(24 days)
The ExiClip™ EXCS-M is intended to provide a biopsy specimen and/or without biopsy under clinical discretion, remove skin lesions less than 6mm in diameter where simultaneous wound closure is desired.
The ExiClip™ EXCS-M skin biopsy with wound closure device is a single use, disposable device consisting of a removable skin clip, a blade, and a manual delivery system. The device is to be provided sterile. The skin clip is non-absorbable. The skin clip provides wound closure and must be removed after the wound has healed.
The provided text does not contain specific acceptance criteria or an explicit study describing the device's performance against such criteria in the format requested.
The document is a 510(k) summary for the ExiClip™ EXCS-M, focusing on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.
However, I can extract information related to the device's intended use and the basis for its substantial equivalence claim, which might implicitly serve as a form of "acceptance criteria" in the context of a 510(k) submission.
Here's an attempt to derive the closest possible answers based on the provided text, acknowledging that the requested study details (sample size, experts, ground truth type, etc.) are not present for "performance against acceptance criteria" as typically found in clinical trials.
1. Table of Acceptance Criteria and Reported Device Performance
As stated, no explicit 'acceptance criteria' are given in terms of numerical thresholds for device performance (e.g., accuracy, sensitivity, specificity). Instead, the substantial equivalence argument relies on functional comparisons to predicate devices.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (as stated in 510(k) summary) |
|---|---|
| For Biopsy/Lesion Removal: | |
| - Provide a tissue sample suitable for pathology analysis | "Both devices provide a tissue sample suitable for pathology analysis" (referring to ExiClip™ and Shoney Scientific Disposable Punch Biopsy) |
| - Remove skin lesions | "remove skin lesions" (referring to ExiClip™ and Shoney Scientific Disposable Punch Biopsy) |
| - Manually powered | "Both devices are manually powered." |
| - Utilizes stainless steel blades | "Both devices utilize stainless steel blades." |
| - Provided sterile | "Both devices are provided sterile." |
| - Same intended use (removal of skin lesions and/or provide tissue sample) | "Both devices have the same intended use - removal of skin lesions and/or provide a tissue sample for pathological analysis." |
| For Wound Closure (Clip): | |
| - Deploy a skin clip for wound closure | "Both devices deploy a skin clip for wound closure by activation by plastic deformation..." (referring to ExiClip™ and AutoClip® Wound Clip with Applier Device) |
| - Activation by plastic deformation of clips | "Both devices deploy a skin clip for wound closure by activation by plastic deformation..." |
| - Use of an applier | "...via the use of an applier." |
| - Comparable retention force to predicate | "The ExiClip™ EXCS-M skin clip has been found to have a comparable retention force to the AutoClip® Wound Clip." |
| - Clip made of stainless steel | "Both devices utilize a clip made of stainless steel." |
| - Manually powered | "Both devices are manually powered." |
| - Same intended use (non-absorbable skin clip for wound closure) | "Both devices have the same intended use which is a non-absorbable skin clip for wound closure." |
Study Information (Based on Available Text):
The document describes a substantial equivalence claim, not a detailed performance study with the requested metrics. Therefore, many of the requested details about a "study" are not explicitly present.
2. Sample size used for the test set and the data provenance:
- Not explicitly stated for a performance test set. The document focuses on comparing the design and function of the ExiClip™ to predicate devices, not on a clinical or analytical test set with a specific sample size. The statement "The ExiClip™ EXCS-M skin clip has been found to have a comparable retention force to the AutoClip® Wound Clip" implies some form of testing, but details on sample size or provenance are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document does not describe a clinical study where ground truth would be established by experts. The "ground truth" for the substantial equivalence claim is the established safety and effectiveness of the predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication is described.
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. This is a medical device for biopsy and wound closure, not an AI or imaging diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a physical medical device. The concept of "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the purposes of this 510(k), the "ground truth" implicitly refers to the established safety and effectiveness of the legally marketed predicate devices (Shoney Scientific Disposable Punch Biopsy and AutoClip® Wound Clip with Applier Device) as demonstrated through their prior market history and regulatory clearance. The ExiClip™ is deemed substantially equivalent because its technological characteristics and intended use are similar to these established devices.
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning product and does not involve a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set is involved.
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.