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Device 300397 Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Device 300397 Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, ilium and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Device 300397 Putty must be used with blood or autogenous bone marrow aspirate and autograff in posterolateral spine.

Device 300397 Putty is an osteoconductive, porous, resorbable bone graft substitute which consists of calcium phosphate granules (a-TCP and hydroxyapatite) and Type I and III porcine collagen. The single-patient, single-use product is supplied in three (3) sizes as a sterile, dry block. When mixed with autogenous bone marrow aspirate, blood or sterile non-pyrogenic saline, the product forms a moldable non-setting putty (net volume: 2.5 cc, 5 cc or 10 cc).

The provided text is a 510(k) Summary for a medical device (Device 300397 Putty), which is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device. This type of submission focuses on comparing a new device to an existing one, rather than presenting a detailed clinical study with acceptance criteria, sample sizes, and ground truth establishment in the way typically seen for a novel diagnostic or AI device.

Therefore, the requested information components related to acceptance criteria, specific study design for proving acceptance criteria for an AI/diagnostic device, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, and standalone performance metrics are not applicable to this document.

This document describes a device approval process based on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety and performance through various tests, primarily non-clinical, not a study designed to meet specific performance metrics against a defined ground truth for a diagnostic outcome.

However, I can extract information regarding the safety and performance studies that were conducted to support the substantial equivalence claim.

Here's a summary based on the provided document, addressing the closest relevant points:

1. Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria in the manner of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implicitly met by successful execution and favorable results of the numerous safety and performance tests to demonstrate substantial equivalence to the predicate device. The "reported device performance" is described qualitatively through these tests.

• Progression in healing vs. time when implanted on decorticated transverse processes in the posterolateral space.
• Further healing at host decorticated transverse process interfaces with new bone formation and active osteoblasts.
• New bone formation directly on the graft material surfaces.
• Confirmed progression and maturation of fusions via histology.
• Bone remodeling and new marrow spaces at the decorticated host transverse process interface, with an association with a reduction in local inflammatory cells. Performance evaluated per FDA guidance for calcium salt bone void fillers. |

2. Sample Size and Data Provenance (for test set for AI/diagnostic devices):

• Not applicable for this 510(k) submission as it's not an AI/diagnostic device.
• For the in vivo animal study, the model used was the NZ White Rabbit Single Level Spinal Fusion Model. The specific number of animals is not provided in this summary. This is a prospective animal model study.

3. Number of Experts and Qualifications (for ground truth for AI/diagnostic devices):

• Not applicable as there is no mention of establishing ground truth by human experts for a diagnostic task.
• The evaluation of the in vivo study results (e.g., histology interpretation, assessment of bone formation) would typically be performed by veterinary pathologists or experts in orthopedics/bone regeneration, but their specific number and qualifications are not detailed in this summary.

4. Adjudication Method (for test set for AI/diagnostic devices):

• Not applicable for this type of device and submission.

5. MRMC Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study for human readers with and without AI assistance was not done, as this is not an AI/diagnostic device.

6. Standalone Performance Study:

• No, a standalone algorithm-only performance study was not done, as this is not an AI/diagnostic device.
• The "standalone" performance for this device is represented by the in vivo animal study where the device's ability to promote bone healing was directly assessed.

7. Type of Ground Truth Used:

• For the in vivo animal study, the "ground truth" for assessing bone healing and tissue reaction was based on histology (microscopic examination of tissue samples) and observation of fusion progression in the animal model. This could be considered similar to "pathology" for human studies, reflecting direct biological evidence of effect.

8. Sample Size for Training Set:

• Not applicable as this is not an AI/machine learning device that requires a training set.

9. How Ground Truth for Training Set Was Established:

• Not applicable as this is not an AI/machine learning device.

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Endoform Dental Membrane is specifically intended for use in extraction sockets and soft tissue grafting. The device contains and prevents migration of guided bone regeneration graft material and prevents loss of alveolar height and ridge following tooth extraction. The device is provided sterile and intended for one-time use.

Endoform Dental Membrane is an ovine derived bioabsorbable extracellular matrix intended for application in dental and periodontal procedures. The device is composed of non-cross linked and non-reconstituted collagen. The device is supplied sterile in a variety of sizes and thicknesses which may be trimmed by a licensed dentist or oral surgeon to meet individual patient needs.

The provided text describes the non-clinical testing performed on the Endoform Dental Membrane to demonstrate its safety and performance. However, it does not include information about acceptance criteria for all the tests, nor does it detail a study that defines "device performance" in terms of clinical or comparative effectiveness against specific criteria in the way you've outlined.

Based on the available text, here's a breakdown of the information that is present, and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document details numerous non-clinical tests. For many, it states that the device "met the pre-defined specification" or "meets the specification," but it often does not explicitly list the numerical acceptance criteria in this summary. The table below compiles the criteria where they are explicitly mentioned.

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

The document describes several non-clinical tests but does not explicitly state the specific numerical sample sizes for each test set. It mentions "All EDM devices" or "all samples" in some contexts.

For the Animal Performance Testing:

• Sample Size (Test Set): Not explicitly stated how many animals were used, but it was an ovine (sheep) defect model study using "selected timepoints (week 4, 8 and 16)".
• Data Provenance: Prospective animal study conducted in an ovine (sheep) defect model. The country of origin is not specified, but the applicant's address is New Zealand.

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

This information is not provided in the document. The non-clinical tests described rely on validated laboratory methods and specifications, which are based on scientific standards rather than expert consensus on a test set in the way clinical diagnostic devices might.

For the animal study, the assessment criteria (resorption, cellular infiltration, inflammatory response, retention of bone grafting material, hard tissue infill) would likely be evaluated by veterinarians or pathologists, but the number and qualifications of these experts are not mentioned.

4. Adjudication Method for the Test Set

This information is not provided as the document focuses on laboratory and animal study results rather than human-read test sets.

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

No. A MRMC comparative effectiveness study was not performed or described. The document explicitly states: "Clinical data was not required to demonstrate substantial equivalence."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a bioabsorbable extracellular matrix (Endoform Dental Membrane), not an AI algorithm. Therefore, "standalone algorithm" performance is not relevant.

7. Type of Ground Truth Used

The "ground truth" for the various tests conducted for the Endoform Dental Membrane is based on:

• Validated Test Methods: For biochemical content (collagen, GAG, DNA), physical properties (moisture, DSC, permeability, suture retention, modulus, thickness), residual substances (Tx-100, EDTA, PAA), bioburden, endotoxin, and shelf-life. These are quantitative measurements against predefined specifications.
• Standards Compliance: For biocompatibility (ISO 10993 series), sterilization (ISO 11135), and packaging (ASTM standards).
• Histopathological and Macroscopic Assessment: For the animal performance study, evaluating resorption, cellular infiltration, inflammatory response, and bone graft retention based on examinations at specific time points. This likely involves expert evaluation of tissue samples, but it's not "expert consensus" on a diagnostic task, rather assessment of biological outcomes compared to a reference device.
• "Critically sized" defects: The animal study also demonstrated that untreated controls did not completely regenerate bone, indicating the defects were appropriately sized for evaluating the device's performance.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI algorithm. Therefore, there is no "training set."

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

Not applicable. As above, there is no training set for this type of device.

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The Nexo-Gide™ Bilayer Collagen Membrane is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

The Geistlich Nexo-Gide™ device, manufactured by Geistlich Pharma AG, is a resorbable collagen membrane of porcine origin, consisting of a compact smooth structure and of a porous structure that serves as an interface between the tendon and the surrounding tissues. Nexo-Gide™ Bilayer Collagen Membrane will be used as a tendon protector sheet that provides a nonconstricting, protective encasement for injured tendon, in the same manner as other tendon cover products like the predicate device TenoGlide (K053655, Integra Life Science).

The Nexo-Gide membrane is made of collagen type I and III without further cross-linking or chemical additives and is sterilized by gamma irradiation. The available sizes are 20x30mm, 30x40mm and 40x50 mm.

The provided text describes a medical device called Nexo-Gide™ Bilayer Collagen Membrane and its substantial equivalence determination to a predicate device, Tendon Wrap Tendon Protector (TenoGlide). However, the document does not describe a study involving an AI or algorithmic device that requires the detailed acceptance criteria and study information typically associated with such submissions (e.g., sample size, expert ground truth, MRMC study, training set details).

This document is a 510(k) summary for a physical medical device (a collagen membrane), not an AI/algorithm-based diagnostic or assistive device. Therefore, the questions related to AI/algorithm performance metrics, ground truth establishment by experts, MRMC studies, training set sizes, and data provenance in the context of an algorithm are not applicable to this submission.

The "Performance Data" section (Page 8-9) details bench testing and animal studies conducted to demonstrate that the Nexo-Gide membrane is substantially equivalent to its predicate.

Here's an attempt to extract relevant information from the provided text, while acknowledging that many of your questions are not applicable due to the nature of the device:

Device: Nexo-Gide™ Bilayer Collagen Membrane (a physical collagen membrane)

Purpose of Study/Submission: To demonstrate substantial equivalence to a predicate device (Tendon Wrap Tendon Protector) for the management and protection of tendon injuries.

Key Findings: The studies concluded that Nexo-Gide™ is substantially equivalent to the predicate device in terms of safety and effectiveness, despite differences in tissue source (porcine vs. bovine) and composition (Type I and III collagen vs. cross-linked Type I collagen and GAG).

1. Table of Acceptance Criteria and Reported Device Performance

The document describes pre-determined acceptance criteria for various bench tests and animal study outcomes, indicating that the device "passed" or "met all acceptance criteria" and demonstrated "similar performance." Specific numeric acceptance criteria are provided for mechanical properties.

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