(50 days)
EsophyX2 HD Device with SerosaFuse Fasteners and Accessories: The EndoGastric Solutions EsophyX2 HD Device with SerosaFuse Fasteners and Accessories is indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia
The subject EsophyX devices are unchanged from the currently cleared devices. The principles of operation for the devices are the same and also remain unchanged from the prior clearances. The indications for use for both models are identical.
The EndoGastric Solutions EsophyX Device models (EsophyX2 HD and EsophyX Z, K142113 and K160960, respectively) with SerosaFuse Fasteners and Accessories are a prescription use only, disposable, single use system consisting of an all mechanical, flexible fastener delivery device with user controls outside the patient's body. The devices are used in an operating room environment, using the Transoral Incisionless Fundoplication (TIF) procedure.
The device is classified as a surface device, mucosal membrane contacting with limited duration. The fastener classification is an implant, with permanent tissue/bone contact. Materials include acrylic/polycarbonate plastics, machined aluminum, stainless steel, nitinol wire, UV cured adhesives, pellethane and nylon.
The implantable tissue fasteners are constructed of injection molded polypropylene.
These transoral devices and tissue fasteners are provided sterile (EO). A separate, commercial endoscope operating independently down the center of the devices' flexible shaft lumen provides visualization of the procedure at all times, from device insertion through extraction. Two fasteners are loaded from a replaceable fastener cartridge containing ten fasteners for each channel. The loaded fasteners are pushed from the proximal device end. to the distal end down two separate channels via lumens in a flexible shaft where they are then in position ready for deployment into tissue. The operator, controlling the distal end of the devices through the mechanical controls at the proximal end of the devices, captures and positions a fold of tissue at the gastroesophageal junction. The fastener controls deploy both fasteners simultaneously in the EsophyX Z model, or individually in the EsophyXo HD model, at the captured tissue position. This creates a permanent surgical partial fundoplication. Additional fasteners are used as needed to complete the valve restoration.
The provided text describes a 510(k) premarket notification for the "EsophyX2 HD Device with SerosaFuse Fasteners and Accessories" and "EsophyX Z Device with SerosaFuse Fasteners and Accessories." This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily due to an expanded indication for use rather than presenting novel performance data for the devices themselves.
Therefore, the typical structure of acceptance criteria and a study proving a device meets them (especially for AI/algorithmic medical devices) is not directly applicable in the way you've outlined. This document is a regulatory submission for a mechanical device that has existing clearances. The "study" here refers to a literature review supporting an expanded indication.
However, I can extract information related to the closest aspects of your request based on the provided text, focusing on how the expanded indication was supported:
Understanding the Regulatory Context
This is a 510(k) submission, meaning the manufacturer is demonstrating that their device is "substantially equivalent" to a legally marketed predicate device. This is not a de novo submission or a PMA, which would typically require more extensive clinical trials to prove efficacy from scratch.
In this specific 510(k), the key element is an expanded indication for use. The devices themselves are stated to be "unchanged from the currently cleared devices" and "identical to the predicates devices." Therefore, the submission is not about demonstrating new performance for the device's core function but rather showing that the expanded use case is safe and effective when combined with the device's established performance.
Response to Your Specific Questions:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a mechanical device whose performance is already cleared, and the new aspect is an expanded indication supported by literature, there isn't a direct "acceptance criteria" table in the AI/algorithm sense.
However, we can infer the "criteria" for the expanded indication were based on clinical outcomes reported in existing literature for the combined procedure (laparoscopic hiatal hernia repair then TIF with the EsophyX device).
| Acceptance Criteria Category (Inferred) | Reported Device Performance / Clinical Outcomes (from Literature) |
|---|---|
| Safety | No long-term postoperative complications (Ihde et al.) |
| Most complications were minor (dysphagia, nausea, vomiting) (Chang et al.) | |
| No adverse effects reported (Janu et al.) | |
| Effectiveness (GERD-HRQL Score) | 73% of patients normalized GERD-HRQL score (Ihde et al.) |
| Greatest GERD-HRQL score improvement (average 20.5 points) observed in HHR + fundoplication (Chang et al.) | |
| HRQL scores improved 85% for heartburn and regurgitation questions (Janu et al.) | |
| Effectiveness (Symptom Elimination) | 73% of patients eliminated heartburn (Ihde et al.) |
| 76% of patients eliminated regurgitation (Ihde et al.) | |
| Effectiveness (Medication Use) | 76% of patients were off daily PPIs (Ihde et al.) |
| Effectiveness (Other Symptoms) | 67% of patients reported elimination of atypical symptoms (Ihde et al.) |
| RSI scores for hoarseness, throat clearing, excess mucus, coughing, chest pain improved 50-80% (Janu et al.) | |
| GSRS questions on heartburn & regurgitation showed 80% improvement (Janu et al.) | |
| Durability | All results durable at 6 and 12 months follow up (Janu et al.) |
| Patient Satisfaction | 88% of patients satisfied with current health condition (Ihde et al.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The clinical outcomes supporting the expanded indication were drawn from a literature review summarizing outcomes from 163 patients across multiple studies.
- Ihde et al.: 48 patients.
- Chang et al.: 221 patients (sub-group underwent HHR + TIF, N=46).
- Janu et al.: ~99 patients.
- Data Provenance: The studies are published clinical literature. The specific countries of origin are not specified, but the journals (e.g., "The American Journal of Surgery," "Journal of the Society of Laparoendoscopic Surgeons") suggest North American or international scope. The studies are retrospective analyses of collected patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not provided in the text. The "ground truth" here is essentially the reported clinical outcomes in peer-reviewed literature. The authors of these papers conducted the studies and presented their findings, which are then summarized in this submission. There is no mention of external experts specifically establishing "ground truth" for a test set in the context of this 510(k) submission.
4. Adjudication Method for the Test Set
- Not applicable. There was no independent "test set" in the sense of a dataset requiring expert adjudication for ground truth. The submission relies on already published clinical findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is not an AI device, and the submission does not describe an MRMC study. It describes a literature review supporting an expanded surgical indication for a mechanical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device, not an algorithm.
7. The Type of Ground Truth Used
- Clinical Outcomes Data from Published Literature: The "ground truth" for the expanded indication is established through the reported efficacy and safety data from published clinical studies on patients undergoing the combined procedure (laparoscopic hiatal hernia repair followed by TIF). This includes objective measures (e.g., GERD-HRQL scores, PPI discontinuation rates) and patient-reported outcomes.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that uses a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, no training set for an algorithm is involved. The "ground truth" for the device's primary function was established during its original clearances (K142113 and K160960). For the expanded indication, it was established by the clinical data collected and reported in the cited scientific literature.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.