(106 days)
Disposable Barrier Envelopes are intended to be used as a disposable barrier for Air Techniques Phosphor Storage Plates. This device is non-sterile and intended for single patient use only.
The ScanX barrier envelopes are made from one layer of clear blown polyethylene film and one layer of black blown polyethylene film heat sealed along three edges. An adhesive strip along the fourth edge is used for temporary barrier. Barrier Envelopes are used with Air Techniques' intraoral Phosphor Storage Plates. Barrier Envelopes are non-sterile, and disposable, single use only- discarded after each use.
The provided document is a 510(k) premarket notification for "ScanX Barrier Envelopes" and describes the acceptance criteria and study results demonstrating that the device meets these criteria.
Here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
| Comparison Criteria | Standards | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility Testing: | |||
| In-Vitro Cytotoxicity | ANSI/AAMI/ISO 10993-5 | Score of Less Than 2 | Pass |
| Sensitization | ISO 10993-10 | Non-Sensitizer | Pass |
| Irritation | ISO 10993-10 | Non-Irritant | Pass |
| Biological Risk Assessment | ISO 10993-1 | Biological Safety | Pass |
| Performance and Mechanical Testing: | |||
| Synthetic Blood Penetration | ASTM F1670/F1670M | Protective Materials Resistance Against Liquid Penetration | Pass |
| Viral Penetration | ASTM F1671/F1671M | Protective Materials Resistance Against Blood Borne Pathogens | Pass |
| Tensile Strength | ASTM D882 | Tensile Properties of Material | Pass |
| Puncture Resistance | ASTM F1342 | Protective Materials Resistance to Puncture/Rupture | Pass |
| Tear Resistance | ASTM D1004 | Tear Resisting Ability | Pass |
| Image Quality | ISO 19232 | Determination of Image Quality of Radiographs ("Determination of Image Quality of Radiographs" is a broad descriptor for the standard, implying the device must maintain image quality when used. The specific quantitative acceptance criteria are not detailed in this section, but the "Pass" result indicates it met what was required.) | Pass |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists standards (e.g., ISO 10993, ASTM) that were followed for testing. These standards specify methodologies and may include sample size requirements within their procedures. However, the exact sample sizes used for each specific test in this study (e.g., "how many barrier envelopes were tested for tensile strength?") are not explicitly reported in this summary.
Regarding data provenance: The tests are material and mechanical property tests of a medical device (barrier envelopes), not clinical data involving patient information. Therefore, 'country of origin of the data' and 'retrospective or prospective' study design are not applicable in the typical sense for these types of non-clinical performance studies. The testing would have been conducted in a laboratory setting.
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 product (ScanX Barrier Envelopes) is a physical barrier device for dental phosphor storage plates. The "ground truth" for its performance is established through objective, standardized laboratory testing of its physical properties (e.g., tensile strength, resistance to penetration, biocompatibility) and its impact on image quality, as outlined by the listed ASTM and ISO standards. It does not involve human expert interpretation of medical images or diagnoses in the way an AI-driven diagnostic device would.
Therefore, this question (number of experts, qualifications, etc.) is not applicable to this type of device and study. The "ground truth" is derived from the results of the physical and chemical tests themselves, performed by qualified technicians in accredited labs according to the specified standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This concept is primarily relevant for studies involving human interpretation (e.g., reading medical images) where discrepancies between readers need to be resolved. Since this study involves objective laboratory measurements of physical properties, adjudication methods are not applicable. The results are quantitative measurements or pass/fail determinations based on predefined criteria within the respective standards.
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
No, an MRMC comparative effectiveness study was not conducted for this device. This type of study is specifically designed to evaluate the impact of an AI algorithm on human reader performance, typically in diagnostic imaging. The ScanX Barrier Envelope is a physical accessory, not an AI diagnostic tool, so such a study would be irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is also not applicable. The device is not an algorithm; it's a physical product. The "standalone performance" here refers to its ability to meet the specified physical and biological safety standards, which was indeed evaluated through the non-clinical tests listed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the ScanX Barrier Envelopes is based on objective, quantitative measurements and qualitative assessments derived from adherence to recognized national and international standards (ASTM, ISO) for material properties, barrier effectiveness, biocompatibility, and image quality. This is not clinical ground truth (like pathology or outcomes data) but rather engineering and safety ground truth.
8. The sample size for the training set
The concept of "training set" is specific to machine learning and AI algorithms. Since this device is not an AI algorithm, there was no training set in that context. The development and testing of the barrier envelopes would involve material science, engineering, and manufacturing processes, not AI model training.
9. How the ground truth for the training set was established
As there was no AI model training set, this question is not applicable.
§ 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.