(127 days)
Disposable Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
The proposed devices. Disposable Barrier Sleeves and Covers, are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These disposable barrier sleeves and covers are offered in various shapes and sizes to fit over and cover the intended dental instruments and equipment. The Disposable Barrier Sleeves slip over the ends of the respective devices, allowing for the attachment and/or protrusion (where applicable) of those parts of the devices used during dental procedures. The Disposable Barrier Cover is placed over equipment, such as dental chair head rests and trays, to cover those parts.
The proposed devices, Disposable Barrier Sleeves and Covers, act as a physical barrier, augmenting existing infection control techniques, and facilitate clean-up.
The document provided is a 510(k) premarket notification for "Disposable Barrier Sleeves and Covers" (K160232) by DENTSPLY International. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the safety and effectiveness of a novel device through extensive clinical trials. Therefore, the information requested regarding acceptance criteria and studies proving a device meets them for a complex AI/ML device is largely not applicable in this context.
However, I can extract the relevant information from the provided document as it pertains to the substantial equivalence determination for this non-AI medical device.
Here's a breakdown based on the provided document and the nature of a 510(k) submission for a non-AI device:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally established by recognized standards for medical device materials and performance. The document defines the "Proposed Device" as "Disposable Barrier Sleeves and Covers" and compares its performance against a "Predicate Device," "TIDIShield™ Curing Light Sleeve (K132953)".
| Element / Test | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Material | Polyethylene film | Polyethylene film |
| Material Composition | Ethylene methyl acrylate copolymer and low density polyethylene film (Predicate) | Supplier #1 (PacDent): low density polyethylene and linear low-density polyethylene film |
| Supplier #2 (MiniTube AB): low-density polyethylene film | ||
| Biocompatibility - In-Vitro Cytotoxicity | Pass (based on ANSI/AAMI/ISO 10993-5) | Pass |
| Biocompatibility - Sensitization | Pass (based on ISO 10993-10) | Pass |
| Biocompatibility - Irritation | Pass (based on ISO 10993-10) | Pass |
| Performance - Synthetic Blood Penetration | Pass (based on ASTM F1670/F1670M) | Pass |
| Performance - Synthetic Blood Penetration at seams and non-continuous components | Pass (based on ASTM F1670/F1670M) | Pass |
| Performance - Viral Penetration | Pass (based on ASTM F1671/F1671M) | Pass |
| Performance - Viral Penetration at seams and non-continuous components | Pass (based on ASTM F1671/F1671M) | Pass |
| Mechanical - Tensile Strength | Acceptable for 0.05mm (Predicate) | 0.02mm Acceptable, 0.03mm Acceptable, 0.05mm Comparable to Predicate |
| Mechanical - Puncture Resistance | Acceptable for 0.05mm (Predicate) | 0.02mm Acceptable, 0.03mm Acceptable, 0.05mm Comparable to Predicate |
| Mechanical - Tear Resistance | Acceptable for 0.05mm (Predicate) | 0.02mm Acceptable, 0.03mm Acceptable, 0.05mm Comparable to Predicate |
| Thickness | 0.05mm (Predicate) | PacDent: 0.02mm, 0.03mm, 0.05mm; MiniTube AB: 0.03mm |
| Shape | Custom design to fit the intended instrument (Predicate) | Custom design to fit the intended dental instruments and equipment they cover (Reference Table 5.3) |
| Dimensions | Determined by the size and shape of the instruments they cover (Predicate) | Determined by the size and shape of the dental instruments and equipment they cover (Reference Table 5.3) |
| Color | Clear (Predicate) | Clear, with some RINN Tight Cover barrier sleeves being clear with white and blue tabs |
| Sterile | Not sterile (Predicate) | Not sterile |
| Single Use | Single use device (Predicate) | Single use device |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for the mechanical and performance tests. It refers to "samples" being tested. For biocompatibility, it states "the proposed devices, Disposable Barrier Sleeves and Covers" underwent testing.
The data provenance is not specified beyond "testing conducted to support substantial equivalence." It's common for such bench testing to be conducted in-house by the manufacturer or by contract labs. There is no indication of country of origin or whether it was retrospective or prospective, as these are typically not relevant for a 510(k) submission for this type of device.
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)
This is not applicable. For a physical barrier device like this, ground truth is established by standardized material and performance testing against recognized industry standards (e.g., ASTM, ISO). There are no "experts" establishing a subjective "ground truth" in the way one would for diagnostic imaging.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of images or data in clinical studies, typically for diagnostic devices. This device is a physical barrier, and its performance is evaluated by objective laboratory tests, not by expert adjudication of subjective assessments.
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
This is entirely not applicable.
* This device is a disposable physical barrier, not an AI/ML-powered diagnostic device.
* No human "readers" are involved.
* No "cases" are being interpreted.
* No AI assistance is provided or claimed.
* No MRMC study was conducted or is relevant for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is entirely not applicable.
* This device is a physical product, not an algorithm.
* There is no "human-in-the-loop" concept for this device's function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on the objective outcomes of standardized laboratory tests as defined by international standards (e.g., ISO, ASTM). For example:
- Biocompatibility: Demonstrated non-cytotoxicity, non-sensitization, and non-irritation as per ISO 10993 series.
- Performance (Barrier): Demonstrated resistance to synthetic blood and viral penetration as per ASTM F1670/F1670M and ASTM F1671/F1671M.
- Mechanical Properties: Measured tensile strength, puncture resistance, and tear resistance as per ASTM D882, F1342/F1342M, and D1004.
These are quantitative measurements against defined criteria, not subjective expert consensus or clinical outcomes data.
8. The sample size for the training set
This is not applicable. This device is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set."
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this type of device.
§ 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.