(159 days)
DigiCap™ is a protective finger guard accessory to the surgeon's glove.
- Intended to provide needlestick and suture/scalpel protection during a variety of surgical procedures. DigiCap™ is a protective finger guard accessory to the surgeon's glove. It is used on the finger or thumb of the non-dominant hand usually used to retract, stabilize, compress, and position tissue during surgical procedures.
- Facilitate suture handling and placement.
The DigiCAP is an accessory to surgeon's gloves. This product is made from a resin and is of a rigid configuration whereas surgeons gloves are usually prepared from latex or vinyl materials.
The provided document is a 510(k) summary for the DigiCAP™, an accessory to surgeon's gloves, seeking to demonstrate substantial equivalence to legally marketed predicate devices. It does not contain information regarding a specific study to establish detailed acceptance criteria or present performance data for the device itself. Instead, it focuses on comparing the DigiCAP™ to existing devices based on intended use and technological characteristics.
Therefore, many of the requested elements for describing the acceptance criteria and a study proving the device meets them cannot be extracted from this document.
Here's an analysis of what can and cannot be provided:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not define specific performance acceptance criteria (e.g., puncture resistance levels, durability standards) for the DigiCAP™ or present quantitative performance results against such criteria. The "Substantial Equivalence" section broadly states that "Descriptive information provided shows that the materials from which the DigiCAP is made provide the protection claimed."
2. Sample size used for the test set and the data provenance
- Cannot be provided. The document does not describe a test set or data derived from one. The evaluation is based on comparison to predicate devices and material characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Cannot be provided. No expert-derived ground truth for a test set is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. No adjudication method is mentioned as there is no described test set that would require one.
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
- Cannot be provided. This is not relevant to the device described. The DigiCAP™ is a physical medical device (an accessory to surgeon's gloves), not an AI or software-as-a-medical-device (SaMD) that would involve human "readers" or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This is not relevant. The DigiCAP™ is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No specific ground truth methodology for performance evaluation is described. The "ground truth" for its regulatory submission is effectively the established safety and effectiveness of predicate devices to which it is compared.
8. The sample size for the training set
- Cannot be provided. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable.
Summary derived from the provided text:
The document describes the DigiCAP™ as an accessory to a surgeon's glove, intended to provide needlestick and suture/scalpel protection during surgical procedures and facilitate suture handling. Its regulatory submission (K012199) is based on demonstrating substantial equivalence to existing legally marketed predicate devices, specifically "Gimbel Puncture Resistant Powder Free Surgical Glove cleared under K003063" and "Percuguard cleared under K992539."
The claim of substantial equivalence is based on:
- Same intended use: To provide protection of the patient and surgeon from needle-sticks and scalpel cuts, and protect the integrity of the glove to body fluids.
- Similar technological characteristics: While made from a different material (rigid polymer resin) compared to typical latex/vinyl gloves, the product is described as providing the "protection claimed" through its material properties. All materials are tested for biocompatibility.
- Descriptive information: Showing that the materials provide the claimed protection and are substantially equivalent in safety and effectiveness to similar products.
The "study" in this context is the submission of descriptive information and comparative analysis demonstrating substantial equivalence, rather than a clinical trial or performance study with defined acceptance criteria and performance metrics.
§ 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.