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Seare Biomedical Silicone Rods are intended for use in the cosmetic correction of soft tissue deformities, and are shaped at the surgeon's discretion to create an implant to aid in the reconstruction process. Some uses have been as temporary stents for the formation of new tendon sheaths, as well as other uses in surgical repair procedures demanding a highly inert and flexible rod shaped material as deemed appropriate by the using surgeon.

Seare Biomedical Silicone Rods are made from specially formulated silicone elastomers designed for implantation. The intended use of the Seare Biomenical silicone rod is for forming a finished device by the surgeon for his or her own custom use. Seare Biomedical Silicone Rods are in the cosmetic correction of soft tissue deformities, and are shaped at the surgeon's discretion to create a custom implant to aid in the reconstruction process. The Seare Biomedical Silicone Rods will be provided in 15cm or 30 cm lengtiss, 3FR - 28FR sizes, sterile and nonsterile. The durometers or hardness (Shore A) will range from 5 to 60. The appearance is dear to slightly opaque. Surface characteristics will vary from smooth to varving degrees of texturing and porosity.

The provided document is a 510(k) summary for the Seare Biomedical Silicone Rods. It states "Clinical Tests: None" for the device. Therefore, a study proving the device meets acceptance criteria was not conducted or reported in this document. The device was found substantially equivalent based on material, function, performance, and design to predicate devices already on the market.

Based on the available information, the following questions cannot be answered as no clinical studies were performed or reported:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

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Seare Biomedical Silicone Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts, and to aid in the treatment of soft tissue deformities.

Seare Biomedical Silicone Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage. The tissue expander assemblies are designed to be implanted completely under the skin, and filled externally via a syringe. All tissue expandic, incremental inflation with sterile saline for injection, until the desired amount of tissue is developed. The Seare Biomedical Silicone Tissue Expanders are constructed as a unit from silicone elastomer and consist of an expansion envelope with a smooth surface, a silicone connection tube, and a remote injection site. The expanders are available in a wide range of styles and sizes to meet diverse surgical needs.

The provided text is a 510(k) summary for a medical device called "Seare Biomedical Silicone Tissue Expanders." This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) summary like this one generally does not include information about acceptance criteria or specific studies proving device performance beyond demonstrating substantial equivalence.

The document explicitly states:

• "Clinical Tests: None"
• "Adverse S&E Information: None" (referring to safety and effectiveness, implying no specific studies were conducted for this submission regarding these aspects for the new device as separate from its predicate.)

Therefore, I cannot provide the requested information because it is not present in the provided text. The submission relies on demonstrating similarity to existing devices already on the market, rather than new performance studies with acceptance criteria.

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Seare Biomedical Nasal Implants are intended for use in augmentation and reconstruction of the nasal contour during rhinoplasty. They are intended for insertion via an intraoral or nasal sill incision.

"L" shaped or straight with a concave convex dorsal aspect which reaches from the alar cartilage to the radix. These silicone rubber implants are made from specially formulated silicone elastomers designed for implantation. Surface characteristics will vary from smooth to varying degrees of texturing and porosity. Seare Biomedical Nasal Implants are intended for use in augmentation of the nasal contour during thinoplasty. They are intended for insertion via an intraoral or nasal sill incision. The Seare Biomedical Nasal Implants will be available in many sizes and styles, all of which are very similar - differing only by a few millimeters in length and projection. The Seare Biomedical Nasal Implants will be provided sterile. Thanium Oxide and Iron Oxide pigments may be added to the silicone to prevent light translucence to these implants when ordered by the physician. These pigments are well known and widely used in cosmetic surgery implant applications, and will be lot tested for cytotoxicity.

The provided text is a 510(k) Summary for a medical device called "Seare Biomedical Nasal Implants." It does not contain information about acceptance criteria or a study proving that the device meets such criteria in the way typically associated with performance evaluations of AI/ML-based medical devices.

Instead, this document focuses on establishing substantial equivalence to a predicate device based on material, function, performance, and design, as well as identical indications for use.

Here's an analysis based on your requested information categories:

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

   • Acceptance Criteria: Not explicitly stated as performance metrics. The implicit "acceptance criteria" for a 510(k) submission of this type is substantial equivalence to a predicate device.
   • Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, precision) are reported because the device is a passive implant, not a diagnostic or AI-powered system that generates numerical results. The performance is deemed equivalent to the predicate device.

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

   • No test set was used for this type of evaluation. The submission states "Clinical Tests: None." This indicates that no human subject data was collected or analyzed for this 510(k) clearance.

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. No test set or ground truth establishment by experts was performed for this 510(k) submission.

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

   • Not applicable. No test set required 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 study was done. This device is a silicone nasal implant, not an AI-assisted diagnostic tool.

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

   • Not applicable. The device is a physical implant, not an algorithm.

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

   • Not applicable. No ground truth measurements were described or required for this type of device clearance.

8. The sample size for the training set

   • Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

   • Not applicable. No training set or ground truth establishment was involved.

In summary, the provided document is a 510(k) submission for a traditional medical device (nasal implants) based on substantial equivalence, not a performance study for an AI/ML-powered device. Therefore, most of the requested information regarding acceptance criteria, test sets, experts, and AI-related studies is not present or applicable.

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Seare Biomedical Malar Implants are intended to be used to augment or reconstruct the maxilla for cosmetic or reconstructive surgery.

Seare Biomedical Malar implants are crescent shaped convex silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. They are manufactured in pairs with a mirror image left and right. Surface characteristics will varying degrees of texturing and porosity. Seare Biomedical Malar Implants are intended to be used to augment or reconstruct the maxilla for cosmetic or reconstructive surgery. The Seare Biomedical Malar Implants will be produced using standard manufacturing molding techniques. The Searc Biomedical Malar Implants will be available in many sizes and styles, all of which are very similar - differing only by a few millimeters in length and projection. The Searc Biomedical Malar Implants will be provided sterile and nonsterile.

The provided text is a 510(k) summary for the Seare Biomedical Malar Implants. It details the device's description, indications for use, and a comparison to a predicate device. However, it explicitly states "Clinical Tests: None" and "Adverse S&E Information: None."

Therefore, based on the information provided, there are no acceptance criteria or studies detailed that prove the device meets acceptance criteria.

The 510(k) submission relies on demonstrating substantial equivalence to a legally marketed predicate device (Allied Biomedical Malar Implants) rather than presenting new clinical performance data for this specific device.

To answer your questions based only on the provided text:

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

   • Acceptance Criteria: Not specified in the document. The submission focuses on substantial equivalence to a predicate device.
   • Reported Device Performance: Not reported as no clinical tests were performed for this device in this submission.

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. No clinical tests were performed.

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. No clinical tests were performed.

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

   • Not applicable. No clinical tests were performed.

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 clinical tests were performed, and this device is not an AI-assisted diagnostic tool.

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

   • Not applicable. No clinical tests were performed, and this device is not an algorithm.

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

   • Not applicable. No clinical tests were performed involving ground truth establishment for this device. The "ground truth" for demonstrating regulatory acceptance was demonstrating substantial equivalence to the predicate device.

8. The sample size for the training set

   • Not applicable. This device is a physical implant, not a machine learning model requiring training data.

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

   • Not applicable. This device is a physical implant, not a machine learning model.

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Seare Biomedical Pectoralis Implants / silicone carving blocks are intended to be used for augmenting the chest by placing the implant in the submuscular space via a trans-axillary incision. They can also be used to reconstruct the pectoralis depression of Poland's Syndrome (Congenitally Absent Pectoralis Muscle).

Searc Biomedical Pectoralis implants are essentially large conceve conver on interestion. They are exponied Device Description: Seare Bromsonally formulated silicone elastomers designed for implantation. They are novided in two (2) orientations for cach of the specially formation and only in the milablity. Surface characterity will way ironton beeks on intended to smooth to varying degrees of lexturing and pornsity. Seare Biometical Pectoralis Implants / silicone carving block same intended to smood for augmenting the chest by placing the inplant in the submuseular space via a trans-axillary incision. The Career Ricer be used to reconstruct the pectoralis depression of Poland's Syndrone Congenitally Absent Pectoralis Muscle). The Seare Biomedical used to reconstition the pectoralis deplession of rolance congramilar - differing in length and proccion. The length of these implants varies from 11.5cm to 20cm. The height varies from 9cm to 18cm and the thickness at the apex varies 1cm to 3.5cm. The Seare Biomedical Pectoralis Implants will be provided sterile and nonsterile.

The provided text is a 510(k) Summary for Seare Biomedical Pectoralis Implants. It focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/medical device performance evaluation.

Therefore, I cannot extract the requested information. The document explicitly states "Clinical Tests: None" and "Adverse S&E Information: None," indicating that no performance studies of the type you're asking about were conducted or reported in this submission.

This 510(k) submission is for a physical medical device (silicone implants), and the review process primarily assesses material, function, performance, and design equivalence to already marketed devices, rather than AI-driven performance metrics.

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Seare Biomedical Chin Implants are utilized to augment or reconstruct the chin or anterior mandibular contour.

Seare Biomedical Chin Implants are crescent shaped concave convex silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. Surface characteristics will vary from smooth to varying degrees of texturing and porosity. The chin implant is used to augment or reconstruct the chin. It is placed over the anterior aspect of the mandible in the midline and placed under the periosteum. It is inserted via an intra-oral or submental incision according to the surgeon's preference. The Seare Biomedical Chins will be available in many sizes and styles, all of which are very similar differing only by a few millimeters in length and projection. The Seare Biomedical Chin Implants will be provided sterile and nonsterile.

This document describes a 510(k) submission for the Seare Biomedical Chin Implants, which are silicone elastomer implants used for chin augmentation or reconstruction. The submission states that no clinical tests were performed to establish substantial equivalence or device performance.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data from a study are provided.
2. Sample size used for the test set and the data provenance: No test set was used for clinical evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no clinical test set.
4. Adjudication method: Not applicable as there was no clinical test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, the document explicitly states "Clinical Tests: None". Therefore, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not a software algorithm.
7. The type of ground truth used: Not applicable as there was no clinical test.
8. The sample size for the training set: Not applicable as there was no training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

The basis for the 510(k) clearance was substantial equivalence to a predicate device (Allied Biomedical Chin Implants) in material, function, performance, and design, with identical indications for use and similar sizes and options.

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For short term application the indications for use are: nasal splinting; wound dressings; management of hypentrophic or kcloid scarring; to prevent soft tissue fibrosis or bony ankylosis following surgical concction of trismus; temporary joint spacers; and laboratory uses. For long-term application the indications for use are: nasal septal repair; orbital floor reconstruction; tympanic membrane repair: dialysis shunt anchoring: duramater repair: staged repair of omphaloccic; for lengthening extra ocular muscles in select cases of strabismus; as a protective sheathing to help facilitate neural regeneration and tendon anastomosis; as a protective sheathing to help facilitate osteogenesis; guided tissue regeneration between teeth and gingival margin, or external ear canal for example; other uses deemed appropriate by the using surgeon. Warning: Not for permanent use in Temporo Mundibular Joint applications.

Seare Biomedical Silicone Sheeting is thate from specially formulated silicone elastomers designed for implantation, LSR soft implant grade silicone elastomer Seare Biomer Sheeting is a flexible, translucent, medical grade silicone elastomer sheeting material designed for a variety of implant applications. It is available in polyester mesh reinforced and nonreinforced in a variety of thicknesses. Surface characteristics will varying degrees of texturing and porosity. The Silicone Sheeting may be readily trimmed with a knife or scissors. This trimmable feature allows the surgeon to custom fabricate, at surgery, an implantable prosthesis for a specific surgical indication.

The provided document, K983041, is a 510(k) summary for the Seare Biomedical Silicone Sheeting. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria.

Therefore, this document does not contain information on acceptance criteria for device performance or a study proving the device meets such criteria in the way a clinical trial would.

Instead, the submission focuses on establishing substantial equivalence based on material, function, performance, and design to already approved Silicone Elastomer Sheeting products.

Here's a breakdown of why the requested information is absent from this specific K983041 document:

1. A table of acceptance criteria and the reported device performance: Not applicable. This document does not establish performance criteria for a novel device, but rather asserts equivalence to existing ones.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There is no "test set" in the context of a performance study described here. The submission refers to the material, function, performance, and design of the device's characteristics compared to predicates.
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. While experts (engineers, material scientists) would have been involved in the design and manufacturing of the device, their role in establishing "ground truth" for a performance study for this type of 510(k) is not discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for a performance study 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: Not applicable. This device is a silicone sheeting material, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices based on their materials, intended use, and history of safe marketing.
8. The sample size for the training set: Not applicable. There is no training set as this is not a machine learning or AI device.
9. How the ground truth for the training set was established: Not applicable.

Key takeaway from the document:

• Clinical Tests: The document explicitly states "Clinical Tests: None." This indicates that no new clinical studies were conducted to prove the safety and effectiveness of this specific device for its 510(k) clearance.
• Substantial Equivalence: The basis for clearance is "Substantial Equivalence" to predicate devices (Dow Corning and Bentec Medical Silicone Elastomer Sheeting) in terms of material, function, performance, and design. The FDA's letter concurs with this finding.

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Seare Biomedical Silicone Blocks are intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process. The contour carving blocks lend themselves to carving chin implants and malar implants.

Searc Biomedical Silicone Blocks are made from specially formulated silicone elastomers designed for implantation, LSR soft implant grade silicone elastomer. The intended use of the Seare Biomedical silicone block is for caring a finished device by the surgeon for his or her own custom use. The square or rectangular blocks are designed for carving flater devices for use in bone onlay for correction of surface defects resulting from skeletal anomalies such as depressions secondary to trauma or cancer resection. The curved blocks are generally used for carved devices such as malar and chin implants. The Seare Biomedical Silicone Blocks will be provided sterile. The appearance is described as clear to slightly opaque. Pigments will optionally be added such as Iron Oxide, to create opacity to light and Radiographic exam.

The provided text is a 510(k) premarket notification for a medical device called "Seare Biomedical Silicone Blocks." This document primarily focuses on establishing substantial equivalence to predicate devices and does NOT contain information about specific acceptance criteria, performance studies, or AI-assisted improvements.

Therefore, many of the requested details about acceptance criteria, study methodology, and AI integration cannot be extracted from this document.

Here's what can be extracted based on the provided text:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The primary criterion is "substantial equivalence in material, function, performance, and design" to predicate devices.
• Reported Device Performance:
  • Material: Made from specially formulated silicone elastomers designed for implantation, LSR soft implant grade silicone elastomer.
  • Function: For carving a finished device by the surgeon for custom use. Designed for carving flatter devices for bone onlay or curved blocks for malar and chin implants.
  • Appearance: Clear to slightly opaque. Optionally, pigments (e.g., Iron Oxide) can be added for opacity to light and radiographic exam.
  • Sterility: Will be provided sterile.

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

• None. The document explicitly states "Clinical Tests: None." This suggests no formal test set or clinical study was conducted for this premarket notification.

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. No clinical tests or ground truth establishment based on expert review were conducted or reported.

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

• Not applicable. No test set or adjudication process was 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

• None. There is no mention of AI assistance or MRMC studies in this document.

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

• Not applicable. This device is a silicone block for implantation, not an algorithm.

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

• Not applicable. No ground truth was established as no clinical studies were performed. The basis for approval is substantial equivalence to legally marketed predicate devices, not clinical performance data from the device itself.

8. The sample size for the training set

• Not applicable. This device is a physical product, not an AI/ML algorithm requiring a training set.

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

• Not applicable. No training set was used.

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