(174 days)
Heartport Thoracic Surgical Trocars are intended to provide access to the thoracic cavity through ports in the intercostal spaces, with minimal to no rib retraction. The Heartport Thoracic Trocar allows endoscopic instruments, thoracoscopes and accessory devices to be inserted and used during cardiac surgery procedures. The trocar cannula may also be used for suture organization.
The Heartport Thoracic Surgical Trocars combine the same functions as the individual predicate devices into a single device. Heartport Thoracic Surgical Trocars may be used with the Heartport Oval Light accessory device to provide illumination to the surgical site.
The provided text describes a 510(k) summary for a medical device, the Heartport™ Thoracic Surgical Trocar. However, it does not contain the specific information requested about acceptance criteria and a study proving those criteria are met in the format of a typical AI/software device evaluation.
Here's why and what information can be extracted:
Why the requested information isn't fully present (and what it implies):
This document is for a physical medical device (a trocar), not an AI or software-as-a-medical-device (SaMD). The questions you've posed (e.g., "AI vs without AI assistance," "standalone performance," "ground truth," "training set") are highly relevant to the evaluation of AI/SaMD, but not typically to a 510(k) submission for a physical surgical tool like a trocar from 1996.
Based on the provided text, here's what can be answered, and where answers are not applicable (N/A):
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from "Performance") | Reported Device Performance |
|---|---|
| In vitro Performance: Compatibility with endoscopic instruments | The device was "evaluated in vitro for performance including compatibility with endoscopic instruments." Performance testing demonstrated that the Heartport Surgical Thoracic Trocar was "safe and effective." The summary states the device "meet[s] the anticipated clinical requirements for its intended use." |
| In vitro Performance: Suture organization ability | The device was "evaluated in vitro for performance including...suture organization ability." Performance testing demonstrated that the Heartport Surgical Thoracic Trocar was "safe and effective." The summary states the device "meet[s] the anticipated clinical requirements for its intended use." |
| In vivo Performance: Safe and effective for intended use during cardiac surgery procedures | The device was "evaluated during in vivo studies." Performance testing demonstrated that the Heartport Surgical Thoracic Trocar was "safe and effective, while meeting the anticipated clinical requirements for its intended use." The intended use is to "provide access to the thoracic cavity... during cardiac surgery procedures" and "allows endoscopic instruments, thoracoscopes and accessory devices to be inserted and used during cardiac surgery procedures. The trocar cannula may also be used for suture organization." |
| Biocompatibility: Materials are safe for human contact | "The materials used to fabricate the Heartport Thoracic Surgical Trocar and Oval Light are the same as, and in most cases identical to, the predicate devices. The materials used... have proven biocompatibility." |
| Substantial Equivalence: In intended use, operational characteristics, and safety/effectiveness compared to predicate devices | "Heartport Thoracic Surgical Trocars have been shown to be substantially equivalent to currently marketed predicate devices" based on "intended use, product information, performance and biocompatibility data." The device combines the functions of multiple predicate devices. |
Note: The acceptance criteria are inferred from the description of the performance tests and the overall claim of "safe and effective" and "substantially equivalent." Specific quantitative metrics or thresholds for "compatibility" or "suture organization ability" are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document only mentions "in vitro" and "in vivo studies" without detailing the number of tests, subjects, or procedures.
- Data Provenance: Not specified.
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)
- Number of Experts: N/A (This is not applicable as the device is a physical surgical instrument, not an AI/SaMD that requires expert ground truth for image/data interpretation). The evaluation would primarily involve surgical and engineering experts assessing mechanical performance and clinical utility.
- Qualifications of Experts: N/A (See above).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: N/A (Not applicable for a physical device where performance is assessed through direct observation, measurement, and clinical outcomes rather than interpretation 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
- MRMC Study Done: No.
- Effect Size of AI Improvement: N/A (Not applicable, as this is not an AI-assisted device).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Test: No (Not applicable, as this is not an algorithm).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For a physical surgical device, "ground truth" is typically established by:
- Direct observation of physical performance (e.g., smooth insertion, instrument fit, suture guidance functionality).
- Biocompatibility testing against established standards.
- Clinical outcomes in in vivo studies (e.g., successful access, no adverse events directly attributable to the trocar).
- Comparison to the known performance and safety profiles of predicate devices.
8. The sample size for the training set
- Sample Size for Training Set: N/A (Not applicable, as there is no AI algorithm to train).
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: N/A (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.