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The APOLLO ESG and ESG SX Systems are intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss by reducing stomach volume through endoscopic sleeve gastroplasty in adult patients with obesity with BMI 30 -50 kg/m2 who have not been able to lose weight, or maintain weight loss, through more conservative measures.

The APOLLO REVISE and REVISE SX Systems are intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss in adult patients with obesity with BMI 30 - 50 kg/m² by enabling transoral outlet reduction as a revision to a previous bariatric procedure.

Endoscopic Sleeve Gastroplasty (ESG) is an endoscopic procedure that involves the creation of plications in the stomach to reduce stomach volume. The plications form a sleeve, which reduces stomach capacity and slows gastric emptying.

Patients having previous Roux-en-Y gastric bypass bariatric surgery may experience dilation of the gastrojejunostomy outlet and the gastric pouch, followed by weight gain. This can be addressed by reducing the diameter of the gastric outlet by suturing. This procedure is often referred to as Transoral Outlet Reduction (TORe).

The APOLLO ESG and APOLLO REVISE Systems are designed to accomplish ESG and TORe, respectively, using a dual channel scope. The APOLLO ESG SX and APOLLO REVISE SX Systems are designed to accomplish ESG and TORe. respectively, using a single channel endoscope. The systems function by delivering the suture to the targeted area to create full thickness bites when approximating soft tissue.

The device components are:

• The OverStitch (SX) Handle is comprised of a needle driver assembly and anchor exchange.
• The Tissue Helix enables the user to manipulate and position tissue before and after suturing.
• The Suture Anchor consists of a polypropylene suture attached to a metal piece.
• The Cinch device is a plastic component that simultaneously cuts the suture and clamps onto the suture.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance Summary

The document describes two main categories of performance testing: Non-Clinical/Bench Studies and Clinical Studies. The acceptance criteria and reported performance for the non-clinical studies are directly provided in Table 3. The clinical performance is evaluated against the primary effectiveness and safety endpoints of the MERIT Trial.

1. Table of Acceptance Criteria and Reported Device Performance

Non-Clinical/Bench Studies

Clinical Studies (MERIT Trial)

2. Sample Size and Data Provenance

Test Set (Clinical Study - MERIT Trial):

• Sample Size:
  • Randomized: 209 subjects (85 Treatment, 124 Control).
  • Modified Intent-to-Treat (mITT) Population: 187 subjects (77 Treatment, 110 Control) after exclusions.
  • Completers Population (52 weeks for effectiveness): 157 subjects (68 Treatment, 89 Control).
  • Safety Population: 150 subjects (77 initial Treatment + 73 cross-over Control subjects who underwent ESG).
• Data Provenance: Prospective, randomized, multicenter study conducted across 9 U.S. sites.

Training Set (Not explicitly tested for AI, but for clinical evidence):

• The document primarily describes a clinical trial (MERIT), real-world registry data, peer-reviewed literature, and post-market surveillance. It does not mention a distinct "training set" in the context of an AI model. The data serves as the evidence base for the device's overall safety and effectiveness.
• Sample Size (Clinical Evidence Base):
  • MERIT Trial: As above, up to 187 subjects (mITT) for effectiveness and 150 subjects for safety.
  • Real-World Registry (AGA partnership): 80 subjects for ESG, 39 subjects for TORe.
  • Ongoing Registry (private practice): 295 subjects for ESG (169 with 6-month data, 116 with 12-month data); 201 subjects for TORe (89 with 6-month data, 30 with 12-month data).
  • Peer-Reviewed Literature: Selected articles from PubMed search ("endoscopic sleeve gastroplasty" OR "transoral outlet reduction") and 9 additional relevant articles.

3. Number of Experts and Qualifications for Ground Truth for Test Set:

• The document describes a clinical trial measuring objective outcomes like weight loss and adverse events. It does not mention the use of experts to establish a "ground truth" for interpretations of images or complex data as would be typical for an AI device. The ground truth for weight loss is objective measurement, and for adverse events, it's clinical diagnosis and Clavien-Dindo grading.
• Medical professionals (gastroenterologists or surgeons) performed the procedures and managed patient care, thus indirectly contributing to the data collection that forms the "ground truth" of patient outcomes. Adverse event classification by Clavien-Dindo grading implies expert medical judgment.

4. Adjudication Method for the Test Set:

• For adverse events, the document states: "All adverse events were recorded." and "The three adverse events rated Clavien-Dindo Grade III or higher were as follows..." This implies that adverse events were classified and graded, likely by clinical investigators, according to the Clavien-Dindo classification system.
• There's no explicit mention of an independent adjudication committee for the clinical outcomes or adverse events in the MERIT trial data presented, beyond the standard clinical trial procedures (e.g., source data verification, monitoring).

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

• No, an MRMC comparative effectiveness study was not performed. This study evaluates the device itself (an endoscopic suturing system), not an AI algorithm assisting human readers. The clinical study compares device use plus lifestyle intervention vs. lifestyle intervention alone.

6. Standalone (Algorithm Only) Performance:

• No, this is a physical medical device, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable. The device's performance is demonstrated in the context of its use by trained clinicians.

7. Type of Ground Truth Used:

• For the clinical study (MERIT Trial), the ground truth for effectiveness was based on objective measurements of patient outcomes:
  • Weight loss: Measured %Total Body Weight Loss (%TBWL) and %Excess Weight Loss (%EWL).
  • BMI change: Measured change in Body Mass Index.
• For safety, the ground truth was based on clinical diagnosis and classification of adverse events using the Clavien-Dindo grading system.
• For non-clinical/bench studies, the ground truth was based on engineering specifications and quantifiable performance metrics (e.g., number of suture passes, tissue acquisitions, tensile strength, MRI compatibility testing).

8. Sample Size for the Training Set:

• As noted in point 2, the document describes a clinical trial and other forms of "real-world" and literature evidence. There is no mention of a distinct "training set" for an AI algorithm. The training for device use is for human clinicians.

9. How the Ground Truth for the Training Set was Established:

• Since there's no AI training set involved, this question is not directly applicable.
• For the training of clinicians, the document states: "APOLLO ESG, ESG SX, REVISE and REVISE SX Systems should only be used by gastroenterologists and surgeons who have undergone specific training by the device manufacturer." This implies the "training" refers to physician training on the use of the device itself. The "ground truth" for this training would be the proper procedural steps and techniques established by the manufacturer and medical consensus for safe and effective use.

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The X-Tack™ Endoscopic HeliX Tacking System is intended for approximation of soft tissue in minimally invasive gastroenterology procedures (e.g. closure and healing of ESD/EMR sites, and closing of fistula, perforation or leaks). X-Tack is not intended for hemostasis of acute bleeding ulcers.

The X-Tack™ Endoscopic HeliX Tacking System is a sterile, single-use device that enables the user to approximate soft tissue in the gastrointestinal (GI) tract using helix tacks and a 3-0 suture through a 2.8 mm or larger working channel of an endoscope (e.g. gastroscope or colonoscope).

OverStitch Suture Cinch
The Overstitch Suture Cinch device is comprised of thermoplastic and stainless steel materials and includes an implantable PEEK Cinch component designed to secure and cut the suture once tissue approximation is complete. It is the final step of the X-Tack procedure. The device functions by squeezing the handle and deploying the PEEK components, which form a press-fit onto the tail end of the suture to maintain suture position in situ.

The X-Tack™ Endoscopic HeliX Tacking System is intended for approximation of soft tissue in minimally invasive gastroenterology procedures. The device's performance was evaluated through non-clinical and animal testing to demonstrate substantial equivalence to a predicate device (K151802 - Resolution™ 360 Clip).

Here's an overview of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Animal Study: 4 pigs and 40 defects (created in the stomach and colon) were used in a randomized, controlled animal study.
• Data Provenance: The animal study was conducted to compare closure rates and healing between X-Tack and the predicate device. The location of the study (country of origin) is not specified. The study appears to be prospective, specifically designed for this comparison.

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

• The document mentions "direct visualization and histological analysis" for evaluation in the animal study. However, it does not specify the number of experts, their qualifications, or their role in establishing ground truth.

4. Adjudication method for the test set:

• The document does not specify any adjudication method (e.g., 2+1, 3+1). The evaluation was based on direct visualization and histological analysis in the animal study.

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:

• No MRMC comparative effectiveness study was done as the device is a medical instrument (tacking system), not an AI-assisted diagnostic tool for human readers.

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

• Not applicable, as this is a physical medical device and not an algorithm.

7. The type of ground truth used:

• For the animal study: Direct visualization and histological analysis of the defects were used to determine closure rates and healing.

8. The sample size for the training set:

• Not applicable, as this device's performance was evaluated through non-clinical (bench) and animal testing, not through machine learning training data.

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

• Not applicable, as there was no training set for a machine learning algorithm.

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To be used in conjunction with an endoscope for foreign body removal or endoscopic procedures requiring multiple insertions of the endoscope into the lower or upper gastrointestinal tract.

The OverTube™ Endoscopic Access System is comprised of a single, polymer extrusion shaft reinforced with a metallic coil. The hub located at the proximal end of the device contains a cuff seal which can be inflated with air using a syringe to reduce loss of pressure when insufflation is used. The device is available in a single effective length of 27 cm with a tapered distal tip. The OverTube™ Endoscopic Access System will be delivered in a manner that a clinician may open one (1) OverTube per clinical procedure. The OverTube™ Endoscopic Access System will be provided in both sterile and non-sterile models. The sterile model is terminally sterilized by ethylene oxide (EO).

Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the OverTube™ Endoscopic Access System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria for the OverTube™ Endoscopic Access System. Instead, it states that "Performance testing was conducted on the OverTube™ Endoscopic Access System to establish substantial equivalence." The tests conducted are listed as:

• Insertion and removal force requirements
• Shaft deflection
• Leakage rate
• Bond strength
• Foreign body removal
• Biocompatibility (in accordance with ISO 10993-1:2009)
• Sterilization cycle validation (in accordance with ISO 11135-1:2007)

The document asserts that these tests "show that the differences between the OverTube™ Endoscopic Access System and predicate device do not raise any questions regarding its safety and effectiveness." This implies that the device performed comparably to, or within acceptable limits for, its predicate device for each of these parameters, thereby meeting the implicit acceptance criteria for substantial equivalence.

Since specific numerical acceptance criteria and reported performance values are not provided, the table below reflects what is stated in the document about the performance evaluation.

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

The document does not specify the quantitative sample sizes for the performance tests (e.g., how many over-tubes were tested for insertion force or leakage rate). It also does not explicitly state the country of origin of the data or whether the data was retrospective or prospective. Given the nature of a 510(k) summary for a medical device that relies on substantial equivalence to a predicate, these tests are typically bench and/or in-vitro tests, not clinical studies involving patient data provenance from specific countries.

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

This information is not provided in the document. For bench/functional testing of a device like an overtube, the "ground truth" is typically established by engineering specifications, standard test methods, and comparison to the predicate device's known performance, rather than expert clinical consensus on a test set.

4. Adjudication Method for the Test Set

This information is not applicable/provided in the context of the described performance testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, especially those involving expert reviews for ground truth establishment, which is not the type of study described here.

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 applicable/provided. The device described is an endoscopic access system (a physical medical device), not an AI algorithm or a diagnostic tool that involves "human readers" interpreting output. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

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

This information is not applicable/provided. As mentioned above, this filing concerns a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the functional performance tests (insertion/removal force, shaft deflection, leakage, bond strength, foreign body removal), the "ground truth" would be the engineering specifications, established test methodologies, and the performance characteristics of the legally marketed predicate device (Guardus® Disposable Overtube). The goal was to demonstrate that the new device performs acceptably within these engineering and predicate-based parameters.

For biocompatibility, the ground truth is established by the requirements of ISO 10993-1:2009.
For sterilization, the ground truth is established by the requirements of ISO 11135-1:2007.

8. The Sample Size for the Training Set

This information is not applicable/provided. As this is a submission for a physical medical device based on substantial equivalence and performance testing, there is no "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 applicable/provided for the same reason as point 8.

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The SuMO™ Access and Tissue Resection System is intended to access, dissect, and resect soft tissue in endoscopic gastrointestinal procedures such as removal of flat polyps.

The Injection Needle is intended for endoscopic injection of solutions such as a procedural aid in endoscopic procedures.

The Tunneling Balloon is intended for soft tissue separation and dilation during endoscopic procedures.

The Dilation Balloon is intended for soft tissue separation and dilation during endoscopic procedures.

The Tissue Resection Tool is intended for endoscopic resection in the gastrointestinal tract.

The SuMO™ Snare is intended to remove polyps and small tumors from the gastrointestinal tract.

The Apollo Endosurgery SuMO Access and Tissue Resection System is a single-use system intended to access, dissect, and resect soft tissue in endoscopic gastrointestinal procedures.

The system is comprised of five component devices:

• Injection Needle ●
• Tunneling Balloon .
• Dilation Balloon .
• Tissue Resection Tool .
• SuMO Snare ●

The SuMO Access and Tissue Resection System underwent various testing to ensure it met acceptance criteria for its intended use.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not provide details on the sample size for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). It generally states that "Product testing was completed and met the acceptance criteria."

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

This information is not available in the provided document. The studies conducted are related to device performance and safety, not diagnostic accuracy requiring expert ground truth establishment.

4. Adjudication method for the test set:

Not applicable. The testing described is performance-based, not involving expert adjudication of results.

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

Not applicable. This is a medical device for tissue access and resection, not an AI or diagnostic tool that would involve human readers or MRMC studies.

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

Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used:

For biocompatibility, the ground truth would be established by standard biological assays confirming the absence of adverse reactions. For sterilization, the ground truth is a sterility assurance level (SAL) of 10^-6. For product testing (dimensional, inflation/deflation, etc.), the ground truth would be the pre-defined engineering specifications and functional requirements for the device components. Electrical safety and EMC ground truth are defined by relevant international standards.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that would require a training set.

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

Not applicable. As this is not an AI/machine learning device, there is no training set or associated ground truth.

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The Gastric Port is intended to be used with an endoscope to facilitate intubation of the endoscope as a guide for various flexible endoscopic instruments for intraluminal procedures.

The safety and effectiveness of this device for Natural Orifice Transluminal Endoscopic Surgery (NOTES) has not been demonstrated.

Gastric Port Models GAP-0016-00, GAP-0018-00, GAP-0020-00

This document is a 510(k) substantial equivalence letter from the FDA to Apollo Endosurgery, Inc. regarding their Gastric Port device. It states that the device is substantially equivalent to legally marketed predicate devices.

This document does NOT contain information about acceptance criteria or a study proving device performance.

The letter establishes that the device can be legally marketed, subject to general controls and potentially additional controls if classified as Class II or III. It also outlines the indications for use, stating that the Gastric Port is intended to be used with an endoscope to facilitate intubation of the endoscope as a guide for various flexible endoscopic instruments for intraluminal procedures. It explicitly states that "The safety and effectiveness of this device for Natural Orifice Transluminal Endoscopic Surgery (NOTES) has not been demonstrated."

Therefore, I cannot provide the requested information from this document.

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The Apollo Endosurgery Endoscopic Monopolar Scissors are designed to cut, dissect, and cauterize tissue during flexible endoscopic procedures.

The Endoscopic Monopolar Scissors is comprised of a flexible metal shaft with a distal mounted scissors which is operated by a proximal handle. The proximal handle also has connections for a monopolar electrocautery source. The scissor blades function as standard scissors for mechanical cutting and for standard electrosurgical cutting, as required.

The provided text describes the Endoscopic Monopolar Scissors and states that "Product testing was completed and met all of the acceptance criteria." However, it does not explicitly detail the acceptance criteria themselves or the specific results that demonstrate they were met. It only lists the types of testing performed.

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

Here's what can be inferred/extracted:

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

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

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Not applicable as the testing described is performance-based on the device itself, not requiring expert ground truth in the traditional sense of diagnostic accuracy studies.

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

• No, this is a medical device, not an AI diagnostic tool.

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

• Not applicable, as this is a physical medical device.

7. The type of ground truth used

• The "ground truth" here would be the physical and electrical specifications/standards that the device needed to meet. The text doesn't specify these, but implies they exist (e.g., "acceptance criteria").

8. The sample size for the training set

• Not applicable, as this product is a physical device, not an AI algorithm.

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

• Not applicable.

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The Electrocautery Dilation Balloon is intended for dilation of strictures of the esophagus and gastrointestinal tract and cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.

The Electrocautery Dilation Balloon is indicated for dilation of strictures of the esophagus and gastrointestinal tract and cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. Using either endoscopic or fluoroscopic means, the balloon is placed at the physician selected site. Once in place, the clinician inflates the balloon to dilate the stricture. The electrocautery needle knife may be used for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. The needle knife is advanced and retracted with the proximal handle.

The provided text describes a 510(k) summary for the Electrocautery Dilation Balloon. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific performance metrics akin to a novel AI device.

Therefore, many of the typical "acceptance criteria" and "study" details requested for an AI device (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect sizes, and types of ground truth) are not applicable to this traditional medical device submission.

Here's a breakdown based on the provided text, highlighting what is and isn't available:

1. Table of Acceptance Criteria and Reported Device Performance:

The submission focuses on "Product testing" to ensure the device performs as intended and is safe. The acceptance criteria are largely based on engineering performance specifications rather than clinical accuracy for diagnostic or prognostic purposes, which would involve concepts like sensitivity, specificity, etc.

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

• Not Applicable. This submission does not describe a clinical "test set" in the context of evaluating diagnostic accuracy or a similar performance claim requiring patient data. The testing mentioned (inflation/deflation/burst, atraumatic tip, electrocautery extension/retraction, and corrosion testing) refers to bench testing of the device itself, likely using a sample of manufactured devices, but the specific number is not provided. Data provenance (country of origin, retrospective/prospective) is also not applicable here.

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

• Not Applicable. There is no "ground truth" to establish in the context of diagnostic performance for this type of device submission. The device is a tool for a medical procedure, and its performance is assessed against engineering and functional specifications, not against a diagnostic gold standard in patient cases.

4. Adjudication Method for the Test Set:

• Not Applicable. As there's no clinical test set requiring expert interpretation or labeling, there's no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. An MRMC study is relevant for evaluating the clinical impact of an AI diagnostic aid on human readers. This device is a surgical/interventional tool, not an AI diagnostic system, so such a study would not be performed for this submission.

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

• Not Applicable. This device is a physical medical instrument, not an algorithm. Standalone performance as typically described for AI devices is irrelevant.

7. The Type of Ground Truth Used:

• Not Applicable (in the AI/diagnostic sense). The "ground truth" for this device's performance would be engineering specifications and functional requirements (e.g., "the balloon must inflate to X pressure without bursting," "the knife must extend and retract smoothly"). These are verified through direct measurement and observation during bench testing.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. As there's no training set, this question is not relevant.

In summary: The provided 510(k) pertains to a traditional device (electrocautery dilation balloon) demonstrating substantial equivalence to predicates through bench testing and material compatibility. The performance criteria are therefore engineering and functional, not clinical diagnostic accuracy, which is why many of the requested AI-centric details are not present in the document.

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The Apollo Endosurgery OverStitch Endoscopic Suture System is intended for endoscopic placement of suture(s) and approximation of soft tissue.

The Apollo Endosurgery OverStitch Endoscopic Suture System provides physicians the ability to perform several different types of tissue apposition within the Gastrointestinal (GI) Tract and peritoneal cavity. Additionally, the system allows the surgeon to 'reload' the suture without the need for removing the endoscope.

The provided text is for a 510(k) summary for the Apollo Endosurgery OverStitch Endoscopic Suture System. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain the detailed acceptance criteria or the specific study data typically found in a clinical performance study report.

Based on the provided text, here is what can be extracted and what information is missing:

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. The document only mentions "Suture placement and securement testing was performed by comparing the OverStitch to commercially available predicate products." without detailing the number of tests performed or any sample size justification.
• Data Provenance: Not specified. It's unclear if this testing was done with ex-vivo, in-vivo, or simulated models, or in which facility/country the testing occurred. Given it's a 510(k) summary, it's highly likely to be internal engineering/bench testing rather than clinical data from human subjects.

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. The testing described appears to be technical/mechanical performance comparisons rather than expert-driven clinical evaluations.

4. Adjudication method for the test set

• This information is not provided. As the testing is described as mechanical and comparative, an adjudication method in the context of clinical ground truth would not typically apply.

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

• No, an MRMC comparative effectiveness study was NOT done. This device is an endoscopic suturing system, a medical device for performing surgical tasks, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

• Not applicable. This is a mechanical device, not an algorithm.

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

• For the "Suture placement and securement testing," the ground truth was effectively defined by the performance of the predicate devices. The OverStitch was deemed "equivalent" if its performance matched or was within an acceptable range of the predicate devices for suture placement and securement. No independent clinical "ground truth" (e.g., pathology, long-term outcomes) is mentioned for this specific testing. For the other mechanical tests, the ground truth would be the pre-defined product specifications.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI/machine learning algorithm that requires a training set.

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

• Not applicable. This is a mechanical device, not an AI/machine learning algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document describes "Product testing was conducted to evaluate conformance to product specification." This included:

• Mechanical strength testing
• Bond strength
• Suture operation
• Suture securement
• Visual / dimensional inspection

Additionally, a comparative study was performed:

• Study Type: Comparative bench testing.
• Comparison: OverStitch was compared against "commercially available predicate products" (K061770 Endoscopic Suturing System (ESS) - Ethicon Endo Surgery, K003956 EndoCinch Suturing System - Davol / Bard, K972911 Auto Suture-Endo Stitch - Tyco Healthcare).
• Methodology: The devices were used "per their respective Instructions for Use."
• Outcome: The results "showed the OverStitch was equivalent to the predicate devices" in terms of suture placement and securement.

This submission is a 510(k) for substantial equivalence. The "study" described is primarily bench testing to demonstrate that the new device performs comparably to already cleared predicate devices and meets its own product specifications. This type of submission relies on the concept that if a new device is substantially equivalent to a legally marketed predicate device, it can be marketed without requiring new clinical trials, as the predicate's safety and effectiveness have already been established.

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