(27 days)
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)
| Criteria Category | Acceptance Criteria (Implied by equivalence to predicate & regulatory standards) | Reported Device Performance (Summary from submission) |
|---|---|---|
| Functional/Performance | Expected to perform similarly to predicate (e.g., suture drag, tensile strength, torque load, tissue acquisition reliability, endoscope compatibility, functional durability). | - Suture Drag Testing: Performed.\n- Tensile Testing: Performed.\n- Torque Load Testing: Performed.\n- Endoscope Compatibility: Tested and confirmed for single-channel endoscopes with OD range 8.8-9.8 mm (same as predicate).\n- Sterility: Tested.\n- Reliability: Performed.\n- Bond Strength: Performed.\n- Tissue Acquisition Reliability: NXT Tissue Helix Pro specifically tested.\n- Functional Durability: Validated to perform 8 stitches for each of 8 sutures (same as predicate).\n- "MaxFlex" Feature: Integrated into the needle driver, providing enhanced retroflexion control (new feature, demonstrated to function).\n- Endoscope Attachment Method: Updated method and materials, tested for functionality.\n- Design/Material Modifications: New materials and design changes implemented to improve durability and manufacturability, validated through testing. |
| Biocompatibility | Meet ISO 10933-1 requirements for risk category. | - Biocompatibility Testing: Performed per ISO 10933-1 (cytotoxicity, irritation, skin sensitization, systemic toxicity, material-mediated pyrogenicity) on "OverStitch devices" (presumably refers to the subject devices, as they are part of the OverStitch family and use similar components/materials) – Same as Predicate. |
| Shelf Life | Established shelf life. | - Shelf Life: Established as 1 year (predicate was 3 years, so this is a difference, but acceptable). |
| Sterilization | Validated sterilization method. | - Sterilization Method: EO (Ethylene Oxide) – Same as Predicate. |
| Packaging Integrity | Maintain sterile barrier and protect device during transport/storage. | - Packaging Integrity: Confirmed by repeating testing in accordance with ASTM F2096-11, ASTM F1980-21, ASTM D4169-22, and ASTM F88/F88M-21. |
| MR Compatibility | Safe for use in specific MR environments. | - MR Compatibility: Safe with 1.5 and 3 T MR scanners with spatial field gradient of 2500 Gauss/cm (extrapolated or less) and SAR of 2.0 W/kg for 15 minutes of continuous scanning – Same as Predicate. |
| Clinical Performance (Leveraged) | Demonstrate equivalent weight loss outcomes and adverse event profiles to the predicate, with proper training. | - Leverages clinical data from the DEN210045 predicate. The ESG and outlet revision procedures performed with these new devices are stated to be "the same (same implant placements and the same implants)". "There is reasonable assurance that the weight loss and adverse events will be the equivalent to the predicate." |
Here's an analysis of the requested elements:
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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.
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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).
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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.
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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.
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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.
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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.
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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.
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The sample size for the training set
- Not Applicable. This device is not an AI/ML algorithm that requires a "training set."
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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.
N/A