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Padded Mitts, Padded-Plus Mitts, Rigid Palm Padded Mitts, and Finger Separator Padded Mitts are intended for patients who remove bandages and dressings, pick and scratch at wounds, grasp and pull out feeding and naso-gastric tubes.

Rigid Palm Padded Mitts have a rigid insert and are intended for patients who require an additional barrier to prevent grasping.

Finger-Separator Padded Mitts have finger channels that help to control hand contracture.

Padded Mitts are constructed from woven polyester that encloses a 3/4-inch-thick foam palm pad. A top piece of polyester mesh is sewn on the mitts to prevent heat build-up. The mitts have a 1 1/4-inch-wide polyester wrist strap that secures by means of a metal buckle. The underside of the mitt cuff has a loop through which a 44-inch-long looped strap passes. This strap is used to secure the patient's hand/arm range of motion. The outer edges are finished with a bias cut binding. All straps are made of polyester webbing.

Padded-Plus Mitts are identical to the above except that the foam used for the palm pad is two-inches-thick.

Finger Separator Padded Mitts are identical to Padded-Plus Mitts except that the polyester mesh top piece is stitched to the polyester woven fabric in a such a way as to form finger channels.

Rigid-Palm Padded Mitts are identical to the Padded Mitts except that they have a pocket on the bottom side which contains a 6mm pvc insert. This rigid insert, which removes for laundering, is used for patients who require an additional barrier to prevent against grasping at feeding and naso-gastric tubes.

The provided text is a 510(k) Summary of Safety and Effectiveness for Padded Mitts and related products. It focuses on device descriptions, indications for use, and a comparison to previously marketed substantially equivalent devices. This document does not contain information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert evaluations as requested in the prompt.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The content is about the regulatory submission of a medical device, specifically protective restraints, and not about a performance study with detailed metrics.

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The Support Vest is intended to provide restraint and upper body support for patients in wheelchairs and restraint for patients in bed.

The Support Vest is a sleeveless, upper body device that has a poncho-style front bib and vest-style rear wings. These wings have 1 1/8-inch-wide polyester webbing sewn to them and brought around to the front of the device, and passed through two slots on the front bib. This closes the vest and causes the wings to criss-cross over the patient's middle chest thus providing posture support. The webbing secures to the wheelchair kickspurs or to the bed frame. The device is edged in bias cut binding in colors that correspond to a size chart included on the package insert. The device is intended for use in the bed or wheelchair.

This 510(k) premarket notification describes a Support Vest, a physical restraint for patients in wheelchairs or beds. The submission does not include a study to prove the device meets specific acceptance criteria based on performance metrics. Instead, it relies on a comparison to an already marketed predicate device and current regulatory frameworks.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. No test set or clinical study data is presented.
• Data Provenance: Not applicable. The submission refers to a currently marketed predicate device and regulatory guidelines, rather than new clinical data.

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

• Not applicable. No ground truth establishment for a test set is discussed, as no performance study was conducted.

4. Adjudication Method for the Test Set

• Not applicable. No test set or adjudication process is mentioned.

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

• No, an MRMC comparative effectiveness study was not done. The submission focuses on comparing the proposed device to a predicate device already on the market and regulatory compliance, not on comparing human readers' performance with and without AI assistance. The device itself is a physical restraint, not an AI-powered diagnostic tool.

6. Standalone Performance Study

• No, a standalone (algorithm only without human-in-the loop performance) study was not done. The device is a physical product, not an algorithm.

7. Type of Ground Truth Used

• Not applicable. No ground truth derived from clinical data, pathology, or outcomes data is used to establish the device's performance. The basis for safety and effectiveness is primarily through substantial equivalence to a predicate device and adherence to regulatory guidance for medical device labeling and use.

8. Sample Size for the Training Set

• Not applicable. There is no training set mentioned, as this is not an AI/ML device requiring training data.

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

• Not applicable. No training set or associated ground truth establishment is described.

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The Safety Poncho is used for restraint. The Shoulder Strap Poncho provides restraint and posture support.

Safety Poncho: A poncho-style, upper body device made from either woven polyester or polyester mesh. A waist strap secures the device to the wheelchair kickspurs. The strap is 1 1/8-inch-wide polyester webbing. The edges of the garment are finished with a bias cut binding, the color of which corresponds to a size chart included on the package insert. The device is intended for wheelchair use only. Shoulder Strap Poncho: The Shoulder Strap Poncho has the same configuration as the above with the addition of a strap sewn on the shoulder area. This strap ties to the wheelchair pushhandles to provide posture support. Strap is 1 1/8-inch-wide polyester webbing.

This document describes a 510(k) submission for the "Safety Poncho" and "Shoulder Strap Poncho" by Skil-Care Corporation. It's important to note that this submission is from 1996, and modern medical device submissions, especially for AI/ML-driven devices, look vastly different and require significantly more rigorous data and study details.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria in the way one would expect for an AI/ML device. This is because the devices described are physical restraints, not AI-powered diagnostics or therapeutics.

Therefore, I cannot populate the requested table or answer most of your detailed questions, as they pertain to the evaluation of AI/ML device performance.

However, I can extract the relevant information from the document as it pertains to the nature of the submission:

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

• No acceptance criteria or reported device performance metrics are provided in the document. The submission is not for a device requiring performance evaluation against quantitative metrics like sensitivity, specificity, or F1 score.

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 evaluating a physical restraint device's performance. The submission refers to 18 years of commercial distribution of the predicate devices.

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. There is no "ground truth" establishment in the context of this submission.

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

• No. This is a physical device, not an AI or diagnostic tool, so an MRMC study is irrelevant.

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.

8. The sample size for the training set

• Not applicable.

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

• Not applicable.

Summary of the K96346 submission relevant to its context:

The core of this 510(k) submission (K96346) is a substantial equivalence claim for two physical restraint devices: the "Safety Poncho" and the "Shoulder Strap Poncho."

• Device Description:
  • Safety Poncho: A poncho-style upper body device made of woven polyester or polyester mesh with a waist strap to secure it to wheelchair kickspurs.
  • Shoulder Strap Poncho: Same as the Safety Poncho but with an additional strap on the shoulder area to tie to wheelchair pushhandles for posture support.
• Indications for Use:
  • Safety Poncho: Used for restraint.
  • Shoulder Strap Poncho: Provides restraint and posture support.
• Predicate Device: The predicate devices are the "Safety Poncho" and "Slider Poncho" already marketed by Skil-Care Corporation.
• Basis for Equivalence: The submission states that the devices used for comparative purposes (the predicate devices) are currently marketed and have been for approximately 18 years. The only difference mentioned is a change in labeling to incorporate suggestions from an FDA draft guidance document for protective restraints.
• Regulatory Context: The document highlights that such restraints are subject to HCFA (Health Care Financing Administration, now CMS) regulations and accreditation standards, which govern their appropriate use and personnel training. This implies that the safety and effectiveness are managed through existing clinical practice guidelines and regulatory oversight for restraint use, rather than through a device-specific performance study presented in this 510(k).

In essence, this is a notification for minor labeling changes to existing, legally marketed devices, rather than a submission for a new device requiring extensive performance data validation in the modern sense, especially as it relates to AI/ML.

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The Sleeper Jacket and the Houdini Safety Sleeper are intended for patients who require restraint while in bed or in the wheelchair and who easily remove standard vest-style and poncho-style restraints.

The Houdini Safety Sleeper is recommended for patients who slide or move toward the foot of the bed or who slide off the wheelchair seat.

Sleeper Jacket: A polyester upper body, jacket-style garment. It has short sleeves, a brass back zipper, 1 1/8-inch-wide- polyester webbing ties sewn across the waist. Each webbing end is terminated with a metal clip that secures to the bed frame. The webbing criss-crosses in front of the patient to allow him/her to roll from side to side while sleeping in bed. The edges of the garment are finished with bias cut binding in a color that corresponds to the garment size as described on package insert. The device has instructions that show how it can be applied in both the bed and the wheelchair.

Houdini Safety Sleeper: Has the same features as the Sleeper Jacket with the addition of a 1 1/2-inch-wide strap sewn to the back of the garment. The strap is brought between the patient's legs and secured in front of the garment. The purpose of this strap is to prevent the patient from sliding down in the bed or wheelchair.

This document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Sleeper Jacket and Houdini Safety Sleeper. It describes the device, its indications for use, and comparative information to a predicate device. It also discusses regulatory context around restraints.

The submission is from 1996 and is for a physical restraint device, not a software or AI/ML device that would typically have acceptance criteria, a test set, ground truth, or an MRMC study as described in your request.

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The Roll Belt is intended for the patient who requires a safety belt while in bed and who requires a reminder not to leave the bed without assistance.

The Roll Belt has a cotton duck pad approximately 26 1/2 inches in length. At its narrowest end, the pad is approximately 6 1/2 inches wide, and at its widest end it is approximately eight inches wide. A 1 1/2-inch-wide, 88-inch-long strap made of polyester webbing is stitched to each end of the cotton duck pad. The wide end has a slot that is approximately 6 1/2 inches long and 1 1/2 inches wide. The webbing from the narrow end is inserted through the slot on the wide end, thereby closing the belt while it encircles the patient's waist. The straps criss-cross in front of the patient permitting him/her to roll from side to side. Both straps are secured to the bed frame. The edges of the device are finished with a bias cut binding.

This document is a 510(k) summary for a medical device (Roll Belt Bed Safety Belt, a protective restraint) and does not contain information about studies related to acceptance criteria or device performance in the way a modern AI/software as a medical device (SaMD) submission would.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory aspects, device description, indications for use, and comparison with a predicate device, noting that the device itself has been marketed for many years and is exempt from certain regulations. The "comparative information" refers to regulatory comparisons, not performance studies.

Summary of missing information:

• Acceptance Criteria Table: Not present.
• Sample Size for Test Set and Data Provenance: No performance study described.
• Number of Experts and Qualifications for Ground Truth: Not applicable as no performance study is described.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not present.
• Standalone Performance Study: Not present.
• Type of Ground Truth: Not applicable.
• Sample Size for Training Set: Not applicable (no AI/machine learning device).
• How Ground Truth for Training Set was Established: Not applicable.

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The sleeved jacket is intended for patients who require support while seated in a wheelchair.

The sleeved jacket with slider control is intended for patients who require support and additional support to prevent sliding forward while seated in a wheelchair.

Both are intended for patients who have a history of removing vest-style and poncho-style restraints.

Sleeved Jacket: The sleeved jacket is a polyester upper body garment, designed to be worn over clothing, with short sleeves, a brass back zipper, and 1 & 1/8 inch polyester webbing ties sewn across the back at the shoulder area and across the front at the waist. The ties are tied to the wheelchair push handles and kick spurs, respectively, to provide patients with postural support. The edges of the garment are finished with bias cut binding in a color to correspond with the garment size as described in the insert labeling.

Sleeved Jacket with Slider Control: The Sleeved Jacket with Slider Control has the same features as the sleeved jacket with the addition of a crotch pad sewn to the bottom center front. The pad is lined with 1/4 inch polyurethane foam and has a 1 & 1/8 inch polyester webbing strap sewn on that is either placed directly under the patient or under the seat of the wheel chair and secured to the wheelchair cross brace to prevent the patient from sliding down.

This document is a 510(k) summary for a medical device (Sleeved Jacket and Sleeved Jacket with Slider Control), which describes the device, its indications for use, and comparative information to a predicate device. It does not contain information about a study that assesses the device's performance against specific acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the provided text lacks this information.

Specifically, the document:

• Does not present a table of acceptance criteria.
• Does not report device performance data.
• Does not mention any studies conducted to evaluate the device's efficacy or safety against quantitative metrics.
• Does not discuss sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

The document primarily focuses on:

• Identifying the device and its manufacturer.
• Describing the device's physical characteristics and intended use.
• Stating that the device is a predicate device already legally marketed and exempt from certain regulations.
• Mentioning a change in labeling to align with FDA draft guidance.
• Discussing regulatory context regarding the use of restraints in healthcare settings.

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The Reusable Limb Holders, Disposable Limb Holders, and Quik Cuff Limb Holders are intended for patients who require limitations placed on their hand and leg movement.

Disposable Limb Holder (Synthetic Sheepskin-Double Tie): These limb holders have a 2 1/2-inch-wide by 12-inch-long synthetic cuff to which is sewn a 19-inch-long wrist strap. The wrist strap is 1 1/8-inch-wide polyester webbing. It is terminated with a 1 1/4-inch-wide metal buckle. Approximately 2 1/2 inches back from the buckle a 102inch-long strap (doubled to form two 51-inch-long sections) is sewn to the wrist band. Just beyond the point where this strap is attached, a one-inch-wide, seven-inch-long strip of Velcro loop material is sewn to the cuff. A 2 1/2-inch-long Velcro hook tab is stitched to the same end of the cuff as the buckle. The Velcro hook and loop position the cuff on the wrist or ankle, the wrist strap and buckle secure the device. Sold in pairs.

Disposable Limb Holders (Synthetic Sheepskin-Single Tie): Identical to the above except that they have a single 51-inch-long strap sewn to the wrist strap.

Disposable Limb Holders (Foam-Double Tie): Identical in construction to the Disposable Limb Holders (Synthetic Sheepskin-Double Tie) except that the cuff is made from 1/4-inch-thick polyurethane foam back with Velcro loop material.

Disposable Limb Holders (Foam-Single Tie): Identical to above except that they have a single 51-inch-long strap sewn to the wrist strap.

Reusable Synthetic Sheepskin Limb Holders: These limb holders have a 2 1/2-inchwide, 12-inch-long synthetic sheepskin cuff to which is sewn a 19-inch-long, 1 1/8inch-wide polyester wrist strap. The wrist strap is terminated with a metal buckle. A polyester strap of 1 1/8 inches in width is stitched to the wrist band approximately 2 1/2 inches beyond the buckle. This strap is 102-inches-long and is doubled to form two 51-inch-long sections.

Quik-Cuff Limb Holders: These have a 2 1/2-inch-wide, 12-inch-long synthetic sheepskin cuff to which is attached a 19-inch-long, one-inch-wide Velcro backstrap that includes a one-inch-wide Delrin d-ring through which the Velcro is secured. A single, 51-inch long strap is stitched to the cuff and the backstrap approximately at the center of the cuff.

This document is a 510(k) summary for limb holders, which are protective restraints. It describes the devices and their intended use. However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria, as typically seen in submissions for AI/ML-enabled medical devices.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study to prove device performance. The provided text is a regulatory submission for a medical device that involves mechanical restraints, not an AI/ML-enabled device.

The information you are requesting (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is typically found in submissions for software as a medical device (SaMD) or AI/ML-enabled devices, which require extensive validation studies. This document predates the widespread use of such technologies in medical devices and focuses on the physical characteristics and regulatory status of the limb holders.

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The Double Support Poncho is used for restraint and to provide upper body posture support.

The Slider Poncho provides restraint, posture support, and slider control.

Double Support Poncho: A poncho-style, upper body device made from either woven polyester or polyester mesh. A chest strap is used to provide upper body posture support. A waist strap secures the device the device to wheelchair kickspurs. All straps are 1 1/8-inch-wide polyester webbing. The edges of the garment are finished with a bias cut binding, the color of which corresponds to a size chart included on the package insert. Device is intended for wheelchair use only.

Slider Poncho: The Slider Poncho has the same configuration as the above with the addition of a crotch pad sewn to the bottom center front. The pad is lined with 1/4 inch polyurethane foam and has a 1 and 1 1/8 inch strap sewn on that is either placed directly under the patient or under the wheelchair seat and secured to the wheelchair cross brace to prevent the patient from sliding down.

This appears to be a 510(k) summary for a medical device (Double Support Poncho and Slider Poncho) that was submitted in 1996. The document describes the device, its intended use, and its predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It focuses on the device description, indications for use, and a comparison to already marketed, legally exempt devices. It also briefly mentions regulatory aspects concerning patient restraints in nursing homes.

Therefore, I cannot provide the requested table and detailed information as the source document does not contain the necessary data about performance metrics or a study demonstrating those metrics.

To answer your request, I would need a document that describes:

1. Specific performance metrics the device is expected to meet (e.g., "device prevents user from sliding down 95% of the time").
2. A study protocol or results that detail how these metrics were tested and what the outcomes were.

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