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ALLOMATRIX® Custom is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. AI.LOMATRIX® Custom is intended to be gently packed into bony voids or gaps of the skeletal system as a bone graft extender (spine) and as a bone void filler in the extremitics and pclvis. These defects may be surginally created osseous defects or osseous defects created from traumatic injury to the bone.

ALLOMATRIX® Custom Putty is provided in the form of a kit with a premeasured powder and CBM chips, premeasured mixing solution, and the tools necessary to mix the components. After the powder is hydrated using all the mixing solution supplied in the kit (or BMA and local bone when used in the spine), the resultant putty cappthen he handled and placed in the appropriate bone voids. This product is supplied sterile for single patient use.

The provided text describes a 510(k) summary for the ALLOMATRIX® Custom Putty, a bone void filler. The submission focuses on demonstrating substantial equivalence to a predicate device and does not involve AI or a diagnostic device. Therefore, many of the requested categories are not applicable.

Here's the breakdown based on the provided information:

Acceptance Criteria and Device Performance for ALLOMATRIX® Custom Putty

This submission is for a modification to a component of an existing device (ALLOMATRIX® Custom Putty) and focuses on demonstrating substantial equivalence, not on specific performance metrics or diagnostic accuracy as would be typical for an AI application. The "acceptance criteria" here relate to the successful verification that the modification has the desired effect and no unintended adverse effects, primarily through demonstrating substantial equivalence to a predicate device, and the "device performance" is based on these demonstrations.

• In vitro surrogate cell-based assay: Measures proliferation of Saos human osteosarcoma cells (osteoiniductivity index), correlated to athymic rat model and clinical results of DBM alone.
• In vitro immunoassay: Assays for native protein (BMP-2), correlated to athymic rat model for DBM alone and ALLOMATRIX® Putty.
  Note: The combination of DBM, CBM, and binding medium has not been evaluated for osteoinductivity, and correlation with human clinical performance is unknown. |
  | Viral Inactivation Validation | Processing method for DBM evaluated for viral inactivation potential using a panel of model human viruses.
  Results: Demonstrated suitable viral inactivation potential for a wide spectrum of potential human viruses. |

Non-Applicable Sections and Explanations:

The following sections are not applicable to this 510(k) summary because the device is a bone void filler, not an AI-powered diagnostic tool, and the submission is focused on demonstrating substantial equivalence for a component modification:

1. Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context would refer to the data used to evaluate AI performance. Here, testing involved a literature search, bench testing, and a canine study. Specific sample sizes for bench testing and the canine study are not detailed in this summary.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a test set requiring expert ground truth in the context of diagnostic device validation. The "ground truth" for the osteoinductivity bioassay refers to correlation with athymic rat models and clinical results of DBM alone, not expert consensus on medical images or patient outcomes.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No such adjudication method is relevant to the type of testing described (bench, canine, in vitro assays).
4. 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 is not an AI-assisted diagnostic device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the osteoinductivity potential, the "ground truth" for the DBM bioassay/immunoassay was correlated with results from an athymic rat model and, in one instance, with clinical results of DBM alone. This is not "expert consensus" or "pathology" in the typical diagnostic sense. For viral inactivation, the "ground truth" would be the demonstrated inactivation of specific model viruses.
7. The sample size for the training set: Not applicable. There is no AI algorithm being trained.
8. How the ground truth for the training set was established: Not applicable. There is no AI algorithm being trained.

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ALLOMATRIX® Custom is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. ALLOMATRIX® Custom is intended to be gently packed into bony voids or gaps of the skeletal system as a bone graft extender (spine) and as a bone void filler in the extremities and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

ALLOMATRIX® Custom Putty is provided in the form of a kit with a premeasured powder and CBM chips, premeasured mixing solution, and the tools necessary to mix the components. After the powder is hydrated using all the mixing solution supplied in the kit (or BMA and local bone when used in the spine), the resultant putty can then be handled and placed in the appropriate bone voids. This product is supplied sterile for single patient use.

The provided text describes a medical device, ALLOMATRIX® Custom Putty, and its substantial equivalence to predicate devices, but not a study that establishes acceptance criteria and proves the device meets those criteria in the way typically associated with AI/software devices (e.g., performance metrics like sensitivity, specificity, AUC).

Instead, the document focuses on:

• Substantial Equivalence: The primary assertion is that ALLOMATRIX® Custom Putty is substantially equivalent to predicate devices.
• Osteoinductivity Potential: This is assessed via in vitro bioassays or immunoassays for the Demineralized Bone Matrix (DBM) component, correlating results to athymic rat models and clinical results of DBM alone.
• Viral Inactivation Validation: The processing method for DBM and CBM is evaluated for its ability to inactivate viruses.
• Product Performance Testing (Clinical): Clinical performance involved a comparison of radiographic outcomes, subjective questionnaires (SF-36, Oswestry, VAS), and adverse events between the subject device (mixed with BMA and local bone) and autograft iliac crest bone for lumbosacral fusion. This study "demonstrated equivalency."

Therefore, I cannot populate the table and answer all the questions directly, as the nature of the evaluation presented is for a physical medical device (bone void filler) and not a software/AI device. There are no "acceptance criteria" in terms of performance metrics like sensitivity/specificity, nor an "AI algorithm" involved.

However, I can extract the relevant information regarding the clinical performance study for the physical device based on the provided text:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: Not explicitly stated for the clinical performance study. "[A] comparison of radiographic outcomes... compared to autograft iliac crest bone" implies a clinical trial with a patient cohort, but the text does not give the number of patients.
• Data Provenance: The document does not specify the country of origin. The study is a "clinical performance" evaluation, suggesting it is prospective (a clinical trial), but it is not explicitly called out as such.

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

• This concept (experts establishing ground truth for a test set) is not applicable to this physical device evaluation. Radiographic outcomes would have been interpreted by clinicians as part of standard medical practice for the clinical trial endpoints.

4. Adjudication method for the test set:

• Not applicable in the context of this device evaluation. Clinical trial endpoints would typically have pre-defined criteria for assessment.

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 is not an AI/software device. The clinical study compared the device to autograft, not human readers with or without AI assistance.

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

• Not applicable. This is not an AI/algorithm.

7. The type of ground truth used:

• For the clinical performance study, the "ground truth" would be clinical outcomes data (radiographic fusion scores, patient-reported outcomes like SF-36, Oswestry, VAS) and adverse event profiles, measured during the clinical evaluation in comparison to a predicate treatment (autograft iliac crest bone).
• For osteoinductivity, the "ground truth" for correlation was results from athymic rat models and clinical results of DBM alone as referenced in the provided studies.
• For viral inactivation, the "ground truth" involved demonstrating inactivation of model potential human viruses.

8. The sample size for the training set:

• Not applicable. This is not a machine learning/AI device requiring a training set.

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

• Not applicable.

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ALLOMATRIX® C Putty, ALLOMATRIX® Custom Putty and ALLOMATRIX® DR Putty Products are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. ALLOMATRIX® C, ALLOMATRIX® Custom and ALLOMATRIX® DR Putty Products are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

ALLOMATRIX® C, ALLOMATRIX® Custom and ALLOMATRIX® DR Putty Products come in the form of a kit with a premeasured powder and CBM chips, premeasured mixing solution, and the tools necessary to mix the components. After the powder is hydrated using all the mixing solution supplied in the kit, the resultant putty can then be handled and placed in the appropriate bone voids. This product is supplied sterile for single patient use.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ALLOMATRIX® Putty products, organized according to your requested information.

It's important to note that this 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria against a specific benchmark. Therefore, some of your requested points, particularly those related to quantitative performance metrics for AI/human reader studies, are not directly applicable or available in this type of submission.

Acceptance Criteria and Reported Device Performance

Study Details (Where Applicable and Provided)

1. Sample size used for the test set and the data provenance:

   • Osteoinductivity Bioassay:

     • Test Set: 101 donor lots for the correlation study with athymic rat model.
     • Provenance: Not explicitly stated, but implied to be human DBM samples. The correlation study references Lindholm TS, Urist MR. A quantitative analysis of new bone formation by induction in compositive 2 grafts of bone marrow and bone matrix, Clin Orthop 1980 Jul-Aug;(150):288-300. for the rat model, and Wilkins, R.M. (1999) Clinical Effectiveness of Demineralized Bone Matrix Assayed in Human Cell l Culture, Advances in Tissue Banking. 3:113-124 for the clinical correlation, suggesting diverse data sources.
     • Retrospective/Prospective: The correlation studies appear to be retrospective analyses of DBM lots. The statement "Each lot of DBM...is evaluated in vitro" implies prospective testing for quality control of the DBM component used in the putties.

   • Clinical Performance (Radiographic/Adverse Events):

     • Test Set: Not explicitly stated how many patients or cases were evaluated for the comparison to predicate devices, but described as "a comparison of radiographic outcomes and the adverse event profiles."
     • Provenance: Not specified (e.g., country of origin, retrospective/prospective). This comparison would typically be based on existing clinical data or published literature related to the predicate devices and the new device's preliminary clinical observations.

   • Canine Model:

     • Test Set: Not specified how many canines were used.
     • Provenance: Not specified (source of animals, experimental design).

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

   • Osteoinductivity Bioassay: Ground truth for osteoinductivity relies on the definition provided: "The product is considered osteoinductive if one specimen (explant) contains new bone (i.e. bone occupied with lamellae), cartilage, and/or chondrocytes." This implies histological evaluation, which would typically be performed by trained histologists or pathologists. The number is not specified.

   • Clinical Performance (Radiographic): For "radiographic outcomes," ground truth would typically be established by radiologists or orthopedic surgeons. The number and qualifications are not specified.

   • Canine Model: Histological evaluation would be performed by experts (e.g., veterinary pathologists/histologists). Number and qualifications are not specified.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not specified for any of the studies mentioned.

4. 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:

   • No MRMC comparative effectiveness study was done. This product is a bone void filler, not an AI or imaging diagnostic device.

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

   • Not applicable. This is not an algorithmic device.

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

   • Osteoinductivity: Primarily pathology/histology (for the athymic rat model, defined by the presence of new bone, cartilage, or chondrocytes) and in vitro bioassay results correlated with clinical healing.
   • Viral Inactivation: Laboratory testing (measuring viral reduction factors for model viruses).
   • Clinical Performance: Radiographic outcomes (interpreted by clinicians) and adverse event profiles (clinical outcomes data).
   • Canine Model: Radiography and histology (pathology).

7. The sample size for the training set:

   • Osteoinductivity Bioassay: No specific "training set" in the machine learning sense is described. The bioassay was correlated with clinical results from Wilkins (1999) and Lindholm & Urist (1980), which would represent datasets used to establish the validity and predictive power of the bioassay. The size of these historical datasets is not specified in detail beyond the 101 donor lots used for the correlation study.
   • Other studies: Not applicable as these are not machine learning models.

8. How the ground truth for the training set was established:

   • Osteoinductivity Bioassay: The ground truth for the bioassay's predictive capability was established through:
     • Pathology/Histology: For the athymic rat model, where bone formation was histologically confirmed and defined.
     • Clinical Outcomes Data: For the clinical correlation mentioned by Wilkins (1999), where radiographic healing for DBM alone was assessed and linked to the bioassay index. This would involve assessment by qualified medical professionals (e.g., radiologists, orthopedic surgeons) interpreting patient radiographs.

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