(29 days)
The autosuture™ VERSAPORT™ PLUS Bladeless Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
The autosuture™ VERSAPORT™ PLUS Bladeless trocar is available in diameters from 5mm to 15mm, including short, standard and long length cannula. The 5mm VERSAPORT™ fixed seal system accommodates 5mm instruments, while the VERSAPORT™ PLUS removable seal systems accommodate instruments ranging from 5 mm to 15 mm (the 10/15mm system includes a converter for 5 mm diameter instruments). There is a stopcock valve for insufflation and rapid desufflation.
The provided text describes a 510(k) summary for a medical device, the autosuture™ VERSAPORT™ PLUS Bladeless Trocar. However, it does not contain detailed information about specific acceptance criteria or the study data proving the device meets those criteria, especially in the context of AI/algorithm performance. The document focuses on establishing substantial equivalence to predicate devices and general performance data from in-vitro and in-vivo tests. It does not refer to AI or machine learning at all.
Therefore, I will explain what information is missing based on your request and what can be inferred from the provided text.
Missing Information and Inferences from the Provided Text:
The provided document describes a traditional medical device (a surgical trocar) and its 510(k) summary. It does not involve AI or machine learning algorithms, which are typically associated with the type of acceptance criteria and studies you've requested (e.g., sample size for test/training sets, ground truth establishment, MRMC studies, standalone algorithm performance).
Therefore, I cannot provide most of the requested details as they are not applicable categories for this specific device and its regulatory submission.
Here's an breakdown of what can be extracted or inferred, and what is absent:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document implies that the acceptance criteria are met by demonstrating substantial equivalence to predicate devices (autosuture™ VERSAPORT, Ethicon Excel™). This means the device performs at least as well as, or comparably to, the existing legally marketed devices for its intended use. Specific quantitative performance metrics or thresholds are not detailed in this summary.
- Reported Device Performance: The document broadly states under "PERFORMANCE DATA": "In-vitro and in-vivo tests were performed to verify that the performance of the autosuture™ VERSAPORT™ PLUS Bladeless trocar is substantially equivalent to the predicate devices, and to validate that the autosuture™ VERSAPORT™ PLUS Bladeless trocar will perform as intended."
- Specific, quantifiable performance metrics (e.g., puncture force, tissue damage, seal integrity, ease of insertion, etc.) and their achieved values are NOT provided in this summary. The summary only states that these tests were done to demonstrate substantial equivalence and intended performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided: For a traditional medical device like a trocar, "test set" in the context of an algorithm is not relevant. The performance studies mentioned (in-vitro and in-vivo) would have involved a certain number of devices or experimental subjects, but these specific numbers are not disclosed in the 510(k) summary. Data provenance is also not provided.
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)
- Not Applicable/Not Provided: "Ground truth" in the context of expert consensus is typically for diagnostic algorithms or image analysis. For a surgical trocar, evaluation would involve surgical experts and engineers, but the specific number and qualifications are not detailed in this summary, nor would they be framed as "establishing ground truth" in the AI sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided: Adjudication methods are specific to conflict resolution in expert labeling for AI/ML validation datasets. This concept is not relevant to the regulatory submission for a surgical trocar.
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 an AI-specific study design. The device is a physical surgical instrument and does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This refers to the performance of an AI algorithm alone. The device is a physical instrument and has no standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Implied: As discussed in point 3, "ground truth" as a concept for validating AI algorithms is not applicable here. Performance evaluation for a physical device would rely on direct measurements, observations, and clinical outcomes documented during in-vitro and in-vivo testing, assessed against established engineering and biological benchmarks for substantial equivalence.
8. The sample size for the training set
- Not Applicable: There is no AI algorithm to train for this device.
9. How the ground truth for the training set was established
- Not Applicable: As above, there is no AI algorithm or training set for this device.
In summary, the provided 510(k) document is for a conventional medical device (a surgical trocar) and therefore does not contain any of the AI/ML-specific information requested in your prompt. The regulatory pathway chosen (510(k)) relies on demonstrating substantial equivalence to existing predicate devices through general performance testing (in-vitro and in-vivo), rather than detailed AI algorithm validation metrics.
§ 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.