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Surgical Procedure Packs are kits for oral implantology, used by dental professionals when performing surgical procedures.

Surgical Procedure Packs are composed of disposable devices intended for professional use in preparing the operating environment with protective coverings and clothes that aid in maintaining cleanliness and limiting risk of contamination during various types of medical and/or dental surgeries.

Omnia Surgical Procedure Packs are composed of disposable devices, drapes, and surgical garb intended for professional use in preparing the operating environment with protective coverings that aid in maintaining cleanliness and limiting risk of contamination during various types of medical and/or dental surgeries. The contents of these kits may include:

• Surgical Gowns (various models) with or without hand towels ●
• Sterile Surgical Drapes (various models) .
• Face mask .
• Protective caps .
• Sheath/Tubing Sleeve .
• Surgical aspirator with adaptor .
• Surgical Gauze .
• Sterile disinfection sponge and/or basin .
• Adhesive Film .
• Syringe (s) .
• Needle(s) .
• . Single-use scalpel
• Small dental mirror/dental explorer/tweezer .
• Bone collector ●
• . Saliva ejector
• . Irrigation/Infusion line
• Stopcock and ramp for infusion .
• Waste bag for contaminated material .

The provided document, K110724, describes Omnia Surgical Procedure Packs and their substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for a novel device's performance. The document focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and reader studies are not applicable or cannot be extracted from this specific 510(k) summary. The summary focuses on comparative data for substantial equivalence, not de novo performance validation against acceptance criteria for a new type of device.

However, I can extract the parts that relate to performance characteristics and the supporting data provided for substantial equivalence.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate)

The acceptance criteria for the Omnia Surgical Procedure Packs are implicitly derived from demonstrating substantial equivalence to the predicate device (Surgical Drape Kit, K041080) and conformance to applicable industry standards for its components. The "performance" here is demonstrating that the new device meets or exceeds the predicate's performance and relevant industry benchmarks for its individual components.

1. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. This summary does not describe a clinical "test set" in the context of diagnostic accuracy or a specific performance study involving patient data beyond demonstrating material and sterilization properties. The "testing" involved non-clinical evaluations of materials and sterilization processes.
• Data Provenance: The non-clinical testing for biocompatibility, sterilization, and individual component performance (gowns, masks, drapes) would have been conducted in a laboratory setting, likely in Italy (the submitter's country). The specific details on where these tests were conducted are not provided. The data is "retrospective" in the sense that it's laboratory test results rather than prospective clinical trials.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This device is a surgical procedure pack, not a diagnostic or AI device requiring expert ground truth for a test set. The validation relies on technical standards (ISO, EN, ASTM) and manufacturing controls.

3. Adjudication method for the test set:

• Not applicable for the reasons stated above.

4. 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 not an AI-powered diagnostic tool, nor does it involve human readers in this context. It's a collection of sterile disposable items.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an algorithmic device.

6. The type of ground truth used:

• Biocompatibility, Sterilization, Component Performance: The "ground truth" for these aspects comes from established international and industry standards (e.g., ISO 10993 for biocompatibility, EN 556 and ISO 11135 for sterilization, ISO 13795, ASTM 2407-06, ASTM 1670-08, ASTM 1671-07 for gowns/masks/drapes). The "truth" is whether the device components meet these predefined performance specifications.

7. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

8. How the ground truth for the training set was established:

• Not applicable.

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The D.I.R.R.A. surgical drape device kit is composed of natural or synthetic materials and intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial or other contamination.

The DIRRA surgical drape device kit is composed of natural or synthetic materials and intended to be used as protective patient covering, such as to isolate a site of surgical incision from microbial or other contamination. The DIRRA surgical drape device kit is to be used by medical and dental professionals when performing surgical procedures.

The DIRRA surqical drape device kit consists of the following components: Gown w/ paper towel (2), Mayo stand cover (1), Sterile sheet (1), Patient drape (1), Transparent drape (1), Adhesive strip (4), Tube holder (1), Cord drape (2), Suction tubing w/tip (1), Flat gauze (20), Round gauze sponge (5), Plastic tray (1), Transparent adhesive film (3), Connector for suction tubing (1), Kit wrapping drape (1).

All the components are wrapped in the DIRRA surgical drape device kit wrapping drape which is closed with a label.

The final measurement of the kit (not enveloped) is approximately cm.30x30x10. The kit is then enveloped in sequence and in accordance with the instructions for use. The pack is then inserted in the Sterilization plastic/tyvek pouch and the pouch is sealed. 2 Kits are put into one cardboard box along with instructions for use,. The box is then closed and sterilized by Bioster. A sterilization batch number is applied on the box after the sterilization process has been completed.

The provided document (K041080) is a 510(k) summary for a Surgical Drape Kit. It is a premarket notification for a medical device seeking clearance from the FDA by demonstrating substantial equivalence to a legally marketed predicate device.

For such a device (Class II, Surgical Drape and Drape Accessories, Product Code: LRO), direct performance studies to establish detailed acceptance criteria and prove performance as one would for a diagnostic or AI-driven device are typically not required in the same manner. The basis of clearance is substantial equivalence to a predicate device, meaning it has the same intended use and similar technological characteristics, and any differences do not affect safety or effectiveness.

Therefore, the detailed information requested regarding acceptance criteria, study design (sample sizes, experts, adjudication, MRMC, standalone performance), and ground truth establishment is not applicable to this type of 510(k) submission for a surgical drape kit.

Here's how to address each point based on the information provided in this 510(k) summary:

1. A table of acceptance criteria and the reported device performance

The document explicitly states: "The determination of substantial equivalence is not based on an assessment of performance data." (Section: Comparison to predicate devices). Therefore, there are no specific performance acceptance criteria or reported device performance metrics in the format typically seen for a diagnostic device validation. The "acceptance criteria" here relate to demonstrating substantial equivalence to the predicate device in terms of intended use, technological characteristics (materials, sterility, dimensions), and showing that any differences do not raise new questions of safety or effectiveness.

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. No performance data or test set was used for this 510(k) clearance, as explicitly stated that the determination of substantial equivalence is not based on an assessment of performance data.

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 test set or ground truth was established for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring adjudication was used.

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 surgical drape kit, not an AI-driven diagnostic or assistive device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a surgical drape kit, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No ground truth was established as performance data was not used for the determination of substantial equivalence. The "ground truth" for this submission would essentially be the predicate device's established safety and effectiveness, to which the new device is compared.

8. The sample size for the training set

Not applicable. This device is a physical product (surgical drape kit), not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for a physical surgical drape kit, no ground truth needed to be established for it.

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