(87 days)
Crosstex Non-Woven Sponges are intended, for medical purposes, to be placed directly on a patient's wound or burn to absorb excess body fluids or exudate.
The Crosstex Non-Woven Sponges consist of non-woven materials quarter folded into:
- 2 X 2" (light) 4-Ply
- 2 X 2" (light)
- 3 X 3" (Premium) 4-Ply
- 4 X 4" (Premium) 4-Ply
sponges used for the absorption of liquids from the patient's skin.
The provided document describes a 510(k) submission for "Crosstex Non-Woven Sponges," which are medical sponges used for absorbing fluids. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing novel performance criteria through a study with specific acceptance criteria as would be typical for a device with a more complex functional output (e.g., an AI-powered diagnostic tool).
Therefore, many of the requested categories in your prompt are not applicable to this type of device and submission. This is a basic medical device (a sponge) where "performance" is primarily assessed through physical and biocompatibility testing against established standards and comparison to similar predicate devices.
Here's an analysis based on the provided text, indicating where information is not applicable (N/A) for this specific submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit from predicate comparison) | Reported Device Performance (as compared to J&J Nu-Gauze K#8211501) |
|---|---|
| Biocompatibility testing requirements (per ERT and EP standards) | Met relevant testing requirements |
| Physical testing requirements (thickness, tensile strength, elongation, bending length, absorption time, absorption capacity, per ERT and EP standards) | Met relevant testing requirements |
| Similar Rayon/Polyester composition | 65/35 Rayon/Polyester composition (similar) |
| Similar unit weight | Similar unit weight |
| Similar single ply thickness | Similar single ply thickness |
| Similar absorption time | Similar absorption time |
| Similar absorption capacity | Similar absorption capacity |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated. The document refers to "testing" performed for biocompatibility and physical properties, but does not provide details on the number of sponges tested.
- Data Provenance: Not specified. Testing would typically be conducted in a laboratory setting. No country of origin for "data" is relevant in the context of a physical product's performance testing.
- Retrospective or Prospective: N/A. This is for product testing, not a clinical study on patient data.
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)
- N/A. This device does not involve subjective interpretation or ground truth establishment by medical experts in the way a diagnostic device would. Performance is measured objectively through standardized tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are relevant for subjective assessments (e.g., expert reads) which are not part of this device's performance evaluation.
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
- N/A. This is a non-AI, non-diagnostic physical product. MRMC studies are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This is a non-AI physical product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is objective measurement against established physical and chemical standards and comparison to a legally marketed predicate device's characteristics. No clinical outcomes data or expert consensus on features is mentioned or needed for this type of device.
8. The sample size for the training set
- N/A. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- N/A. Not an AI/machine learning device.
N/A