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510(k) Data Aggregation
(73 days)
DemeTECH DemeDIOX absorbable surgical suture
DemeDIOX Absorbable Surgical Suture is indicated for use in general soft tissue approximation including pediatric cardiovascular tisue where growth is expected to occur and ophthalmic surgery, but not for use in adult cardiovascular, microsurgery and neural tissue. These sutures are useful where absorbable suture with extended wound support (up to six weeks) is desirable.
DemeDIOX Absorbable Surgical Suture is an absorbable, sterile surgical monofilament suture composed of polyester, poly (p-dioxanone). The DemeTECH Suture meets all requirements in the latest edition of the USP monograph for absorbable surgical sutures and the modification from the existence 510k K082097 is that thread is winded around the needle, a foam needle park is applied to the needle to securely hold the needle in place with the thread. One to four needles will be placed in a suture size 6-0, 5cm length, no thread attached to the needle. The material is dyed violet or un-dyed and contains no additives.
The provided text describes a 510(k) premarket notification for a medical device, the DemeDIOX Absorbable Surgical Suture. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for an AI/algorithm-based medical device. Therefore, much of the requested information regarding AI study details (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) is not applicable or cannot be extracted from this document, as it pertains to a physical surgical suture.
However, I can extract the acceptance criteria and the "device performance" in terms of compliance with standards and equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
For DemeDIOX Absorbable Surgical Suture, the "acceptance criteria" are compliance with established regulatory and pharmacopeial standards, and "device performance" is demonstrated by meeting or exceeding these requirements and showing substantial equivalence to a predicate device.
| Acceptance Criteria (Standard/Requirement) | Reported Device Performance (Compliance/Equivalence) |
|---|---|
| USP Monograph for Absorbable Surgical Sutures (latest edition/USP 40/41) | DemeTECH Suture meets all requirements in the latest edition of the USP monograph for absorbable surgical sutures. |
| Suture Diameter and Suture Length | Physical properties and functionality testing assured that the device conformed with suture diameter and suture length (methods outlined in USP 41). Suture Material meets or exceeds the performance requirements defined in USP for "Suture Length Requirement" (95% of stated label length). |
| Extractable Color | Physical properties and functionality testing assured that the device conformed with extractable color (methods outlined in USP 41). |
| Sterility | Physical properties and functionality testing assured that the device conformed with sterility (methods outlined in USP 41). Labeling specifies "Sterile, Single Use". Sterilization method is Ethylene Oxide (EO). |
| Biocompatibility (ISO 10993-1) | Biocompatibility testing was conducted in accordance with ISO 10993-1. DemeTECH's material used was selected based on known biocompatibility (per ISO 10993) and established history of use in the surgical suture industry. Biocompatibility data demonstrated substantial equivalence. |
| In-vitro and In-vivo Resorption | In-vitro and in-vivo resorption testing was conducted to further demonstrate substantial equivalence to the predicate devices. |
| Predicate Device Equivalence (K082097) | DemeDIOX Absorbable Surgical Suture is composed of the same material (Polydioxanone) and has the same design (sterile, flexible, monofilament absorbable thread) as the predicate device. It shares the same product code (NEW), common name (Polydioxanone Absorbable Suture), suture characteristic (absorbable Polydioxanone surgical suture), labeling (Sterile, Single Use), intended use (soft tissue approximation), technical characteristics (monofilament, synthetic absorbable suture prepared from polyester, poly-(p-dioxanone)), material (prepared from polyester, poly-(p-dioxanone)), and sterilization method (Ethylene Oxide (EO)). Most USP performance requirements for "Absorbable Surgical Suture" in USP 40 are met or exceeded, with exceptions for Tensile Strength and Needle Attachment due to specific product configuration (see below). |
| Tensile Strength Requirements (USP 40 for "Tensile Strength" ) | Exception: Length of the thread is too short to perform the knot pull (for the specific configuration tested: suture size 6-0, 5cm length, no thread attached to the needle). |
| Needle Attachment Requirements (USP 40 for "Needle Attachment" ) | Exception: Thread is not attached to the needle (for the specific configuration tested: suture size 6-0, 5cm length, no thread attached to the needle). |
| Suture Packaging | Suture Material is packaged in the same or equivalent manner with sterile single or double package having labeling conforming to 21 CFR and USP 40. |
Regarding the study that proves the device meets the acceptance criteria:
The "study" in this context refers to a series of non-clinical tests and demonstrations of equivalence to a legally marketed predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated as a number of "samples" in the traditional sense of a clinical trial or AI dataset. The testing was done on the DemeDIOX Absorbable Surgical Suture itself, likely using batches or representatives of the manufactured suture according to standard test methods for medical devices (e.g., USP monographs).
- Data Provenance: Not specified. Being a US FDA submission, the tests were presumably conducted in facilities adhering to relevant good laboratory practices (GLP), but the country of origin of the specific data is not mentioned.
- Retrospective or Prospective: Not applicable in the conventional sense for non-clinical device testing. These were pre-market, non-clinical performance and equivalence tests conducted specifically for this submission.
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)
Not applicable. This device is a physical surgical suture, not an AI/algorithm-based diagnostic device where expert ground truth establishment for a test set would be relevant. Compliance was assessed against established pharmacopeial and ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/algorithm study involving human interpretation or 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
Not applicable. This is a physical medical device (surgical suture), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by its compliance with:
- The United States Pharmacopeia (USP) monographs for absorbable surgical sutures (e.g., USP 40, USP 41).
- ISO 10993-1 for biocompatibility.
- General device requirements and FDA Guidance for Surgical Sutures 510(k).
These are objective, quantitative standards for material properties, sterility, and biological safety.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
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