(49 days)
The Apollo Endosurgery OverStitch Endoscopic Suture System is intended for endoscopic placement of suture(s) and approximation of soft tissue.
The Apollo Endosurgery OverStitch Endoscopic Suture System provides physicians the ability to perform several different types of tissue apposition within the Gastrointestinal (GI) Tract and peritoneal cavity. Additionally, the system allows the surgeon to 'reload' the suture without the need for removing the endoscope.
The provided text is for a 510(k) summary for the Apollo Endosurgery OverStitch Endoscopic Suture System. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain the detailed acceptance criteria or the specific study data typically found in a clinical performance study report.
Based on the provided text, here is what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical strength testing meets product specifications | "Testing included mechanical strength testing, bond strength, suture operation, suture securement and visual / dimensional inspection." - Implies conformance, but no specific values or thresholds are given. |
| Bond strength meets product specifications | "Testing included mechanical strength testing, bond strength, suture operation, suture securement and visual / dimensional inspection." - Implies conformance, but no specific values or thresholds are given. |
| Suture operation meets product specifications | "Testing included mechanical strength testing, bond strength, suture operation, suture securement and visual / dimensional inspection." - Implies conformance, but no specific values or thresholds are given. |
| Suture securement meets product specifications | "Testing included mechanical strength testing, bond strength, suture operation, suture securement and visual / dimensional inspection." - Implies conformance, but no specific values or thresholds are given. |
| Visual/dimensional inspection meets product specifications | "Testing included mechanical strength testing, bond strength, suture operation, suture securement and visual / dimensional inspection." - Implies conformance, but no specific values or thresholds are given. |
| Suture placement and securement performance equivalent to predicate devices | "Suture placement and securement testing was performed by comparing the OverStitch to commercially available predicate products. The products were used per their respective Instructions for Use. The results showed the OverStitch was equivalent to the predicate devices." - Concludes equivalence, but no specific metrics or statistical results are provided. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only mentions "Suture placement and securement testing was performed by comparing the OverStitch to commercially available predicate products." without detailing the number of tests performed or any sample size justification.
- Data Provenance: Not specified. It's unclear if this testing was done with ex-vivo, in-vivo, or simulated models, or in which facility/country the testing occurred. Given it's a 510(k) summary, it's highly likely to be internal engineering/bench testing rather than clinical data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The testing described appears to be technical/mechanical performance comparisons rather than expert-driven clinical evaluations.
4. Adjudication method for the test set
- This information is not provided. As the testing is described as mechanical and comparative, an adjudication method in the context of clinical ground truth would not typically apply.
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, an MRMC comparative effectiveness study was NOT done. This device is an endoscopic suturing system, a medical device for performing surgical tasks, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI" is not applicable here.
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 (expert consensus, pathology, outcomes data, etc.)
- For the "Suture placement and securement testing," the ground truth was effectively defined by the performance of the predicate devices. The OverStitch was deemed "equivalent" if its performance matched or was within an acceptable range of the predicate devices for suture placement and securement. No independent clinical "ground truth" (e.g., pathology, long-term outcomes) is mentioned for this specific testing. For the other mechanical tests, the ground truth would be the pre-defined product specifications.
8. The sample size for the training set
- Not applicable. This is a mechanical device, not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a mechanical device, not an AI/machine learning algorithm.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document describes "Product testing was conducted to evaluate conformance to product specification." This included:
- Mechanical strength testing
- Bond strength
- Suture operation
- Suture securement
- Visual / dimensional inspection
Additionally, a comparative study was performed:
- Study Type: Comparative bench testing.
- Comparison: OverStitch was compared against "commercially available predicate products" (K061770 Endoscopic Suturing System (ESS) - Ethicon Endo Surgery, K003956 EndoCinch Suturing System - Davol / Bard, K972911 Auto Suture-Endo Stitch - Tyco Healthcare).
- Methodology: The devices were used "per their respective Instructions for Use."
- Outcome: The results "showed the OverStitch was equivalent to the predicate devices" in terms of suture placement and securement.
This submission is a 510(k) for substantial equivalence. The "study" described is primarily bench testing to demonstrate that the new device performs comparably to already cleared predicate devices and meets its own product specifications. This type of submission relies on the concept that if a new device is substantially equivalent to a legally marketed predicate device, it can be marketed without requiring new clinical trials, as the predicate's safety and effectiveness have already been established.
§ 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.