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SOCKET GRAFT is a bone grafting material indicated for use in dental extraction sockets that have all walls remaining. Socket Seal is a temporary implantable material intended for use in the oral cavity to be used as a space maintaining barrier over bone and other tissue. Socket Seal is indicated for use over bone grafts. Socket Seal in indicated for use over extraction sockets in the maxilla and mandible.

SOCKET GRAFT is intended to regenerate bone in dental extraction sockets. SOCKET GRAFT is dual phase calcium phosphate biocement that is wetted by sterile water to a putty consistency. Extraction sockets are filled with SOCKET GRAFT and covered by the enclosed Socket Seal. SOCKET GRAFT is fully resorbed in 12-14 weeks resulting the extraction socket. SOCKET GRAFT is supplied in sterile, single use 1.5 cc syringes. Socket Seal is a closed cell, medical grade, polyethylene foam material that is a nonporous, biocompatible semi-rigid sheet. Socket Seal is designed to stabilize, support and protect bone graft material and provide space maintenance for regenerative healing.

Here's a breakdown of the acceptance criteria and the study information for the Socket Graft and Socket Seal devices, based on the provided 510(k) summary:

This submission primarily relies on demonstrating substantial equivalence to predicate devices rather than independent performance studies with detailed acceptance criteria and clinical outcomes. The "performance testing" section focuses on comparing physical and chemical properties to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

For SOCKET GRAFT:

For SOCKET SEAL:

The performance testing for Socket Seal is less detailed and focuses on material similarity to predicate devices rather than specific quantitative criteria beyond material composition. The characteristics listed, such as material (polyethylene), design (sheets), sterility (sterile), sterilization method (gamma), biocompatibility (yes), resorbable/nonresorbable (nonresorbable), and porosity (nonporous), are compared directly to the predicate devices. The acceptance criterion is implicitly that these properties are equivalent to the legally marketed predicate devices.

2. Sample Size for the Test Set and Data Provenance

• Test Set Sample Size: No dedicated test set in the traditional sense of a clinical trial for K113049 is described. The performance assessment relies on non-clinical comparative testing against a predicate device (K052493) for physical and chemical properties.
• Data Provenance: The "published research article" cited for the predicate device (K052493) regarding implant success "The healing socket and socket regeneration. Compend Contin Educ Dent. 2008 Mar;29(2):114-6, 118, 120-4" involved One Hundred implants. The country of origin is not specified, but the publication in a dental journal suggests a clinical context. This is retrospective data used to support the established performance of the predicate, which is then extended to the new device through substantial equivalence arguments.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Not applicable. This submission does not involve an expert-adjudicated test set for performance comparison in the context of diagnostic accuracy or clinical outcomes for the new device. The "ground truth" for the non-clinical comparative tests is based on standard laboratory analysis and established material specifications.
• For the clinical outcomes of the predicate device, "The healing socket and socket regeneration" article would have involved clinical experts (dentists/oral surgeons) for patient follow-up, but their specific number or qualifications are not provided in this 510(k) summary.

4. Adjudication Method for the Test Set

• Not applicable. No expert adjudication method is described as the "test set" consists of non-clinical material property comparisons and reference to existing literature for the predicate device.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No. An MRMC comparative effectiveness study was not done as this device does not involve human readers evaluating output (e.g., medical images). It is a bone grafting material and a barrier membrane.

6. Standalone (Algorithm Only) Performance Study

• No. This is not a software or AI-driven device, so standalone algorithm performance is not relevant or reported.

7. Type of Ground Truth Used

• For K113049 comparative testing: Laboratory measurements of chemical and physical properties (trace impurities, particles, Ca/P ratio, pH, volumetric porosity, solubility).
• For supporting the predicate device's clinical performance: Clinical outcomes data from a published study on the predicate device, specifically implant integration and function at 3 years after placement in 100 cases. This relies on established clinical practice and patient outcomes.

8. Sample Size for the Training Set

• Not applicable. There is no training set mentioned, as this is a physical medical device (bone graft and barrier), not a device that uses machine learning or requires data for "training."

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no training set.

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Bone void filler for use in dental extraction sockets

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This document is a 510(k) clearance letter for a medical device called "SOCKET GRAFT", which is a bone void filler for dental extraction sockets. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Medical device clearance letters typically confirm substantial equivalence to a predicate device but do not detail performance studies or acceptance criteria for the device itself.

Therefore, I cannot provide the requested information based on the input document.

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