(50 days)
The SPIDER Surgical Instruments are intended for use in minimally invasive abdominal laparoscopic surgical procedures for grasping, mobilizing, dissecting, retracting, cutting, cutting, cauterizing, ligating, suction/irrigation and other manipulation of tissues and vessels during laparoscopic procedures.
The Flex Monopolar Hook is a pre-sterilized, single use, disposable, electrosurgical device. These devices are gamma sterilized.
Here's an analysis of the provided 510(k) summary, as it pertains to acceptance criteria and the study that proves the device meets those criteria:
Device: SPIDER™ Surgical Instruments, Flex Monopolar Hook
The provided document is a 510(k) summary for a medical device seeking clearance, not an AI/software device. Therefore, the questions related to AI-specific metrics, ground truth, expert consensus, and training/test sets for AI models are not applicable to this document. The document describes the safety and effectiveness testing for a physical surgical instrument.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a physical surgical instrument and not an AI device, the "acceptance criteria" are tied to performance standards and biocompatibility. The summary doesn't present a formal table with quantitative acceptance criteria in the way one would for an AI model's accuracy, sensitivity, or specificity. Instead, it describes compliance with recognized standards and successful outcomes in functional, biocompatibility, and other performance tests.
| Acceptance Criteria Category | Specific Standard/Test Name (as mentioned) | Reported Device Performance | Comments |
|---|---|---|---|
| Functional Performance | Bench top simulation studies | Found to perform its intended function for laparoscopic surgical procedures (grasping, mobilizing, dissecting, retracting, cutting, cauterizing, ligating, suction/irrigation, manipulation). | Included passing instruments through IDTs, manipulation within SPIDER, evaluation of instrument interference, ability to cauterize. |
| Preclinical animal study | Evaluated system performance to ensure ability to perform intended clinical function, using all instruments and the SPIDER device together. | No specific numerical results are provided, but the outcome is stated as successful. | |
| Biocompatibility | ISO 10993-1:2003 | Conducted in accordance with standards for external communicating devices, exposure ≤ 24 hours. | No specific adverse reactions or failures reported. |
| ISO 10993-5:1999 (Cytotoxicity) | Conducted in accordance with standards. | No specific adverse reactions or failures reported. | |
| ISO 10993-10:2002/A1:2006 (Irritation/Hypersensitivity) | Conducted in accordance with standards. | No specific adverse reactions or failures reported. | |
| ISO 10993-12:2007 (Sample Preparation) | Conducted in accordance with standards. | No specific adverse reactions or failures reported. | |
| Sterilization | ISO 11137-1:2006 | Validated gamma process maintaining a Sterility Assurance Level (SAL) of 1x10⁻⁶. | Based on determination of bioburden. |
| ISO 11137-2:2007 | Conducted to establish sterilization dose. | No specific failures reported. | |
| Packaging Validation | ISO 11607-1:2006 | 3-lot packaging validation was successful. | Assured consistency of the packaging process. |
| ISO 11607-2:2006 | Conducted for validation requirements. | No specific failures reported. | |
| Shelf Life | ISO 11607-1 & 11607-2, ASTM F1980-07 | Accelerated and real-time shelf life studies conducted. | No specific failures reported due to sterilization change. |
| Transit Testing | ASTM D 4169-05 | Conducted in accordance with standards. | No specific failures reported. |
| ISTA Project 2A Series (2008) | Conducted in accordance with standards. | No specific failures reported. | |
| ASTM F 2096-04 (Gross Leaks) | Conducted in accordance with standards. | No specific failures reported. | |
| ASTM F 88-09 (Seal Strength) | Conducted in accordance with standards. | No specific failures reported. | |
| Electrical Safety | IEC 60601-1 | Performed according to related sections. | No specific failures reported. |
| IEC 60601-1-2 | Performed according to related sections. | No specific failures reported. | |
| IEC 60601-2-2 | Performed according to related sections. | No specific failures reported. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated with a numerical value for each test. For packaging validation, it mentions a "3 lot packaging validation." For the animal study, the number of animals or trials is not specified. For benchtop testing, "simulation studies" are mentioned, implying multiple tests, but no size is given.
- Data Provenance: Not specified (e.g., country of origin). The testing described is primarily laboratory-based ("bench top simulation studies," "preclinical animal study," "biocompatibility testing," "sterilization validation," "packaging validation," "shelf life studies," "transit testing," "electrical safety testing"). These are prospective tests conducted by the manufacturer or accredited labs to assess the device's conformance to standards and functionality.
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. As a physical surgical instrument, "ground truth" in the context of expert review for diagnostic accuracy (common in AI/imaging devices) is not relevant here. The "truth" is established by direct measurement against engineering specifications, functional performance during simulations/animal use, and adherence to recognized international standards for safety and performance (e.g., ISO, ASTM, IEC).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert opinions, typically for establishing ground truth in diagnostic studies. This is not reported as relevant for the functional and safety testing of this physical device.
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/software-specific study design. This document pertains to a physical surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This question relates to AI algorithm performance. This document pertains to a physical surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For this physical device, "ground truth" is defined by:
- Functional Performance: Successful execution of intended actions (grasping, cutting, cauterizing, etc.) in benchtop and animal models.
- Compliance with Standards: Meeting the requirements and specifications outlined in various ISO, ASTM, and IEC standards (e.g., a Sterility Assurance Level of 1x10⁻⁶, biocompatibility profile, electrical safety parameters).
- Predicate Device Equivalence: Demonstrating that the device performs "as safe and effective as the predicate device" through direct comparison of design, materials, and performance in these tests.
8. The sample size for the training set
- Not Applicable. This question relates to AI algorithm training data. This document pertains to a physical surgical instrument and does not involve a training set.
9. How the ground truth for the training set was established
- Not Applicable. This question relates to AI algorithm training data. This document pertains to a physical surgical instrument and does not involve establishing ground truth for a training set.
§ 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.