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indicated for use in soft tissue to bone fixation for reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with recurrent anterior dislocation or subluxation of the shoulder.

comprised of a pin. which widens distally, and a socket, which consists of a cannulated head with circumferential teeth on the underside, as well as four ribbed legs emanating from the underside of the head.

The provided text describes a 510(k) premarket notification for a medical device called the "Surgical Dynamics™ Pop Rivet." This submission focuses on establishing substantial equivalence to a predicate device, the "Poly-Medics Lactosorb® Pop Rivet (K951658)."

Based on the provided information, there is no study described that demonstrates the device meets specific acceptance criteria in terms of performance metrics. The submission instead focuses on demonstrating equivalence in design, materials, manufacturing, indications for use, and processing.

Therefore, most of the requested information cannot be extracted from the given text.

Here is an attempt to address your questions based only on the provided text, highlighting what is not available:

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

   Acceptance Criteria (Performance)	Reported Device Performance
   Not specified in text	Not specified in text

   Explanation: The document focuses on demonstrating substantial equivalence to a predicate device (Poly-Medics Lactosorb® Pop Rivet K951658) across various aspects (indications, design, materials, manufacturing, sterilization, packaging, and method of use). It does not present specific quantitative performance acceptance criteria or report performance data for the Surgical Dynamics™ Pop Rivet itself.

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

   Not provided. There is no mention of a "test set" or any performance study involving patient data.

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)

   Not provided. This information is irrelevant given the type of submission (equivalence, not performance).

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

   Not provided. This is not relevant to an equivalence submission.

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/Not provided. This is not an AI-enabled device, and no MRMC study is mentioned.

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

   Not applicable/Not provided. This is not an AI algorithm; it's a surgical implant.

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

   Not provided. No performance studies or "ground truth" establishment are mentioned. The "ground truth" in this context is the predicate device's established safety and effectiveness.

8. The sample size for the training set

   Not applicable/Not provided. This is not an AI-enabled device requiring a "training set."

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

   Not applicable/Not provided. This is not an AI-enabled device.

In summary, the provided text is a 510(k) summary focused on demonstrating substantial equivalence, not on presenting performance data from a clinical or analytical study with defined acceptance criteria for the device itself. The "acceptance criteria" here are met by meticulously comparing the characteristics of the new device to a legally marketed predicate device and showing they are sufficiently similar that the new device is as safe and effective.

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