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K Number
K223889
Device Name
Stativ® Knotted UHMWPE Suture Anchor
Manufacturer
Healthium Medtech Limited
Date Cleared
2023-03-22

(85 days)

Product Code
MBI
Regulation Number
888.3040
Type
Traditional
Panel
Orthopedic
Reference & Predicate Devices
K203268,K192709
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The STATIV® Knotted UHMWPE Suture Anchor is indicated for the fixation, by use of sutures, of soft tissue to bone in the following surgical procedures:

  1. Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.

  2. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction.

  3. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.

  4. Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty).

  5. Elbow: Biceps tendon reattachment, Ulnar or Radial collateral ligament reconstruction.

  6. Hip: Acetabular labral repair, Capsular repair, Gluteal Tendon Repair.

Device Description

The STATIV® Knotted UHMWPE Suture Anchor is a fixation device intended to provide secure fixation of soft tissue to bone and is available in self-tap/self-punching variant also. It consists of a soft Suture Anchor with attached non-absorbable suture(s) to an inserter with handle. The Anchor are available in various sizes, preloaded with suture, tape or suture-tape combinations. This device is provided sterile, for single use only.

AI/ML Overview

The provided text is a 510(k) Summary for the STATIV® Knotted UHMWPE Suture Anchor. It primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and performance data.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance for the subject device. Instead, it states:

  • "The pull-out strength and displacement under cyclic loading of STATIV® Knotted UHMWPE Suture Anchor and Predicate device. The results were reviewed and side by side comparisons were done with the identified predicate device and it demonstrated that there were no significant differences between the STATIV® Knotted UHMWPE Suture Anchor and the predicate device."
  • "During the bench testing of subject device, it was observed that the changes in dimensions are not leading to any kind of new risks with the performance of subject device, and the acceptance criteria was met in each of the performance tests as per defined guidelines and applicable standards." (Emphasis added)

While it indicates that acceptance criteria were met, the specific numerical values for these criteria and the measured performance of the STATIV® Knotted UHMWPE Suture Anchor are not detailed in this summary. It only broadly mentions "Pull out Strength" and "Cyclical Loading" as performance data.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "bench testing" and "literature study."

  • For the direct performance testing of the subject device (Pull out Strength and Cyclic Loading), the sample size is not specified.
  • The provenance of this data (e.g., conducted by Healthium Medtech Limited in India) is not explicitly stated, although the manufacturer is based in Bangalore, India.
  • The nature of the study (retrospective or prospective) is also not specified, but given it's bench testing for a new device, it would typically be considered prospective.

For "SE Analysis 1: Anchor Material," a "literature study" is referenced: "The influence of suture material on the strength of horizontal mattress suture configuration for meniscus repair." Reference 1 points to https://pubmed.ncbi.nlm.nih.gov/23340094/. The details of this secondary study's sample size and provenance would be found in the linked publication, but are not present in this FDA document.

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 to the provided document. The device is a physical suture anchor, and the evaluation involves bench testing of mechanical properties, not interpretation of data by experts for ground truth establishment in the way it would be for a diagnostic AI device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This section is not applicable as the evaluation relies on physical bench testing rather than subjective human interpretation requiring 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

This is not applicable. The device is a surgical implant (suture anchor), not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a surgical implant (suture anchor), not an algorithm. Performance testing was done on the physical device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the bench performance data (pull-out strength and cyclic loading), the "ground truth" would be established by standardized mechanical testing procedures and measurements using calibrated equipment, as per "defined guidelines and applicable standards." These are objective, quantitative measurements, not expert consensus or pathology in the context of diagnostic devices.

8. The sample size for the training set

This is not applicable. The device is a physical medical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable. As stated above, the device is not an AI model.

§ 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.