(49 days)
The SabreSource™ Drape is intended to help prevent contamination of the SabreSource™ device when used in the operating room or other surgical environments.
The SabreSource™ Drape is to be used in an operating room environment to cover the SabreSource™ device when it is mounted on an x-ray machine for procedures wherein it is deemed desirable to protect the SabreSource™ device from contamination with patient fluids or liquids.
The SabreSource™ Drape is a sterile plastic bag to cover the SabreSource™ Targeting System. The drape contains an optically clear window shaped like a section of a hemisphere with a 30 cm radius that will allow undistorted transmission of the laser beam from the SabreSource™ to the patient.
The provided text describes a 510(k) premarket notification for the SabreSource™ Drape. This is a medical device accessory and the submission focuses on its substantial equivalence to predicate devices, rather than establishing its performance through a study with acceptance criteria in the typical sense of a diagnostic or therapeutic device.
Therefore, the requested information for acceptance criteria and a study proving performance cannot be fully provided in the format requested, as that type of study was not conducted or required for this device. The information provided outlines the technological characteristics and intended use that form the basis for its substantial equivalence, which is the primary "proof" for this type of device.
Here's how to address the request based on the provided document:
Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" for this device revolves around its ability to function as a sterile barrier and allow laser transmission, thereby being substantially equivalent to existing devices.
| Acceptance Criterion (Implicit from description) | Reported Device Performance |
|---|---|
| 1. Ability to prevent contamination of the SabreSource™ device. | Described as "a sterile plastic bag to cover the SabreSource™ Targeting System." The intended use explicitly states, "The SabreSource™ Drape is intended to help prevent contamination of the SabreSource™ device." This is inherent in its design as a sterile drape. |
| 2. Allowing undistorted transmission of the laser beam. | "The drape contains an optically clear window shaped like a section of a hemisphere with a 30 cm radius that will allow undistorted transmission of the laser beam from the SabreSource™ to the patient." |
| 3. Substantial equivalence to predicate devices (regarding safety and effectiveness). | "Any dimensional or design differences between the SabreSource™ Drape and the predicate devices are minor and raise no new issues of safety or effectiveness." The FDA's 510(k) clearance explicitly states the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." |
Study Details (Not applicable for this type of submission)
The provided document describes a 510(k) submission for a medical device accessory (a drape). For such devices, the primary "proof" is demonstrating substantial equivalence to existing legally marketed predicate devices, rather than conducting a controlled clinical study with specific acceptance criteria, sample sizes, and ground truth in the way one would for a diagnostic algorithm or a novel therapeutic device.
Therefore, the following information is not available or applicable from the provided text:
- Sample size used for the test set and the data provenance: No test set or clinical study was mentioned or required for this 510(k) submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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, as this is not an AI diagnostic device or one involving human reader performance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm-based device.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context is established by the functional characteristics of the drape (sterility, optical clarity) and its equivalence to predicates.
- The sample size for the training set: Not applicable, as this is not a machine learning/AI device.
- How the ground truth for the training set was established: Not applicable.
In summary: The K041846 submission for the SabreSource™ Drape is a 510(k) premarket notification that relies on demonstrating substantial equivalence to predicate devices. The "proof" is in showing that its technological characteristics and intended use are similar to already approved drapes, and any differences raise "no new issues of safety or effectiveness." This type of submission does not typically involve the detailed performance studies, ground truth establishment, and expert reviews that would be required for a novel diagnostic or AI-powered 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.