Search Results

Inion Spinal Graft Containment System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

Inion Spinal Graft Containment System includes plates, meshes and screws which are made of degradable polylactic acid copolymers, P(L/DL)LA. Based on in vitro data: the implants retain most of their initial strength 16 weeks and gradually lose their strength thereafter. Bioresorption takes place within two to four years. The plates and screws include tantalum spheres for postoperative radiographic imaging. The implants are offered in different shapes and sizes suitable for this application. Inion Spinal Graft Containment System implants are provided sterile to the user and are noncollagenous. The shelf life of the device is 3 years.

The provided text is a 510(k) summary for the Inion Spinal Graft Containment System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a de novo study. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment (as would be found in a performance study for a novel device or a device requiring clinical evidence) is not present in this type of submission.

Here's a breakdown of what can be extracted and what is not applicable/provided:

1. Table of acceptance criteria and the reported device performance

• Not applicable/provided. This 510(k) summary is not a report of a performance study against specific acceptance criteria. Its purpose is to demonstrate substantial equivalence to existing devices. The "performance data" mentioned refers to mechanical and degradation characteristics that show it behaves similarly to predicates, not metrics against pre-defined clinical acceptance criteria.

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

• Not applicable/provided. There is no "test set" in the context of a clinical or performance study as usually understood for AI/diagnostic devices. The submission relies on a comparison of material properties and intended use with predicate devices.

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

• Not applicable/provided. Ground truth establishment is not relevant in this type of regulatory submission, as it doesn't involve subjective interpretations (e.g., image-reading by experts).

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

• Not applicable/provided. Adjudication is not relevant here.

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/provided. This device is a physical implant, not an AI or diagnostic tool. Therefore, MRMC studies are not relevant.

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

• Not applicable/provided. This device is a physical implant, not an algorithm.

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

• Not applicable/provided. Ground truth, in the context of clinical or diagnostic device performance, is not established for this type of submission. The "truth" here relates to material properties and bio-compatibility, which are assessed through engineering and biological testing, not expert consensus or pathology data in a clinical trial.

8. The sample size for the training set

• Not applicable/provided. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable/provided. Not an AI/machine learning device; thus, no training set or ground truth for it.

Summary based on the provided document:

The 510(k) summary for the Inion Spinal Graft Containment System demonstrates substantial equivalence to legally marketed predicate devices, rather than meeting specific performance acceptance criteria from a novel study. The key arguments for substantial equivalence are based on:

• Intended use: Both the Inion system and predicates are used in spinal fusion procedures to maintain the position of weak bony tissue (allografts or autografts) in conjunction with rigid fixation, and are not intended for load-bearing.
• Material composition and scientific technology: The components are made of degradable polylactic acid copolymers, P(L/DL)LA, similar to the predicate devices.
• Degradation profile: The implants retain most strength for 16 weeks and resorb within 2-4 years, which is compared to predicates.
• Mechanical properties: These are considered equivalent, although specific data points are not included in this summary.
• Radiographic markers: The inclusion of tantalum spheres for post-operative imaging is deemed equivalent to the Biomet Tantalum Beads predicate.

The FDA's decision to clear the device is based on this demonstration of substantial equivalence, with the added limitation that the device's "safety and effectiveness... when used without rigid supplemental internal fixation has not been established. This device is not designed to withstand physiologic loads when used by itself." This limitation highlights a critical aspect of how the device must be used, reinforcing that its performance is tied to its use as an adjunct rather than a standalone load-bearing implant.

Ask a specific question about this device

A. General indications: In the presence of appropriate additional immobilization or fixation, indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures, and cement restriction in total joint arthroplasty procedures.

B. Specific indications:

1. Craniofacial skeleton, cranium, mid-face, maxilla, and mandible
2. Metacarpus, proximal and middle phalangeal bones
3. Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax

Inion CPS/OTPS FreedomPlate™ implants are made of resorbable polylactic acid / trimethylenecarbonate copolymers and they are provided in sizes typical to this application. Inion CPS/OTPS FreedomPlate 1.5 implants gradually lose their strength during 18-36 weeks in vivo. Bioresorption takes place within two to four years.

Inion CPS/OTPS FreedomPlate™ implants are provided sterile to the user. The shelf life of the device is 3 years.

The provided text is a 510(k) summary for the Inion® CPS/OTPS FreedomPlate™. This document establishes substantial equivalence to predicate devices, rather than outlining a study that proves the device meets specific acceptance criteria in the way a medical AI/software device would.

Therefore, many of the requested categories are not applicable to this type of medical device submission. The device is a physical bone fixation plate, not a software algorithm that performs a diagnostic or predictive task.

Here's an attempt to address the questions based on the provided text, indicating "Not Applicable" where the information is not present or relevant to this type of device.

1. Table of acceptance criteria and the reported device performance

For substantial equivalence, acceptance criteria are typically met by demonstrating that the new device has the same intended use, similar technological characteristics, and no new questions of safety or effectiveness compared to predicate devices. The "performance" is primarily defined by its material properties and degradation profile being comparable.

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

Not applicable. This is a physical medical device (bone fixation plate) being submitted for substantial equivalence, not a software device or diagnostic test. The evaluation is based on material properties, design, and comparison to existing devices, not a clinical trial or AI test set.

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. Ground truth as typically understood for an AI/software device does not apply here. The evaluation is based on engineering principles, material science, and regulatory comparison.

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

Not applicable.

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 device is a physical bone fixation plate, not an AI software.

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

Not applicable.

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

Not applicable in the typical sense. The "ground truth" for this submission is regulatory in nature: the established safety and effectiveness of the predicate devices based on their material properties, mechanical performance, and clinical history. The new device demonstrates "substantial equivalence" to this established "truth."

8. The sample size for the training set

Not applicable. This is a physical medical device.

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

Not applicable.

Ask a specific question about this device

A. General indications: These INION OTPS™ BIODEGRADABLE FIXATION SYSTEM issuplants are generally intended for maintenance of reduction of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization.

B. Specific indications:

• Fractures and osteotomies of the malleoli
• Ankle fractures

The modified Inion OTPS™ Biodegradable Fixation system implants are identical to the currently cleared devices except for the modifications which have been detailed in section 3 of this submission.

Inion OTPS™ Biodegradable Fixation System implants are made of resorbable polylactic acid / trimethylenecarbonate copolymers. Inion O'EPS™ Biodegradable Fixation System implants gradually lose their strength during 18-36 weeks in vivo with complete strength loss and resorption within two to four years.

This document is a 510(k) summary for a modification to an existing biodegradable fixation system. It confirms the device's substantial equivalence to a predicate device and does not involve AI or a clinical study to establish acceptance criteria or device performance in the way described in your request. Therefore, I cannot provide the detailed information about acceptance criteria, study design, and AI performance from this document.

The document indicates:

• The device is a modified Inion OTPS™ Biodegradable Fixation System.
• The modification makes the implants identical to currently cleared devices except for the modifications detailed in section 3 (which is not provided in the extracted text).
• The manufacturer is asserting substantial equivalence to their predicate device (K030900) based on performance data and specifications.
• No applicable mandatory performance standards exist, but compliance to voluntary consensus standards is listed in the application (details not provided).
• The FDA has reviewed the submission and found the device substantially equivalent.

No information regarding AI, acceptance criteria, or clinical study data is present in these sections of the 510(k) summary.

Ask a specific question about this device

The INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW is intended for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissuc grafts.

Inion Hexalon™ Biodegradable ACL/PCL screws are intended to be used for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissue grafts. The new screws are identical with the other implants in the previously 510(k) cleared Inion Hexalon™ Biodegradable ACL/PCL Screw (K021280) in terms of copolymer composition, colour additive, intended use and indications for use as described in the device labelling. manufacturing method and sterilization method.

This document is a marketing approval for a medical device (510(k) clearance) rather than a study report with detailed performance data or acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving performance cannot be extracted directly from the provided text.

Specifically, the document states: "No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application." This indicates that there are no specific, quantitative acceptance criteria for device performance laid out in this clearance document. Instead, the clearance relies on demonstrating substantial equivalence to a predicate device.

Here's what can be extracted from the provided text, and what cannot:

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

• Cannot be provided. The document does not specify quantitative acceptance criteria or detailed reported device performance in terms of metrics like accuracy, sensitivity, or specificity. It focuses on demonstrating substantial equivalence.

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

• Cannot be provided. The document describes a "510(k) summary for the line extension" and states "Based on the performance data and specifications presented, it can be concluded that the intended use, material composition and scientific technology, degradation profile and substantially equivalent with the predicate device". This implies performance data was presented elsewhere in the full 510(k) application, but it is not detailed in this summary. There is no mention of a "test set" in the context of a study demonstrating performance.

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)

• Cannot be provided. Not applicable as no specific test set and ground truth establishment process is described.

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

• Cannot be provided. Not applicable as no specific test set and ground truth establishment process is described.

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

• Cannot be provided. This device is a biodegradable orthopedic screw, not an AI-powered diagnostic device. Therefore, an MRMC study or AI assistance is not relevant or applicable.

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

• Cannot be provided. This device is a physical medical implant, not an algorithm. Standalone performance as typically described for software or AI devices is not relevant.

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

• Cannot be provided. The concept of "ground truth" as used in algorithm performance evaluation does not directly apply to the approval of an orthopedic implant based on substantial equivalence. The "truth" in this context relates to the safety and effectiveness of the device compared to a legally marketed predicate.

8. The sample size for the training set

• Cannot be provided. This device is a physical implant, not an AI model requiring a training set.

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

• Cannot be provided. Not applicable to this type of device.

Summary of what the document implies about "meeting criteria":

The device meets the acceptance criteria by demonstrating substantial equivalence to an already approved predicate device (Inion Hexalon™ Biodegradable ACL/PCL Screw, K021280).

The study that proves the device meets the criteria (i.e., is substantially equivalent) is inferred from the statement: "Based on the performance data and specifications presented, it can be concluded that the intended use, material composition and scientific technology, degradation profile and substantially equivalent with the predicate device Inion Hexalon™ Biodegradable ACL/PCT. screw (K021280)."

The "performance data and specifications presented" would have been part of the full 510(k) submission, but are not detailed in this summary. They would typically involve:

• Material composition analysis: Ensuring the new screws use the same copolymer and color additive.
• Mechanical testing: Demonstrating that the new screws have comparable mechanical strength, fatigue resistance, and interference fixation properties to the predicate.
• Degradation profile studies: Showing that the degradation rate and byproducts are similar to the predicate device.
• Biocompatibility testing: As required for implants, although often covered by the predicate if materials are identical.
• Manufacturing and sterilization method consistency: Confirmation that these are identical to the predicate.

The acceptance criterion for approval in this context is the FDA's determination that the new devices do "not raise new questions of safety and effectiveness" compared to the predicate device, thereby confirming substantial equivalence under 21 CFR 807.92(a)(3). The "study" is the entirety of the data and analysis provided in the 510(k) submission to support this claim of substantial equivalence.

Ask a specific question about this device

The INION S-1™ BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM, in conjunction with traditional rigid fixation (i.e., posterior interspinous wiring), is intended for use in cervical spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts and autografts. This device is not intended for load bearing indications.

Inion S-1™ Biodegradable Anterior Cervical Fusion System, in conjunction with traditional rigid fixation (i.e., posterior interspinous wiring), is intended for use in cervical spinal fusion rigit fixances (10), posterinain the relative position of weak bony tissue such as allografts and autografts. This device is not intended for load bearing indications.

Inion S-1 ™ Biodegradable Anterior Cervical Fusion System consist of cervical spinal fusion plates and screws, and is made of resorbable polylactic acid copolymers, P(L/DL)LA 80:20.

Based on in vitro testing: Inion S-1 Biodegradable Anterior Cervical Fusion System retain most of it's strength up to 16 weeks and gradually loose it's strength thereafter, and bioresorption takes place within two to four years.

Inion S-1 ™ Biodegradable Anterior Cervical Fusion System is provided sterile to the user and is non-pyrogenic. The shelf life of the device is 3 years.

The provided document is a 510(k) summary for the Inion S-1 Biodegradable Anterior Cervical Fusion System, which is a medical device. This type of document focuses on establishing substantial equivalence to previously marketed devices rather than detailing a study with acceptance criteria for device performance as would be seen for AI/ML software.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not available in the provided text.

The document states:

• "No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application."
• "Based on in vitro testing: Inion S-1 Biodegradable Anterior Cervical Fusion System retain most of it's strength up to 16 weeks and gradually loose it's strength thereafter, and bioresorption takes place within two to four years."

This indicates that in vitro testing was performed for mechanical properties and bioresorption, but specific acceptance criteria and detailed study results from this testing are not provided in this summary. The 510(k) process for a device like this primarily relies on demonstrating substantial equivalence to predicate devices, focusing on materials, intended use, and general performance characteristics rather than specific quantitative performance criteria and clinical trial data typically associated with AI/ML software.

Ask a specific question about this device

The INION OTPS™ BIODEGRADABLE DISTAL RADIUS PLATE implants are indicated for use in open reduction and internal fixation of fractures, and radiolunocarpal fusion of the distal radius in the presence of appropriate immobilization.

Inion OTPS™ Biodegradable Distal Radius Plate implants are indicated for use in open reduction and internal fixation of fractures, osteotomies, and radiolunocarpal fusion of the distal radius in the presence of appropriate immobilization. Inion OTPS 100 Biodegradable Distal Radius Plate implants are made of is made of resorbable polylactic acid / trimethylenecarbonate copolymers and it is provided in sizes typical to this application.

Inion OTPS™ Biodegradable Distal Radius Plate implants gradually lose their strength during 18-36 weeks. Bioresorption takes place within two to four years.

Inion OTPS™ Biodegradable Distal Radius Plate implants are provided sterile to the user and is non-pyrogenic. The shelf life of the device is 3 years.

The provided document is a 510(k) summary for the Inion OTPS™ Biodegradable Distal Radius Plate. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about a study that establishes acceptance criteria for device performance or provides reported device performance data, especially in the context of AI/ML software.

The document discusses the mechanical properties and degradation profile of the Inion OTPS™ plate in relation to a predicate metallic device, but this is a comparison based on product specifications and potentially bench testing, not a clinical study involving specific acceptance criteria for performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot fulfill your request for the detailed table and study information as it is not present in the provided text.

The 510(k) process for medical devices like this typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to establish and meet specific performance acceptance criteria for a novel AI/ML application. The performance here refers to the physical properties and functional equivalence of the biodegradable plate to a metallic plate, not the diagnostic or predictive accuracy of a software.

Ask a specific question about this device

The INION CPS™ BABY 1.5 BIOABSORBABLE FIXATION SYSTEM is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face and maxilla. Specific indications: Fractures of the cranium, mid-face and maxilla; Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations); LeFort (I, II, III) osteotomies; Pediatric reconstructive procedures; Orthognathic or reconstructive procedures of the cranium, mid-face, or maxilla; Craniotomy flap fixation.

The Inion CPS™ Baby 1.5 Bioabsorbable Fixation System is indicated for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face and maxilla. Specific indications: Fractures of the cranium, mid-face and maxilla; Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations); LeFort (I, II, III) osteotomies; Pediatric reconstructive procedures; Orthognathic or reconstructive procedures of the cranium, mid-face, or maxilla; Craniotomy flap fixation. The new large X plate is identical with the other implants in the previously 510(k) cleared Inion CPSTM Baby 1.5 Bioabsorbable Fixation System (K010351) in terms of copolymer composition, intended use and indications for use as described in the device labelling, manufacturing method, sterilization method and packaging solution.

The provided text is a 510(k) summary for a medical device (Inion CPS™ Baby 1.5 Bioabsorbable Fixation System). It focuses on establishing substantial equivalence to a predicate device and discusses product specifications, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through a dataset analysis.

The document states:

• "No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application." This suggests that the primary evaluation was against existing standards and predicate devices, rather than a specific performance study with acceptance criteria.
• "Based on the performance data and specifications presented, it can be concluded that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion CPS™ Baby 1.5 Bioabsorbable Fixation system large X plate are substantially equivalent with the other Inion CPS™ Baby 1.5 Bioabsorbable Fixation system (K010351) implants as well as the predicate device Howmedica Leibinger Resorbable Fixation System (K982531)." This highlights the reliance on equivalence to predicate devices, not a standalone performance study as described in your prompt's questions.

Therefore, I cannot extract the requested information based on the input document as it does not contain details about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, number of experts, or adjudication methods for a test set.
3. Multi-reader multi-case (MRMC) comparative effectiveness study.
4. Standalone (algorithm only) performance study.
5. Type of ground truth used for a test set.
6. Sample size for the training set or how its ground truth was established.

This document is a regulatory submission focused on demonstrating substantial equivalence of a new design (large X plate) to an already cleared device and a predicate device under 510(k) regulations, rather than a clinical or performance study report with specific acceptance criteria as you've outlined.

Ask a specific question about this device

• General indications: The INION CPSTM BABY 1.5 BIOABSORBABLE FIXATION A. SYSTEM is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face and maxilla.
• B. Specific indications:
  • · Fractures of the cranium, mid-face and maxilla
  • · Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations)
  • · LeFort (1, II, III) osteotomies
  • · Pediatric reconstructive procedures
  • · Orthognathic or reconstructive procedures of the cranium, mid-face, or maxilla
  • · Craniotomy flap fixation

The Inion CPS™ Baby 1.5 Bioabsorbable Fixation System is indicated for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face and maxilla. The new 40-hole plate and 64-hole plate are identical with the other implants in the previously 510(k) cleared Inion CPS™ Baby 1.5 Bioabsorbable Fixation System (K010351) in terms of copolymer composition, intended use and indications for use as described in the device labelling, manufacturing method, sterilization method and packaging solution.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) summary for a "Special 510(k)" for a line extension of an existing bioabsorbable fixation system. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing performance data against specific acceptance criteria.

The document states: "No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application." This further indicates that no specific performance benchmarks or studies against them would be presented in this type of submission summary.

Therefore, I cannot provide the requested information in the table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies.

Ask a specific question about this device

The Inion OTPSTM Biodegradable Pin is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

The Inion OTPS™ Biodegradable Pin is indicated for maintenance of alignment and fixation The missi OFF . Breedomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

Previously 510(k) cleared Inion OTPS™ Biodegradable Pin (K031712) is manufactured by extrusion followed by grinding and cutting. With this special 510(k) we inform for additional manufacturing method by injection moulding followed by cutting. Injection moulded Inion OTPSTM Biodegradable Pins are identical in all the other aspects with the predicate pins except this manufacturing method. Material recipe with copolymer composition is identical. Only difference is that the molecular weight is slightly higher with the extrusion recipe than with the injection moulding recipe.

The provided text is a Special 510(k) Summary for a medical device called the "Inion OTPS™ Biodegradable Pin." This document describes a modification to the manufacturing method of an already cleared device, not the initial approval of a new device or its performance against acceptance criteria in a clinical study.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, specifically:

• A table of acceptance criteria and reported device performance.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Standalone (algorithm only) performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence of a modified manufacturing method (injection molding) to a previously cleared manufacturing method (extrusion). It states that the injection-molded pins are "essentially identical" and "substantially equivalent" to the predicate device, with "no new risks associated with use... as compared to the predicate device." This equivalence is "shown by the verification testing," but details of this testing (specific criteria, results, sample sizes, etc.) are not included in this summary.

The document's purpose is to inform the FDA that a manufacturing change does not alter the device's safety or effectiveness, allowing it to remain on the market. It's not a report of a new clinical or performance study establishing new acceptance criteria or proving their fulfillment.

Ask a specific question about this device

These INION OTPSTM BIODEGRADABLE FIXATION SYSTEM implants are intended for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).

Screws are generally intended for alignment and fixation of bone fractures, osteotomies, arthrodeses and bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast or brace). The Inion OTPS™ Screws are offered in several dimensions and lengths typical for this application. The Inion OTPS™ Screws are made of resorbable polylactic acid / trimethylenecarbonate [poly(L-lactide-co-D,L-lactide) and poly (L-lactide-co-trimethylenecarbonate)]. The Inion OTPS™ Screw gradually loses its strength during 18-36 weeks in vivo with complete strength loss and resorption within two to four years.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Inion OTPS™ 2.5/2.8/3.1 Biodegradable Screws:

The provided 510(k) summary (K043142) does not contain specific numerical acceptance criteria or detailed study data to prove the device meets such criteria. The document focuses on demonstrating substantial equivalence to predicate devices based on two general aspects: mechanical characteristics and biocompatibility.

Therefore, many of the requested sections below cannot be populated with specific data from the provided text.

Acceptance Criteria and Reported Device Performance

Study Information (Based on available text)

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

   • The document states "Based on the performance data presented in section I of this premarket notification..." However, Section I is not provided in the given text. Therefore, specific sample sizes for test sets or data provenance (country, retrospective/prospective) are not available here.

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

   • Not available/not mentioned. The document discusses the device's characteristics and equivalence to predicates, not a study involving expert-established ground truth on a test set.

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

   • Not applicable/not mentioned. This type of adjudication method typically applies to studies where human readers are interpreting images or data, which is not described here.

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. This is a medical device (biodegradable screws), not an AI/imaging diagnostic device. Therefore, no MRMC study or AI assistance evaluation would be relevant or conducted for this type of product.

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

   • No. This is a physical medical implant, not an algorithm or software. Standalone performance for an algorithm is not applicable.

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

   • For the demonstration of mechanical characteristics, the "ground truth" would likely be engineering specifications, material testing standards (e.g., ISO, ASTM), and comparison to the known performance of predicate devices.
   • For biocompatibility, the "ground truth" would be established through a series of standardized biocompatibility tests (e.g., cytotoxicity, sensitization, irritation, genotoxicity, implantation tests, hemocompatibility) performed according to ISO 10993 standards. These tests have defined pass/fail criteria.
   • No "expert consensus," "pathology," or "outcomes data" in the typical sense of a clinical diagnostic study is described as the ground truth. The substantial equivalence argument relies on meeting established engineering and biological safety profiles.

7. The sample size for the training set:

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

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

   • Not applicable. As above, no training set for an algorithm is involved.

Ask a specific question about this device