuracy thresholds). The acceptance criteria for a 510(k) submission like this revolve around demonstrating substantial equivalence to legally marketed predicate devices in terms of indications for use, technological characteristics, and safety and effectiveness.

The "performance data" mentioned refers to in-vitro and in-vivo testing to support the intended use and biological evaluation in accordance with ISO 10993-1:2003 for patient contact materials. However, specific quantitative results or how these results meet pre-defined acceptance criteria are not detailed in this summary.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) context):

Study Details (Based on available information in the document)

Since this is a 510(k) summary for conventional surgical instruments, there is no mention of an AI-powered device or associated studies. Therefore, many of the questions related to AI performance, ground truth, and expert evaluation are not applicable.

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

   • Not Applicable / Not provided. The document refers to "in-vitro and in-vivo testing" but does not specify sample sizes, provenance, or whether the data was retrospective or prospective. This kind of detail is typically found in the full test reports, not a 510(k) summary.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not Applicable. As this is not an AI device, there's no concept of establishing "ground truth" by experts in this context for diagnostic performance.

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

   • Not Applicable. This is relevant for diagnostic studies with human readers or AI.

4. 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:

   • No. This document does not mention an MRMC study or AI assistance.

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

   • No. This is not an AI algorithm.

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

   • Not Applicable. For mechanical surgical instruments, "ground truth" would relate to successful mechanical operation, tissue manipulation, and safety, assessed through engineering tests, pre-clinical models (in-vitro/in-vivo), and potentially clinical observations, not derived from expert consensus on images or pathology.

7. The sample size for the training set:

   • Not Applicable. There is no AI model mentioned, thus no training set.

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

   • Not Applicable. There is no AI model mentioned, thus no training set ground truth.

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The device is intended for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair

Absorbatack™ Absorbable Fixation Devices are sterile single use devices for the fixation of prosthetic material such as hernia mesh to soft tissue. The Tack is constructed of an absorbable synthetic polyester copolymer derived from lactic and glycolic acid. The device is offered with of 5, 10 or 20 tacks.

Here's an analysis of the provided text regarding the Absorbatack™ Absorbable Fixation Device. It appears this documentation describes a 510(k) submission for a medical device and not a study demonstrating the device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would.

The document primarily focuses on establishing substantial equivalence to a predicate device, which is a regulatory pathway for medical devices in the US. It does not contain information on a study with acceptance criteria and reported device performance in the context of, for example, diagnostic accuracy or treatment efficacy.

Therefore, many of the requested sections about study design, sample size, ground truth, and expert evaluation are not applicable in this context.

Analysis of Absorbatack™ Absorbable Fixation Device (K091900)

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: In a 510(k) pathway, the "acceptance criteria" are typically regulatory requirements for demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily achieved by showing identical technological characteristics, intended use, and materials, or by conducting performance testing to demonstrate equivalence if there are differences. This document explicitly states "Absorbatack™ Absorbable Fixation Device is identical to the predicate device" and "There has been no change to the Absorbatack ™ Absorbable Fixation Device." Therefore, no new performance data comparing it against specific quantitative acceptance criteria is presented for this particular submission.

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

• Sample Size: Not applicable. No test set (in the context of clinical or algorithm performance evaluation) is described.
• Data Provenance: Not applicable. The document relies on the identical nature of the device to its predicate, rather than new performance data from a specific test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. Ground truth establishment is not relevant for this type of submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method

• Adjudication Method: Not applicable.

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

• MRMC Study: No. No such study is described or referenced.
• Effect Size: Not applicable.

6. Standalone (Algorithm Only) Performance Study

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

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable. The ground for this submission is the established safety and effectiveness of the predicate device (K071920) through its prior clearance, and the assertion that the current device is identical.

8. Sample Size for the Training Set

• Sample Size: Not applicable. As this device is not an algorithm, there is no "training set."

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

• Ground Truth Establishment: Not applicable.

Summary of the Document's Content:

The provided documents detail a 510(k) premarket notification for the "Absorbatack™ Absorbable Fixation Device." The core of this submission is the claim that the device is substantially equivalent to a previously cleared predicate device (K071920), also named "Absorbatack™ Absorbable Fixation Device."

Key points from the submission:

• Identity to Predicate: The submitter explicitly states: "Absorbatack™ Absorbable Fixation Device is identical to the predicate device" and "There has been no change to the Absorbatack ™ Absorbable Fixation Device."
• Materials Evaluation: The materials were evaluated according to ISO 10993-1: 2003, "Biological Evaluation of medical devices - Part I Evaluation and Testing," and again, stated to be identical to the predicate device.
• Performance Data: The document states, "The modified labeling for the subject device is based on performance testing obtained for the predicate device." This indicates that no new performance testing for the subject device itself was conducted for this specific 510(k) submission; rather, it leveraged the existing data from the identical predicate.
• Intended Use: Fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures (e.g., hernia repair), which is consistent with the predicate.

In essence, this is a regulatory filing asserting that a device, which remains unchanged from a previously cleared version, is still substantially equivalent to that predicate. Therefore, it bypasses the need for new, extensive performance studies with specific acceptance criteria that would typically be seen for a novel device or a device with significant modifications.

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The Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units (SULUs) have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

The Autosuture™ ENDO GIA™ Staplers when used with the ENDO GIA™ Curved-Tip Single Use Loading Unit (SULUs) can be used to blunt dissect or separate target tissue from other certain tissue.

The Autosuture™ ENDO GIA™ Staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the appropriate Single Use Loading Unit (SULU). The staplers will accommodate any of the single use loading units that are available in 30 mm, 45 mm and 60 mm lengths.

This 510(k) reports a new version of our currently marketed Autosuture™ ENDO GIA™ Staplers (K061095). This new version is considered a modification of the currently marketed Autosuture™ ENDO GIA™ Staplers. The modifications are as follows:

• Ergonomic and performance enhancements to the ENDO GIA™ Stapler Instrument.
• Addition of ENDO GIA™ Single Use Loading Units (SULUs) with Tri-Staple™ technology. Tri-Staple™ technology means that each of the two triple-staggered rows has a stepped configuration whereby the staples in the outer row are a taller height then the staples in the middle row which in turn are a taller height than the staples in the inner row. The ENDO GIA™ SULUs with Tri-Staple™ technology are available in articulating 30 mm, 45 mm and 60 mm length cartridges.
• Addition of ENDO GIA™ Single Use Loading Units (SULUs) which have a curved-tip anvil configuration. The curved-tip can be used to dissect and manipulate tissue when locating target tissue for subsequent firing and placement of staples.

The provided document is a 510(k) summary for a surgical stapler. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the specific information requested regarding detailed acceptance criteria, device performance metrics, study designs (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set details.

The document states: "Bench and animal model performance evaluations were completed to verify that the Autosuture™ ENDO GIA™ Staplers with the new ENDO GIA™ Single Use Loading Units are safe and effective and perform as intended." This indicates that performance data was generated, but the specifics of what those performance evaluations entailed and what criteria were used for acceptance are not provided in this public summary.

Therefore, I cannot fulfill your request with the information given. The provided text is a regulatory submission summary, not a detailed study report.

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The SILS™ Stitch 10 mm single use suturing device has application in endoscopic surgery for the placement of interrupted or running stitches in soft tissues

SILSTM Stitch is an endoscopic suturing device that contains two jaws at its distal end, with opposing handles and a toggle lever at its proximal end. The device holds and passes a needled suture between the two jaws. The suture needle is passed from one jaw to another by squeezing the opposing handles and secured in each jaw by activating the toggle lever.

The provided text states that "No additional in-vitro or in-vivo testing has been performed in support of the intended use of this device." This means there is no performance data or study described. Therefore, the requested sections cannot be filled.

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For multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures

Three laparoscopic trocars and an insufflation tube bound by a flexible port.

The provided text is a 510(k) summary for the SILS™ Port, a surgical trocar. It includes information about the device's intended use and performance data, but it does not contain the specific details required to answer your questions about acceptance criteria, study design, and ground truth establishment.

The document states: "In-vitro and in-vivo testing has been performed in support of the intended use of this device." However, it does not elaborate on the specific acceptance criteria, the results of these tests, sample sizes, expert qualifications, or how ground truth was established.

Therefore, I cannot fulfill your request for the following information based on the provided text:

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: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method for the test set: This information is not present.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size: This information is not present.
6. If a standalone study was done: While "in-vitro and in-vivo testing" is mentioned, the specific nature of these studies (e.g., standalone vs. human-in-the-loop) and their results are not detailed.
7. The type of ground truth used: This information is not present.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, material biocompatibility, and the general statement of performance testing, rather than a detailed breakdown of a specific clinical or performance study with acceptance criteria and ground truth methodology.

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The Modified Endo Stitch™ 10 mm single use suturing device has application in endoscopic surgery for the placement of interrupted or running stitches in soft tissues

The Modified Endo Stitch™ is an endoscopic suturing device that contains two jaws at its distal end, with opposing handles and a toggle lever at its proximal end.

The provided text describes a 510(k) premarket notification for a medical device called the "Modified Endo Stitch™ Endoscopic Suturing Device." However, the document does NOT contain explicit acceptance criteria, detailed study designs, or specific performance metrics that would typically be found in a clinical study report.

The information primarily focuses on the device description, intended use, materials, and a general statement about performance data.

Therefore, many of the requested details cannot be extracted from the provided text. Below is an attempt to answer the questions based on the available information and to indicate where the information is not present.

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

Based on the provided text, specific acceptance criteria and detailed quantitative performance metrics are not explicitly stated. The document only broadly mentions:

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 provided in the document. The text mentions "In-vitro and in-vivo testing has been performed" but does not specify sample sizes, origin of data, or study design (retrospective/prospective).

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. Such details would typically be part of a detailed study report, which is not present here.

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

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This device is an endoscopic surgical suturing device, not an AI-powered diagnostic or imaging interpretation tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with or without AI assistance is not relevant to this type of device and is not described in the provided text.

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

This question is not applicable as the device is a manual surgical tool and not an algorithm.

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

The document only states that "In-vitro and in-vivo testing has been performed in support of the intended use of this device." (Page 21, {1}). It does not specify the type of ground truth used for these tests. In the context of a surgical device, "ground truth" would likely relate to the successful and safe performance of the suturing function, potentially evaluated through physical-mechanical testing (in-vitro) and animal or human studies (in-vivo) assessing factors like suture strength, tissue closure, and absence of complications, but these specifics are not elaborated.

8. The sample size for the training set

This information is not provided in the document. The concept of a "training set" is usually associated with machine learning or AI models, which is not the nature of this device.

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

This question is not applicable as the device is a manual surgical tool and not an AI-powered system that requires a "training set" with established ground truth in the typical sense.

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The autosuture™ VERSAPORT™ PLUS Bladeless Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.

The autosuture™ VERSAPORT™ PLUS Bladeless trocar is available in diameters from 5mm to 15mm, including short, standard and long length cannula. The 5mm VERSAPORT™ fixed seal system accommodates 5mm instruments, while the VERSAPORT™ PLUS removable seal systems accommodate instruments ranging from 5 mm to 15 mm (the 10/15mm system includes a converter for 5 mm diameter instruments). There is a stopcock valve for insufflation and rapid desufflation.

The provided text describes a 510(k) summary for a medical device, the autosuture™ VERSAPORT™ PLUS Bladeless Trocar. However, it does not contain detailed information about specific acceptance criteria or the study data proving the device meets those criteria, especially in the context of AI/algorithm performance. The document focuses on establishing substantial equivalence to predicate devices and general performance data from in-vitro and in-vivo tests. It does not refer to AI or machine learning at all.

Therefore, I will explain what information is missing based on your request and what can be inferred from the provided text.

Missing Information and Inferences from the Provided Text:

The provided document describes a traditional medical device (a surgical trocar) and its 510(k) summary. It does not involve AI or machine learning algorithms, which are typically associated with the type of acceptance criteria and studies you've requested (e.g., sample size for test/training sets, ground truth establishment, MRMC studies, standalone algorithm performance).

Therefore, I cannot provide most of the requested details as they are not applicable categories for this specific device and its regulatory submission.

Here's an breakdown of what can be extracted or inferred, and what is absent:

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

• Acceptance Criteria: The document implies that the acceptance criteria are met by demonstrating substantial equivalence to predicate devices (autosuture™ VERSAPORT, Ethicon Excel™). This means the device performs at least as well as, or comparably to, the existing legally marketed devices for its intended use. Specific quantitative performance metrics or thresholds are not detailed in this summary.
• Reported Device Performance: The document broadly states under "PERFORMANCE DATA": "In-vitro and in-vivo tests were performed to verify that the performance of the autosuture™ VERSAPORT™ PLUS Bladeless trocar is substantially equivalent to the predicate devices, and to validate that the autosuture™ VERSAPORT™ PLUS Bladeless trocar will perform as intended."
  • Specific, quantifiable performance metrics (e.g., puncture force, tissue damage, seal integrity, ease of insertion, etc.) and their achieved values are NOT provided in this summary. The summary only states that these tests were done to demonstrate substantial equivalence and intended performance.

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

• Not Applicable/Not Provided: For a traditional medical device like a trocar, "test set" in the context of an algorithm is not relevant. The performance studies mentioned (in-vitro and in-vivo) would have involved a certain number of devices or experimental subjects, but these specific numbers are not disclosed in the 510(k) summary. Data provenance is also not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable/Not Provided: "Ground truth" in the context of expert consensus is typically for diagnostic algorithms or image analysis. For a surgical trocar, evaluation would involve surgical experts and engineers, but the specific number and qualifications are not detailed in this summary, nor would they be framed as "establishing ground truth" in the AI sense.

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

• Not Applicable/Not Provided: Adjudication methods are specific to conflict resolution in expert labeling for AI/ML validation datasets. This concept is not relevant to the regulatory submission for a surgical trocar.

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 an AI-specific study design. The device is a physical surgical instrument and does not involve AI assistance for human readers.

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

• Not Applicable: This refers to the performance of an AI algorithm alone. The device is a physical instrument and has no standalone algorithm performance.

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

• Not Applicable/Implied: As discussed in point 3, "ground truth" as a concept for validating AI algorithms is not applicable here. Performance evaluation for a physical device would rely on direct measurements, observations, and clinical outcomes documented during in-vitro and in-vivo testing, assessed against established engineering and biological benchmarks for substantial equivalence.

8. The sample size for the training set

• Not Applicable: There is no AI algorithm to train for this device.

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

• Not Applicable: As above, there is no AI algorithm or training set for this device.

In summary, the provided 510(k) document is for a conventional medical device (a surgical trocar) and therefore does not contain any of the AI/ML-specific information requested in your prompt. The regulatory pathway chosen (510(k)) relies on demonstrating substantial equivalence to existing predicate devices through general performance testing (in-vitro and in-vivo), rather than detailed AI algorithm validation metrics.

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