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PRO OSTEON® 500R Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. PRO OSTEON® 500R is indicated to be gently packed into bony volds or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PRO OSTEON® 500R can be combined with autogenous bone marrow aspirate, autogenous blood, and/or sterile fluids (saline or Ringer's solution). The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Pro Osteon® 500R Resorbable Bone Graft Substitute is an osteoconductive porous implant similar in structure to human cancellous bone. It is supplied sterile in various shapes and sizes.

When Pro Osteon® 500R is placed in direct contact with viable bone, the reticulated spaces in the implant are infiltrated with tissue. Bone formation occurs in apposition to the Pro Osteon® 500R surface and within the interstices of the implant skeleton. As the implant resorbs, bone and soft tissue grow into the space previously occupied by the implant.

Here's an analysis of the provided information regarding the Pro Osteon® 500R device:

This 510(k) summary does not include any acceptance criteria or studies proving the device meets them in the way you've outlined. Instead, it demonstrates substantial equivalence to previously marketed predicate devices. This is a crucial distinction in medical device regulation.

Here's a breakdown based on your criteria, highlighting what's not present in this document:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This document does not present specific acceptance criteria (e.g., a detection accuracy threshold, a false positive rate limit) or the results of a study designed to meet those criteria. The submission is based on substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No "test set" in the context of an algorithm or diagnostic device performance evaluation is described.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. There's no mention of experts establishing ground truth for a test set, as this is a bone graft substitute, not a diagnostic device requiring expert interpretation of results.

4. Adjudication Method

Not applicable. No adjudication method is described.

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

No. This document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." An MRMC study would be a type of clinical testing.

6. Standalone (Algorithm Only) Performance Study

No. This device is a physical bone graft substitute, not an algorithm.

7. Type of Ground Truth Used

Not applicable. For a bone graft substitute, the "ground truth" would typically relate to biological outcomes (e.g., bone healing, resorption rate, integration), which would be assessed through preclinical (animal) or clinical studies. This submission specifically states "Non-clinical laboratory testing was previously performed to determine substantial equivalence. The results indicated that the device was functional within its intended use," but details of this testing are not provided. It also states "Clinical Testing: None provided as a basis for substantial equivalence."

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a "training set."

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

Not applicable.

Summary of the K063346 Submission:

This 510(k) premarket notification for Pro Osteon® 500R seeks to demonstrate substantial equivalence to existing legally marketed predicate devices. The basis for this equivalence is primarily:

• Technological Characteristics: The manufacturer states that the materials, design, sizes, and indications of Pro Osteon® 500R are "similar to or identical to that of the predicate devices."
• Non-Clinical Testing: Limited non-clinical laboratory testing was previously performed to support the "functional within its intended use" claim, likely comparing its physical and chemical properties to the predicates, but detailed results are not provided in this summary.
• Absence of Clinical Data: The submission explicitly states that no clinical testing was provided as a basis for substantial equivalence.

The FDA's review letter confirms that based on the information provided, the device is found substantially equivalent to the predicate devices and can be marketed. This is a common pathway for many medical devices, particularly those with a clear predicate and incremental changes, or in device categories where extensive new clinical trials are not deemed necessary for substantial equivalence.

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