(124 days)
The Standard Clamp is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues.
The Standard Clamp is a reusable, non-energized, stainless steel surgical instrument designed for use in laparoscopic procedures to clamp long planes of soft tissue such as the stomach. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is an inline grip with two knobs which are manually rotated in order to manipulate the end effector. The shaft is sized to fit a standard 12 mm trocar. The end effector of the clamp is comprised of an upper and lower jaw that close parallel in order to grasp tissue.
The provided text describes a 510(k) premarket notification for a medical device called the "Standard Clamp." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving device performance against those criteria in the context of an AI/ML algorithm.
Therefore, many of the requested details about acceptance criteria, study design for AI/ML performance, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI/ML are not available in this document.
However, I can extract the information related to the device's pre-clinical evaluation which serves as a form of performance data for this physical medical device.
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of quantifiable acceptance criteria with corresponding performance metrics for the Standard Clamp. Instead, it describes a pre-clinical evaluation and its outcome.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Ability to clamp long planes of soft tissue without damage | "Testing demonstrated acceptable performance of the Standard Clamp." "No damage to surrounding tissues were caused by any of the clamps." |
| Histological tissue effects comparable to control/predicate devices | "The histology demonstrated similar types of tissue effects between the three clamps." |
| Conformance to device specifications | "The data demonstrate conformance to the device specifications." |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of animals or trials. The text mentions "a live anesthetized pig" (singular) and "the porcine stomach laparoscopically." It then refers to "histology samples... for each clamp," implying multiple clamping actions or multiple clamps tested on the same animal. The exact number of clamping instances or samples is not specified.
- Data Provenance: Prospective, in-vivo animal study. The location (country of origin) is not specified, but the submission is to the U.S. FDA.
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 histological analysis would typically be performed by a veterinary pathologist, but their number and qualifications are not mentioned.
4. Adjudication method for the test set
Not applicable/not described. This was a direct observation and histological analysis, not a human reader study requiring adjudication.
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 study was not done. This device is a surgical instrument, not an AI/ML diagnostic tool, so this type of study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical surgical instrument.
7. The type of ground truth used
The ground truth was established through:
- In-vivo observation of tissue effects during and after clamping.
- Histological analysis of resected stomach tissue after clamping.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.