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DigiCap™ is a protective finger guard accessory to the surgeon's glove.

1. 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.
2. 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.

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The ASLS is indicated for the placement of synthetic monofilament sutures in soft tissues and for the ligation of tubular structures wherever conventional monofilament sutures or surgical staples are appropriate. The ASLS is indicated for use in both traditional open surgery and ondoscopic surgical procedures.

The Axya Automatic Suturing and Ligating System (ASLS) is a device for the placement of sutures in soft tissue to close either traumatic or surgically produced wounds. It uses curved, hollow needles to place the suture through soft tissue structures and secures the suture loop with an ultrasonic weld. The ultrasonic energy source used to weld and secure the suture loop is similar to the energy source used in the UltraCision Harmonic Scalpel. The device is sterilized by exposure to gamma irradiation.

Here's an analysis of the provided text regarding the Axya Automatic Suturing and Ligating System (ASLS), broken down into the requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size for the test sets in either the in vivo or in vitro studies. It mentions:

• In Vitro Studies: "respective sizes and types of suture materials tested" and "one-week intervals over seven weeks."
• In Vivo Studies: "dorsal skin and in bowel tissue of New Zealand rabbits." This indicates rabbit models were used.
• Data Provenance: The studies were conducted by Axya Medical, Incorporated. The location is not specified, but the submission is to the U.S. FDA, implying the data would be expected to adhere to U.S. regulatory standards. The studies described are prospective as they were conducted specifically to evaluate the ASLS.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document mentions "investigators" who concluded on the safety and efficacy of the in vivo studies. However, it does not specify the number of experts, their qualifications, or how they established the ground truth beyond their conclusions based on histopathologic analysis.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "investigators" reached conclusions, implying a collegiate or consensus-based approach, but no specific process is detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study involving human readers is not described. The study compared the device's performance to conventional knotting or to USP standards.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, the studies described are standalone in the sense that they evaluate the performance of the ASLS device itself (suture strength, strength retention, tissue reaction) without a human operator's diagnostic or interpretative input being part of the primary outcome measure. The device replaces manual knot-tying, so its performance is measured against the output of that manual process.

7. The Type of Ground Truth Used

• Suture Strength: Based on USP requirements and comparisons to "conventional knotting techniques."
• Strength Retention: Based on the suture manufacturer's package insert profile and USP requirements.
• Biocompatibility/Tissue Reaction: Established through histopathologic examination of tissue samples from the animal models, with "investigators" providing the conclusions.
• Thermal Injury: Implied from the design features of the device (no tissue contact) and possibly verified by temperature monitoring, though not explicitly detailed.

8. The Sample Size for the Training Set

The document does not mention a training set because this device is a mechanical/energy-based surgical instrument, not an AI/algorithm-based diagnostic system that requires machine learning training.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set, the establishment of ground truth for a training set is not applicable.

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