(113 days)
Used for more accurate placement of pneumothorax decompression devices than the current standard of care auditory assessments. The Pneumothorax Decompression Indicator is a colorimetric capnography device indicated to detect the carbon dioxide in the gas passing through the device used to treat pneumothorax with suspected tension physiology.
The Pneumeric Capnospot Pneumothorax Decompression Indicator is a capnography device that provides objective, real-time feedback during decompressive thoracostomy. Specifically, the device detects the presence of carbon dioxide in the gas from the decompressed pneumothorax, permitting more accurate placement of the needle or thoracostomy device compared to the current standard of care based upon auditory assessments.
The Pneumeric Capnospot is a therapeutic device intended to guide the placement of pneumothorax decompression needles and thoracostomy devices.
The product consists of a cylindrical polycarbonate tube containing a carbon dioxide detecting paper. The device has a male luer connector on the distal end of the device to connect to decompression needles and thoracostomy devices, a diaphragm to prevent backflow of gases, a color changing indicator and a female luer on the proximal end of the device that can be used to connect accessories.
The product is shipped non-sterile and labeled for single use only.
The provided text describes a medical device called the "CapnoSpot™ Pneumothorax Decompression Indicator" and its 510(k) submission to the FDA. However, the document does not contain information about a study proving the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or accuracy, particularly concerning an AI-driven component or human reader assistance.
The document discusses "Performance Data" in section 6.5, but this section focuses on design verification and shelf-life tests (visual inspection, dimensionals, backflow, cracking pressure, torque, luer leakage, animal data) to ensure the device meets specifications, rather than clinical performance metrics in humans or AI-driven acceptance criteria.
The 510(k) submission for this device is based on substantial equivalence to a predicate device (Turkel Pneumothorax Kit K923028), rather than demonstrating clinical efficacy or AI performance through a comparative study.
Therefore, based on the provided text, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them in the context of sensitivity, specificity, accuracy, or human reader improvement with AI. The document does not provide details on:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy.
- Sample size used for a test set, its provenance, or how ground truth was established for such a test set.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method for a test set.
- Whether an MRMC comparative effectiveness study was done or its effect size.
- Whether a standalone AI performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for diagnostic performance.
- Training set sample size or how its ground truth was established.
The "Performance Data" refers to engineering and durability tests, and an "Animal Data" point is mentioned, but no details of a study with acceptance criteria for a diagnostic/AI performance are present.
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(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 § 878.9.