Search Results
Found 2 results
510(k) Data Aggregation
(29 days)
MONODERM™ (PGA-PCL) suare is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Monoderm™ (PGA-PCL) suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and e-carpolactone. The Monoderm™ (PGA-PCL) suture is available dyed and undyed in Size 1 through Size 6-0.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Monoderm™ (PGA-PCL) Surgical Suture, structured according to your request:
Acceptance Criteria and Study for Monoderm™ (PGA-PCL) Surgical Suture
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device must conform to) | Reported Device Performance (How the device met the criteria) |
|---|---|
| USP monograph for absorbable sutures | Conforms to the USP monograph for absorbable sutures |
| Performance requirements for substantial equivalence to predicate device | Demonstrates substantial equivalence to the predicate device, including in vitro post-hydrolysis tensile testing |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size for a "test set" in terms of individual sutures tested. The reference is to "performance testing" being conducted. The data provenance is implied to be from non-clinical laboratory testing conducted by the company, Surgical Specialties Corporation, likely in the USA (given the company's address and FDA submission). The nature of the testing suggests it is prospective in the sense that the new Monoderm™ (PGA-PCL) suture was manufactured and then subjected to these tests to evaluate its properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" for suture performance is typically established by physical and chemical properties measured against established standards (like the USP monograph), rather than expert human interpretation of images or other subjective data. Therefore, expert consensus in the traditional sense is not directly applicable here.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used for human review of subjective data, typically in diagnostic imaging or clinical trials where expert consensus is needed. For product performance testing of a physical device like a suture, the assessment is based on measured physical properties against predefined specifications, not human adjudication of subjective 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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This submission is for a physical surgical suture, not an AI device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone study (in the context of an algorithm) was not done. This submission is for a physical surgical suture.
7. The Type of Ground Truth Used
The ground truth used for evaluating the suture's performance is based on:
- Established standards and specifications: Specifically, the USP monograph for absorbable sutures.
- Comparative data against a legally marketed predicate device: "in vitro post-hydrolysis tensile testing" to demonstrate substantial equivalence. This implies that the predicate device's performance characteristics served as a reference "ground truth" for comparison.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. This submission is for a physical medical device (suture) and does not involve an algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable as there is no training set for an algorithm in this context.
Ask a specific question about this device
(84 days)
Monoderm™sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Coated Monoderm™(Polyglactone 72) suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and e-caprolactone. Coated Monoderm™ suture is prepared by coating Monoderm™ suture with a mixture of caprolactone, glycolide and glycolic acid.
The provided text describes a 510(k) summary for a surgical suture device (Monoderm™), which focuses on establishing substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with the kind of details requested.
Therefore, many of the requested items (e.g., acceptance criteria table with reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect sizes, standalone performance, ground truth for training set) are not applicable or not provided in this type of regulatory submission.
However, I can extract information related to performance data and equivalency claims as much as possible.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
This information is not presented in a table format with explicit acceptance criteria values. Instead, the document states general conformance to standards and describes performance relative to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Conformance to USP 27 standards for surgical sutures. | "Physical testing was performed on Monoderm™Coated, Synthetic, Absorbable sutures to USP 27, including <861>Suture Diameter, <871>Suture Needle Attachment,<881> Tensile Strength." (Specificity of "conformance" implies meeting the USP requirements, but no specific values are given.) |
| Biocompatibility (ISO 10993) | "Animal testing was performed for conformance to ISO 10993 for biocompatibility..." (Specificity of "conformance" implies meeting the ISO requirements, but no specific results are given.) |
| Rates of tensile strength and mass loss (in vivo / implant studies) | "...and implant studies to demonstrate rates of tensile strength and mass loss." (No specific rates or numerical performance values are provided, only that studies were done to demonstrate them.) |
| Dissolution / Absorption Time | "Coated Monoderm sutures are made of a synthetic absorbable suture material, which will dissolve essentially in 91 days."(Comparison to predicates: Caprosyn: 56 days; Monocryl: 91-119 days) |
| Material composition and characteristics | "Surgical Specialties Corporation's Monoderm™Synthetic, absorbable suture is made from a mixture of Glycolide/e-caprolactone. The material has been well characterized through absorption studies and biocompatibility studies. The product is similar to the predicate devices, Monocryl and Caprosyn, in that they are both made from a polymer blend of synthetic absorbable materials." (This is more of a characteristic description than a performance metric with an acceptance criterion.) |
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: Not specified in the provided text. The document mentions "Physical testing" and "Animal testing" but does not give the number of samples or animals used.
- Data Provenance: Not specified. The studies were performed by Surgical Specialties Corporation. The country of origin of the data is not mentioned. Whether studies were retrospective or prospective is also not stated, but typically, these types of tests for product clearance are 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)
- Not applicable. This is not the type of device or study that typically involves expert ground truth for a test set in the way an AI diagnostic device would. Performance is assessed against physical and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept is typically relevant for studies involving human interpretation or subjective assessments, which is not the case for this physical and biological product testing.
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 device is a surgical suture, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical surgical suture, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For physical testing (diameter, needle attachment, tensile strength), the "ground truth" would be established by standardized measurement techniques defined by USP 27.
- For biocompatibility and implant studies, the "ground truth" would be established by histopathological examination and assessment of biological responses according to ISO 10993 guidelines, and measurement of physical properties (tensile strength, mass loss) over time.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML product developed with training sets.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML product developed with training sets.
Ask a specific question about this device
Page 1 of 1