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Temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

The Progenix Select Stim (Model: PRO1205-OTC1) device is a portable, battery powered (9 V battery) two channel device designed to provide Transcutaneous Electrical Nerve Stimulation (TENS) for the purpose of the symptomatic relief of pain.

The device consists of the TENS stimulator, two lead wires and set of four Skin Electrodes. It provides 10 preset TENS treatment programmes. The programs include four modes of operation: Conventional TENS(Continuous), Burst Mode, Modulation mode and HAN TENS. The device LCD screen shows the information of program, intensity level of each channel and operating time.

The electrode pads are cleared by FDA (510(k) number K160138). They are used as an accessory to the TENS device unit, to transmit electrical current to patient skin. The electrodes consist of biocompatible self-adhesive conductive application use. These electrodes are sized 50x50mm and are sold under the model number PRO5050.

The provided FDA 510(k) clearance letter for the Progenix Select Stim (K242460) is for a Transcutaneous Electrical Nerve Stimulator (TENS) device. Based on the document, this device is cleared as substantially equivalent to a predicate device (HIVOX OTC Electrical Stimulator, K190347).

It is crucial to understand that a 510(k) clearance, especially for devices like TENS units, primarily relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than requiring extensive de novo clinical trials or complex AI performance studies. The provided document explicitly states under "9. Clinical Performance Data" that it is "Not applicable." This means the clearance was granted based on non-clinical (bench) testing demonstrating that the device performs similarly to the predicate and meets relevant safety standards.

Therefore, the request to describe "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) is not directly applicable to this specific device and clearance. The device is a TENS unit, not an AI/ML-driven diagnostic or interpretative system.

However, I can extract and structure the information related to the device's performance relative to its substantial equivalence claim and the non-clinical testing performed, which serves as its "proof of meeting acceptance criteria" in this context.

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

Acceptance Criteria and Study that Proves the Device Meets the Acceptance Criteria (for a TENS Device)

For the Progenix Select Stim (K242460), the "acceptance criteria" are primarily defined by its substantial equivalence to the predicate device and compliance with applicable voluntary safety standards. The "study that proves the device meets the acceptance criteria" refers to the non-clinical (bench) testing performed to demonstrate this equivalence and safety.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is not an AI/ML device, the "performance" is about meeting electrical and mechanical specifications, and adherence to safety standards, rather than diagnostic accuracy metrics. The table below summarizes key comparative parameters that demonstrate substantial equivalence, which serve as "acceptance criteria" for the device's design and function.

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PROGENIX® Plus is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure (i.e. spine, pelvis and extremities). The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PROGENIX® Plus provides a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. The device may either be use alone or mixed with autograft bone and used as a bone graft extender.

PROGENIX® contains human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. PROGENIX® is available in two versions: Putty and Plus. PROGENIX® Plus is a putty containing two different sized demineralized bone particles. PROGENIX® is a single use product intended for use as a bone graft substitute. bone graft extender and bone void filler in bony voids or gaps of the skeletal system (i.e. spine, pelvis and extremities) not intrinsic to the stability of the bony structure. Additionally, this product is not designed to impart any mechanical strength to the surgical site. PROGENIX® is provided in ready-to-use malleable forms that may be molded or manipulated by the surgeon into various shapes. This product has been shown to be osteoconductive as well as osteoinductive in an athymic rat assay, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing.

This is a 510(k) premarket notification for a medical device called PROGENIX® Plus, a bone void filler. This document is not a study report or clinical trial. It is a regulatory submission to the FDA to demonstrate substantial equivalence to a predicate device.

Therefore, the requested information about acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone AI performance, and training set details are not applicable in this context.

Instead, the document focuses on demonstrating that PROGENIX® Plus is substantially equivalent to previously cleared devices based on its composition, intended use, and pre-clinical testing, primarily in an athymic rat assay for osteoinductivity and viral inactivation studies.

Here's a breakdown of what is available in the document related to some of your points:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria (Implicit for Substantial Equivalence):

  • Osteoinductivity: "All DBM used in the preparation of PROGENIX® Plus must induce bone formation when evaluated in a validated athymic nude rat assay. Additionally, PROGENIX® must also induce bone formation in this assay system prior to being released for use." (Page 2)
  • Histologic evidence: "The raw material and final product screening must show histologic evidence of osteoinduction through the presence of osteoblasts, chrondoblasts and/or woven bone." (Page 2)
  • Viral Inactivation: Processing steps must be "validated to inactivate a panel of viruses representative of those that are clinically relevant." (Page 2)
  • Intended Use, Technology, Performance: Demonstrate equivalence to predicate devices (PROGENIX® DBM Putty and GRAFTON® DBM Crunch) in terms of intended use, technological characteristics, and performance characteristics (as supported by pre-clinical data).

• Reported Device Performance (as stated in the document):

  • Osteoinductivity: "This product has been shown to be osteoconductive as well as osteoinductive in an athymic rat assay, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing." (Page 1) and "Osteoinduction assay results using the athymic rat assay should not be interpreted to predict clinical performance in human subjects." (Page 2)
  • Viral Inactivation: "The viral inactivation testing demonstrates suitable viral inactivation potential of the processing methods for a wide range of potential human viruses." (Page 2)

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

• Not applicable for clinical studies. This document refers to an "athymic nude rat assay" for osteoinductivity. The sample size for this assay is not provided, nor is the provenance of data as it's a pre-clinical, lab-based assay.

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

• Not applicable. This relates to clinical studies with expert reviewers, which is not the nature of this document.

4. Adjudication method for the test set:

• Not applicable. This relates to clinical studies with expert reviewers, which is not the nature of this document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not done. This is a regulatory submission based on substantial equivalence, not a clinical effectiveness trial in human subjects. The document explicitly states: "Osteoinduction assay results using the athymic rat assay should not be interpreted to predict clinical performance in human subjects." (Page 2)

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

• Not applicable. This is not an AI/algorithm-based device. It is a biological product (bone graft substitute).

7. The type of ground truth used:

• Pre-clinical animal model (athymic rat assay) for osteoinduction: Histologic evidence (presence of osteoblasts, chondroblasts, and/or woven bone) was used to assess osteoinductivity.
• Laboratory-validated viral inactivation studies for viral safety.

8. The sample size for the training set:

• Not applicable. This refers to AI/machine learning models, which is not relevant to this device.

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

• Not applicable. This refers to AI/machine learning models.

In summary: The provided document is a 510(k) summary demonstrating substantial equivalence for a bone graft substitute, relying on pre-clinical animal and lab testing to support claims of osteoinductivity and viral inactivation. It does not involve clinical studies with human subjects, AI models, or the associated methodologies for evaluating such technologies.

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PROGENIX® DBM Putty and PROGENIX® Plus may be used alone or in combination with autograft bone and/or autogenous bone marrow for use as a bone graft extender. substitute, and bone void filler in bony voids or gaps, not intrinsic to the stability of the bony structure, of the cranial, oral and maxillofacial region. The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PROGENIX® DBM Putty and PROGENIX® Plus provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process.

PROGENIX® DBM Putty and PROGENIX® Plus are intended to be used alone or in combination with autogenous bone and/ or bone marrow aspirate for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of cranial oral maxillofacial and dental intraosseous defects including but not limited to:

Ridge augmentation Filling of cystic defect Filling of extraction sites Filling of lesions of periodontal origin Craniofacial augmentation Filling of defects of endodontic origin Mandibular reconstruction Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture

Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.

The PROGENIX® products contain human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. PROGENIX® is available in two versions: Putty and Plus. The PROGENIX® Plus version contains two different sized demineralized bone particles.

PROGENIX® DBM Putty and PROGENIX® Plus are single use products intended for use in the oralmaxillofacial region. Additionally, these products are not designed to impart any mechanical strength to the surgical site. Both versions are provided in readyto-use malleable forms that may be molded or manipulated by the surgeon into various shapes. These products have been shown to be osteoinductive in an athymic rat assay. as well as osteoconductive, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing.

The provided text is a 510(k) summary for the Medtronic Sofamor Danek PROGENIX® device. It describes the product, its intended use, and its substantial equivalence to previously cleared devices. However, this document does not contain the kind of information requested regarding acceptance criteria and studies that prove the device meets those criteria, especially in the context of device performance metrics like sensitivity, specificity, etc.

The 510(k) process for devices like PROGENIX® (a bone void filler) typically relies on demonstrating substantial equivalence to a predicate device based on similar materials, intended use, technological characteristics, and performance data (which often includes biocompatibility, mechanical properties, and osteoinductivity/osteoconductivity in animal models). It usually does not involve "acceptance criteria" in the sense of predictive algorithm performance (e.g., sensitivity, specificity) against a ground truth, as might be found for AI/ML-driven diagnostic or image analysis devices.

Therefore, I cannot populate the requested table and answer the questions based on the provided text. The document focuses on regulatory approval based on demonstrating equivalence, not on a detailed clinical performance study with acceptance criteria for statistical metrics.

Here's why the information isn't available in the provided text:

• Type of Device: PROGENIX® is a medical device (bone void filler) composed of human demineralized bone matrix (DBM) and a biocompatible carrier. It's a biological/material product, not a software algorithm or diagnostic tool that would typically have performance metrics like sensitivity, specificity, or rely on human expert consensus for "ground truth" in the way an AI diagnostic device would.
• 510(k) Process for this device: The 510(k) summary confirms "substantial equivalence" to previously cleared predicate devices (other DBM products). This means the FDA determined the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. This determination relies on demonstrating similar intended use, technological characteristics, and performance data (e.g., osteoinductivity in rats, osteoconductivity, resorption rate). It does not typically involve human reader studies or comparison to an AI algorithm.
• Missing Information: The document does not discuss:
  • Specific quantitative acceptance criteria (e.g., statistical thresholds for performance).
  • Clinical studies designed to measure such criteria in humans (beyond showing it is resorbed and replaced by host bone).
  • Test sets, training sets, data provenance, expert ground truth establishment, or multi-reader multi-case studies. These are concepts relevant to AI/ML or diagnostic device evaluations, not directly to a bone graft material's regulatory submission as presented here.

In summary, the provided document is a regulatory clearance for a medical device (bone void filler) based on substantial equivalence, not a clinical study report for an AI/ML or diagnostic device with performance metrics and acceptance criteria as outlined in your request.

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PROGENIX® DBM Putty and PROGENIX® Plus are intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects including but not limited to:

Ridge augmentation

Filling of cystic defect

Filling of extraction sites

Filling of lesions of periodontal origin

Craniofacial augmentation

Filling of defects of endodontic origin

Mandibular reconstruction

Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture

Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.

PROGENIX® contains human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. PROGENIX® is available in two forms: Putty and Plus. The PROGENIX® Plus version contains two different sized demineralized bone particles.

PROGENIX® DBM Putty and PROGENIX® Plus are single use products intended for use in the oralmaxillofacial region. Additionally, these products are not designed to impart any mechanical strength to the surgical site. Both versions are provided in ready-to-use malleable forms that may be molded or manipulated by the surgeon into various shapes. These products have been shown to be osteoinductive in an athymic rat assay, as well as osteoconductive, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing.

The provided text is a 510(k) summary for a medical device called PROGENIX® Plus, a resorbable calcium salt bone void filler device. It is a Special 510(k) for a device modification, seeking to include a new formulation to an already cleared product line. The primary goal is to demonstrate substantial equivalence to predicate devices, not necessarily to prove a specific level of performance against quantitative acceptance criteria through a clinical study.

Therefore, the information typically requested in your template (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, specific ground truth types) is largely not applicable in this context, as a clinical study with such detailed parameters was not conducted or required for this type of submission.

Instead, the "acceptance criteria" and "study" are focused on demonstrating the osteoinductive potential and viral inactivation effectiveness of the product, primarily through non-clinical testing, and showing substantial equivalence to existing devices.

Here's a breakdown based on the available information:

Acceptance Criteria and Reported Device Performance

Study Details

Given the nature of a 510(k) for a bone void filler, the "studies" refer to non-clinical tests rather than human clinical trials involving extensive statistical analysis of human performance.

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

   • Osteoinductivity Assay: The sample size would refer to the number of athymic nude rats used in the in vivo assay. This information is not provided in the summary.
   • Viral Inactivation: Not applicable in terms of a "test set" like a clinical study. It refers to in vitro validation studies on the manufacturing process.
   • Data Provenance: Not explicitly stated, but typically these non-clinical studies are conducted in a controlled laboratory environment (e.g., manufacturer's labs or contract research organizations), likely in the country of manufacture (USA for Medtronic Sofamor Danek). All data would be prospective for the purpose of validating the new formulation.

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

   • Osteoinductivity Assay: The "ground truth" for osteoinductivity would be established by histopathological evaluation of the rat tissue. The number and qualifications of the pathologists or histologists performing this evaluation are not provided.
   • Viral Inactivation: The ground truth is based on established virology assays to quantify viral reduction. The experts would be virologists and microbiologists within the testing facility. This information is not provided.

3. Adjudication method for the test set:

   • Osteoinductivity Assay: Adjudication methods for histological evaluation (e.g., multiple pathologists reviewing slides) are not specified. Standard practice may involve independent review, but it's not detailed here.
   • Viral Inactivation: Not applicable.

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 device is a bone void filler, not an AI-powered diagnostic imaging device.

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

   • Not applicable. This is a physical medical device.

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

   • Osteoinductivity: Histopathology (microscopic examination of tissue samples for the presence of osteoblasts, chondroblasts, and woven bone).
   • Viral Inactivation: Quantitative virology assays (measuring reduction in viral titers).

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device requiring a training set in that sense. The "training" for the product refers to the development and manufacturing processes.

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

   • Not applicable. As above, it is not an AI/ML device.

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PROGENIX™ DBM Putty is intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects including but not limited to:

Ridge augmentation
Filling of cystic defect
Filling of extraction sites
Filling of lesions of periodontal origin
Craniofacial augmentation
Filling of defects of endodontic origin
Mandibular reconstruction
Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture
Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.

PROGENIX™ DBM Putty contains human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. All DBM used in the preparation of PROGENIX™ DBM Putty must induce bone formation when evaluated in a validated athymic nude rat assay. Although, findings from an animal model are not necessarily predictive of human clinical results.

PROGENIX™ DBM Putty is a single use product intended for use in the oralmaxillofacial region. Additionally, this product is not designed to impart any mechanical strength to the surgical site. PROGENIX™ DBM Putty is provided in ready-to-use malleable forms that may be molded or manipulated by the surgeon into various shapes. This product has been shown to be osteoconductive as well as osteoinductive in an athymic rat assay, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing

The provided text is a 510(k) premarket notification for a medical device called PROGENIX™ DBM Putty. This document focuses on demonstrating substantial equivalence to existing devices rather than presenting a study of the device's performance against specific acceptance criteria in a clinical setting.

Therefore, many of the requested sections about explicit acceptance criteria, detailed study design, and performance metrics are not directly found in the provided text. The submission is a regulatory filing for market clearance, not typically a detailed report on clinical trial outcomes with specific statistical thresholds.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission for a bone void filler, the "acceptance criteria" are primarily related to substantial equivalence to predicate devices and demonstrating the device's ability to induce bone formation and be osteoconductive. No specific numerical performance metrics are provided in the context of clinical acceptance criteria.

The key "performance" mentioned is in an animal model:

Study Details (Based on available information)

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

   • The primary "test set" described for performance is an athymic nude rat assay. The exact number of animals (sample size) is not specified in this document.
   • Data Provenance: Animal model data (athymic nude rat assay). The location of the assay or the origin of the facility is not stated, but it's part of the product development for a US company. This would be considered prospective data generation for the purpose of demonstrating device characteristics.

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

   • Not applicable in the context of this animal model. The "ground truth" for the animal assay (e.g., presence/absence of bone formation, rate of resorption) would be determined by standard histological and imaging analyses conducted by trained veterinary pathologists or researchers, but specific details about their number or qualifications are not provided as it's a foundational biological assay.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for human clinical assessments or image interpretation where expert agreement is needed to establish a "ground truth" diagnosis. This document references an animal assay where outcomes are generally assessed objectively through histological examination.

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 a bone void filler product, not an AI-powered diagnostic device, so MRMC studies involving human readers and AI assistance are not relevant.

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

   • Not applicable. This device is a bone void filler, not an algorithm. Performance is evaluated on its biological effects (osteoinduction, osteoconduction, resorption) within a biological system.

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

   • For the animal assay, the ground truth for osteoinduction, osteoconduction, and resorption rate would be established through histopathology (microscopic examination of tissue samples) and potentially imaging techniques appropriate for small animal models.

7. The sample size for the training set:

   • Not applicable. This product is a physical bone void filler, not a machine learning model, so there is no "training set" in the context of AI.

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

   • Not applicable for the reason stated in point 7.

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PROGENIX™ DBM Putty is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure (i.e. spine, pelvis and extremities). The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PROGENIX™ DBM Putty provides a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. When used in the extremeties or pelvis, the device is used by itself. When used in the spine, the device must be mixed with autograft bone and used as a bone graft extender.

PROGENIX™ DBM Putty contains human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. PROGENIX™ DBM Putty is a single use product intended for use as a bone graft substitute, bone graft extender, and bone void filler in bony voids or gaps of the skeletal system (i.e. spine, pelvis and extremities) not intrinsic to the stability of the bony structure. Additionally, this product is not designed to impart any mechanical strength to the surgical site. PROGENIX™ DBM Putty is provided in ready-to-use malleable forms that may be molded or manipulated by the surgeon into various shapes. This product has been shown to be osteoconductive as well as osteoinductive in an athymic rat assay, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing.

Acceptance Criteria and Device Performance for Medtronic Sofamor Danek PROGENIX™ DBM Putty

This document describes the acceptance criteria and the study used to demonstrate the performance of the PROGENIX™ DBM Putty, as outlined in the provided 510(k) summary (K072265).

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the expanded indication of PROGENIX™ DBM Putty (use as a bone graft extender in spinal fusion procedures) were based on demonstrating its effectiveness in producing spinal fusion.

2. Study Design and Data Provenance

The study that demonstrated the expanded indication for PROGENIX™ DBM Putty was a rabbit study.

• Sample Size: Not explicitly stated in the provided text, but the study was conducted on a sufficient number of rabbits to "suggest that PROGENIX™ DBM Putty is effective."
• Data Provenance: The study was conducted in a pre-clinical animal model (rabbit). No country of origin is specified for the study location. The study is prospective as it evaluates the device's performance in a controlled environment.

3. Number of Experts and Qualifications for Ground Truth

The provided text does not specify the number of experts used or their qualifications for establishing the ground truth of the rabbit study. However, the assessment of spinal fusion (radiographic and manual palpation) would typically involve trained veterinary radiologists and/or surgeons.

4. Adjudication Method

The adjudication method used for the rabbit study is not explicitly stated. However, given the nature of radiographic assessment and manual palpation, it is likely that the evaluation was performed by one or more trained individuals.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed as this is a pre-clinical animal study for a bone graft substitute, not a diagnostic imaging device.

6. Standalone Performance (Algorithm Only)

Not applicable. This device is a bone graft substitute, not an algorithm or software. Its performance is assessed through biological outcomes in vivo.

7. Type of Ground Truth Used

The ground truth used in the rabbit study was based on direct observation and objective assessments of fusion in an animal model:

• Radiographic criteria: Imaging evidence of spinal fusion.
• Manual palpation criteria: Physical assessment of spinal fusion.

8. Sample Size for the Training Set

Not applicable. This is a biological device, not an AI/ML algorithm that requires a training set. The "study" refers to the pre-clinical validation for the expanded indication.

9. How Ground Truth for Training Set Was Established

Not applicable. See point 8.

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PROGENIX™ DBM Putty is intended for use as a bone graft substitute, and bone void filler in bony voids or gaps of the pelvis, ilium and extremities not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PROGENIX™ DBM Putty provides a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process.

PROGENIX™ DBM Putty contains human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. All DBM used in the preparation of Progenix DBM Putty must induce bone formation when evaluated a validated athymic nude rat assay. Additionally, every lot of PROGENIX DBM PUTTY must also induce bone formation in this assay system prior to being released for use. Findings from an animal model are not necessarily predictive of human clinical results. PROGENIX™ DBM Putty is a single use product intended for use in filling bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. Additionally, this product is not designed to impart any mechanical strength to the surgical site. PROGENIX™M DBM Putty is provided in ready-to-use malleable forms that may be molded or manipulated by the surgeon into various shapes. This product has been shown to be osteoconductive as well as osteoinductive in an athymic rat assay, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing.

This document is a 510(k) summary for a medical device (PROGENIX™ DBM Putty), which focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics. Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes, expert involvement, and comparative effectiveness is not typically found in such a submission.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for the athymic nude rat assay. Clinical human trial data, or a 'test set' in the typical sense for medical imaging or AI, is not mentioned for performance evaluation. The substantial equivalence relies on comparison to predicate devices, not de novo clinical testing of this specific device's efficacy in humans.
• Data Provenance: The athymic nude rat assay is an animal model. No country of origin is specified for the animal data. The study is prospective in the sense that each lot and all DBM used must undergo this testing.

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

• This information is not applicable. The primary performance evaluation cited is an animal model (athymic nude rat assay) and demonstration of substantial equivalence. There is no mention of a human 'test set' requiring expert adjudication for ground truth.

4. Adjudication Method for the Test Set

• Not applicable as there is no human 'test set' requiring adjudication described in this document. The animal assay results would likely be evaluated by laboratory personnel or veterinarians, but no specific adjudication method is detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is typical for diagnostic devices (e.g., AI in radiology) comparing human reader performance with and without AI assistance. This document describes a bone void filler device and its regulatory clearance based on substantial equivalence and animal model performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical product (DBM Putty), not an algorithm or AI system.

7. The Type of Ground Truth Used

• For the performance claims (osteoconductivity, osteoinductivity, resorption), the ground truth is based on observations and measurements from the athymic nude rat assay. The assay itself is a validated model designed to assess bone formation.
• For viral inactivation, the ground truth refers to the results of validated laboratory processing steps demonstrating viral inactivation.

8. The Sample Size for the Training Set

• Not applicable. There is no mention of a 'training set' in the context of an AI/machine learning model. The product's development and testing would involve R&D and quality control procedures, but not a "training set" like in AI development.

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

• Not applicable, as there is no 'training set' in the AI sense.

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