(112 days)
The SPIDER™ (Single Port Instrument Delivery Extended Reach) is intended to establish a path of entry for laparoscopic instruments for use during minimally invasive abdominal laparoscopic surgery.
The SPIDER™ is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures. Following a Hasson cut down incision, the multi-channel cannula is inserted through a small abdominal incision. The channels are deployed allowing laparoscopic instruments to pass through each channel into the abdomen to perform laparoscopic surgery. Two channels known as IDTs (Instrument Delivery Tubes) are positioned east to west and include extended lumens to facilitate manipulation of flexible surgical instruments, enabling control of the instruments over extended distances. These 2 IDTs are flexible and allow for x, y, and z motion for a multidirectional approach of the surgical field, mimicking the approach of standard laparoscopic surgery. Two (2) rigid channels, north to south, can accommodate an endoscope or a rigid surgical instrument. The device includes ports for insufflation or smoke evacuation. Pneumoperitoneum is maintained in the abdomen during the surgical procedure. The single use SPIDER™ device is provided pre-sterilized and is a single use device. The SPIDER™ device also includes a Support Arm accessory. The support arm is provided to mount and stabilize the device.
The provided text describes a medical device called the SPIDER™ Single Port Surgical Device (K090902), not a system for generating unique identifiers (UIDs). Therefore, the information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for a UID generation system is not available in the provided document.
However, I can extract the information related to the SPIDER™ medical device:
1. Acceptance Criteria and Reported Device Performance (Summary based on the provided text):
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Verification and validation studies were conducted to demonstrate. |
| Sterility | Verification and validation studies were conducted to demonstrate. |
| Functionality | Verification and validation studies were conducted to demonstrate. |
| Equivalency to Standard Multi-Incision Laparoscopic Surgery | Pre-clinical studies were conducted to demonstrate. |
| Intended Use Validation | Pre-clinical studies were conducted to validate. |
| Support Arm Cleaning and Autoclaving | Tested and validated. |
| Support Arm Retention Strength | Tested and found adequate. |
| Support Arm Mechanical Strength (simulated use) | Tested and found adequate. |
| Support Arm Functionality (repeated use) | Tested and found adequate. |
| Overall Safety and Effectiveness | Concluded to be as safe and effective as predicate devices, performs similarly, and does not raise new safety or effectiveness issues. |
| Substantial Equivalence | Determined by the FDA to be substantially equivalent to legally marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for the verification and validation studies or pre-clinical tests. It refers generally to "studies" and "tests." It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided in the document. The text indicates that "pre-clinical studies were conducted," but details on expert involvement or ground truth establishment are absent.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No mention of an MRMC comparative effectiveness study, human readers, or AI assistance is made in the provided text, as the device is a surgical instrument, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance:
This is not applicable as the device is a physical surgical instrument, not an algorithm or software requiring standalone performance testing in that context.
7. Type of Ground Truth Used:
The document mentions "pre-clinical studies were conducted to demonstrate equivalency to the medical effect achieved with standard multiple incision laparoscopic surgery and to validated the intended use of the device." This suggests the ground truth was likely established by comparing the device's performance (e.g., surgical outcomes, ease of use, ability to perform tasks) against established standards of care or predicate devices in a pre-clinical setting. Specific types of ground truth (e.g., pathology, outcomes data with specific metrics) are not detailed.
8. Sample Size for the Training Set:
This information is not provided in the document. The mention of "pre-clinical studies" suggests testing, but not a distinct "training set" in the context of machine learning, which is not applicable here.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided and is not applicable, as the device is a physical surgical tool and not an AI/ML algorithm requiring a training set with established ground truth.
In summary, the provided document is a 510(k) summary for a medical device (surgical instrument) and, as such, focuses on demonstrating substantial equivalence to predicate devices through various verification and validation tests rather than specific AI-related study design elements.
§ 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.