(29 days)
The PONTiSTM Nonabsorbable Ultra-High Molecular Weight Polyethylene Braided Sutures are indicated to secure soft tissue to soft tissue reattachment in the hand:
- Collateral Ligaments around the PIP, DIP and MCP Joints .
- . Flexor and Extensor Tendons
The PONTiSTM 3mm Nonabsorbable Suture Anchors with Ultra-High Molecular Weight Polyethylene Braided Suture are indicated to secure soft tissue to bone reattachment in the hand:
- Collateral Ligaments around the PIP, DIP and MCP Joints .
- Flexor and Extensor Tendons ●
The PONTISTM 3mm anchor is made of 316L stainless steel and incorporates non-absorbable UHMWPe sutures which are available in United States Pharmacopoeia (USP) sizes 4-0 to 2-0 in various lengths and cleared to market under K094028. UHMWPe sutures and 316L Stainless steel are used in a wide variety of medical devices including previously approved implants of this type. The UHMWPe Sutures will be secured by knot tying. The UHMWPe sutures are supplied sterile and armed with cutting needles. A single use driver and hand piece will hold the excess suture, which delivers the preloaded anchor into the bone. The suture strands are used to reapproximate and secure the soft tissue to bone. The anchor is the same as was cleared under K101126, PONTIS Sutures and Suture Anchor with Optional Crimps.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: PONTIS™ Ultra-High Molecular Weight Polyethylene Suture and PONTIS™ 3mm Nonabsorbable Suture Anchors with Ultra-High Molecular Weight Polyethylene Braided Suture
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily centered around demonstrating substantial equivalence to a predicate device (PONTIS™ Sutures and Suture Anchors with Optional Crimps K101126) and confirming safety and performance. Since this is a 510(k) submission for a modified device (suture material change), the "acceptance criteria" are implicitly met if the new device performs at least as well as the predicate and the changes do not raise new questions of safety or efficacy.
| Acceptance Criteria Category | Specific Criteria (Implicitly Derived from 510(k)) | Reported Device Performance |
|---|---|---|
| Intended Use Equivalence | Intended use is equivalent to predicate device. | Confirmed; same indications for use. |
| Operational Principle Equivalence | Operational principles are equivalent to predicate device. | Confirmed. |
| Indications for Use Equivalence | Indications for use are equivalent to predicate device. | Confirmed; same indications for use. |
| Biocompatibility | All components are biocompatible for intended use. | Confirmed; biocompatibility testing from predicate (K101126) remains applicable since core materials (except for suture type) are the same. UHMWPe sutures were cleared under K094028, indicating their safety. |
| Suture Strength (Knot Pull) | Suture strength (knot pull) is equivalent to products currently marketed for the same indications. | Documented and confirmed as equivalent to marketed products. |
| Anchor Insertion Torque | Anchor insertion torque is within acceptable ranges and equivalent to predicate/marketed devices. | Documented and confirmed. |
| Pull-out Failure Mechanism | Failure mechanism (pull-out or suture break strength) is acceptable and comparable to predicate/marketed devices. | Documented and confirmed. |
| Pull-out Failure Force | Pull-out failure force is equivalent to predicate/marketed devices. | Documented and confirmed. |
| Cyclic Pull-out Performance | Cyclic pull-out performance is characterized and equivalent to predicate/marketed devices. | Characterized and confirmed. |
| No New Safety/Efficacy Questions | Changes (suture type) do not introduce new questions of safety or efficacy. | Confirmed; testing demonstrated equivalence and no new safety/efficacy concerns. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text only refers to "a collection of tests" using "standardized foam bone model materials." It does not specify the sample size for the non-clinical tests. The data provenance is laboratory-based testing using in vitro standardized foam bone model materials, not human or animal data. Therefore, there is no country of origin or retrospective/prospective distinction.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for these non-clinical tests is based on engineering measurements and comparisons to established benchmarks/literature values, not expert human interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. As this is non-clinical laboratory testing, there is no need for human adjudication methods like 2+1 or 3+1. The results are objective measurements.
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 medical device (suture and suture anchor), not an AI/imaging device. Therefore, no MRMC study looking at human reader improvement with AI assistance was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for the non-clinical tests was based on objective engineering and material science measurements of properties like anchor insertion torque, suture strength (knot pull), pull-out failure mechanism, pull-out failure force, and cyclic pull-out performance. These measurements were then compared against the literature documenting the comparative characteristics of suture anchors and against the predicate device (implicitly, or performance accepted for the predicate).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. (See #8)
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.