(31 days)
The PRO-DENSE™ Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the PRO-DENSE™ Core Decompression Procedure Kit is not intended to be used as a load-bearing device.
The design features of the PRO-DENSE™ Core Decompression Procedure Kit are substantially equivalent to the design features of the PRO-DENSE Bone Void Filler submission (510(k); K070437). The implant material of the PRO-DENSE™ Core Decompression Procedure Kit is exactly the same as the predicate above. The PRO-DENSE Core Decompression Procedure Kit includes Class I and Class II (premarket notification exempt) instrumentation to facilitate a standard core decompression procedure. A brief description of the PRO-DENSE™ implant is provided below.
PRO-DENSE™ consists of a calcium sulfate - calcium phosphate composite bone void filler consisting of a powder component and an aqueous mixing solution. When the two components are mixed, according to directions, an injectable paste is formed which subsequently hardens via hydration reactions. The paste can be injected and cured in situ or formed into pellets which can be gently packed into bony defects.
The provided text is a 510(k) summary for the PRO-DENSE™ Core Decompression Procedure Kit. It establishes substantial equivalence to a predicate device (PRO-DENSE™ Bone Void Filler, K070437).
However, the document does not describe specific acceptance criteria and a study proving the device meets those criteria in the way you've outlined. This type of regulatory submission (510(k)) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against pre-defined acceptance criteria through a specific clinical study with detailed statistical targets.
Here's an analysis based on the information provided, highlighting why many of your requested items cannot be answered from this document:
Overall Conclusion from the Document:
The PRO-DENSE™ Core Decompression Procedure Kit demonstrated substantial equivalence to the PRO-DENSE™ Bone Void Filler (K070437) based on:
- Intended Use: Same.
- Type of interface, operating principles, shelf life, and design features: Substantially equivalent.
- Implant material: Exactly the same.
- Safety and effectiveness: Adequately supported by substantial equivalent information, materials data, and testing results provided within the Premarket Notification (though these specific tests are not detailed in the provided summary).
Therefore, there is no specific performance study described in this document with defined acceptance criteria that would allow me to fill in your requested table and information points. The FDA clearance is based on the comparison to a predicate device, not on meeting new, specified performance thresholds from a clinical trial.
Attempted Answer based on Lack of Information in the Provided Text:
Since the provided document is a 510(k) summary focusing on substantial equivalence, it does not include the detailed clinical study information typically associated with establishing specific performance criteria for AI/ML devices. Therefore, most of your questions cannot be answered from this text.
Here's an attempt to address each point, acknowledging the limitations of the provided document:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as performance metrics in this 510(k) summary. The primary "acceptance criteria" for a 510(k) in this context is demonstrating substantial equivalence to a predicate device.
- Reported Device Performance: Not reported in terms of specific clinical outcomes or statistical performance metrics. The document states its safety and effectiveness are "adequately supported by the substantial equivalent information, materials data, and testing results," but does not detail these results or the performance observed.
Performance Metric Acceptance Criteria Reported Device Performance Not Applicable Not Applicable Not Applicable Rationale: The 510(k) summary focuses on demonstrating substantial equivalence, not on presenting results from a clinical trial designed against specific performance criteria.
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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)
- Sample Size (Test Set): Not mentioned.
- Data Provenance: Not mentioned.
Rationale: This information would typically be part of a clinical study report, which is not included in this high-level 510(k) summary.
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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)
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
Rationale: Ground truth establishment is irrelevant in a substantial equivalence filing for a bone void filler where performance is typically assessed through material testing and biological response, not interpretive tasks requiring expert consensus.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not mentioned.
Rationale: Same as above. Adjudication is relevant for interpretive tasks, not for material devices like a bone void filler in this regulatory context.
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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
- MRMC Study: Not applicable/not mentioned. This device is a bone void filler and surgical instrument kit, not an AI/ML radiology device that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable/not mentioned. This device is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated. For "materials data, and testing results" mentioned in the substantial equivalence statement, the "ground truth" would likely refer to established engineering and biocompatibility standards, and possibly animal model or in-vitro test results confirming material properties, resorption rates, and biological response. Clinical "outcomes data" might be part of the predicate device's evidentiary basis, but no new clinical outcomes study for this specific kit is detailed here.
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The sample size for the training set
- Sample Size (Training Set): Not applicable/not mentioned. This is a physical device, not an AI/ML model that requires a training set.
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How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable/not mentioned.
Summary of what the document does provide regarding "performance" and "acceptance":
- Acceptance based on Substantial Equivalence: The FDA determined the device is substantially equivalent to the predicate device (K070437). This is the key "acceptance" criterion for a 510(k) pathway.
- Basis for Equivalence: The claimed equivalence relies on:
- Identical intended use.
- Substantially equivalent design features, interface, operating principles, and shelf life.
- Exactly the same implant material.
- "Adequately supported by the substantial equivalent information, materials data, and testing results provided within this Premarket Notification" (which are not detailed in this summary).
In essence, the "study" proving the device meets "acceptance criteria" here is the comparison to the predicate device (K070437) and the underlying data (materials testing, etc., not detailed) that support that comparison. This is a common shortcut for devices deemed to be sufficiently similar to already cleared products.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.