(77 days)
Indications for the Resorbable Interference Screw includes use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications include the following:
Shoulder: Batkart repair, SLAP lesion repair, acromio-clavioular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnat/radial collateral ligament
reconstruction.
Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.
Elbow: Tennis elbow repair, ultar or radial collateral ligament reconstruction, biceps tendon reconstruction.
Knee: Extra-capsular repair, medial collateral ligament (MCL) repair, lateral collateral ligament (LCL) repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis reconstruction, patellar ligament/tendon repair, and vastus medialis obliquus (VMO) muscle advancement.
In addition to the above indications, the 7.0, 8.0, 9.0, 10.0, 11.0, and 12.0mm screws are indicated for the following uses:
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- To provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction.
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- To provide interference fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis).
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- To provide interference fixation during posterior cruciate ligament (PCL) reconstruction.
The 3 mm, 4 mm, 6 mm, 10 mm, 11 mm, and 12 mm as well as the 9 mm x 35 mm Resorbable Interference Screws are an addition to the 7 mm, 8 mm, and 9 mm interference screws already cleared in 510(K) K982497. They are made of the same LactoSorb® material as the predicate devices.
The provided text describes a 510(k) premarket notification for a medical device, the "Resorbable Interference Screw." This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through extensive studies.
Therefore, the input document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria, as typically understood for new device performance claims.
Here's a breakdown of why and what information is present related to equivalency:
Why the requested information is not available in the document:
- Acceptance Criteria and Device Performance: The document does not define specific performance metrics (e.g., tensile strength, degradation rate, biocompatibility standards with defined thresholds) that the "Resorbable Interference Screw" had to meet. Instead, it relies on demonstrating that the new screw is substantially equivalent to existing, legally marketed screws.
- Study Proving Acceptance Criteria: Because specific acceptance criteria with defined thresholds are not provided, there's no study described that "proves" the device meets them in the conventional sense. The "study" mentioned is "Non-Clinical Testing" for substantial equivalence.
Information available related to equivalency:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit for Substantial Equivalence): The implicit acceptance criterion is that the "Resorbable Interference Screw" must be substantially equivalent to the predicate devices.
- Reported Device Performance (as demonstrated for substantial equivalence):
- Non-Clinical Testing: "Mechanical testing was done on the 3.0 mm Resorbable Interference Screw. This testing indicated that the Resorbable Interference Screw was substantially equivalent to the predicate devices."
- Materials & Manufacturing: "The Resorbable Interference Screw is made of the same materials, using the same manufacturing processes, and conforming to the same standards as the predicated Arthrotek Interference Screw (K982497)."
- Intended Use & Indications: The new device shares the same intended use (soft tissue fixation to bone) and expanded indications (specific shoulder, wrist/hand, ankle/foot, elbow, and knee procedures, including ACL/PCL reconstruction) as the predicate devices and prior cleared versions.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document states "Mechanical testing was done on the 3.0 mm Resorbable Interference Screw." It does not specify the sample size for this mechanical testing.
- Data provenance (country, retrospective/prospective) is not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was mechanical testing, not a study requiring expert readers or ground truth established by clinical experts.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method is mentioned as it was mechanical testing.
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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 not an AI or imaging device. No MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the mechanical testing, the "ground truth" would be the established engineering and materials standards (implied by "conforming to the same standards as the predicated Arthrotek Interference Screw") and the performance characteristics of the predicate devices.
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The sample size for the training set:
- Not applicable. There is no mention of a "training set" as this is not a machine learning device.
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How the ground truth for the training set was established:
- Not applicable. There is no mention of a "training set."
Conclusion:
The document focuses on demonstrating substantial equivalence to existing devices through similar materials, manufacturing, intended use, and general performance (indicated by mechanical testing outcome). It explicitly states, "Clinical testing: Clinical testing was not required for these components to support substantial equivalence." This means the device was not subjected to a study designed to meet specific new acceptance criteria in the way a novel, high-risk device or an AI device might be.
§ 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.