FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

SmartScrew® II is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses of cancellous bone with the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and 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aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the 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condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone 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Device Description

SmartScrew® II is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses of cancellous bone with the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and 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AI/ML Overview

This 510(k) premarket notification for the SmartScrew II is a Special 510(k), meaning it is for a modification to a previously cleared device (the SmartScrew/NuGenFX Screw, K012001). As such, the submission focuses on demonstrating that the revised device is substantially equivalent to the predicate device, especially regarding the modification, rather than proving performance against novel acceptance criteria through extensive clinical studies like a de novo device might require.

Therefore, the provided document does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria in the way a new device would. Instead, the "study" is more accurately a comparison to the predicate device focusing on the impact of the design change.

Here's how to address your request based on the provided text, recognizing the nature of a Special 510(k):

Acceptance Criteria and Reported Device Performance

The acceptance criteria for a Special 510(k) revolve around demonstrating that the modifications do not negatively impact the safety and effectiveness of the device and that it remains substantially equivalent to the predicate. The performance is assessed by comparing the new design feature (screw head) against the predicate.

Acceptance Criteria Category	Criteria (Implicit from Special 510(k) context)	Reported Device Performance (as per submission)
Intended Use	The device maintains the same intended use as the predicate.	"the same indicated use"
Principles of Operation	The fundamental mechanism by which the device achieves its purpose remains unchanged.	"uses the same operating principle"
Basic Design of Thread	The screw thread design, crucial for fixation, is identical to the predicate.	"incorporates the same basic design of thread"
Basic Dimensions	Overall critical dimensions are maintained, except for the specific head modification.	"utilizes the same basic dimensions" (implying the functional dimensions outside the head modification are similar)
Manufacturing Process	The method of production remains consistent.	"is manufactured by machining"
Packaging & Sterilization	The safety and efficacy of these processes are unchanged.	"is packaged and sterilized using the same materials and processes"
Shelf Life	The stability and integrity of the device over time are not affected.	"has the same shelf life"
Effect on Torsion Properties	The new head design should not compromise the screw's ability to withstand torsional forces during insertion.	"The main purposes were smaller size of screw head and improvement of installation properties without scarifying torsion properties of the screw model." (This is a claim, and generally, for a special 510(k), bench testing data would be provided to support this, even if not detailed in the summary. The summary implies that testing demonstrated no negative impact on torsion properties, or perhaps an improvement in installation without loss of torsion.)
Material / Biocompatibility	Raw materials remain the same, ensuring continued biocompatibility.	"The revision of head design has no effect on... raw material"
Sterilization	Sterilization methods remain the same.	"The revision of head design has no effect on... sterilization"
Risk Assessment (Safety/Efficacy)	No new risks are introduced, and overall safety and effectiveness are maintained.	The entire submission aims to demonstrate this by showing substantial equivalence in all critical aspects. The FDA's clearance confirms this was deemed met.

Study Information (Based on Special 510(k) Context)

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. For a Special 510(k) focused on a design change like this, the "test set" would typically involve bench testing of the new screw head design and the predicate design for properties like torsional strength, insertion torque, and perhaps pull-out strength. The sample size for such bench tests would likely involve a statistically significant number of screws of each type, but this is not detailed in the summary.
- Data Provenance: Not stated. Given the manufacturer is based in Finland, the testing would likely have been conducted in Europe or by contractors. It would be prospective bench testing designed specifically to compare the new and predicate designs.
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 is not applicable in the context of this 510(k). "Ground truth" established by experts (like radiologists for imaging devices) is relevant for diagnostic devices or those requiring subjective clinical assessment. For a mechanical fixation device undergoing a minor design change evaluated by substantial equivalence, "ground truth" is typically established through objective engineering tests (bench testing) and comparison against established performance criteria of the predicate. Engineers and biomechanical specialists would design and execute these tests.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods (like 2+1 for discordant expert reads) are used in studies involving human interpretation or clinical outcomes where subjectivity might exist. For objective engineering bench tests, results are typically quantitative and directly compared, not "adjudicated."
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 mechanical orthopedic fixation device, not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic performance, particularly with AI assistance in image interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this type of device, especially for a special 510(k), is primarily objective engineering and biomechanical data (e.g., torsional strength, insertion torque, material properties) derived from bench testing comparing the modified device to the predicate device and ensuring it meets its original performance specifications and does not introduce new risks.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device, so there is no "training set" in that sense. If referring to product development testing, materials were iterated and developed, but not as a "training set" for an algorithm.
How the ground truth for the training set was established:
- Not applicable. See point 7.

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K Number

K012001

Device Name

SMARTSCREW

Manufacturer

BIONX IMPLANTS, LTD.

Date Cleared

2001-07-18

(21 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K003077,K952471,K974876,K992947

Intended Use

The SmartScrew™ is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts within the condylar aspects of the upper extremity, ankle and foot, in the presence of appropriate brace and/or immobilization. Specifically, it is intended for phalangeal fusion and fracture, metacarpal fusion and fracture, carpal fusion and fracture, wrist arthrodesis, Distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies and correction of hallux valgus.

The SmartScrew™ is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except those in the hand and foot) and proximal femoral fractures, 2) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism).

Device Description

The SmartScrew™ is composed of poly-L,D-lactide copolymer. It is supplied fully threaded with diameters 2.0mm - 4.5mm and lengths 10 - 70mm.

AI/ML Overview

This 510(k) premarket notification for the SmartScrew™ bioabsorbable fixation rod does not contain the detailed information typically found in a clinical study report or a pre-market approval (PMA) submission regarding acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving safety and effectiveness through new clinical trials as would be required for a PMA. Therefore, most of the information requested in your prompt (e.g., specific acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment) is not present.

The key points from this document relevant to your request are:

Basis of Approval: The approval is based on a determination of substantial equivalence to previously cleared predicate devices (K952471, K974876, K992947, K003077). This means the FDA found the new device to be as safe and effective as the predicate devices, not that it met specific, predefined performance acceptance criteria from a new study.
Similarities to Predicate Devices: The document explicitly states the new SmartScrew™ has the same indicated use, operating principle, basic design, dimensions, packaging, sterilization, shelf life, and trade name as the cleared SmartScrew (K003077). It further states that minor technological differences do not raise new issues of safety or effectiveness. This is the "proof" provided for a 510(k) – alignment with a device already deemed safe and effective.

Given this, I will answer the questions based on the absence of the requested information, which is characteristic of a 510(k) submission focused on substantial equivalence rather than new performance studies.

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance (as per 510(k) Summary)
(Not explicitly defined in this 510(k) summary as performance criteria for a new study)	The device is substantially equivalent to predicate devices (K952471, K974876, K992947, K003077) based on:

Same indicated use
Same operating principle
Same basic design of threads
Same basic dimensions
Same packaging and sterilization methods
Same shelf life
Same trade name |

Note: For a 510(k) submission, "acceptance criteria" are generally met by demonstrating that the device is as safe and effective as a legally marketed predicate device. This often involves comparison of technological characteristics and performance data (e.g., mechanical testing, biocompatibility) if differences exist, but not necessarily against predefined clinical performance thresholds for a novel device.

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

Not applicable. This 510(k) submission does not describe a new clinical "test set" or a new clinical study with a sample size. The approval is based on substantial equivalence to existing devices.

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

Not applicable. This 510(k) submission does not describe a new clinical study involving expert-established ground truth for a test set.

4. Adjudication method for the test set

Not applicable. This 510(k) submission does not describe a new clinical study involving a test set 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

Not applicable. This device (a bioabsorbable fixation implant) is a physical surgical implant, not an AI or imaging diagnostic device. Therefore, an MRMC study is not relevant.

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

Not applicable. This device is a physical surgical implant, not an algorithm or AI device.

7. The type of ground truth used

Not applicable. This 510(k) submission focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of design, materials, manufacturing processes, and intended use, rather than through new clinical performance data that would require "ground truth" as typically understood in diagnostic or AI studies. The "ground truth" effectively comes from the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This 510(k) submission does not describe an AI/ML device that requires a training set.

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

Not applicable. This 510(k) submission does not describe an AI/ML device or a training set.

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K Number

K010554

Device Name

MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A

Manufacturer

BIONX IMPLANTS, INC.

Date Cleared

2001-05-25

(88 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

Device Description

AI/ML Overview

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K Number

K003077

Device Name

SMARTSCREW MODEL 222006...227510

Manufacturer

BIONX IMPLANTS, LTD.

Date Cleared

2001-04-26

(205 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

Device Description

AI/ML Overview

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K Number

K992947

Device Name

CANNULATED SMARTSCREW MODELS 224540C, 224570C

Manufacturer

BIONX IMPLANTS, LTD.

Date Cleared

1999-09-21

(20 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K952471,K974876

Intended Use

Cannulated SmartScrew™ is intended for maintenance of alignment of cancellous fractures of the malleolus of the ankle in the presence of appropriate immobilization. In conjunction with adequate surgical technique and postoperative immobilization, the Cannulated SmartScrew™ provides secure fixation and will maintain sufficient physical integrity and mechanical holding properties within the bone, well beyond the five to eight weeks needed for complete biological healing and realignment of the fixation site.

The Cannulated SmartScrew™ is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (diaphyseal area), 2) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism).

Device Description

The Cannulated SmartScrew™ is composed of 100% poly-L-lactide ("PLLA") polymer. It is supplied with diameter 4.5mm and lengths 40, 45, 50, 55, 60, 65, 70mm. It is cannulated for 1.5mm K-wire.

AI/ML Overview

The provided text is a 510(k) summary for the Bionx Implants Inc. Cannulated SmartScrew™. It describes the device, its intended use, and argues for substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a standalone study with detailed statistical results. The document states: "Furthermore, the minor technological differences between the Cannulated SmartScrew™ and the predicate devices do not raise any new issues of safety or effectiveness." This implies that due to its similarity to already approved devices, extensive new performance studies were not deemed necessary for this submission.

Therefore, I cannot provide the requested information from the given text.

Summary of missing information:

Acceptance Criteria Table: Not present.
Reported Device Performance: Not present.
Sample size for test set and data provenance: Not applicable as a dedicated test study with a test set isn't described.
Number of experts used to establish ground truth & qualifications: Not applicable.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not conducted/described.
Standalone (algorithm only) performance: Not applicable.
Type of ground truth used: Not applicable.
Sample size for training set: Not applicable.
How ground truth for training set was established: Not applicable.

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510(k) Data Aggregation

Acceptance Criteria and Reported Device Performance

Study Information (Based on Special 510(k) Context)