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The ImproVise™ Absorbable Cement Flow Restrictor is intended for use as an absorbable bone cement flow restrictor for use in the intramedullary canal. This device is not intended for use in the spine.

The ImproVise™ Absorbable Cement Flow Restrictor is designed to provide a quick, simple, and effective method of plugging the intramedullary canal with an easy-to-place absorbable foam plug. Based on the size of the reamer used to form the channel, the appropriate size foam plug is selected and is then guided onto the tip of the tool. The ImproVise™ Insertion tool is then used to advance the plug down the canal to the desired depth, using the Cement Restrictor as a guide. The ImproVise™ foam plugs are deformable and bank against the irregular shape of the canal, effectively sealing the canal at the insertion point. The cement restrictors are available in sizes small, medium, large and extra-large (9.5-11 mm, 11-13 mm, 13-15 mm, 15-17.5 mm), both in straight cylindrical and tapered versions. The restrictor can be easily carved with a scalpel at the time of surgery, or press-fit into the bone. The ImproVise™ Absorbable Cement Flow Restrictor is manufactured from a proprietary polylactic acid foam, which is greater than 90% void space.

The provided text describes the regulatory clearance (510(k)) of the ImproVise™ Absorbable Cement Flow Restrictor and presents a comparison to a predicate device, the Resorbaplug™ Bone Plug. However, the document does not contain a study report or detailed acceptance criteria for the ImproVise™ device's performance, nor does it describe a study specifically designed to prove the device meets such criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed performance study against pre-defined acceptance criteria.

Despite the lack of explicit study details, some information relevant to the request can be extracted or inferred:

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

The only "performance" metric mentioned that resembles acceptance criteria, and for which data is provided for both devices, is:

Note: This is the only direct performance comparison provided in the document. It's listed in the "Performance" row of Table 1 under "Interference fit that provides 100N push-out force." The values (1.9-2.9 mm for ImproVise™ and 2.5 mm for Resorbaplug™) likely refer to the amount of interference fit (compression/diameter difference) required to achieve a 100N push-out force.

2. Sample size used for the test set and the data provenance

• Sample Size: Not mentioned in the provided text.
• Data Provenance: Not mentioned in the provided text (e.g., country of origin, retrospective/prospective). The data appears to be from laboratory testing rather than clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The performance metric (push-out force) is a physical test and does not involve expert interpretation or ground truth establishment in the traditional sense of clinical or diagnostic studies.

4. Adjudication method for the test set

Not applicable, as there is no expert interpretation or consensus involved for this physical performance test.

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. This device is a physical bone plug, not an AI or diagnostic imaging device, so MRMC studies involving human readers are irrelevant.

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

Not applicable. This device is a physical bone plug.

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

The "ground truth" for the reported performance (interference fit vs. push-out force) would be the objective measurement taken from mechanical testing apparatus. There is no expert consensus, pathology, or outcomes data mentioned in relation to this specific performance metric.

8. The sample size for the training set

Not applicable. This is a physical device, and the context provided does not involve machine learning or a "training set."

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

Not applicable.

Summary of Device Acceptance Criteria and Study (Based on Provided Text):

The provided 510(k) summary (K011943) for the ImproVise™ Absorbable Cement Flow Restrictor focuses on demonstrating substantial equivalence to a predicate device, the Resorbaplug™ Bone Plug (K920118). The core of this submission, concerning "acceptance criteria" and "proof," is the comparison of material, intended use, and a specific physical performance characteristic.

• Acceptance Criteria (Inferred from Substantial Equivalence): The implicit acceptance criteria are that the ImproVise™ device performs comparably to the predicate device, the Resorbaplug™, especially regarding its mechanical function as a cement flow restrictor. The key comparable performance metric identified is the "interference fit that provides 100N push-out force."
• Study That "Proves" Performance: The document itself is the "study" in the context of a 510(k) summary, as it presents data for the new device and compares it to the predicate. The "study" here is a comparative analysis, likely based on non-clinical (benchtop) testing as opposed to a full-scale clinical trial.
  • Evidence: The table (Table 1) directly compares the ImproVise™ to the Resorbaplug™ across various attributes including "Performance: Interference fit that provides 100N push-out force."
  • ImproVise™ Performance: 1.9-2.9 mm
  • Resorbaplug™ Performance: 2.5 mm
  • The close proximity of these values is presented as evidence of substantial equivalence and, by extension, that the ImproVise™ meets the expected performance for its intended use, as established by the predicate device.

Missing Information:

Crucially, the document lacks detailed information on the methodology of the mechanical testing, exact sample sizes for these tests, the precise definition of the "1.9-2.9 mm" range (e.g., mean, range, standard deviation, confidence interval), or the specific test standards followed. This level of detail would typically be found in a full test report, not a 510(k) summary.

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