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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 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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