(252 days)
Integra™ Jarit® Video Assisted Thoracic Surgery (VATS) Instruments are manually operated instruments designed to perform specific functions such as cutting, grasping, clamping, dissecting, probing, draining, aspirating, suturing or ligating during open, mini-open, or thoracoscopic surgical procedures.
Integra™ Jarit® Video Assisted Thoracic Surgery (VATS) Instruments are a family of manual, stainless steel instruments consisting of clamps, forceps, needle holders, scissors, knot tiers/pushers, and suction instruments. These reusable devices are packaged non-sterile and are steam sterilizable.
The Integra™ Jarit® Video Assisted Thoracic Surgery (VATS) Instruments are manual, stainless steel surgical instruments. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than a standalone clinical study on AI performance. Therefore, most of the requested information regarding AI study details (like sample sizes for test/training sets, expert qualifications, MRMC studies, etc.) is not applicable to this submission.
Here's a breakdown of the acceptance criteria and performance data as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Testing Performed | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Manual Cleaning Validation (Protein Analyses) per AAMI TIR30:2003. | Conformance to AAMI TIR30:2003 guidelines for cleaning, specifically for protein removal. (Details of specific protein levels are not provided.) | Pass |
| Mechanical Cleaning Validation (Protein Analyses) per AAMI TIR30:2003. | Conformance to AAMI TIR30:2003 guidelines for cleaning, specifically for protein removal. (Details of specific protein levels are not provided.) | Pass |
| Pre-Vacuum (wrapped) Steam Sterilization Validation per ANSI/AAMI ST79:2010 & A1:2010 and ANSI/AAMI/ISO 14937:2009 at 270°F (132°C) with an Exposure Time of 4 minutes. | Sterilization to achieve sterility assurance level (SAL). (Specific SAL not detailed, but implied by standard conformance.) | Pass |
| Repeated Autoclave Testing, Boiling Water Testing, Copper Sulfate Corrosion Testing and Thermal Testing per ISO 13402 and ASTM F 1089-02. | Maintenance of integrity and functionality after exposure to specified conditions, including resistance to corrosion and thermal exposure. (Specific pass/fail thresholds not detailed.) | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this document describes the validation of physical surgical instruments, not an AI device or a study involving human-in-the-loop performance with an AI. The "test set" here refers to the physical instruments tested. The report indicates the testing was performed, but details on the number of instruments or specific units tested are not provided. The testing was conducted by Integra York PA, Inc., likely within the US, but explicit provenance is not stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. Ground truth in this context would refer to the objective standards set by the cited performance standards (e.g., a specific level of protein removal, a defined sterility assurance level, or physical properties of materials). The assessment of "pass" or "fail" is based on these objective criteria as measured in laboratory settings, not on expert interpretation of images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are relevant for studies involving human interpretation or subjective assessments. The performance tests here are objective measurements against defined standards.
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
This is not applicable. This submission is for manual surgical instruments, not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This submission is for manual surgical instruments, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for these tests is based on established industry and international standards for medical device performance, material science, and sterilization. These include:
- ANSI/AAMI ST79:2010 & A1:2010 (Sterilization)
- ANSI/AAMI/ISO 14937:2009 (Sterilization)
- ASTM TIR 30:2003 (Cleaning)
- ASTM F 1089-02 (Corrosion)
- ISO 13402:1995 (Resistance against autoclaving, corrosion, thermal exposure)
- ISO 7153-1:2001 (Metallic Materials - Stainless Steel)
- ASTM F899-11 (Wrought Stainless Steels for Surgical Instruments)
The "ground truth" is defined by the requirements and methodologies within these standards.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This is 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.