(74 days)
Bondek Plus Synthetic Absorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
Bondek Plus Synthetic Absorbable Surgical Suture is a sterile, absorbable, braided multifilament suture composed of a homopolymer of glycolic acid. The suture material is coated with a copolymer of polycaprolactone and polyglycolic acid.
This document describes the marketing authorization for the BONDEK® PLUS Synthetic Absorbable Surgical Suture. It is a 510(k) Summary of Substantial Equivalence, which means the manufacturer demonstrated that their device is as safe and effective as a legally marketed predicate device.
Key takeaway: This device is a surgical suture, and the acceptance criteria and supporting studies will revolve around its physical properties, biocompatibility, and performance in comparison to existing sutures, rather than accuracy metrics for a diagnostic device.
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not contain a specific table detailing "acceptance criteria" and "reported device performance" in the context of typical diagnostic or AI device studies (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence for this surgical suture is based on its similarity in intended use, materials, design, and performance characteristics to predicate devices, and conformance with voluntary performance standards.
Therefore, the "acceptance criteria" are implied to be meeting the requirements of these standards and being comparable to the predicate devices. The "reported device performance" refers to the demonstration of this conformance and comparability.
| Acceptance Criteria Category (Implied) | Relevant Standards / Description of Performance Demonstrated (Based on Document) |
|---|---|
| Intended Use Equivalence | Indicated for general soft tissue approximation and/or ligation, including ophthalmic procedures (excluding cardiovascular and neurological procedures), similar to predicate devices. |
| Material Equivalence | Composed of a homopolymer of glycolic acid, coated with a copolymer of polycaprolactone and polyglycolic acid, similar to predicate devices. |
| Design Equivalence | Sterile, absorbable, braided multifilament suture, similar to predicate devices. |
| Biocompatibility | Conformance with ISO 10993-1 Biological Evaluation of Medical Devices. (Implicitly met, no specific performance data given). |
| Physical Performance (e.g., tensile strength, knot security, absorption profile) | Conformance with U.S.P. Section 1475 - Absorbable Surgical Sutures. (Implicitly met, no specific performance data given). |
| Labeling Compliance | Conformance with FDA Guidance Document "Alternate Suture Labeling Resulting from January 11, 1993 Meeting with HIMA". (Implicitly met). |
| Manufacturing & Quality Control | Implied adherence to general controls (registration, listing, GMP), and the requirement to maintain documentation regarding vendor certification, manufacturing/QC procedures, and sterilization validation. Any deviations would require new premarket notification. |
| Regulatory Compliance (Predicate Devices) | Demonstrated substantial equivalence to: |
- Bondek Synthetic Absorbable Surgical Suture (#K905482, #K930378 and #K991191(pending))
- Sherwood-Davis & Geck Dexon® PGA Suture (#K972566, #K951352, #K900198)
- Lukens Medical Corp. Lukens® PGA suture (#K965162) |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not mention a specific "test set" in the way one would for diagnostic device studies involving data samples. The evaluation of a surgical suture primarily involves bench testing (to meet physical standards) and biocompatibility testing (often in vitro and in vivo animal studies, or reliance on established material safety).
- Sample Size: Not specified in terms of clinical or data samples. The "data" here refers to the results of bench and biocompatibility testing required by the aforementioned standards.
- Data Provenance: Not specified. This would typically be from laboratory testing conducted by the manufacturer or accredited labs, and potentially animal studies for biocompatibility, rather than human patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission for a surgical suture. "Ground truth" established by experts (e.g., radiologists) is relevant for diagnostic devices that interpret medical images or data. For a physical device like a suture, the "ground truth" is established by adherence to recognized engineering, material science, and biological standards through objective testing.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This is not applicable. Adjudication methods are used in studies where multiple human readers or algorithms provide interpretations that need to be reconciled for a definitive "ground truth." This is not how a surgical suture's performance or equivalence is evaluated. Its performance is measured against objective standards.
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. MRMC studies and the concept of "human readers improving with AI assistance" are relevant for diagnostic AI devices, not for a synthetic absorbable surgical suture.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This question pertains to AI algorithms, which are not part of this medical device (a surgical suture).
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For this surgical suture, the "ground truth" is defined by:
- Voluntary Performance Standards: Such as ISO 10993-1 (biocompatibility) and U.S.P. Section 1475 (physical properties of sutures).
- Material Science and Engineering Principles: Ensuring the suture material meets specifications for strength, degradation, and handling characteristics.
- Comparability to Predicate Devices: Demonstrating that the new device performs equivalently to existing, legally marketed sutures based on their established performance profiles.
There is no "expert consensus" or "pathology" in the typical sense for establishing performance of the suture itself, although expert surgeons would evaluate its handling characteristics in practice. Outcomes data might be collected in a larger clinical trial for novel claims, but for a 510(k) for a well-understood device type, it's primarily bench and biocompatibility data.
8. The Sample Size for the Training Set
This is not applicable. The concept of a "training set" refers to data used to train machine learning algorithms. This device is a physical surgical suture, not an AI or software device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this 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.