(252 days)
The REDIDIOX Suture is used in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues.
The REDIDIOX is a (Polydioxanone) monofilament synthetic absorbable suture prepared from the polyester poly (p-dioxanone). The empirical molecular formula of the polymer is (C4HgO3). Polydioxanone polymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption. Based on absorption study it takes 182 days for total absorption. The monofilament material is available undyed and dyed. The dyed material is colored violet, dyed with D&C Violet. REDIDIOX sutures comply with USP requirements, except for diameter.
Here's an analysis of the provided text regarding the acceptance criteria and study for the REDIDIOX Suture:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly present a dedicated "acceptance criteria" table with corresponding "reported device performance" in a quantitative format for all aspects. Instead, it relies on demonstrating compliance with established standards (USP, ISO) and equivalence to a predicate device. However, we can extract the key performance parameters and their reported outcomes:
| Acceptance Criteria / Performance Parameter | Reported Device Performance / Compliance |
|---|---|
| Indications for Use: Soft tissue approximation, including ophthalmic surgery, but not for cardiovascular and neurological tissues. | Identical to predicate device. |
| Material Composition: Synthetic absorbable, sterile, flexible monofilament thread, composed of polydioxanone. Inert, noncollageneous, nonantigenic. | Yes (Identical) |
| Dye: Dyed with D&C Violet #2, content below 0.1 wt%, monofilament, not coated. | Yes (Identical). The text states "being monofilament it is coated" for the predicate, but "not coated" in the description, suggesting a minor discrepancy or an oversight in the table. However, the "Identical" column usually indicates full agreement. Given the overall context, the dye presence and concentration are key. |
| Availability: Offered in variety of lengths and range of diameters with or without various needles attached. | Yes (Identical) |
| Single Use: Supplied for single use only. | Yes (Identical) |
| Sterilization: Sterilized by EtO gas. | Yes (Identical) |
| Packaging & Labeling: Same or equivalent manner and labeling claims as predicate device (indications, warnings, cautions, precautions). | Yes (Identical) |
| Performance Requirements (USP "Absorbable Surgical Suture"): Meets or exceeds requirements (exceptions diameter). | Yes (Identical) |
| Performance Requirements (USP "Suture Length Requirement"): 95% of stated label length. | Yes (Identical) |
| Performance Requirements (USP Sterility): Meets requirements. | Yes (Identical) |
| Biocompatibility: Biologically compatible per ISO 10993. | Yes (Identical) |
| Toxicity: Non-toxic per ISO 10993. | Yes (Identical) |
| Absorbability/Strength Retention: | |
| - 14 days Implantation | 70% Approximate Original Strength Remaining (Identical to predicate) |
| - 28 days Implantation | 50% Approximate Original Strength Remaining (Identical to predicate) |
| - 42 days Implantation | 25% Approximate Original Strength Remaining (Identical to predicate) |
| Total Absorption Time | 182 days for total absorption (mentioned in Device Description). This is stated as a characteristic of the polydioxanone polymer. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of a clinical trial or a specific patient data set. The evaluation performed is non-clinical laboratory testing. Therefore, there is no information on sample size and data provenance related to patient data. The "test set" for this device would refer to the physical suture samples subjected to various laboratory tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the non-clinical laboratory testing described. "Ground truth" established by experts is typically relevant for medical imaging or diagnostic AI devices where human interpretation is involved. For a surgical suture, compliance is determined by laboratory measurements against predefined standards (USP, ISO).
4. Adjudication method for the test set
This is not applicable as the study involves non-clinical laboratory testing against established specifications rather than expert interpretation or a diagnostic assessment requiring adjudication.
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
This is not applicable. The device is a surgical suture, not an AI-assisted diagnostic or prognostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a surgical suture, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the REDIDIOX Suture testing is based on established regulatory and industry standards and specifications:
- USP Monograph for Absorbable Sutures: This defines the requirements for tensile strength, diameter, needle attachment, suture length, and sterility.
- ISO 10993 (Biological Evaluation of Medical Devices Part 1): This standard dictates the requirements for biocompatibility and toxicity testing.
- Predicate Device Characteristics: The performance and characteristics of the legally marketed predicate device (PD SYNTH, K081001) serve as a comparative "ground truth" to demonstrate substantial equivalence, particularly for parameters like strength retention and indications for use.
8. The sample size for the training set
This is not applicable. As this is a 510(k) submission for a surgical suture based on substantial equivalence and non-clinical testing, there is no mention of a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set involved for this type of device submission.
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.