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(246 days)
The DW-1 C comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.
DW-1C synthetic absorbable PDO suture is made of polydioxanone. The pigment for the violet dye is D&C Violet No.2. The DW-1C is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue. Each dyed (violet) suture has bi-directional barbs along the long axis of the suture monofilament without needle attachment. The DW-1C Synthetic Absorbable PDO suture approximate tissue, without the need to tie surgical knots, by using the opposing barbs on the surface to embed in the tissues after the surgeon precisely places the suture within the tissues.
The provided text describes Dongwon Medical Co., Ltd.'s DW-1C absorbable polydioxanone surgical suture and its substantial equivalence to the predicate device, MINT. The document primarily focuses on demonstrating the safety and performance of the DW-1C through various tests.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document provides two main tables for performance data: "Biocompatibility test" on page 5 and "Bench (performance) testing" on page 6.
Table: Biocompatibility Test Acceptance Criteria and Results
| Test Identification | Criteria | Reported Device Performance |
|---|---|---|
| Cytotoxicity MEM Elution Method (Cytotoxicity) | No evidence of causing cell lysis or toxicity to fibroblast cells | Not Cytotoxic (PASS) |
| ISO Guinea Pig Maximization Sensitization Test | No delay in dermal contact sensitization | No evidence SC and CSO extracts causing delayed dermal contact sensitization (PASS) |
| ISO Acute Intracutaneous Reactivity Study | No irritation | Primary Irritation Index Characterization SC extract = 0.0 CSO extract = 0.0 (PASS) |
| ISO Systemic Toxicity Study in Mice | No reaction, No Mortality during this study or evidence of systemic toxicity | No Mortality or Evidence or Significant Systemic toxicity (PASS) |
| Bacterial Reverse Mutation study (Ames test) | Tester strain char must exhibit sensitivity to crystal violet, UV, no growth biotin plates and growth histatine-biotin plates; number of mutation revertants (including spontaneous reversions) statistically less than negative control results | The Saline and dimethyl sulfoxide test article extracts were considered to be non-mutagenic to Salmonella typhimurium and Escherichia coli tester strains. (PASS) |
| Genotoxicity: In Vitro Chromosomal Aberration | Whether the extract would cause genotoxicity in Chinese Hamster Ovary cells | Not considered genotoxic (Pass) |
| Mouse Bone Marrow Micronucleus | No cellular toxicity | Not considered to be genotoxic (Pass) |
| 4 Week Subchronic Toxicity | No signs of behavioral change or toxicity in rats | No significant evidence of systemic toxicity from the subcutaneous article into rats. (Pass) |
| ISO Muscle Implantation Study in Rabbits | No significant macroscopic and microscopic reactions nonirritant compared to USP Negative Control Implant Material | Macroscopic reaction for the test article device was not significant as compared to the USP negative control implant material (PASS) |
Table: Bench (Performance) Testing Acceptance Criteria and Results
| No. | Title | Criteria | Result Summary |
|---|---|---|---|
| 1 | USP 32:2009 Absorbable Surgical Suture | Implicit criteria based on similar absorbable sutures, no explicit numerical criteria provided | In vivo absorption of absorbable suture were observed at 10, 80, 120, 220 days after implantation. Absorption time of MONOSORB was 180-220 days. |
| 2 | Dimension Test USP 37-NF 32:2014 <861> Sutures - Diameter | Acceptance Criteria for this testing ±5% | No failed results were performed in any DW-1C during the performing period. |
| 3 | Tensile Strength USP 37-NF 32: 2014 <881> Tensile Strength | Acceptance Criteria for this testing Not less than 300gf. | No failed results were performed in any DW-1C during the performing period. |
| 4 | Holding forces | No explicit numerical criteria provided, but implied to be comparable to reference samples. | There was no significant difference between test samples and reference samples. |
| 5 | Weights | Implied criteria would be a expected decrease over time as degradation occurs. | The weights of test samples in 1st (G1, Week 2), 2nd (G2, Week 4), 3rd (G3, Week 6), 4th (G4, Week 8), 5th (G5, Week 10), 6th (G6, Week 12) and 7th (G7, Week 14) necropsy groups were statistically significantly lower than that of the test samples in before implantation (p<0.001). |
| 6 | Biodegradation (absorption rate) | Implied criteria would be a expected increase in biodegradation over time. | The biodegradation levels of test samples in 1st, 2nd, 3rd, 4th, 5th, 6th and 7th necropsy groups were significantly lower than that of the test samples in before implantation (p<0.001). |
| 7 | Mechanical property (Tensile strengths) | Implied criteria would be a expected decrease in tensile strength over time, and becoming unmeasurable as degradation completes. | The tensile strengths of test samples in 3rd, 4th, 5th and 6th necropsy groups were significantly lower than that of test samples in 1st necropsy group (p<0.05, p<0.05, p<0.05 and p<0.01). In case of 7th necropsy groups, the test samples were degraded into small particles, so it was not possible to measure the tensile strengths. |
| 8 | Endotoxin test | Endotoxin concentration of the test sample is less than 0.1 EU/device. | Endotoxin concentration of the test sample is less than 0.1 EU/device. |
| 9 | Pyrogen test | Implied criteria is absence of pyrogenicity. | There was non-pyrogenicity to the extraction solution. |
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: The document does not explicitly state a specific sample size for each individual test within the "Biocompatibility test" and "Bench (performance) testing" sections. For some tests like "4 Week Subchronic Toxicity" and "ISO Muscle Implantation Study in Rabbits", it mentions rats and rabbits but not the exact number used. For the "Bench (performance) testing," it refers to "test samples" without specifying quantities.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective.
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)
This section is not applicable as the document describes a physical medical device (surgical suture) and its performance through laboratory and in-vivo animal testing, not an AI/imaging device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reason as point 3. The performance is assessed by standardized laboratory procedures and observation of biological responses, not human expert adjudication of diagnostic findings.
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 section is not applicable as the document describes a physical medical device (surgical suture), not an AI-powered diagnostic or decision support system that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section 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 performance of the surgical suture is established through:
- Standardized Test Methods: Adherence to international standards (ISO 10993, USP monographs) for biocompatibility, physical dimensions, tensile strength, absorption rates, and sterility.
- Biological Responses: Observation of animal models (mice, rabbits, guinea pigs, rats) for cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, and implantation reactions.
- Quantitative Measurements: Direct measurements of properties like diameter, tensile strength, weights, and biodegradation levels in a controlled laboratory setting.
8. The sample size for the training set
This section is not applicable, as this is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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