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The Converge™ is indicated for fractures of various bones, including the clavicle, pelvis, scapula, long bones (humerus, radius, ulna, femur, tibia and fibula), and small bones such as metacarpals, metatarsals and phalanges.

The BME Converge™ consists of a sterile bone plate offered in various configurations and sterile titanium screws. The Converge™ is situated on two bones, across the fracture site, with titanium locking screws extending through the plate and cortex. The Converge™ is activated at room temperature upon release from retention brackets. In its final configuration, the plate actively provides continuous compression across the fusion site.

The Converge™ system contains plates and screws in similar shapes and sizes and manufactured from the same materials according to the same steps as the reference device, Nitinol Compression Plating System™ (NCP). However, the Converge™ includes the addition of K-wire and retention brackets (as opposed to NCP's restraining instrument). The configurations of the BME Converge™ system include Straight shaped implants. Additionally, the BME Converge has been MR tested and results indicate it is MR Conditional, whereas the BME Nitinol Compression Plating System has not undergone MR testing.

The main differences between the BME Converge™ and the primary predicate, GPC Medical Bone Plates and Bone Screws include the configurations and the material. The GPC Medical Bone Plates are made out of titanium whereas the BME Converge plates are made out of nitinol. The GPC Medical Bone Plate system is either a rectangular or "T" shaped implant with four to seven holes for screws, while the Converge plate system includes a straight shape. Additionally, results of MR testing conclude that BME's Converge™ may be listed as MR Conditional. It is unclear whether GPC Medical bone Fixation Plates and Screw System have undergone MR testing.

This document describes a 510(k) premarket notification for the "Converge™" device, a bone plate and screw system. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's an analysis based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that "The results demonstrate substantial equivalence to predicate device" for a series of non-clinical tests. This implies that the acceptance criteria were met by demonstrating performance comparable or superior to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for each of the non-clinical tests. It only lists the types of tests performed. The data provenance (country of origin, retrospective/prospective) is not mentioned, but as this is a non-clinical study, it would typically be conducted at an engineering or testing lab and not involve human subjects or geographical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is Not Applicable as the submission is for a medical device (bone plate and screws) and relies on non-clinical engineering and material testing, not human-read clinical data. Therefore, there's no "ground truth" to be established by medical experts in this context.

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

This section is Not Applicable for the same reason as point 3. Adjudication methods are typically used in clinical studies involving interpretation of medical images or patient outcomes.

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

This section is Not Applicable. The document explicitly states "Clinical Evidence: Not Applicable." The submission is for a device, not an AI or imaging diagnostic tool, and therefore does not involve human readers interpreting data or AI assistance.

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

This section is Not Applicable. The device is a physical bone plate and screw system, not an algorithm.

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

For the non-clinical tests, the "ground truth" is established by engineering standards and direct measurement according to scientifically validated test methods. For example, a "static bend" test would establish its ground truth based on measurable mechanical properties and material failure points as defined by engineering principles, rather than expert consensus or pathology reports.

8. The sample size for the training set

This section is Not Applicable. There is no "training set" as this is a non-clinical device submission, not a machine learning or AI algorithm.

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

This section is Not Applicable for the same reason as point 8.

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Fracture and osteotomy fixation and joint arthrodesis of the hand and foot. Fixation of proximal tibial metaphysis osteotomy. Fixation of small fragments of bone (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.

The Elite™ Nitinol Fixation System, like primary predicate Speed Titan™ K133780, is a Nitinol implant for bone fixation and is designed to be delivered to the operating room in an "open" (legs parallel) and constrained state. The Elite™ Nitinol Fixation System was designed for surgeons who desire additional fixation points for increased rotational stability. The implant does not require any external heating. The implant is fully active at room and body temperature so that the legs compress after release from instrument (additional legs in Straight design compress in tandem). The primary differences between the Elite™ Nitinol Fixation System and the cleared Speed Titan™ K133780 are the configurations featured. The Speed Titan™ K133780 is a staple with two legs, while the Elite™ Nitinol Fixation System introduces three configurations: a Straight (with two and four legs), a Y-shape (three and four legs) and an H-shape (four legs).

The provided text is a 510(k) summary for the Elite™ Nitinol Fixation System, which is a bone staple. Medical device submissions like this primarily focus on showing substantial equivalence to a predicate device rather than comprehensive clinical studies proving specific performance metrics against acceptance criteria like those seen for AI/ML devices. Therefore, a direct answer for all your requested points, especially related to AI/ML device testing (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies), cannot be fully provided based solely on this document.

However, I can extract the information that is present and indicate where information is not available in the given text.

Here's the breakdown based on the provided document:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a specified threshold (e.g., Sensitivity > X%, Specificity > Y%). Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. The "reported device performance" is framed as meeting or exceeding the performance of the predicate in these tests.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the implied "acceptance criteria" (i.e., substantial equivalence) is a non-clinical performance testing study. The document states: "Performance testing includes: Corrosion (ASTM F2129-08), Elastic Static Bending (ASTM F564-10, A4) Pull-out Fixation Strength (ASTM F564-10, A2) and MR Compatibility (ASTM F2052, ASTM F2213, ASTM F2119, ASTM F2182) results of which demonstrate substantial equivalence or better."

Information Not Available (or Not Applicable for this type of device according to the document):

2. Sample sized used for the test set and the data provenance: Not applicable/provided in this document format. This is a physical bone staple, not an AI/ML device. The "test set" would refer to the samples used in the physical performance tests (e.g., number of staples tested for pull-out strength). This detail is not specified in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This concept is for AI/ML diagnostic devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept is for AI/ML diagnostic devices.
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 a physical bone staple, not an AI/ML diagnostic device meant to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical bone staple.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable/Provided. For non-clinical performance testing of a physical device, the "ground truth" is typically defined by the ASTM standard test methods themselves and the physical measurements obtained.
8. The sample size for the training set: Not applicable. This is a physical staple, not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established: Not applicable. This is a physical staple.

Summary of what the document focuses on:

The Elite™ Nitinol Fixation System is cleared based on substantial equivalence to existing predicate devices (Speed Titan™ K133780, Speed Triad™ K133844, OSSplate™ K993714). The rationale for substantial equivalence is based on:

• Identical Indications for Use.
• Same technological characteristics: both are made of nitinol, follow the same manufacturing procedures, and function similarly.
• Non-clinical performance testing: demonstrating that the new device performs "substantially equivalent or better" than the predicate in terms of corrosion resistance, elastic static bending, pull-out fixation strength, and MR compatibility, according to specific ASTM standards.
• No new questions of safety or effectiveness are raised by the design changes (changes in geometry, number of legs, width, and implant shapes).
• No clinical evidence was deemed necessary ("N/A" for "Substantial Equivalence Clinical Evidence").

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The Nitinol Compression Plating System™ is indicated for:

• Fractures of various bones, including the clavicle, pelvis, scapula, long bones (humerus, radius, ulha, femur, tibia and fibula), and small bones such as metacarpals, metatarsals and phalanges.

The BME Nitinol Compression Plating System™ (NCP) consists of a sterile bone plate offered in various configurations (outlined below) and sterile titanium screws. The Nitinol bone plate is situated on two bones, across the fracture site, with titanium locking screws extending through the plate and cortex. The Nitinol bone plate is activated at room temperature upon release from a constraining instrument. In its final configuration, the plate actively provides continuous compression across the fusion site.
The NCP system contains plates and screws in the same shapes and sizes as those offered in the GPC system. The configurations of the BME system include Straight, T-shaped and X-shaped implants.
The main difference between the BME Nitinol Compression Plating System™ and the primary predicate, GPC Medical Bone Fixation Plates and Screw System™ is that the NCP plate component is made of Nitinol and provides active compression while the GPC plate is made of titanium alloy (Ti-6Al-4V) and does not provide active compression. The second difference is that the BME implants are offered sterile and for single use, while GPC Medical offers their products as non-sterile. BME Nitinol Compression Plating System™ is a fully sterilized kit comprised of the bone plate, titanium screws, sizing templates and instruments. The GPC Bone Plates and Bone Screws are offered non-sterile in reusable trays.

Here's a breakdown of the acceptance criteria and study information for the Nitinol Compression Plating System™ based on the provided document:

The document describes a 510(k) premarket notification for a Class II medical device, indicating that the primary goal of the studies was to demonstrate substantial equivalence to existing predicate devices, rather than establishing standalone performance against specific clinical efficacy metrics. Therefore, the "acceptance criteria" are predominantly related to mechanical and material performance benchmarks compared to predicates, and the "study" involves bench testing to demonstrate this equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are typically defined by the performance of the predicate device or established ASTM standards. The "reported device performance" is the finding of substantial equivalence to these criteria.

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

• Sample Size for Test Set: The document mentions "The test device is the representative worst-case condition for all configurations" (Page 5). While it specifies the part number NP-35S-5 for the tested device, it does not explicitly state the number of samples tested for each benchmark. It implies that a sufficient number was tested to represent the worst-case and draw conclusions.
• Data Provenance: The data provenance is from bench testing conducted by BioMedical Enterprises, Inc. (BME). This is not clinical data, so it doesn't involve countries of origin or retrospective/prospective distinctions.

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

This section is not applicable as the described studies are bench tests, not clinical studies involving "ground truth" established by medical experts. The "ground truth" here is the adherence to engineering standards and comparison to predicate device performance.

4. Adjudication Method for the Test Set

This section is not applicable as the described studies are bench tests, not clinical studies requiring adjudication of outcomes by experts.

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

This is not applicable. The device is a physical bone plating system, not an AI-powered diagnostic or decision-support tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.

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

This is not applicable. The device is a physical bone plating system, not an algorithm.

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

The "ground truth" for these studies is:

• Engineering Standards: Specifically, ASTM F382(2008) e1, ASTM F2129-08, and ASTM F3044-14.
• Predicate Device Performance: The observed mechanical and material performance characteristics of the GPC Medical Bone Fixation Plates and Screw System™ and BME Speed Triad™ (K133844).

8. The Sample Size for the Training Set

This section is not applicable. The described studies are bench tests for a physical medical device. There is no "training set" in the context of machine learning or AI models. The design and manufacturing process would involve internal development and testing, but not a "training set" in this sense.

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

This section is not applicable for the reasons stated in point 8.

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The Speed™, Speed Shift™, Speed Titan™ and Speed ArcTM are indicated for:

• Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
• Fixation of proximal tibial metaphysis osteotomy. ●
• Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
• Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.

The Speed™ product family consists of nitinol staple implants offered in a range of sizes for bone fixation. The Speed™ product family consists of Speed™, Speed Shift™, Speed Arc™, and Speed Titan™ with the primary difference being the shape of the bridge. The bridges range from flat (Speed™ and Speed Titan™), arched (Speed Arc™), and stepped (Speed Shift™) to conform to patient and osteotomy anatomy.

All of the Speed™ implants are delivered to the operating room with the legs parallel in a constraining plastic inserter. The implant is then released from the inserter and transformed by ambient and body heat after insertion so that the legs converge. The implants do not require any external heating; they are completely transformed at typical operating room temperatures or body heat.

The difference between the Speed™ implant staples and the primary predicate implant staples are their heat activating temperature as well as bridge shape (stepped or curved). The predicate BME OSStaple™ requires an external heating unit to warm the staples and activate the compression function. The bundled implant staples are activated at typical operating room temperatures or body temperature, and provide active compression without an external heating requirement.

The provided document describes the safety and performance of "Speed™," "Speed Shift™," "Speed Titan™," and "Speed Arc™" bone staples through various bench tests, comparing them to predicate devices. It does not contain information about studies involving human readers or AI.

Here's a breakdown of the available information regarding acceptance criteria and device performance:

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

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

The document does not provide specific sample sizes for the test sets in any of the performance bench tests. The data provenance is controlled laboratory testing, not medical data from patients.

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

Not applicable. These are bench tests on physical devices, not assessments requiring expert interpretation of medical data.

4. Adjudication method for the test set

Not applicable. This is not a study involving human readers or adjudication.

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

No MRMC comparative effectiveness study was done. This document focuses on the physical performance of bone staples, not AI-assisted diagnosis or human reader performance.

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

This is not applicable, as the device is a physical bone staple, not an algorithm.

7. The type of ground truth used

The ground truth for these tests is based on the established material science and mechanical engineering standards (ASTM standards) that define the test methods and the expected performance for such medical devices. For example, "superior pull-out resistance" is a direct measurement against a standard and comparison to a predicate, not an expert opinion or pathology.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

Not applicable.

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The HammerLock® 2 is indicated for: Small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.

The HammerLock® 2 is a nitinol implant that comes in a range of sizes to provide intramedullary fixation for fingers and toes. The HammerLock® 2 device is situated in the intramedullary space and the legs extend into the cancellous bone. After reaching body temperature, the legs fully deflect outward to create an anchoring force. The changes for the HammerLock® 2 system involve design changes to the implant and new disposable instrumentation.

The provided text describes a 510(k) premarket notification for a medical device called HammerLock® 2. This document focuses on demonstrating substantial equivalence to a predicate device through material and mechanical testing, rather than clinical study data involving AI or human interpretation. Therefore, many of the requested elements for AI/imaging studies are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

For the remaining points, please note that this is a 510(k) summary for a mechanical medical device (implant) and not an AI or imaging diagnostic device. Therefore, many of the questions are not applicable to this document.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   • Sample Size: Not explicitly stated as a numerical sample size of "devices" in the same way a clinical trial would report patients. For mechanical testing, samples of the device (HammerLock® 2) and the predicate (K131640 HammerLock®) were used for each test. The ASTM standards (F382-99 for bending, F2129-08 for corrosion) would specify the minimum number of samples required for robust testing, but these numbers are not detailed in the summary.
   • Data Provenance: The data is generated from laboratory bench testing conducted in accordance with ASTM standards. The summary does not specify the country of origin of the lab or if it was prospective/retrospective; however, bench testing is inherently prospective in its execution (i.e., new tests are run for the new device).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

   • Not Applicable. This document describes mechanical testing of an orthopedic implant, not an diagnostic imaging device that requires interpretation by medical experts to establish ground truth.

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

   • Not Applicable. As above, this pertains to expert review of diagnostic results, which is not relevant to this device's testing. Mechanical testing results are objective measurements (e.g., stiffness values, corrosion rates), not subject to expert adjudication in this context.

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. No MRMC study was performed as this is a device for surgical implantation, not an AI or imaging diagnostic tool that assists human readers.

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

   • Not Applicable. This is a mechanical implant, not an algorithm.

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

   • For Mechanical Testing: The "ground truth" is defined by the objective performance parameters (stiffness, strength, corrosion resistance) as measured against established ASTM standards and compared to a legally marketed predicate device. The "ground truth" for the predicate's performance is its previously characterized mechanical properties.
   • For Substantial Equivalence: The ultimate "ground truth" being demonstrated is that the HammerLock® 2 is as safe and effective as its predicate.

8. The sample size for the training set

   • Not Applicable. There is no "training set" as this is a physical medical device undergoing mechanical validation, not a machine learning model.

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

   • Not Applicable. See point 8.

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The Speed Shift™ is indicated for: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.

The Speed Shift™ is a nitinol implant that comes in a range of sizes and models for use in extremity bone fragment fixation, osteotomy fixation, and joint arthrodesis. The implant is delivered to the operating room in an "open" martensitic state. The implant is then transformed by ambient and body heat after insertion, and contracts to a "closed" austenitic state. The implants do not require any external heating; they are completely transformed by body heat. This configuration change for the Speed Shift™ consists of a step bend of the staple back where the bend is in line with the legs of the staple rather than perpendicular to the legs as in the predicate devices. This in line bend allows Speed Shift™ to be useful for step osteotomies such as in the calcaneal slide procedure and other various mid-foot procedures reducing the prominence of the staple back after implantation as compared to the predicate devices.

The provided documentation describes the Speed Shift™ device, a nitinol implant for fracture and osteotomy fixation and joint arthrodesis of the hand and foot. The submission focuses on demonstrating substantial equivalence to predicate devices (BME OSStaple™ and OSStaple™ Chill) through comparison of technological characteristics and performance bench testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the traditional sense of specific numerical thresholds for performance. Instead, the performance studies aim to demonstrate that the Speed Shift™ is equivalent or superior to the predicate devices in key mechanical properties. The acceptance is implicitly based on achieving this equivalence or superiority.

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

• Sample Size for Test Set: The document states that "Specimens of the largest and smallest sizes of the Speed Shift™ were used and compared to a comparably sized predicate OSStaple™" for pull-out and bending strength tests. For corrosion resistance, "representative samples of the new Speed Shift™" were compared to the predicate. The exact number of samples (n-value) for each test is not specified.
• Data Provenance: The studies are described as "Performance Bench Testing." This indicates the data was generated in a laboratory setting, likely in the US, by the manufacturer (BioMedical Enterprises, Inc.). It is retrospective in the sense that the device had already been designed and manufactured, and then tested for comparison. It is not clinical data from human subjects.

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

This question is not applicable to the provided information. The "ground truth" here refers to the actual mechanical properties, which are measured using well-established ASTM standards, not subjective expert assessment. No experts were used to establish ground truth for this type of bench testing.

4. Adjudication Method for the Test Set:

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image interpretation to resolve discrepancies between human readers or between human readers and an AI. In mechanical bench testing, the results are quantitative measurements, not subject to human adjudication in the same way.

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:

This question is not applicable. The Speed Shift™ is a physical medical implant (a bone staple), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study involving human readers and AI assistance is entirely irrelevant to this device.

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

This question is not applicable. As explained above, the Speed Shift™ is a physical surgical implant, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used:

The ground truth used for these performance studies is physical measurement against established industry standards.

• For pull-out strength and bending strength: ASTM F564-10 (2010)
• For corrosion resistance: ASTM F2129-08

These standards define methods for objectively measuring the mechanical properties of bone fixation devices.

8. The Sample Size for the Training Set:

This question is not applicable. The Speed Shift™ is a manufactured device, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithms. The device undergoes design, manufacturing, and then testing.

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

This question is not applicable, as there is no "training set" for a physical medical device.

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Additional indications for the OSStaple™ are: For use in conjunction with traditional rigid fixation in cervical fusion procedures as a means to maintain the relative position of bony tissue such as allografts. This device is for use with traditional rigid fixation devices such as the Ransford Loop, Hartshill rectangles, cerclage wiring or other legally marketed cervical spine stabilization device. This device is not intended to be used alone for load bearing applications.

The OSStaple™ Staple system consists of two prong staples fabricated from Nitinol. The staple's prongs are parallel during insertion. Application of an electrical current from the OSSforce™ Controller to the staple causes the staple prongs to deflect inward and the "S" shaped back to contract until constrained. This inward deflection and contraction causes staple retention. This device is for use with traditional rigid fixation devices such as the Ransford Loop, Hartshill rectangles, cerclage wiring or other legally marketed cervical spine stabilization device.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance as requested in your prompt. The document is a 510(k) summary for the OSStaple™ Staple System, detailing its intended use, device description, and substantial equivalence to predicate devices, and the FDA's decision letter. It does not include specific performance studies or acceptance criteria for those studies.

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Original indications for the Memograph® Staple System are as defined in 510(k) K993714. Additional indications fro the OSStaple" are the fixation of maxillofacial and mandibulofacial fractures and osteotomies.

The BioWarm™ represents a modification to the Warmsystem currently in use with the OSStaple" bone staple system. The BioWarm" has an on/off switch and two user adjusted controls. A user adjusted current and user adjusted time controls are on the front of the console. The controls are set to the requirements of a specific staple size and configuration. The BioWarm" gives both visual and audible indications of current delivery and an audible signal upon automatic completion of current delivery. The BioWarm", on the electrode handle, also provides visual indication of positive contact between the electrode and staple to be heated and visual indication of actual current flow. Current is activated with a button switch on the handle of the BioWarm™ electrode and will cease if the button is released prior to the automatic cessation by the circuitry

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details that would allow me to answer your request. The document is a 510(k) summary for a medical device modification (BioWarm™) and the FDA's response letter indicating substantial equivalence to a predicate device. It discusses the device's intended use and classification but offers no data from studies or specific performance metrics.

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Indications for the OSStaple" are fixation of unloaded craniofacial bone fractures and The OSStaple™ is contraindicated for craniofacial patients with a skull cranioplasty. thickness less than the selected prong length.

The BioWarm™ represents a modification to the Warmsystem currently in use with the OSStaple" bone staple system. The BioWarm" has an on/off switch and two user adjusted controls. A user adjusted current and user adjusted time controls are on the front of the console. The controls are set to the requirements of a specific staple size and configuration. The BioWarm™ gives both visual and audible indications of current delivery and an audible signal upon automatic completion of current delivery. The BioWarm", on the electrode handle, also provides visual indication of positive contact between the electrode and staple to be heated and visual indication of actual current flow. Current is activated with a button switch on the handle of the BioWarm" electrode and will cease if the button is released prior to the automatic cessation by the circuitry

This document (K023488) focuses on the BioWarm™ Product, a device modification to an existing system, the Warmsystem, used to heat shape memory Nitinol staples (OSStaple™) for compression. The document primarily discusses the substantial equivalence of this modification to previously approved devices, rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, many of the requested elements for a performance study are not present in this submission.

Here's an analysis based on the provided text, highlighting the information that is present and noting what is absent:

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

This information is not provided in the document. The submission is a 510(k) summary for a device modification (BioWarm™), arguing for substantial equivalence rather than presenting an independent performance study with defined acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided. As this is a 510(k) for a modification (BioWarm™) deemed substantially equivalent to a predicate, a new dedicated clinical performance study with a test set is not described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided. This typically applies to studies evaluating diagnostic accuracy against an expert-established ground truth, which is not the nature of this submission.

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

This information is not provided.

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

There is no indication that an MRMC comparative effectiveness study was done. This document describes a medical device for heating staples, not an AI-assisted diagnostic tool.

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

This is not applicable as the device is a physical instrument (heater) and not an algorithm.

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

This information is not relevant in the context of this 510(k) submission for a device modification. The device heats staples; its "performance" would likely be around temperature control, heating time, and safety, not diagnostic accuracy against a ground truth.

8. The sample size for the training set

This information is not provided. This is not a machine learning or AI device that would have a training set.

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

This information is not applicable as there is no training set for this type of device.

Summary of what the document does provide regarding the BioWarm™ Product:

• Intended Use: The BioWarm™ is a modification to the Warmsystem, which is used to heat shape memory Nitinol staples (OSStaple™) to achieve compression.
• Indications for Use (for OSStaple™): Fixation of unloaded craniofacial bone fractures and cranioplasty.
• Contraindications (for OSStaple™): Craniofacial patients with a skull thickness less than the selected prong length.
• Device Description:
  • Has an on/off switch.
  • Two user-adjusted controls: current and time, set according to staple size/configuration.
  • Provides visual and audible indications of current delivery.
  • Audible signal upon automatic completion of current delivery.
  • Electrode handle provides visual indication of positive contact and actual current flow.
  • Current is activated by a button on the handle and stops if released or automatically.
• Substantial Equivalence: The BioWarm™ is presented as a modification to the Warmsystem, previously approved via 510(k)s K993714, 001219, 001353, and 001354. No fundamental technology changes are claimed.

In essence, this 510(k) submission argues that the BioWarm™ modification does not introduce new questions of safety or effectiveness when compared to the original Warmsystem, thus negating the need for new, extensive performance studies with detailed acceptance criteria typically associated with novel devices. The "proof" is the demonstration of substantial equivalence to already approved predicate devices.

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