(61 days)
The Gauss Pixel App is intended to be used to aid current clinical practices in recording the number of surgical sponges and for visibility for assessment of sponge images.
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I am sorry I cannot fulfill your request to describe the acceptance criteria and study proving device efficacy based on the provided document. The document primarily consists of a 510(k) clearance letter from the FDA, an "Indications for Use" form, and general regulatory information. It does not contain the specific details about the acceptance criteria, study design, results, or data provenance you are asking for.
The information provided only states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance. It does not include the detailed performance testing data that would be part of a full study report.
§ 880.2740 Surgical sponge scale.
(a)
Identification. A surgical sponge scale is a nonelectrically powered device used to weigh surgical sponges that have been used to absorb blood during surgery so that, by comparison with the known dry weight of the sponges, an estimate may be made of the blood lost by the patient during surgery.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.