(130 days)
The Sapimed Self Ligh®t Disposable Anoscopes are intended for physician use to examine the anal sphincter and anus, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The Sapimed Self Light ® Disposable Anoscopes are clear, transparent plastic anoscopes in a range of sizes to suit varying clinical needs. Illumination is provided by either coldlight source GLF 100 or pen-light. The anoscopes are provided in the following configurations: Models A.4018 and 4019 are clear anscopes for a clear and easy rectal examination. Models A.4023 and 4024 are anoscopes for examination and use in surgical procedures. The Self-Light® Disposable Operating Anoscopes are clear, transparent disposable anoscopes for various proctological procedures. Illumination is provided by either coldlight source GLF 100 or pen-light. Model A.4081 is an operating anoscopes with a curved shape, transparency and length suitable for open and close hemorrhoiectomy, spincterotomy , coleo/ileo anastamosis, anoplasty, etc. Model A.4082 Basile's cone shaped operating anoscope has a graduated scale visible on the internal part of the instrument. ModelA.4083 The Beak is a surgical anoscope with a closed and rounded tip and a fulllength open channel 2-2.5cm wide
The provided text is a 510(k) summary for the Sapimed Self Light Disposable Anoscope. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed study results typical of clinical efficacy or analytical validation studies for novel devices.
Therefore, many of the requested elements for a performance study (like sample size, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable or not present in this type of regulatory submission. The assessment of this device is based on its similarity to previously cleared devices.
Here's the information that can be extracted or inferred from the provided text, along with a clear indication of what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device and submission, explicit "acceptance criteria" for a performance study in the sense of accuracy, sensitivity, specificity, etc., are not defined because it's a substantially equivalent submission for a physical instrument, not a diagnostic or AI-driven device. The "performance" assessment is based on demonstrating similar fundamental characteristics, intended use, and safety/efficacy to predicate devices.
| Acceptance Criteria Category | Specific Criteria (Inferred from submission type) | Reported Device Performance |
|---|---|---|
| Intended Use | Must be substantially equivalent to predicate devices. | "The Sapimed Self Light® Disposable Anoscopes are intended for physician use to examine the anal sphincter and anus, and, using additional accessories, to perform various diagnostic and therapeutic procedures." Assessment: Identical to predicate device intended uses. |
| Technological Characteristics | Must demonstrate similar design, material (plastic), single-use nature, packaging (clean, non-sterile/sterile), and illumination method (coldlight source or pen-light). No new questions concerning safety and efficacy. | Description: Clear, transparent plastic anoscopes, various sizes, illumination by coldlight source or pen-light. Models for examination and surgical procedures. Features like curved shape, graduated scale, full-length open channel. |
| Comparison Table: All predicated devices use plastic, are disposable, and are packaged as clean/non-sterile or sterile. | ||
| Assessment: "The Sapimed disposable anoscopes have a similar intended use, technological characteristics and mode of operation as the predicate products, both disposable and reuseable and presents no new questions concerning safety and efficacy." | ||
| Material Safety (Biocompatibility) | Must meet ISO10993 standards. | "ISO10993 standards" (implicitly met or claimed to be met, further details would be in the full submission, not the summary). |
| Shelf Life | Must have a substantiated expiration date. | "Accelerated aging testing was performed to substantiate an expiration of 5 years." |
Regarding the Absence of Performance Study Details:
The provided document is a 510(k) summary for a medical device (anoscope), which is a physical instrument. It is not an AI/ML-driven diagnostic or imaging device. Therefore, a "study that proves the device meets the acceptance criteria" in the context of clinical performance metrics like sensitivity, specificity, accuracy, or reader studies, is generally not required or presented for this type of submission.
The "acceptance criteria" here relate to demonstrating substantial equivalence in terms of intended use, technological characteristics, safety, and physical properties (like material, sterility, shelf life) to legally marketed predicate devices. The "study" that proves this is primarily the comparison to predicates, biocompatibility testing, and shelf-life testing, as mentioned.
Let's address the specific numbered points based on the nature of this submission:
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. This submission does not involve a "test set" or clinical performance data in the typical sense for a diagnostic device. The evaluation is based on engineering principles (material properties, design), biocompatibility testing results (which would involve samples of the device material), and accelerated aging studies (which use samples of the final product). The provenance of data for these engineering tests is generally from the manufacturer's testing facilities (SAPIMED S.P.A., Alessandria, ITALY).
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. No "ground truth" establishment by medical experts for a test set is part of this type of device submission. The safety and effectiveness are established through comparison to predicates and standard engineering/biocompatibility testing managed by qualified laboratory personnel.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No "test set" and thus no adjudication method for expert review of cases.
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 device is a manual, physical instrument, not an AI-driven system. Therefore, no MRMC study was conducted or is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. The "ground truth" for the characteristics assessed (e.g., biocompatibility) would be defined by the results of the ISO 10993 tests themselves against established acceptable limits for those tests. For shelf-life, the ground truth is the physical and material integrity of the device over time demonstrated by accelerated aging.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. No 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.