(18 days)
The Surgical Dynamics Meniscal Staple is intended for the repair of vertical longitudinal full thickness tears (i.e., bucket-handle) in the red-red and red-white zones.
The currently marketed Surgical Dynamics Meniscal Staple is an absorbable implantable staple. The staple consists of two rigid resorbable barbed legs connected by a length of resorbable, flexible braided filament. The staple is designed to facilitate meniscal repair in the vascular zone of the meniscus.
The provided text is a 510(k) summary for the Surgical Dynamics Meniscal Staple, a medical device. It does not include information about acceptance criteria, study details, or performance metrics that would typically be found in a clinical study report or a detailed validation document for a new device.
The context of this document is a submission to the FDA requesting clearance based on "substantial equivalence" to a previously marketed device, not a de novo clearance requiring extensive clinical performance studies. Therefore, many of the requested details about performance studies, such as sample size, ground truth, and expert qualifications, are not present in this type of submission.
Here's a breakdown of why the requested information is absent and what the document does tell us:
- Substantial Equivalence: The key phrase in the document is "substantially equivalent." This means the manufacturer is asserting that the modified Surgical Dynamics Meniscal Staple is as safe and effective as a legally marketed predicate device (the "currently marketed version of the device"), and therefore does not require new, extensive clinical studies to prove effectiveness.
- Device Description and Indications for Use: The document clearly states the device description and its intended use, which are crucial for defining the scope of equivalence.
- No New Performance Data Required for 510(k) Equivalence: For a 510(k) submission based on substantial equivalence, the FDA typically relies on the performance data of the predicate device, or bench testing / non-clinical data to show that the new device performs as safely and effectively as the predicate. Extensive clinical trials with specific acceptance criteria are usually not required unless there are significant differences in technology, indications for use, or safety/effectiveness concerns compared to the predicate.
Given this, I cannot provide the requested information in the format you asked for.
However, I can extract what is explicitly stated or can be inferred from the provided text:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as performance metrics. The underlying "acceptance criterion" for a 510(k) is "substantial equivalence" to a predicate device. This typically involves demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate device.
- Reported Device Performance: Not explicitly reported in terms of clinical outcomes or specific quantitative metrics in this summary. The summary states, "The modified Surgical Dynamics Meniscal Staple was claimed to be substantially equivalent* to the currently marketed version of the device." This implies that its performance is considered equivalent to the predicate, but specific performance data or a comparison table is not provided.
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Sample sized used for the test set and the data provenance:
- Not applicable/Not provided. There is no mention of a clinical "test set" or human subject data in this 510(k) summary for the modified device. Equivalence would likely be demonstrated through engineering specifications, material properties, and potentially non-clinical testing comparing it to the predicate.
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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/Not provided for the reasons above.
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Adjudication method for the test set:
- Not applicable/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:
- Not applicable. This is not an AI device, nor is a MRMC study typically required for this type of 510(k) submission.
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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:
- Not applicable. As no clinical "test set" is described, no ground truth determination method is mentioned. The "ground truth" here is the established safety and effectiveness of the predicate device.
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The sample size for the training set:
- Not applicable. No training set is mentioned as this is not an AI/machine learning device.
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How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence, not a detailed clinical study report. Therefore, it lacks the specific performance data and study design details (like sample sizes, ground truth establishment, expert qualifications, etc.) that would be associated with proving device performance against explicit acceptance criteria in a de novo or PMA submission.
§ 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.