(29 days)
The Bilok® Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon places the graft in tibial and/or femoral tunnels and inserts screws between the tunnel wall and graft to hold the graft in place.
The Bilok® Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
The Bilok® Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).
The Bilok® Screw is a cannulated, sterile, single use bone screw manufactured from a composite mix of calcium phosphate and poly L-lactic acid (PLLA).
The provided documentation for the Bilok® Screw (K071091) does not contain specific acceptance criteria or a detailed study report proving the device meets particular performance metrics beyond substantial equivalence to a predicate device.
Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, which is a common pathway for 510(k) clearance. This means that the device is shown to be as safe and effective as a device already on the market, rather than meeting novel performance criteria through independent testing.
Based on the provided text, here's what can be extracted and inferred regarding the "study" that proves the device meets acceptance criteria:
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Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly available in the provided text. The document repeatedly states that "Documentation provided demonstrates that the Bilok® Screw is substantially equivalent to the legally marketed predicate device and any differences do not raise any concerns regarding safety and effectiveness." This implies that the 'acceptance criteria' are implicitly met if substantial equivalence to the predicate is established. Without knowing the predicate device and its specific performance data, no quantitative table can be generated from this document for the Bilok® Screw.
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Sample size used for the test set and the data provenance: This information is not provided. The document only mentions "Non Clinical Testing" but does not detail the methodology, sample sizes, or provenance of any data used for comparison or testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. As no specific test set or data generating study is described, there's no mention of experts establishing ground truth.
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Adjudication method for the test set: This information is not provided.
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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: This is not applicable. The Bilok® Screw is a bone screw, not an AI-powered diagnostic device. Therefore, MRMC studies with human readers and AI assistance are not relevant to its regulatory submission.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This is not applicable. The Bilok® Screw is a physical medical device, not an algorithm.
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The type of ground truth used: This information is not explicitly provided. Given the nature of a bone screw, "ground truth" would likely relate to biomechanical properties (e.g., pull-out strength, insertion torque, fatigue life) compared against the predicate device. However, the specific type of data (e.g., direct measurement, mechanical testing standards, in-vivo animal studies) isn't detailed. The document only refers to "Non Clinical Testing."
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The sample size for the training set: This is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
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How the ground truth for the training set was established: This is not applicable.
In summary of the "Study" mentioned:
The "study" referenced in the document is a "Non Clinical Testing" process that aims to demonstrate "Substantial Equivalence" of the Bilok® Screw to a legally marketed predicate device.
- Acceptance Criteria: Implicitly, the acceptance criterion is that the Bilok® Screw performs at least as well as and shares similar technological characteristics to the predicate device in terms of safety and effectiveness, such that any differences "do not raise any concerns."
- Proof: The "documentation provided" (which is not included in this extract in detail) contains the results of this non-clinical testing.
- Key Phrase: "Documentation provided demonstrates that the Bilok® Screw is substantially equivalent to the legally marketed predicate device and any differences do not raise any concerns regarding safety and effectiveness."
This type of submission often relies on a combination of:
- Material characterization: Ensuring the composite material (calcium phosphate and PLLA) meets specifications and is comparable to materials used in the predicate.
- Biomechanical testing: Comparing properties like insertion torque, pull-out strength, and fatigue resistance of the Bilok® Screw to the predicate device using standardized in-vitro methods.
- Dimensional comparison: Matching the design, dimensions, and cannulation to the predicate device.
Without the actual "documentation provided" mentioned, specific details about exact tests, data, and criteria remain undisclosed in this 510(k) summary.
§ 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.