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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 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 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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