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The Auto Suture™ Endo Clip III™ 5mm Clip Applier is primarily indicated for patients undergoing laparoscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures, and for radiographic markings.

The Autosuture™ ENDO CLIP™ III 5mm Clip Applier contains 18 titanium clips. The applier is designed for introduction and use through an appropriately sized Trocar sleeve, or larger with the use of a converter. The ENDO CLIP™ III 5mm Clip Applier consists of a trigger handle, shaft rotation knob, clip counter window and a 33 cm shaft with jaws at its distal end. Squeezing the handle places a titanium clip in the jaws and closes the jaws to close the clip on the vessel or structure.

The provided text describes a 510(k) summary for the Autosuture™ ENDO CLIP™ III 5mm Clip Applier. However, it does not contain the specific details required to answer all aspects of your request, particularly regarding acceptance criteria, device performance, sample sizes, and expert qualifications for ground truth establishment in a study context. This document focuses on demonstrating substantial equivalence to a predicate device for an updated indication.

Here's the information that can be extracted and a note on what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "In-vitro and in-vivo animal tests were performed to support the inclusion of 'manipulation of tissue and the dissection of blood vessels and other tubular structures' to the general indications for the Autosuture™ ENDO CLIP™ III 5mm Clip Applier."

Without access to the full test reports, specific acceptance criteria and detailed performance metrics are not provided in this summary. The summary only indicates that tests were performed to support the new indication.

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

The document mentions "in-vitro and in-vivo animal tests."

• Sample Size: Not specified for either in-vitro or in-vivo tests.
• Data Provenance: "in-vivo animal tests" imply animal data. The country of origin is not specified, but the submission is from the United States Surgical, a division of Tyco Healthcare Group LP in Norwalk, CT, USA. The study type (retrospective or prospective) is not explicitly stated, but typically these types of tests for 510(k) submissions would be prospective.

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

Not applicable. This device is a surgical clip applier, not an AI/diagnostic device that typically relies on expert-established ground truth for its performance evaluation in the way a diagnostic algorithm would. The performance is assessed through mechanical and biological (animal) testing.

4. Adjudication Method

Not applicable for a device performance study of this nature. Adjudication is typically used for expert consensus in diagnostic ground truth establishment.

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

No. An MRMC study is relevant for AI image analysis or diagnostic tools involving human readers. This document describes a physical medical device (clip applier) and its performance in a surgical context.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

For the in-vivo animal tests, the "ground truth" would be the observed biological outcomes in the animals related to the new indications (e.g., successful occlusion of blood vessels, lack of adverse events related to tissue manipulation/dissection). For in-vitro tests, the ground truth would be established by direct measurement of device characteristics (e.g., clip closing force, material integrity).

8. The Sample Size for the Training Set

Not applicable. This involves performance testing of a physical device, not an AI algorithm requiring a training set.

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

Not applicable. No training set is involved.

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The Syneture™ Absorbable Tack and Applicator are intended for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.

The Syneture™ Absorbable Tack and Applicator are sterile single use devices for the fixation of prosthetic material, such as hernia mesh, onto soft tissue. The Absorbable Tack is formed from synthetic polyester derived from a lactic acid and glycolic acid copolymer. The Applicator is offered with a range of 5 to 20 tacks.

The provided text describes a 510(k) summary for the Syneture™ Absorbable Tack and Applicator. This is a medical device, not an AI/ML algorithm or software as a medical device (SaMD). Therefore, the information requested in points 1-9 (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) is not applicable to this type of submission.

510(k) submissions for devices like the Syneture™ Absorbable Tack and Applicator typically focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance metrics against specific acceptance criteria for diagnostic or algorithmic accuracy.

• Acceptance Criteria & Device Performance: The document states "Performance testing was conducted to verify that the Syneture™ Absorbable Tack and Applicator is safe and effective and performs as intended." However, it does not provide a table of specific acceptance criteria (e.g., tensile strength, degradation rate, biocompatibility standards) or the quantitative results of these tests. This information would typically be detailed in the full 510(k) submission, but is summarized here. The summary explicitly states that the device "is identical to the predicate device in terms of intended use and mode of operation," which is the primary form of 'performance' justification in a 510(k) for substantial equivalence.

Given the nature of the device and the provided document, the requested details for AI/ML evaluation metrics are not present.

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The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier has applications in many types of endoscopic procedures to achieve hemostasis following transection of vessels and other tubular structures, and for radiographic markings.

The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier contains 16 titanium clips. The applier is designed for introduction and use through an appropriately sized trocar sleeve, or larger with the use of a converter. The ENDO CLIP™ III 5mm Clip Applier consists of a trigger handle, shaft rotation knob, clip counter window and a 33 cm shaft with jaws at its distal end. Squeezing the handle places a titanium clip in the jaws and closes the jaws to close the clip on the vessel or structure.

The provided document is a 510(k) summary for the "Auto Suture™ ENDO CLIP™ III 5mm Clip Applier," a surgical device. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and an AI study. Therefore, most of the requested information regarding AI device performance, sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment cannot be found in this document.

However, I can extract the relevant information that is available:

Table of Acceptance Criteria and Reported Device Performance:

The document states: "In-vitro and in-vivo tests were performed to verify that the ENDO CLIP™ III 5mm Clip Applier was substantially equivalent to the predicate device in occluding vessels and other tubular structures and to validate that the ENDO CLIP™ III 5mm Clip Applier performed as intended."

This implies the acceptance criterion was "substantial equivalence," meaning the new device performed comparably to the predicate device in its intended function (occluding vessels/tubular structures). Specific quantitative performance metrics or thresholds are not provided in this summary.

Here's a breakdown of the other requested information based on the provided text, indicating where information is not available (N/A) for this type of device submission:

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

   • See table above. The acceptance criteria are implicitly tied to demonstrating "substantial equivalence" and "performing as intended" in occluding vessels and tubular structures. Specific quantitative performance figures are not provided in this summary.

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

   • N/A. The document mentions "In-vitro and in-vivo tests" were performed but does not specify sample sizes, country of origin, or whether the tests were retrospective or 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)

   • N/A. This is a surgical clip applier, not an AI-driven diagnostic device. The concept of "ground truth" established by experts in the context of an AI study does not apply here. Performance would be assessed by engineers/scientists conducting the tests and potentially surgeons using the device.

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

   • N/A. Adjudication methods are relevant for ambiguous cases in diagnostic studies, particularly with AI. This does not apply to the performance testing of a mechanical surgical device.

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

   • N/A. An MRMC study is specific to evaluating diagnostic AI systems and how they impact human reader performance. This device is a surgical instrument, not an AI solution.

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

   • N/A. This is a hardware device, not an algorithm.

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

   • N/A. For a mechanical device like this, "ground truth" would be established by direct observation of successful vessel occlusion and proper clip deployment in controlled in-vitro and in-vivo settings. It's not a diagnostic outcome requiring expert consensus, pathology, or long-term outcomes data in the way an AI diagnostic device would.

8. The sample size for the training set

   • N/A. This is not an AI device, so there is no training set.

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

   • N/A. This is not an AI device, so there is no training set or ground truth in that context.

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The autosuture™ Circular EEA™ Staplers have application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.

The autosuture™ Circular EEA™ family of staplers place a circular, double staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis. They are indicated for use in the creation of anastomoses in various surgical procedures in both open and laparoscopic surgeries.

This document is a 510(k) summary for a surgical stapler, not a study evaluating an AI-powered device. Therefore, most of the requested information regarding acceptance criteria, study design, and AI performance metrics is not present in the provided text.

The document focuses on demonstrating substantial equivalence of the new stapler to a predicate device, which is a regulatory pathway for medical devices that are similar to devices already on the market. It does not involve clinical studies or performance evaluations intended for AI devices.

However, I can extract the following relevant information:

1. Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative "acceptance criteria" in the way one would for an AI device's performance (e.g., a specific sensitivity or specificity threshold). Instead, it states that the device was deemed "substantially equivalent" to its predicate.

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not specified. The document mentions "in-vitro and in-vivo tests," but does not provide details on the number of samples or subjects used in these tests.
• Data Provenance: Not specified. It's likely these tests were conducted internally or by a contracted lab, but the country of origin or whether they were retrospective/prospective is not mentioned.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. The "ground truth" for a surgical stapler involves mechanical and biological performance, not interpretive tasks requiring expert radiologists or similar specialists.

4. Adjudication Method for Test Set:

Not applicable. This concept is relevant for reconciling discrepancies among human readers or between human and AI interpretations, which is not the nature of this device's evaluation.

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

Not applicable. This type of study is for evaluating the impact of AI on human reader performance, which doesn't apply to a surgical stapler.

6. Standalone Performance Study:

A standalone performance evaluation (in-vitro and in-vivo tests) was conducted for the device itself to verify substantial equivalence. However, this is not a standalone algorithm performance in the context of AI.

7. Type of Ground Truth Used:

The "ground truth" would have been established through a combination of:

• Engineering measurements (e.g., staple formation, anastomotic strength).
• Biological observations (e.g., tissue healing, leak rates) in animal models (for in-vivo tests).

8. Sample Size for Training Set:

Not applicable. This device is a mechanical surgical stapler, not an AI algorithm, so there is no training set in the AI sense.

9. How Ground Truth for Training Set Was Established:

Not applicable (as above).

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The autosuture™ Modified VERSAPORT™ trocar with fixation sleeve 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™ Modified VERSAPORT™ trocar with fixation sleeve is available in 5 mm short length, 5 mm regular length, 11 mm regular length, 12 mm regular length, and 12 mm long length sizes. The autosuture™ Modified VERSAPORT™ trocar with fixation sleeve has a sharp linear blade with a spring- loaded locking shield. Upon entry into a free space the shield advances to cover the blade, reducing the potential for injury to internal structures. The trocar sleeve contains an internal seal to prevent loss of pneumoperitoneum when instruments are inserted or withdrawn. The VERSASEAL™ self-adjusting seal accommodates instruments ranging from 5 mm to 12 mm and is designed to effectively reduce the seal diameter to allow insertion of smaller instruments. There is a stopcock valve for insufflation and rapid desufflation.

The provided text is a 510(k) summary for a medical device (autosuture™ Modified VERSAPORT™ trocar with fixation sleeve). It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about acceptance criteria, efficacy studies, or AI performance metrics as typically found in studies for AI-based medical devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, or AI specific performance details (MRMC studies, standalone performance, etc.) because these details are not present in the provided document.

The "PERFORMANCE DATA" section states: "In-vitro and in-vivo tests were performed to verify that the autosuture™ Modified VERSAPORT™ trocar with fixation sleeve is substantially equivalent to the predicate devices in creation and maintaining a port of entry and to validate that the creation and maintaining a port of entry of a trocar with fixation sleeve will perform as intended."

This statement indicates that performance data exists to show substantial equivalence for mechanical/functional aspects (creating and maintaining a port of entry), but it does not provide the specific acceptance criteria or the results of these tests. It also does not mention any AI components or related performance metrics.

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The Auto Suture™ ENDO GIA™ Staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomoses. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

The Auto Suture™ ENDO GIA™ Stapler places 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 2.0 mm, 2.5 mm 3.5 mm or 4.8 mm single-use loading unit (SULU). The ENDO GIA™ Stapler will accommodate any of the single-use loading units that are available in 30 mm, 45 mm and 60 mm sizes.

The provided text describes a 510(k) submission for the Auto Suture™ ENDO GIA™ Stapler. This is a surgical stapling device, not an AI or imaging device, so many of the requested categories related to AI performance, imaging, and ground truth establishment are not applicable.

Here's an analysis based on the information provided for this specific medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative "acceptance criteria" in the format typically seen for AI/software devices (e.g., minimum sensitivity, specificity). Instead, for this surgical stapler, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device and supporting the expanded indication through performance data.

The "performance data" section indicates:

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

• Test Set Sample Size: Not explicitly stated as a numerical sample size in the document. The performance data section vaguely mentions "in-vivo animal tests" and a "clinical literature search."
• Data Provenance:
  • In-vivo animal tests: The country of origin is not specified, nor is whether this data was retrospective or prospective. It is implied to be prospective testing for the K061095 submission.
  • Clinical literature search: This would involve existing published data, likely from various countries and methodologies (retrospective/prospective, depending on the individual studies included). The specifics are not detailed.

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

This category is not applicable for this type of medical device submission. The "ground truth" for a surgical stapler's performance is typically established through observable clinical outcomes, tissue integrity, and successful procedural results, not through expert consensus on image interpretation. The submission discusses animal testing and literature review, which are forms of performance data, not expert-adjudicated ground truth as understood in AI/imaging studies.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers interpret data (e.g., images) to establish a consensus ground truth. For animal testing and clinical literature review, the "adjudication" is inherent in the study design and clinical assessments, rather than a separate expert-consensus process.

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

This is not applicable. MRMC studies are specific to evaluating imaging devices or AI algorithms that assist human readers in interpreting medical images. The Auto Suture™ ENDO GIA™ Stapler is a physical surgical tool.

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

This is not applicable. This question pertains to AI algorithms.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the evidence used to validate the device's performance for the new indication. It includes:

• In-vivo animal test results: Direct observation and assessment of the stapler's performance in living tissue (likely related to staple line integrity, hemostasis, tissue healing, etc.).
• Clinical literature: Published evidence of the device's or similar devices' performance and safety when used in liver resection/transection. This could include pathology reports, surgical outcomes, patient follow-up data, etc., as documented in the literature.

8. The Sample Size for the Training Set

This is not applicable. "Training set" refers to data used to train an AI algorithm. For a physical medical device, there is no AI training set.

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

This is not applicable.

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Modified USS polypropylene sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.

Modified USS Polypropylene Suture is composed entirely of biocompatible materials which are in compliance with ISO 10993-1 for their intended patient contact profile.

The provided text describes a 510(k) premarket notification for a medical device: the Modified USS Polypropylene Suture. This type of submission aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a comprehensive clinical study.

Therefore, the input does not contain the information requested in the prompt regarding acceptance criteria, a specific study proving device performance against those criteria, or details about sample sizes, ground truth establishment, or expert involvement in such a study.

Instead, the submission focuses on demonstrating that the performance of the Modified USS Polypropylene Suture is substantially equivalent to a previously marketed predicate device (USS Polypropylene Suture, K954808, and Modified USS Polypropylene Suture, K010909). This is typically achieved through bench testing and material characterization to show that the new device has the same technological characteristics and performs similarly to the predicate.

Here's a breakdown of what can be inferred from the provided text, and what cannot:

Information that CANNOT be Extracted from the Provided Text:

• A table of acceptance criteria and the reported device performance: This document does not detail specific acceptance criteria or performance metrics for the Modified USS Polypropylene Suture as part of a standalone study. It only states its performance is "substantially equivalent" to predicate devices.
• Sample size used for the test set and the data provenance: Not applicable to this type of submission which relies on substantial equivalence.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned or applicable.
• Standalone (algorithm only) performance study: Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical study with "ground truth" is described.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

What can be inferred from the text about the "study" (in the context of a 510(k)):

The "study" in this context is primarily a comparative analysis demonstrating substantial equivalence.

1. Type of "Study": Comparative analysis for substantial equivalence.
2. Acceptance Criteria & Reported Performance:
   • Acceptance Criteria Implied: The device must demonstrate similar mechanical properties, biocompatibility, and intended use as the predicate device(s).
   • Reported Performance: "The performance of the Modified USS Polypropylene Suture is substantially equivalent to the currently marketed USS Polypropylene Suture, which has been successfully used in clinical applications as a wound closure device."
3. Ground Truth for Comparison: The established performance and safety profile of the predicate device (USSC Polypropylene Suture K954808 and Modified USS Polypropylene Suture K010909) serves as the "ground truth" for comparison.
4. Training Set (Analogy): The historical data and successful clinical use of the predicate device could be considered analogous to a "training set" in that it informs the performance expectations and safety profile against which the new device is compared. The specific details of this data are not provided in the extract.
5. How Ground Truth for "Training Set" was established: For the predicate device, its ground truth was established through its own 510(k) clearance based on substantial equivalence and subsequent "successful clinical applications."

Summary Table:

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The Modified SPACEMAKER* System:

SPACEMAKER* Structural Balloon Trocar

The SPACEMAKER* Structural Balloon Trocar is primarily indicated for patients undergoing laparoscopic surgical procedures requiring a sealed port of access and/or tissue retraction. This is also indicated in patients undergoing laparoscopic surgery requiring a sealed port of access and/or tissue separation in extraperitoneal procedures, such as in hernia repair, lymphadenectomy or bladder neck suspension procedures.

SPACEMAKER* Blunt Tip Trocar

The SPACEMAKER* Blunt Tip Trocar is intended for use in establishing a port of access for insertion of endoscopic instruments into the abdominal cavity or extraperitoneal space in abdominal and extraperitoneal surgery.

SPACEMAKER* Dissection Balloon

The SPACEMAKER* Dissection Balloon is primarily indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.

The Modified SPACEMAKER* System consists of a balloon dissector and trocar which are used in conjunction to provide a port of access and tissue separation during laparoscopic surgery.

The provided text is a 510(k) Summary for a medical device called the "Modified SPACEMAKER* System." It details the device's description, indications for use, and identifies predicate devices. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes for testing or training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving the device meets them from the provided text. The document is primarily a regulatory submission outlining the device's features and intended use in comparison to existing devices, not a scientific study report.

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The Herculon* Soft Tissue Reattachment System is indicated for the reapproximation of soft tissue.
SHOULDER: Bankart, Slap lesion, Rotator cuff, and Deltoid repair. Acromio-clavicular separation, capsular shift/capsulolabral reconstruction and Biceps tenodesis.
ELBOW: Tennis elbow repair, biceps tendon reattachment.
KNEE: Extra capsular repairs; reattachment of medial and lateral ligaments, posterior oblique ligament or joint capsule to tibia, and joint capsule closure to anterior proximal tibia; Extra capsular reconstruction, ITB tenodesis, Patellar ligament and tendon avulsions.
ANKLE: Lateral and medial instability, Achilles tendon repair/reconstruction.
PELVIS: Fixation in pubic bone for the purpose of bladder neck suspension.

The Herculon* Soft Tissue Reattachment System is a nonabsorbable repair device used to attach soft tissue to bone using sutures. The device is a self tapping, Ti-6Al-4V threaded implant that accommodates one or two sutures. The sterile package includes a Suture Anchor, Inserter, and polyester suture.

I apologize, but the provided text from the 510(k) summary (K040594) for the "Herculon* Soft Tissue Reattachment System" does not contain information about acceptance criteria or specific studies performed to prove device performance.

The document primarily focuses on:

• Device Description (suture anchor system)
• Classification Information
• Indications for Use
• Materials
• Predicate Device identification ("Ogden* Suture Anchor with Suture (K020352)")
• A declaration of substantial equivalence to the predicate device.
• The FDA's letter of clearance.

There is no mention of:

• A table of acceptance criteria or reported device performance metrics.
• Details of any specific studies (e.g., sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, types of ground truth, training set information) that would typically be included to demonstrate device efficacy or safety.

The 510(k) process often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than requiring extensive new clinical trials or performance studies that generate new acceptance criteria and detailed performance data, especially for devices like this which are often evaluated based on material safety and mechanical properties similar to existing devices.

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The Auto Suture* TA* & knifeless GIA* staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomoses, including occlusion of the left atrial appendage in open procedures.

The Auto Suture* TA* & GIA* Staplers are designed to place multiple staggered rows of titanium or stainless steel staples in various types of tissues.

This submission pertains to the Auto Suture TA & GIA Staplers. However, the provided document does not contain information about acceptance criteria or a study demonstrating device performance. Instead, it is a 510(k) summary and FDA clearance letter primarily focused on establishing substantial equivalence to predicate devices based on identical technological characteristics and changes only in the indication for use statement.

Therefore, the requested information cannot be extracted from the provided text. The document states: "The Auto Suture* TA* & GIA* Staplers are identical to the predicate devices. The only changes are in the indication for use statement." This implies that performance data proving the device meets acceptance criteria would likely be covered by the predicate device's clearance and not explicitly re-stated or re-generated for this particular submission, as the device itself is considered identical.

To address the prompt fully, if such a study were present in alternative documentation (not provided here), the sections would be populated as follows:

1. Table of acceptance criteria and the reported device performance: This table would list specific quantitative or qualitative criteria that the device's performance needed to achieve (e.g., staple formation strength, leakage rates, successful tissue transection in a certain percentage of cases) and then show the results from the study, demonstrating how the device met or exceeded those criteria.

2. Sample size used for the test set and the data provenance: This would state the number of devices or procedures included in the test phase of the study and describe if the data was collected retrospectively (from existing records) or prospectively (specifically for the study), along with the geographic origin of the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This would detail how many medical professionals (e.g., surgeons, pathologists) reviewed the outcomes of the test procedures and their expertise (e.g., Board-certified surgeon with 20 years of experience in abdominal surgery).

4. Adjudication method for the test set: If multiple experts were used, this would describe how disagreements were resolved (e.g., "2+1" meaning if two out of three experts agreed, that was the final decision; "3+1" might imply a tie-breaking fourth expert, or simply all three must agree).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This information is specific to AI/software-assisted diagnostic devices. For a surgical stapler, an MRMC study comparing human performance with and without AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Again, this is relevant for AI/software devices. For a surgical stapler, this concept does not apply.

7. The type of ground truth used: This would specify the definitive standard against which the device's performance was measured (e.g., pathology reports confirming successful tissue approximation, outcomes data like absence of anastomotic leaks, expert consensus on visual inspection of stapled lines).

8. The sample size for the training set: If a learning algorithm was involved (not applicable here), this would be the number of cases or data points used to train the algorithm.

9. How the ground truth for the training set was established: Again, if applicable, this would describe the process of labeling or categorizing the training data.

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