(87 days)
The Intromit is inserted into the patient's abdomen to provide abdominal access for the surgeon's hand while preserving the peritoneum during laparoscopic surgery.
Intromit™ will be sold as a kit that includes a flexible access tube, medical grade adhesive, sterile lubricant and incise template. The access tube consists primarily of an outer sleeve, an inner sleeve, and an adhesive coated flange, which is welded to the distal end of the outer sleeve. The inner and outer sleeves are welded together. The principal components of the access tube are made of polymer film. Intromit™ is packaged into sterile double tyvek pouches and is labeled as a single-patient use device.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them, structured as requested:
Device Name: Intromit™ Hand Access Port for Hand Assisted Laparoscopic Surgery
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for the clinical study. Instead, it frames the study results in terms of "equivalence" or "no more likely/higher/equivalent" compared to a control group or existing procedures.
| Acceptance Criteria (Implied) | Reported Device Performance (Intromit™ HALC vs. LC with trocars) |
|---|---|
| Procedure time is not longer | Overall procedure time for HALC with the Intromit™ is at least as short as the overall procedure time for LC with trocars. |
| Conversion to open surgery is not more likely | Patients in the Intromit™ device group are no more likely to convert to open surgery than patients in the LC group. |
| Instrument changes are not more frequent | No more instrument changes are required for HALC with the Intromit™ than LC with trocars. |
| Mortality is not related to the device | The one death that occurred during the clinical trial was not related to the Intromit™ device. |
| Morbidity is equivalent | The morbidity for HALC with the Intromit™ is equivalent to the morbidity for LC with trocars. |
| Hospital costs are not higher | The direct hospital costs associated with HALC using the Intromit™ are no higher, and possibly lower, than the direct hospital costs associated with LC using trocars. |
| Hospital stays are equivalent | The hospital stays for patients who receive HALC with the Intromit™ are equivalent to the hospital stays for patients who receive LC with trocars. |
| Shorter reconvalescence compared to open surgery is maintained | The HALC with the Intromit™ has retained one of the major advantages of laparoscopic surgery, i.e., a shorter reconvalescence when compared to open surgery. |
| Overall Safety and Effectiveness | The clinical study shows that the HALC with the Intromit™ are as safe and effective as LC with trocars. |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: Forty-four (44) patients were enrolled in the clinical study.
- Data Provenance: The text does not specify the country of origin. It describes a "clinical study," which implies it was prospective in nature, as patients were "enrolled" and their outcomes compared between two surgical approaches.
3. Number of Experts and Qualifications for Ground Truth
- The document does not explicitly mention the number of experts used to establish ground truth or their specific qualifications. For a surgical device study like this, the "ground truth" would be established by the performing surgeons and other medical staff involved in the patient's care (e.g., assessing procedure time, complications, hospital stay). However, the document does not elaborate on an independent ground truth review panel.
4. Adjudication Method for the Test Set
- The document does not mention an explicit adjudication method (e.g., 2+1, 3+1). For a clinical trial comparing surgical procedures, patient outcomes (such as procedure time, conversion to open surgery, morbidity, mortality) are typically recorded and analyzed according to predefined study protocols, rather than being subject to an "adjudication" process akin to image review by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not explicitly described. The study compared surgical procedures (Hand Assisted Laparoscopic Colectomies with Intromit™ vs. Standard Laparoscopic Colectomies with trocars), not the diagnostic performance of a device with and without AI assistance involving human readers.
- Therefore, there is no effect size reported on how much human readers improve with AI vs. without AI assistance.
6. Standalone (Algorithm Only) Performance
- The Intromit™ is a physical surgical device, not an AI algorithm. Therefore, no standalone (algorithm only) performance study was done. The performance described is of the device as used by a surgeon.
7. Type of Ground Truth Used
- The ground truth for this device's efficacy and safety was based on clinical outcomes data from a comparative study of surgical procedures. This includes metrics like procedure time, rates of conversion to open surgery, instrument changes, mortality, morbidity, direct hospital costs, and hospital stay duration.
8. Sample Size for the Training Set
- The concept of a "training set" is typically associated with machine learning or AI models. Since the Intromit™ is a physical surgical device, there is no training set in this context. The clinical study of 44 patients serves as the primary performance evaluation.
9. How the Ground Truth for the Training Set Was Established
- As there is no training set for a physical surgical device, this point is not applicable. The clinical outcomes mentioned above served as the basis for evaluating the device's performance in the clinical study.
§ 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.