(86 days)
ControlRad Sterile Cover is a single use sterile equipment cover intended for use by professionals in a sterile clinical setting to cover the ControlRad Trace Tablet and create a sterile barrier between the rest of the sterile field to prevent contamination during various procedures.
The ControlRad Sterile Cover is a terminally sterilized device intended to cover the ControlRad tablet in order to operate a ControlRad tablet in a sterile environment.
The provided text describes the regulatory clearance for the "ControlRad Sterile Cover," a surgical drape accessory. It details the device's characteristics, indications for use, and a comparison to predicate devices, along with non-clinical testing results.
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:
Important Note: The provided document is a 510(k) summary for a "Sterile Cover," which is a physical device (a surgical drape accessory). It is not an AI/ML-driven device or a diagnostic device, therefore, many of the typical acceptance criteria and study designs associated with AI/ML or diagnostic performance (like MRMC studies, expert ground truth establishment for diagnostic accuracy, standalone algorithm performance, training set details) are not applicable to this type of medical device. The "performance" here refers to the physical and functional integrity of the sterile cover.
1. Table of Acceptance Criteria and Reported Device Performance
| Name of Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Liquid Barrier | Ensure cover protects against liquid penetration | No liquid penetration | PASS |
| Viral Penetration via ASTM F1671 / F1671M-13 | Ensure cover protects against viral penetration | No viral penetration | PASS |
| Tensile Strength via ASTM D882 | Characterization of tensile strength | Characterization testing (Implies meeting a certain profile, though no specific numerical threshold is given in the table, "PASS" indicates compliance) | PASS |
| Tear Resistance via ASTM D1004 | Characterization of tear resistance | Characterization testing (Implies meeting a certain profile, though no specific numerical threshold is given in the table, "PASS" indicates compliance) | PASS |
| ISO 11135-1:2014: Sterilization of Health-Care Products - Ethylene Oxide | Ensure sterility assurance level of 10⁻⁶ | SAL 10⁻⁶ | PASS |
| ASTM F88/F88M-15 | Seal Strength (TyVek pouch - primary sterile barrier) | Seal Strength > 1lbf for all seals | PASS |
| ASTM F1929-15 | Dye Penetration | No dye penetration via visual inspection | PASS |
| ISO 10993-5 Biological evaluation of medical devices: Part 5 Tests for in vitro Cytotoxicity | Biocompatibility Testing | Cell culture treated with test sample exhibited no reactivity (Grade 0) | PASS (Non-cytotoxic) |
Specifics Not Applicable or Not Provided for This Device Type:
Given that this is a physical medical device (sterile cover) and not an AI/ML diagnostic or treatment planning system, several items in the prompt are not applicable to the type of data and studies required for its clearance.
-
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes for each non-clinical test. These tests are typically conducted on a representative sample of the manufactured device.
- Data provenance is not specified in terms of country of origin or retrospective/prospective, as this applies more to clinical data or imaging datasets, which are not relevant here.
-
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like a sterile cover is established through objective physical, chemical, and biological testing as per international standards (e.g., ASTM, ISO). There are no human "experts" establishing diagnostic ground truth in this context.
-
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for subjective interpretations of data (e.g., image reads by radiologists), which is not part of the testing for this device.
-
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 type of study is for evaluating the impact of AI on human diagnostic performance, which is irrelevant for a sterile cover.
-
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
-
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is derived from the established and validated methodologies of the referenced ASTM and ISO standards for physical properties, barrier integrity, sterility, and biocompatibility.
-
8. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires training data.
-
9. How the ground truth for the training set was established: Not applicable.
In summary, the "study" proving the device meets acceptance criteria is a series of non-clinical laboratory tests performed according to recognized international and national standards (ASTM, ISO). The acceptance criteria are objective, quantifiable thresholds or observations (e.g., no penetration, specific strength values, sterility assurance level) that the device must meet to demonstrate its safety and effectiveness as a sterile barrier.
§ 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.