(230 days)
These products have the same intended use, to act as a physical barrier, augmenting existing infection control techniques and make clean-up and disinfection easier. These are the same as those of the predicate devices. These products also have the same intended uses as similar products currently cleared for marketing by the 510(k) process.
These disposable plastic shields are for use with various small hand-held dental instruments such as handpieces, ultrasonic scalers, jet polishers, contra angle handpieces, and similar hand instruments.
In other forms, they are used to cover various devices such as dental chairs, headpieces, accessory trays, x-ray heads, and others.
They are manufactured from clear polyethylene and formed to provide excellent tactile control combined with simple coverage and removal from the instrument.
These shields act as as physical barriers which augment existing infection control techniques and simplify existing clean-up and disinfection methods. They do not obviate, in any way, existing good dental practices such as sterilizing handpieces, hand instruments, etc between each patient.
The various products are designed to slip over the ends of the respective devices, allowing for attachment and/or protrusion of those parts of the devices that are inserted into the patient's mouth (instruments), or otherwise contact the patient (chair covers).
The products will be sold non-sterile, prepackaged, and are disposable, single use only.
The provided text is a 510(k) summary for unclassified infection control barriers (e.g., dental chair sleeves, instrument covers). It focuses on establishing substantial equivalence to previously cleared devices rather than providing a study with specific acceptance criteria and performance metrics.
Therefore, most of the requested information cannot be extracted from this document, as it describes a different kind of regulatory submission. The document emphasizes that the device has "not been classified" and that "None [performance standards] established under section 514."
Here's what can be stated based on the provided text:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified. The submission aims for substantial equivalence based on intended use and technological characteristics to predicate devices.
- Reported Device Performance: Not specified in quantifiable terms. The device is described as acting "as a physical barrier which augment existing infection control techniques and simplify existing clean-up and disinfection methods."
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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 test set or study data is described. This is a substantial equivalence submission based on comparison to existing products.
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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 or expert review process is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication process is described.
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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 physical barrier, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical barrier, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc.)
- Not applicable. No ground truth is described.
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The sample size for the training set
- Not applicable. This device is a physical barrier; there is no training set in the context of an algorithm.
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How the ground truth for the training set was established
- Not applicable. No training set or ground truth establishment is described.
Summary of the study/submission:
The document describes a 510(k) submission to establish "substantial equivalence" for various disposable plastic infection control barriers (e.g., chair sleeves, instrument covers). The basis for equivalence is that the products have the "same intended use" and "same technological characteristics" as predicate devices already cleared for marketing. The document explicitly states that no performance standards have been established for this type of device under section 514. The submission references existing predicate devices like Hydro-Med Product's "Surgical Microscope Drape," Cottrell's "Protouch Overglove," and Dentsply's "Disposa-Shield" to demonstrate equivalence. Performance is qualitatively described as augmenting infection control and simplifying cleanup. No specific studies with acceptance criteria or quantitative performance data are provided, as the regulatory pathway chosen (510(k) substantial equivalence for an unclassified device without performance standards) does not require them in this context.
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.