(69 days)
The SurgiSure™ Tissue Removal System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous and open surgical procedures whenever access to the surgical site is limited.
The SurgiSure™ Hysteroscopic Tissue Removal System consists of the following procedural components:
- SurgiSure™ Tissue Removal Device
- SurgiSure™ Control Unit
- SurgiSure™ Foot Pedal
The SurgiSure™ Control Unit contains an electric motor and firmware motor controller that drives the SurgiSure Tissue Removal Device. The Control Unit motor is activated and deactivated by the SurgiSure Foot Pedal. The SurgiSure Tissue Removal Device is a tissue morcellator that is connected to the Control Unit via a flexible drive cable. The SurgiSure Tissue Removal Device features a rotating/reciprocating (2mm OD) cutter blade encased in a (3 mm OD) outer tube. The device's cutter blade is controlled by a drive system that enables simultaneous rotation and reciprocation of the cutter is also connected to a vacuum source which aspirates resected tissue through a side-facing cutting window in the device's outer tube. Distension fluid and resected tissue are transported from the SurgiSure Tissue Removal Device to a tissue trap and vacuum canister via a tube protruding from the proximal end of the Tissue Removal Device. The SurgiSure Tissue Removal System is compatible with commercially available fluid management systems and may be used with endoscopes that have a straight ≥3 mm working channel.
The provided document is a 510(k) summary for the SurgiSure™ Tissue Removal System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.
However, based on the information provided, we can extrapolate and infer some aspects related to acceptance criteria and the "study" (performance testing) that supports it.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
Since specific numerical acceptance criteria (e.g., minimum tissue removal rate, maximum power consumption) and direct reported performance values are not explicitly stated in the document, we must infer the criteria based on the comparison to predicate devices and the general safety and performance claims. The acceptance criterion is essentially "equivalent to or performs similarly to the predicate devices" in the specified aspects.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance (Summary) |
|---|---|---|
| Safety | Meets relevant electrical safety and Electromagnetic Compatibility (EMC) standards. Patient contact materials meet biocompatibility requirements of ISO 10993-1. | "The SurgiSure™ Tissue Removal System meets electrical safety and EMC standards. Patient contact materials in the SurgiSure device meet the biocompatibility requirements of ISO 10993-1 Biological Evaluation of Medical Devices." |
| Functional Equivalence | Principles of operation, primary functional specifications, and method of operation are identical or similar to predicate devices (MyoSure™ Hysteroscopic Tissue Removal System and VersaCut™ Tissue Morcellator System). Morcellator design (rotating/reciprocating cutter, outer tube, vacuum, cutter blade tip) is identical to MyoSure. | "The principles of operation and primary functional specifications of the SurgiSure™ Tissue Removal System are identical to those of the predicate MyoSure™... and similar to those of the predicate VersaCut™." "The SurgiSure™ morcellator is identical to the predicate MyoSure™ morcellator..." "The SurgiSure inner tube or cutter rotates and reciprocates at a fixed rate that is identical to the predicate MyoSure device. The SurgiSure cutter blade tip design is identical..." |
| Tissue Cutting Rate | Tissue cutting rate performs equivalent to the predicate VersaCut™ device. | "In addition, in-vitro testing demonstrated that the SurgiSure™ Tissue Removal System performs equivalent to the predicate VersaCut™ device." "Because the SurgiSure Tissue Removal Device is smaller in diameter than the predicate VersaCut Morcellator System, it's tissue cutting rate is similar to but slightly slower than the VersaCut Morcellator System." (This implies the performance is still within an acceptable range for equivalence, despite being "slightly slower"). |
| Intended Use | Intended use is identical to the predicate VersaCut™ Morcellator System and similar to the predicate MyoSure™ Hysteroscopic Tissue Removal System. | "The SurgiSure™ Tissue Removal System's intended use is identical to that of the predicate VersaCut™ Morcellator System and similar to that of the predicate MyoSure Hysteroscopic Tissue Removal System." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "in-vitro testing" for tissue cutting rate. It does not specify the sample size, data provenance (country of origin), or whether it was retrospective or prospective. It is highly likely to be prospective data generated specifically for this submission.
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 as the performance testing described is "in-vitro" and does not involve human readers/experts evaluating device output. The ground truth for functional performance like tissue cutting rate would be established by objective measurements (e.g., mass of tissue removed per unit time) during the in-vitro tests, rather than expert evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described in point 3, the testing is objective and in-vitro, not relying on subjective expert judgment or 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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes a submission for a tissue removal system, which is a physical surgical device, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a form of standalone performance testing was done. The "in-vitro testing" for tissue cutting rate, electrical safety, and biocompatibility are all standalone tests performed on the device itself without human intervention in the performance measurement. The device's motor, firmware, and mechanical components are assessed directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the in-vitro tests:
- Electrical Safety & EMC: Ground truth is defined by the objective pass/fail criteria of the relevant international standards (e.g., IEC 60601 series).
- Biocompatibility: Ground truth is defined by the objective pass/fail criteria of ISO 10993-1.
- Tissue Cutting Rate: Ground truth would be objective measurements of tissue mass removed over time, or a similar quantitative metric, compared against the predicate device's measured performance.
8. The sample size for the training set
This is not applicable. The SurgiSure™ Tissue Removal System is a mechanical device, not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this type of device.
§ 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.