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The Apollo ESG NXT System is 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 between 30-50 kg/m2 who have not been able to lose weight, or maintain weight loss, through more conservative measures.

The Apollo REVISE NXT System is intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss in adult patients with between 30-50 kg/m2 by enabling transoral outlet reduction as a revision to a previous bariatric procedure.

These devices are used to perform gastric remodelling through the placement of anchor-sutures and locking cinch device. The Apollo ESG NXT system is for intended for endoscopic sleeve gastroplasty (ESG) while the Apollo REVISE NXT device is intended for transoral outlet reduction, as a revision to a previous bariatric procedure. The two device systems differ in terms of the number of anchor-sutures and cinches needed to perform ESG and TORe procedures. Both systems are comprised of a Needle Driver Assembly and Anchor Exchange Device, and accessories such as the Tissue Helix, Suture Cinch and Suture-Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials.

The Apollo ESG NXT and Apollo REVISE NXT needle driver assembies are designed to be compatible with single channel endoscopes. The endcap assembly of the needle driver is mounted onto the endoscope using polyester medical tape. The external catheter sheath has two working channels through which the Anchor Exchange and other accessories can operate, independent of the endoscope channel. The needle driver assembly also incorporates a pull string feature that, when pulled, allows the physician to further control the retroflexion capabilities of the endoscope.

The handle of the Needle Driver Assembly is squeezed to actuate the needle body and exchange the proprietary Suture-Anchor Assembly with the Anchor Exchange to perform stitching operations. A previously cleared Tissue Helix is provided with Apollo ESG NXT while the NXT Tissue Helix Pro is provided with Apollo REVISE NXT. Both instruments are used for manipulating tissue into the suturing window of the needle driver assembly. These devices also include a matching number of anchor-sutures and cinches to perform the gastroplasty or revision procedure.

The NXT Tissue Helix Pro is used to acquire tissue by rotating the device's handle to to gather tissue onto the exposed exposed helix coil. The acquired tissue is then pulled into proximity of the needle body to complete the stitching operation. Tissue is released by rotating the handle in the opposite direction.

The provided document describes a 510(k) premarket notification for the Apollo ESG NXT System and Apollo REVISE NXT System. The study presented here focuses on demonstrating substantial equivalence to a predicate device (DEN210045-Apollo ESG Sx System, Apollo Revise Sx System) rather than proving the device meets acceptance criteria for a new, independent performance claim for an AI/ML-based device.

Therefore, many of the requested elements pertaining to an AI/ML device's acceptance criteria, performance study design (e.g., ground truth establishment, MRMC studies, standalone performance), and expert input are not applicable to this submission, as the fundamental claim is one of equivalence based on similar design, materials, and intended use as a physical medical device.

However, I can extract the information relevant to what types of testing were performed to show this equivalence and where "acceptance criteria were met."

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance (as demonstrated for Substantial Equivalence)

Here's an analysis of the requested elements:

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

   • See table above. The "acceptance criteria" are implied by the need to demonstrate substantial equivalence to the predicate device and adherence to relevant standards for biocompatibility, sterility, etc. The "reported device performance" is a summary of the non-clinical testing performed.

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

   • The document does not specify sample sizes for the bench or functional testing (e.g., number of devices tested for tensile strength, torque, etc.). It states: "Appropriate product testing was performed... All devices were evaluated to their individual functional and reliability requirements, as well as system compatibility."
   • The document primarily relies on non-clinical (bench and ex vivo) testing for the current device and leverages existing clinical data from the predicate device (DEN210045).
   • Data Provenance: The new testing is likely proprietary, conducted at Boston Scientific facilities or their chosen testing labs. No information is given about the country of origin for the data itself. The clinical data is leveraged from the predicate's De Novo clearance, which would have had its own clinical study details (not provided in this 510(k) summary).

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. This is a physical medical device submission, not an AI/ML diagnostic or image analysis device. There is no concept of "ground truth" established by experts in the context of image interpretation or diagnosis for this device's performance claims. The "ground truth" for the device's function (e.g., successful suturing, material integrity) is established through engineering and performance testing against specifications.

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

   • Not Applicable. As per point 3, this is not an AI/ML or diagnostic study requiring human expert adjudication of output.

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

   • Not Applicable. This is not an AI-assisted diagnostic or image analysis device, so no MRMC studies were performed. The device is a surgical/endoscopic suturing system.

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

   • Not Applicable. This device does not have an "algorithm only" or a "human-in-the-loop" component in the context of AI/ML performance. Its standalone performance refers to its mechanical and functional reliability as a physical instrument.

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

   • For the non-clinical testing: The "ground truth" refers to the established engineering specifications and validated test methods (e.g., a specific tensile strength must be met, a specific number of stitches must be capable of being performed successfully).
   • For the clinical performance: The document states "These devices, which use the De Novo clearance devices as predicates, leverage the clinical data presented in that De Novo." This implies that the 'ground truth' for clinical efficacy (weight loss) and safety (adverse events) for the predicate device would have been established through its own clinical trials, likely using patient outcomes data. The current submission argues that because the new device performs the "same procedures" with "same implant placements and the same implants," the clinical data from the predicate is applicable.

8. The sample size for the training set

   • Not Applicable. This device is not an AI/ML algorithm that requires a "training set."

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

   • Not Applicable. As per point 8, there is no AI/ML training set for this device.

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The OverStitch NXT Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.

The OverStitch NXT Endoscopic Suturing System (ESS) and accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing a single-channel endoscope. The system is comprised of the Needle Driver Assembly and Anchor Exchange Device (collectively referred to as ESS), and accessories such as the Tissue Helix or NXT Tissue Helix Pro, Suture Cinch and Suture-Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials.

The OverStitch NXT ESS is designed for compatibility with single channel endoscopes. The ESS is mounted onto the endoscope using polyester medical tape for the endcap assembly. The external catheter sheath has two working channels through which the Anchor Exchange and OverStitch accessories can operate, independent of the endoscope channel.

The handle of the Needle Driver Assembly is squeezed to actuate the needle body and exchange the proprietary Suture-Anchor Assembly with the Anchor Exchange to perform stitching operations.

The document is a 510(k) summary for the OverStitch NXT Endoscopic Suturing System, indicating that clinical performance data was not required to demonstrate substantial equivalence. Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on clinical performance or AI algorithm output. The acceptance criteria and performance data mentioned in section {5} refer to non-clinical bench testing, functional testing on an ex vivo model, and packaging integrity, as well as biocompatibility.

Here's the information derived from the document regarding the non-clinical performance:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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

This document describes non-clinical testing. It does not provide specific sample sizes for the bench tests, ex vivo model, or packaging integrity tests. The provenance of the data is from Apollo Endosurgery Inc./Boston Scientific's own testing procedures. The tests are prospective in the sense that they were conducted specifically for this submission.

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

This information is not applicable to the non-clinical and ex vivo testing described. There were no human expert evaluations in the context of clinical "ground truth" establishment for this submission as clinical data was not required.

4. Adjudication Method for the Test Set

Not applicable as it was non-clinical and ex vivo testing, not human expert adjudication.

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 study was conducted. This device is not an AI-assisted diagnostic or therapeutic device that would involve human readers.

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

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

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" was established by engineering specifications, validated test methods (e.g., ASTM standards), and comparison to the predicate device's established performance parameters. For the ex vivo model, the ground truth was the expected device function and intended use observed in the model.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable for the same reason as point 8.

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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 OverStitch Sx Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.

OverStitch™ Sx Endoscopic Suturing System and The accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing a single-channel endoscope. The system is comprised of the Needle Driver Assembly and Anchor Exchange Device (collectively referred to as ESS), and accessories such as the Tissue Helix, Suture Cinch and Suture-Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials.

The OverStitch Sx ESS is designed for compatibility with single channel endoscopes. The ESS is mounted onto the endoscope using thermoplastic polyurethane straps for the endcap assembly. The external catheter sheath has two working channels through which the Anchor Exchange and OverStitch accessories can operate, independent of the endoscope channel.

The handle of the Needle Driver Assembly is squeezed to actuate the needle body and exchange the proprietary Suture-Anchor Assembly with the Anchor Exchange to perform stitching operations.

The provided text is a 510(k) summary for the Apollo Endosurgery OverStitch™ Sx Endoscopic Suturing System. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test or training sets, ground truth establishment methods, or information about human expert involvement or MRMC studies for AI performance. The document explicitly states "Clinical testing was not required to demonstrate substantial equivalence."

Therefore, I cannot provide a table of acceptance criteria, detailed study results proving acceptance, or information about AI-related aspects (sample sizes, ground truth, experts, MRMC, standalone AI performance) based on the provided text.

The closest information available regarding "acceptance criteria" is a general statement about non-clinical performance data:

"Acceptance criteria were met in each of the studies listed above. The results confirmed equivalency between the subject and predicate devices, and that no new issues of safety or efficacy were raised."

The studies mentioned are:

• Non-Clinical Performance Data:
  • Bench testing: suture drag testing, tensile testing, endoscope compatibility, reliability, and bond strength.
  • Functional Testing: an ex vivo model utilized under the same test methods as the predicate.
  • Packaging Integrity: testing in accordance with ASTM F2096-11, ASTM F1980-16, ASTM D4169-16 and ASTM F88/F88M-15.
• Biocompatibility: Testing and toxicological assessments performed in accordance with ISO 10933-1, including cytotoxicity, irritation and skin sensitization, systemic toxicity, and material mediated pyrogenicity.

Without specific numerical values or targets for these tests, a table of acceptance criteria and reported performance cannot be generated. Moreover, the device described is a physical medical device (suturing system), not an AI/ML powered device, which explains the absence of information related to AI models, ground truth, expert reviews, and MRMC studies.

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

The OverStitch™ Endoscopic Suturing System and accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing either a dual channel or single-channel endoscope. The system is comprised of the Needle Driver Assembly and Anchor Exchange Device (collectively referred to as ESS), and accessories such as the Tissue Helix, Suture Cinch and Suture Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials.

This document is a 510(k) summary for a medical device (OverStitch Endoscopic Suturing System) and thus does not contain the detailed study data, acceptance criteria, or ground truth establishment typically found in a full clinical study report or a premarket approval (PMA) application. A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, often relying on bench testing and comparisons of technological characteristics rather than extensive clinical trials for new functionality.

Based on the provided text, here's what can be extracted and what cannot:

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

The document states: "Appropriate product testing was performed to evaluate conformance to USP requirements, product specifications, and equivalence to the predicate design. The device was evaluated against individual functional and reliability requirements, as well as OverStitch Endoscopic Suturing System compatibility."

Specific quantitative acceptance criteria are not explicitly listed in this summary. Instead, it refers to conformance with USP requirements and product specifications.

The performance reported is qualitative: "The results of all studies confirmed substantial equivalence between the subject and predicate designs, and that no new issues of safety or efficacy were raised."

Performance Testing Mentioned:

• Bench testing included:
  • Needle passing reliability
  • Suture Cinch deployment and pull-off strength
  • Tensile strength per USP
  • Needle pull off strength per USP
  • Suture diameter measurements per USP
• Packaging Integrity: Confirmed by repeating testing in accordance with ASTM F1929-15, ASTM DI69-16, and ASTM F1886/F1886M-16.
• Biocompatibility: Performed in accordance with ISO 10933-1, including extractable and leachable studies (ISO 10993-18: 2005) and toxicological risk assessment (ISO 10993-17: 2002).

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

• Sample Size: Not specified in the provided summary.
• Data Provenance: The tests are "bench testing" and "packaging integrity" studies, which implies laboratory-based, non-clinical data. No specific country of origin is mentioned, but the FDA approval implies compliance with US standards. This is retrospective in the sense that the testing was completed prior to submission.

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

• This information is not applicable as the evaluation relies on a comparison to a predicate device and bench testing against established standards (USP, ASTM, ISO), rather than a clinical study requiring expert assessment of patient outcomes or images for ground truth.

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

• Not applicable. As this is primarily bench testing and comparison to a predicate device, there is no need for an adjudication method as would be used in a clinical study with human readers or assessments where consensus is required.

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 study was done. This device is a mechanical endosurgical suturing system, not an AI or imaging-based diagnostic tool. The concept of "human readers improving with AI assistance" is not relevant to this device. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence."

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. Its performance is assessed through bench testing of its mechanical properties and functionality.

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

• The "ground truth" for this submission is established through conformance to recognized standards (USP, ASTM, ISO) and comparison to the performance characteristics of the legally marketed predicate device (K181141 - OverStitch™ Endoscopic Suturing System). It is not based on clinical "outcomes data" or "expert consensus" in the traditional sense of a diagnostic or therapeutic clinical trial. The phrase "no new issues of safety or efficacy were raised" implies the performance is deemed equivalent to the previously cleared device, which serves as a benchmark.

8. The sample size for the training set:

• Not applicable. This refers to a mechanical device, not a machine learning algorithm that requires a "training set."

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

• Not applicable. See point 8.

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

The OverStitch™ Endoscopic Suturing System and accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing either a dual channel or single-channel endoscope. The system is comprised of the Needle Driver Assembly and Anchor Exchange Device (collectively referred to as ESS), and accessories such as the Tissue Helix, Suture Cinch and Suture-Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials.

The provided text is a 510(k) summary for the OverStitch™ Endoscopic Suturing System and Accessories. It outlines the device's technical specifications and the non-clinical performance data used to demonstrate substantial equivalence to a predicate device. However, it explicitly states that clinical performance data was not required for this submission.

Therefore, I cannot provide information on acceptance criteria and a study proving the device meets those criteria from this document, as the document focuses on non-clinical testing for substantial equivalence, not on establishing device performance against clinical acceptance criteria through a clinical study.

Here's a breakdown of what can be and cannot be extracted from the provided text based on your request:

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

• Cannot be provided. The document details non-clinical performance testing (e.g., needle passing reliability, pull-off strength) to show equivalence to a predicate device, but it does not specify explicit "acceptance criteria" for these performance metrics or report quantitative results against such criteria in a manner suitable for a table. It only states that the testing "confirmed conformance to product specifications" and "equivalency between the subject and predicate devices."

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

• Cannot be provided. The document mentions "product testing" and "bench testing" but does not detail the sample sizes used for these tests. Data provenance (country of origin, retrospective/prospective) is also not mentioned for the non-clinical tests.

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. This document describes non-clinical bench testing and verification/validation activities for a physical medical device. The concept of "ground truth" established by experts, as would be relevant for diagnostic AI/imaging devices, does not apply to the type of testing described here.

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

• Not applicable. As above, the testing described is non-clinical performance testing of a physical device, not an interpretation-based study where adjudication would be relevant.

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. The document explicitly states: "Clinical Performance Data: Clinical testing was not required to demonstrate substantial equivalence." An MRMC study is a type of clinical study, typically for diagnostic devices or AI applications, which was not performed or submitted here.

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

• No. This device is a mechanical endoscopic suturing system; it is not an algorithm or AI system.

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

• Not applicable. "Ground truth" in the context of expert consensus, pathology, or outcomes data is relevant for clinical studies, particularly for diagnostic devices or AI. The testing described here is non-clinical performance testing against product specifications.

8. The sample size for the training set

• Not applicable. This device is a physical medical instrument, not a machine learning model, so there is no "training set."

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

• Not applicable. As above, this is not a machine learning model.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence for a physical medical device through non-clinical performance, materials, and sterilization testing, rather than presenting clinical study data with acceptance criteria for device performance.

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The OverStitch™ Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.

The OverStitch™ Endoscopic Suturing System and accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing either a dual channel or single-channel endoscope. The system is comprised of the Needle Driver Assembly and Anchor Exchange Device (collectively referred to as ESS), and accessories such as the Tissue Helix and Suture Cinch devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone and stainless steel materials.

The OverStitch ESS is designed for compatibility with dual channel endoscopes. The endcap of the Needle Driver Assembly attaches to the distal end of the endoscope, and the handle attaches to the proximal end. The handle of the Needle Driver Assembly is squeezed to actuate the needle body and exchange the proprietary suture assembly with the Anchor Exchange to perform stitching operations.

The OverStitch Sx ESS is designed for compatibility with single channel endoscopes. The ESS is mounted onto the endoscope using silicone straps distributed along the length of the catheter and endcap assembly. The external catheter sheath has two working channels through which the Anchor Exchange and OverStitch accessories can operate, independent of the endoscope channel. The handle of the Needle Driver Assembly is squeezed to actuate the needle body and exchange the proprietary Suture-Anchor assembly with the Anchor Exchange to perform stitching operations.

The OverStitch Helix is an optional device that is designed to acquire tissue by rotating the device handle into targeted area until tissue is gathered into the exposed helix coil. The acquired tissue is then pull into proximity of the needle body to complete the stitching operation.

The OverStitch Suture-Anchor Assembly is comprised of a 510(k) cleared suture product, manufactured from either polydioxanone or polypropylene materials attached to an implantable anchor manufactured from cobalt chrome and stainless steel. The Anchor component is intended to function with the OverStitch ESS device to perform stitching operations and serves as an anchor to secure suture placement, once released from the ESS.

The Overstitch Suture Cinch device is comprised of thermoplastic and stainless steel materials and includes an implantable PEEK Cinch component designed to secure the placement of suture as a final step of an OverStitch procedure. The device functions by squeezing the handle and deploying the PEEK components that press-fit onto the tail end of the suture to maintain suture position in situ.

The Apollo Endosurgery OverStitch Endoscopic Suturing System is a Class II medical device intended for endoscopic placement of suture(s) and approximation of soft tissue. The 510(k) summary provides information on the device's technological characteristics and non-clinical performance data to demonstrate substantial equivalence to its predicate device (K081853).

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a structured format. However, it states that "Appropriate product testing was performed on all subject devices to evaluate conformance to product specifications and equivalence to the predicate designs. Verification and validation for the proposed system of devices was conducted in accordance with protocol. All devices were evaluated to their individual functional and reliability requirements, as well as system compatibility with various endoscopes."

The performance tests mentioned are:

The overall conclusion is that "The results of all studies confirmed equivalency between the subject and predicate devices, and that no new issues of safety or efficacy were raised." This implies that the device met its defined performance specifications, which serve as the acceptance criteria for each test.

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

The document does not explicitly state the specific sample sizes used for each performance test (e.g., number of needles tested, number of suture cinches). It indicates that "Appropriate product testing was performed on all subject devices."

The data provenance is retrospective, as the tests were conducted as part of a 510(k) submission to demonstrate substantial equivalence to an already marketed predicate device. The country of origin of the data is not specified.

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

This information is not applicable as the document describes an evaluation of a physical medical device (suturing system) through engineering and bench testing, not an AI/software device that requires expert-established ground truth for image or data interpretation.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Adjudication methods are typically used in clinical studies or AI evaluations where there might be disagreement among reviewers or interpreters.

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. The device is a suturing system, not an AI or imaging diagnostic device that would involve human readers or AI assistance for interpretation.

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

This information is not applicable. The device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

For the performance testing, the "ground truth" refers to the established engineering specifications, physical measurements, and regulatory standards for device functionality, sterility, shelf-life, and biocompatibility.

• Bench Testing: Engineering specifications and physical measurements (e.g., strength measurements, deployment mechanisms).
• Sterility: Conformance to ISO 11135:2014.
• Shelf-Life: Functional and sterility testing results on aged products.
• Biocompatibility: Conformance to ISO 10933-1.

8. The Sample Size for the Training Set:

This information is not applicable as the document describes the evaluation of a physical medical device, not an AI/machine learning model that requires a training set.

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

This information is not applicable for the same reasons as point 8.

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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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