(71 days)
The Smith & Nephew Suture Collet is intended for use in the management of soft vessel ligation and / or fixation of soft tissue structures during open and endoscopic procedures.
The Smith & Nephew Suture Collet is indicated for use in the management of soft vessel ligation and / or fixation of soft tissue structures during open and endoscopic procedures, including thoracoscopic surgery, laparoscopic procedures, and general surgery. The device is not indicated for use in contraceptive tubal ligation.
The Smith & Nephew Suture Collet System comprises three main components:
• the suture collet implant (ring and pin),
• the disposable cartridge assembly with threader, and
• the reusable delivery instrument.
The provided text describes a 510(k) summary for the "Smith & Nephew Suture Collet" device. This is a submission demonstrating substantial equivalence to a predicate device, not a study proving the device meets acceptance criteria in the sense of performance metrics against a medical condition.
Therefore, many of the requested sections about acceptance criteria, study design, expert ground truth, etc., are not applicable to this type of regulatory submission as they are focused on performance equivalence to a legally marketed device rather than clinical efficacy or diagnostic accuracy.
Here's an attempt to answer the questions based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion for a 510(k) submission is typically substantial equivalence to a legally marketed predicate device. This is primarily demonstrated by comparing design, materials, intended use, indications, and performance characteristics.
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance (Summary of Equivalence) |
|---|---|
| Substantial Equivalence to Predicate | The Smith & Nephew Suture Collet is substantially equivalent to the Suture Lock, and silk 2-0 suture. Comparative strength testing demonstrates the equivalence of the Suture Lock to the predicate devices. |
| Similar design | Yes, similarities in design identified. |
| Similar materials | Suture Collet implant: Implant grade polyacetal. Suture Lock implant: Implant grade polyacetal. Delivery Instrument: Aluminum and Stainless Steel (both devices). |
| Similar intended use | Suture Collet: Management of Soft Tissue. Suture Lock: Management of Soft Tissue. |
| Similar indications for use | Suture Collet: Open and Endoscopic/Laparoscopic/Thoracoscopic Surgical Procedures. Suture Lock: Open and Arthroscopic Surgical Procedures. (While "Thoracoscopic" is added for the Suture Collet, the general scope is similar). |
| Similar sterilization method | Implant: Ethylene Oxide (both devices). Delivery Instrument: Steam autoclave or ethylene oxide (both devices). |
| Performance (e.g., strength) | Comparative strength testing demonstrates the equivalence of the Suture Collet to the predicate devices (Suture Lock and silk 2-0 suture). Specific numeric values for strength are not provided in this summary. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The submission mentions "Comparative strength testing," but does not provide details on the number of samples or tests performed.
- Data Provenance: Not explicitly stated. The testing would have likely been conducted by the manufacturer (Smith & Nephew, Inc.) as part of their product development and regulatory submission process. It is not described as involving external clinical data or retrospective/prospective studies on patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in the clinical sense (e.g., disease diagnosis) is not relevant to this type of device submission, which focuses on mechanical equivalence. The "ground truth" here is the performance of the predicate device and USP standard suture.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1 for clinical consensus) are not relevant to demonstrating substantial equivalence for a medical device through comparative strength testing.
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 a medical device for tissue fixation/ligation, not an AI-assisted diagnostic or imaging device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to the established characteristics and performance of the legally marketed predicate devices (Suture Lock and 2-0 silk suture), against which the new device's properties (materials, design, intended use, indications, and strength) were compared. This is a regulatory "ground truth" for demonstrating equivalence rather than a clinical ground truth for a medical condition.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI model.
§ 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.